chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Pt initially started feeling lethargic with muscle aches. The next day, a red rash developed from the site of injection. Per pt, the rash was similar to a "sunburn but it's about 7in long down the arm, and 4in wide." Pt was concerned because she didn't have a reaction at all the first time she had it. Pt states she has no issues with ROM and does not have any severe pain or swelling. The rash itself is warm and tender to touch.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: 8/20/20 - Bruising on upper arm, soreness, tenderness 8/21/20 - More Bruising - larger area - red faint line on upper arm 8/22/20- Bruise encompasses 1/4 arm - large prominent red line 5-6" lengthwise, swelling, pain, soreness, tenderness
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: hives, rash, pruitis
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Insomnia, Myalgia
Clinical narrative: Awakened 1:30 a.m. 08-06-2020.  Muscle pains all over.  Unable to sleep rest of night.  Took no med.  Felt like a bad case of flu but without fever all  that day into the night.  In bed some of the time.   Awakened 08-07-2020 feeling good but rather weakened.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: None reported, but patient received 3 doses instead of 2
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site urticaria, Pruritus
Clinical narrative: Large hive/wheal approx. 12 inches around injection site.  Itching, no respiratory symptoms
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: Hives, i..e  chronic itching all over body, i..e hands nose, lips, insect bite sores, etc.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pyrexia
Clinical narrative: Awoke 08-06-2020 feeling like a bad flu.  Didn't feel like doing anything but had to work a short time.  By evening dragging, feeling really tough and with fever.  As I, awoke the next day better but needing time to regain strength.  Doesn't want to talk about a second shot.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient reports rash on her stomach area.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; expired dose of MMRII was administered; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-AUG-2020, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) lot # R019978 established to be valid, expiration date 11-JUL-2020 (dose and route of administration were not reported) for prophylaxis. There was no temperature excursion. No additional adverse events were reported. The outcome of the event was unknown.   This is a non-valid report due to lack of the patient's identifiers.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: fainted; This spontaneous report was received from a physician via company representative, referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.  On 18-AUG-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  It was reported  that on the same date the patient was vaccinated, he fainted (syncope) in the office. It was unknown how much time had passed once the vaccine was administered and when the patient fainted. Additionally, it was reported the patient recovered from syncope on an unspecified date.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the syncope event was not reported.  Upon internal review, syncope event was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 19-MAR-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a pharmacist at a pharmacy, for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles and postherpetic neuralgia. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. The reporter considered the events of shingles and postherpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE or PQC reported; Out of date vaccine administered to patient; This spontaneous report was received from a Licensed Practical Nurse via company representative and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history  On an unknown date, the patient was vaccinated with a out of date hepatitis a vaccine, inactivated(VAQTA), 0.5 ml, intramuscularly, expiration date was April 2020 (anatomical location was not reported) as second dose in a series. No other adverse event or product quality complaint was reported.
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Headache
Clinical narrative: intense headache; This spontaneous report was received from a registered nurse and refers to an 11-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 19-AUG-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (exact dose, site of injection, frequency, lot# and expiration date were not reported for prophylaxis (indication reported as "vaccination"), meningococcal vaccine (unspecified) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (exact dose, site and route of administration, lot# and expiration date were not reported) for prophylaxis. On 21-AUG-2020, the patient woke up with an intense headache. She did not seek medical attention, she just reported the event to her healthcare provider.  The outcome of the event was unknown. The relatedness between the event and suspect vaccines was not provided.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: the patient received an improperly stored dose of Rotateq; This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 17-AUG-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number 1660981 was verified to be valid, expiration date reported and validated as 13-APR-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis.  The administered dose of vaccine experienced a temperature excursion of 9.1 Celsius degrees for 37 minutes. There was no previous temperature excursion. Digital Data Logger was involved
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Food allergy, Pyrexia
Clinical narrative: diagnosed with alpha gal / alpha gal allergy; shivering; fever; Condition aggravated; This case was reported by a pharmacist via sales rep and described the occurrence of alpha-gal allergy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included alpha-gal allergy.   On 19th August 2020, the patient received Shingrix. On 19th August 2020, less than a day after receiving Shingrix, the patient experienced alpha-gal allergy, shivering, fever and condition aggravated. On an unknown date, the outcome of the alpha-gal allergy, shivering, fever and condition aggravated were unknown.   It was unknown if the reporter considered the alpha-gal allergy, shivering, fever and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and was diagnosed with alpha gal and was inquiring if her symptoms could be exacerbated due to her allergy.  The patient had shivering as if it were aggressive and patient also had a fever. The pharmacist stated they understand those are listed adverse reactions however, the pharmacist was hoping to get more information if there might be a link in patients with an alpha gal allergy. This case linked with US2020167483 and US2020167477, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020167477:same reporter US-GLAXOSMITHKLINE-US2020167483:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Severe headache; Dizziness; Balance issues; Fatigue; Lack of appetite; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received the 2nd dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced headache, dizziness, balance disorder, fatigue and appetite absent. On an unknown date, the outcome of the headache, dizziness, balance disorder, fatigue and appetite absent were not recovered/not resolved.   It was unknown if the reporter considered the headache, dizziness, balance disorder, fatigue and appetite absent to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had severe headache, dizziness, balance issues, fatigue, lack of appetite.  The pharmacist said side effects last about 4 days. The reporter wanted to know how long side effects would lasts.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Gait inability, Headache, Injection site pain
Clinical narrative: redness; started with a rash from her neck down to her hips, both sides/she is still with this rash; Felling dizzy; Stated she cannot walk to her work.; bad pain all over her body; Headache; pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for injection site pain, headache, general body pain and dizzy.   On 11th August 2020, the patient received the 1st dose of Shingrix. In August 2020, the patient started Tylenol at an unknown dose and frequency. On 12th August 2020, 1 days after receiving Shingrix, the patient experienced dizziness, unable to walk, general body pain, headache and injection site pain. On 14th August 2020, the patient experienced erythema and rash. The action taken with Tylenol was unknown. On an unknown date, the outcome of the erythema and rash were not recovered/not resolved and the outcome of the dizziness, unable to walk, general body pain, headache and injection site pain were recovered/resolved.   It was unknown if the reporter considered the erythema, rash, dizziness, unable to walk, general body pain, headache and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and she experienced pain at the injection site, headache, bad pain all over her body, felling dizzy.  The patient could not walk to her work. The patient  was under Tylenol for this.  On Friday 14th August 2020, the patient felt a little relief of all of the symptoms, she also mentioned that they were over. But on same day afternoon started with a rash from her neck down to her hips, both sides, redness, it does not itch , it was not painful but she was still with this rash. The reporter consented to follow up.  No further details were reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: redness; started with a rash from her neck down to her hips, both sides/she is still with this rash; Felling dizzy; Stated she cannot walk to her work.; bad pain all over her body; Headache; pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for injection site pain, headache, general body pain and dizzy.   On 11th August 2020, the patient received the 1st dose of Shingrix. In August 2020, the patient started Tylenol at an unknown dose and frequency. On 12th August 2020, 1 days after receiving Shingrix, the patient experienced dizziness, unable to walk, general body pain, headache and injection site pain. On 14th August 2020, the patient experienced erythema and rash. The action taken with Tylenol was unknown. On an unknown date, the outcome of the erythema and rash were not recovered/not resolved and the outcome of the dizziness, unable to walk, general body pain, headache and injection site pain were recovered/resolved.   It was unknown if the reporter considered the erythema, rash, dizziness, unable to walk, general body pain, headache and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and she experienced pain at the injection site, headache, bad pain all over her body, felling dizzy.  The patient could not walk to her work. The patient  was under Tylenol for this.  On Friday 14th August 2020, the patient felt a little relief of all of the symptoms, she also mentioned that they were over. But on same day afternoon started with a rash from her neck down to her hips, both sides, redness, it does not itch , it was not painful but she was still with this rash. The reporter consented to follow up.  No further details were reported.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Patient had febrile seizure within 24 hours of vaccine administration that required emergency room visit
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine give Saturday PM.  Sunday evening (24 hours after the vaccine) patient noticed the injection site was starting to get raised, swollen, warm to the touch.  Over the next 36 hours the area continued to get larger and not until Tuesday afternoon patient noticed swelling was decreasing.  As of this morning-Wed 8/26/20, area is looking more normal with just some mild bruising.  Patient did not use any NSAIDS, ice, ect...just watched area.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: 6:30 am when I got up after sleeping I had hives on my left side neck, left arm, back of neck, stomach.  I took a claritin antihistamine at 7 and hives subsided for two hours and then reoccured.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Hypoacusis, Visual impairment
Clinical narrative: After completion of vaccines (11:15 am ), per client  she was "woozy".  Her skin became clammy, BP 70/48.  She stated that she had a couple moments that it was hard for her to hear and see. No respiratory distress. BP taken at 11:20 was 76/56, and then a few minutes later 92/66.  Client was given water, and remained sitting.  She sat for approximately 5 minutes, and then she said she felt better.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was in the office for his 12 month shots. MMR, VZV and Hep A were given. We were not made aware that shots were given at the health department until after shots were given
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Hypoaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Patient reported feeling some numbness and tingling sensations on her finger tips, chills and pain around the injection site at about 7:30 PM on 08/23/20. By morning she was unable to lift her arm and had to seek medical attention today. (08/25/20) As at 6:30PM today, the arm looked red and swollen all around the upper left arm. Patient was prescribed BACTRIM DS
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Paraesthesia
Clinical narrative: Patient reported feeling some numbness and tingling sensations on her finger tips, chills and pain around the injection site at about 7:30 PM on 08/23/20. By morning she was unable to lift her arm and had to seek medical attention today. (08/25/20) As at 6:30PM today, the arm looked red and swollen all around the upper left arm. Patient was prescribed BACTRIM DS
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event, Parasite blood test
Clinical narrative: Vaccine expired 8/9/2020- no reaction
Sex: M
Vaccine: MENB
Symptoms: Discomfort, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: sick; fever; fatigue; headache; general discomfort; This is a spontaneous report from a contactable nurse via Pfizer Sales Representative.  An 18-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sick, fever, fatigue, headache, general discomfort. The outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: dizzy and woozy; This spontaneous report as received from a registered nurse via a field representative referring to a 14 years old female patient. Information about pertinent medical history, drug reactions/allergies and concomitant medication was unknown.  On 19-AUG-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, lot # and expiration date were not reported) via intramuscular route for prophylaxis.  On the same date, the patient felt dizzy and woozy. No treatment was given for the event. The patient rested for a couple minutes and recovered in the office on the same date. The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reported considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Syringe issue, Underdose
Clinical narrative: also a little amount of blood returned to the syringe during the administration; It was either the needle or the medication syringe that was probably defective; It was either the needle or the medication syringe that was probably defective; some of the medication leaked out onto the patient's arm; some of the medication leaked out onto the patient's arm; some of the liquid came out of the injection and the patient didn't get the full dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a 65-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: AW7402, Expiry Date: Nov2021, NDC: 0005197102), via unspecified route of administration on 10Aug2020 10:30 at 0.5ml single dose for routine pneumonia immunization. Medical history and concomitant medications were reported as none. Historical Vaccine included Shingrix intramuscular on left arm. It was reported that when pressing down to administer vaccine, some of the liquid came out of the injection and the patient didn't get the full dose on 10Aug2020. Caller stated that he was calling about Prevnar 13, in regard to a regarding defective syringe, he asked was it possible get a replacement. He clarified that he did call this morning, he went through a safety and product quality report but because in that moment he had questions of what to do in regards to the patient, he did not get to ask his question about replacement. The call today was about an injection given this morning, in which liquid came out of syringe, he did not know what part of syringe it was coming out of but then blood was drawn into the syringe when administering. He re-vaccinated the patient and so gave 2 shots and would like a replacement for one of syringes since the patient cannot be billed for 2. He already went through a safety report with the nurse. The Syringe was in sharps container. He went through Lot, Expiry, and NDC in his initial call. Both syringes were in the sharps container, 1 had blood in it, he didn't know how it had blood in it. His only purpose to calling back is for a replacement or credit. He stated there was no issues with the second injection. Only 1 syringe had issues, it was 0.5mL syringe, it came in a box count size of 10. Caller asked to please send follow up PQC reference number via both methods of mail and email, as mail going to the pharmacy can be lost at times. The needle was screwed on tightly and proper technique was applied. However, some of the medication leaked out onto the patient's arm, and some blood was drawn up into the needle into the syringe. It was either the needle or the medication syringe that was probably defective. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Gait inability, Parkinsonism
Clinical narrative: Parkinson's-like reaction; she cannot walk.; This is a spontaneous report from a contactable consumer (patient's friend). The reporter reported two reports, this is the 2nd of 2 reports. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration in 2019 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient had a Parkinson's-like reaction to pneumococcal 13-val conj vac (dipht crm197 protein) a year ago (in 2019) where she cannot walk. The outcome of events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020327996 same reporter/drug, different patient/event
Sex: U
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: got very swollen for a few days; This is a spontaneous report from a contactable Pharmacist via  sales representative. A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. After use of the product, the patient got very swollen for a few days on an unspecified date with outcome of unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Spinal pain
Clinical narrative: It started with chills then fever, bad headache and pain at the tail of my spine.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Discomfort, Injection site pain, Limb discomfort
Clinical narrative: Patient reports that her right upper arm hurt the first day, then less so the following day. By the third day it started to hurt more again and by day 4 she was in tears with the discomfort- felt a lot of arm " heaviness"- even dropped a cup she was holding bc she could not hold it. denied any numbness or tingling. No local redness or swelling. Taking Advil with fairly good relief. Today she is having less discomfort but still reporting 3/10 pain. No recent illnesses. No known injury.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Exercise tolerance decreased, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Patient called after hour with concern of low grade fever of 99 and mild flu like symptoms for 1 day after vaccines. He also reports his arm is very sore he states  "I cannot do a push up". He reports there may be mild swelling but there is no redness. I advised ice, monitor and take tylenol or motrin for the pain. I advised to seek medical attention of symptoms worsen or there was change in skin.  Patient verbalizes understanding.
Age: 58.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: After administering  vaccinations, I realized that the >65 dose of Flu vaccine was administered.  I notified Patient, who was feeling fine and was having no adverse reactions.  I faxed/phoned  Patient's doctor.  I  filed Self report and completed this vaers.
Age: 66.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Blister, Pain of skin
Clinical narrative: Developed blisters that erupted, were non-purulent, on palms and fingers of both hands.  They were non-painful or itchy.  The new skin was tender.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Retching, Vomiting projectile
Clinical narrative: Patient reported projectile vomiting for about 1 and 1/2 hours starting at 6:30 pm the same day as vaccine (vaccine given around 1:30 pm).  Patient reports then having dry heaving and a temperature of 99.1 F. We followed up with patient the next day. She stated she was able to keep down some food and fluids and was resting. Temperature on the day after vaccine was 98.8 F
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Dyspnoea, Ear swelling, Eye swelling
Clinical narrative: Within a few hours, I experienced shortness of breath, chest tightness, difficulty breathing, dry cough, and ear/throat swelling. Around 5 pm, my eyes became swollen, along with my face. I took benadryl and tylenol  at 4pm and 8 pm to relieve some of the symptoms. I rested and used a cool, damp cloth on my eyes to help with swelling.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: Within a few hours, I experienced shortness of breath, chest tightness, difficulty breathing, dry cough, and ear/throat swelling. Around 5 pm, my eyes became swollen, along with my face. I took benadryl and tylenol  at 4pm and 8 pm to relieve some of the symptoms. I rested and used a cool, damp cloth on my eyes to help with swelling.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Paraesthesia oral, Pharyngeal swelling
Clinical narrative: Pt has prophylactic like reactions, she had swelling of throat, could not breathe, lips were tingling
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient reported that she experienced hives going up her left arm, in between her fingers, on her neck, and around her nose.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Flushing, Headache, Oropharyngeal pain, Pain in extremity, Sensation of foreign body
Clinical narrative: Pt feeling flushed, lump in throat/sore throat, arm pain. Within 15 minutes of onset of symptoms pt started with hives on bilateral arms, sore throat, headache. Vital signs were taken multiple times. Pt was given water, sat down, and given 20mL/50mg PO Benadryl. Within 15-20 minutes of administration of Benadryl patient's symptoms aside from hives and flushed cheeks completely resolved.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Pt feeling flushed, lump in throat/sore throat, arm pain. Within 15 minutes of onset of symptoms pt started with hives on bilateral arms, sore throat, headache. Vital signs were taken multiple times. Pt was given water, sat down, and given 20mL/50mg PO Benadryl. Within 15-20 minutes of administration of Benadryl patient's symptoms aside from hives and flushed cheeks completely resolved.
Age: 12.0
Sex: M
Vaccine: HPV9, MMRV, MNQ, TDAP
Symptoms: Blood glucose normal, Nausea
Clinical narrative: Patient received vaccines and reported feeling queasy prior to leaving clinic. Upon assessment patient with NAD noted. O2 sat 99% on RA. Pulse 100 BPM. Blood glucose 108.  Pt given water and crackers and reports feeling better at 2:53 pm. Pt escorted to vehicle by staff member and left in care of Father.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Administration site reaction, Rash erythematous
Clinical narrative: Patent reported red rash enlarging at site of administration; rash no itchy or painful
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: PATIENT EXPERIECING REDNESS AROUND INJECTION SITE. REDNESS WARM TO THE TOUCH. CURRENTLY NO PAIN AND NOT GROWING. PT WAS CONCERNED AND CAME INTO THE PHARMACY FOR US TO LOOK AT. PATIENTS PRIMARY MD WILL BE FOLLOWING UP WITH HER.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Joint swelling, Urticaria
Clinical narrative: patient's husband called and said patient was experiencing swollen ankles and wrists and hives across body except for face. no local injection site reaction reported. advised patient to go to the doctor, and husband said he would take patient to urgent care. i will call patient tomorrow to follow up.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia, Pain in extremity, Skeletal injury
Clinical narrative: Patient says that the needle hit her bone and was extremely painful. Her arm is still painful 2 days later and she cannot sleep because of the pain.
Age: 77.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Rash pruritic
Clinical narrative: Patient's arm swelled up and a rash began running down the left arm.  It was very itchy.  Patient received antibiotics from physician.
Age: 21.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Limb discomfort
Clinical narrative: Patient feels as though someone is repeatedly punching his arm. It started last night at around 10:00pm. Currently, the injection site is red, appears bruised, and is painful to the touch at the injection site. Patient has taken 800mg of ibuprofen and 250mg of acetaminophen, which he claims has not helped. He has also applied ice to the area, which seemed to help. He does not have shortness of breath, a fever, or trouble breathing.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash macular
Clinical narrative: Patient stated they had soreness on arm the following day near the fatty tissue area. Red blotches were form on top where shoulder was. No itchiness, just redness and sore.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Chills, Deafness, Night sweats, Ototoxicity
Clinical narrative: Tinnitus.  I am a internal medicine physician. After the first in the Shingrix series, I experienced 5 days of fever/chills/rigors, and 7 days of nocturnal diaphoresis which was longer than I had expected but overall not entirely unexpected. What I did not expect was tinnitus, which started a few days after the vaccine, and remains 5 weeks later. I was evaluated by Audiology and found to have high frequency hearing loss, at ~ 8 kHz, consistent with ototoxicity.  I am quite concerned that this is permanent.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Tinnitus.  I am a internal medicine physician. After the first in the Shingrix series, I experienced 5 days of fever/chills/rigors, and 7 days of nocturnal diaphoresis which was longer than I had expected but overall not entirely unexpected. What I did not expect was tinnitus, which started a few days after the vaccine, and remains 5 weeks later. I was evaluated by Audiology and found to have high frequency hearing loss, at ~ 8 kHz, consistent with ototoxicity.  I am quite concerned that this is permanent.
Age: 41.0
Sex: F
Vaccine: MENB, MMR, MNQ, VARZOS
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Patient requested Varicella injection.  Dr. ordered Varicella injection. Writer gave patient Shringrix injection instead of Varicella injection in error.  After error was discovered, writer discussed with Dr. and patient was contacted by writer and advised of error. Patient stated, " I understand. It's ok. I work in the medical field and I know mistakes will be made. I am ok. My arms are a little sore from the injections but other than that, I'm fine. I will come in on Monday to get my Varicella because I need it for school. Writer apologized to patient for the error. Writer also reported error to immediate supervisor.
Age: 65.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Erythema, Joint range of motion decreased, Pain, Skin warm, Swelling
Clinical narrative: increasingly red, warm to touch, swelling, pain, and decreased range of motion since vaccinated until patient came to pharmacy to have me look at it. I send her to urgent care for continued care. Patient stated feeling "completely fine" otherwise and stated no  anaphylaxis type symptoms
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, PNC13
Symptoms: Appetite disorder, Febrile convulsion, Feeling hot, Irritability, Seizure
Clinical narrative: Wellness check up 830 am. 8pm bed time felt slightly warm given tylenol   10 pm convulsions and vomiting. Called ambulance taken to E.R.. Seen Dr.  Around 1030 temp check at er was 103.5 given motrin. Doc diagnosis was febrile siezure temp check 101 discharged follow up with primary dr   Aug 26 and 1130.  No fever present still irritable sleepy and not normal appetite but is coming back. And becoming good natured again. Dr. checked nose and ears double check for signs of infections listened to tummy and lungs all is good.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, PNC13
Symptoms: Somnolence, Vomiting
Clinical narrative: Wellness check up 830 am. 8pm bed time felt slightly warm given tylenol   10 pm convulsions and vomiting. Called ambulance taken to E.R.. Seen Dr.  Around 1030 temp check at er was 103.5 given motrin. Doc diagnosis was febrile siezure temp check 101 discharged follow up with primary dr   Aug 26 and 1130.  No fever present still irritable sleepy and not normal appetite but is coming back. And becoming good natured again. Dr. checked nose and ears double check for signs of infections listened to tummy and lungs all is good.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site mass
Clinical narrative: THE PATIENT CALLED TO REPORT SHE FELT FATIQUED AND THAT THE INJECTION SITE WAS RED  WITH A LUMP.  DURING A FOLLOW-UP CALL THE FOLLOWING DAY,  THE PATIENT STATED SHE FELT BETTER, THE REDNESS WAS SUBSIDING BUT THE SITE WAS THE SIZE OF A COFFEE CUP
Age: 66.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Patient reported reaction in the left arm. Arm was more than a little swollen with hives and itching.
Age: 61.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Myalgia
Clinical narrative: Patient  reports superficial muscle pain across chest that began on 8/26/20.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Cough, Decreased appetite, Diarrhoea, Pain in extremity
Clinical narrative: Patient states a delayed reaction after a few days.  Patient experiencing (still) stomach pain described as fire coming out of her stomach, diarrhea, vomiting, fever, epiglotis is swollen at night causing a cough, pain running along the inside of her right arm and loss of appetite.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Swelling, Vomiting
Clinical narrative: Patient states a delayed reaction after a few days.  Patient experiencing (still) stomach pain described as fire coming out of her stomach, diarrhea, vomiting, fever, epiglotis is swollen at night causing a cough, pain running along the inside of her right arm and loss of appetite.
Age: 53.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dyspnoea, Heart rate increased, Nausea
Clinical narrative: Pt complained of temporary increase in heart rate, nausea, and trouble breathing. Pt stated this occurred late into the evening ~8 to 12 hours after receipt of vaccine. Pt currently reports no ADRs and does not report any need for emergency services
Age: 66.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Headache, Injection site pain, Nausea, Vomiting
Clinical narrative: The patient called the pharmacy 8/26/20 and stated she had experienced nausea and vomiting starting the evening after she received the vaccinations.  She stated she had vomited twice on 8/25/20 but was beginning to feel better on 8/26/20.  She also stated she has a slight headache and some minor injection site pain.
Age: 19.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Hyperhidrosis, Tunnel vision
Clinical narrative: Patient was walking around the store with his dad when he started to get tunnel vision. This has happened before so he knew what was coming and told his dad and his dad was able to ease him down to a sitting position. He was sweaty and light-headed but it subsided in about 10-15 minutes. He drank a bottle of water and then stood up slowly and felt better and was able to leave the store with his dad.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: About 3-5 minutes after receiving vaccine, patient complained of dizziness, nausea, and sweating.  Temperature dropped from 95.8 to 92.6.  Administered Epipen 0.3mg into the right thigh then called 911. Paramedics arrived about 7 -10 minutes later and transferred patient to check vital signs. Unknown yet whether patient decided to go to the emergency room or not yet.  Will follow up
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea, Erythema, Headache, Peripheral swelling
Clinical narrative: pt arm had extreme fever and chills, hot and bright red on most of arm, very swollen, got diarrhea and headache, - pt took tylenol and some benadryl to help- going to follow up with dr if doesnt reduce soon
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: pt arm had extreme fever and chills, hot and bright red on most of arm, very swollen, got diarrhea and headache, - pt took tylenol and some benadryl to help- going to follow up with dr if doesnt reduce soon
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Rash, Swelling face
Clinical narrative: Patient woke up with swollen lips and face and rashes throughout body. Patient contacted the doctor and was instructed to take antihistamines. Patient didn't want to take Benadryl due to drowsiness, so I recommended Zyrtec instead, but should also take a Benadryl at bedtime. Patient did not have any problems breathing. She was instructed to contact her doctor or seek medical attention if the symptoms did not improve or got worse.
Age: 21.0
Sex: F
Vaccine: FLUR4, HPV9
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Vomiting
Clinical narrative: Pt started vomiting immediately within 60 seconds of vaccines given. Pt was also sweating profusely. After 10 minutes, pt stated she felt fine and she could stand up and walk fine.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: pt had rednes at injection site, with swelling (silver dollar sized) this area was warm to touch. pt stated that they also had a headache on the following day (8/25/2020) this was gone by 8/26/2020
Age: 43.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Chills, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Both vaccines were given at around 11:55AM on 8/24/2020- that same evening the patient experienced fever, nausea, headache, chills, dizziness and muscle aches.  All symptoms resolved by the following morning 8/25/2020
Age: 43.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pyrexia
Clinical narrative: Both vaccines were given at around 11:55AM on 8/24/2020- that same evening the patient experienced fever, nausea, headache, chills, dizziness and muscle aches.  All symptoms resolved by the following morning 8/25/2020
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash about 1cm below the injection site on bicep
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site became very painful,red,swollen.
Age: 68.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Cold sweat, Eye movement disorder, Heart rate decreased, Nausea, Pallor
Clinical narrative: MMR and Fluzone HD were administered. After administration the patient asked his wife to get him some water. I offered to get him some water. I left to ask a technician to help find me find water for the patient. Upon returning with water and nearing the immunization room, the wife opened the door and asked for someone to call 911. I ran into the room. The patient was coming to. Wife stated his eyes rolled back and his head tilted back. She thought he had a seizure as he had a history of hemorrhagic stroke. He was alert and asked what happened. He remained in his chair during the event. It did not appear that patient had any loss of bladder control.  He did have some water and placed a wet paper towel on his forehead. I took his blood pressure (123/86) and pulse (60). He was clammy and wife stated he looked ashen. Paramedics arrived and took over monitoring his blood pressure and pulse. His pulse was was lower in the 30-40s. He told paramedics he was feeling nauseous. They encouraged patient to be transported to the hospital to be checked out. Wife stopped back in later the same evening and stated he was doing fine and had been released. They were told it was a vagal response.
Age: 68.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Posture abnormal, Presyncope
Clinical narrative: MMR and Fluzone HD were administered. After administration the patient asked his wife to get him some water. I offered to get him some water. I left to ask a technician to help find me find water for the patient. Upon returning with water and nearing the immunization room, the wife opened the door and asked for someone to call 911. I ran into the room. The patient was coming to. Wife stated his eyes rolled back and his head tilted back. She thought he had a seizure as he had a history of hemorrhagic stroke. He was alert and asked what happened. He remained in his chair during the event. It did not appear that patient had any loss of bladder control.  He did have some water and placed a wet paper towel on his forehead. I took his blood pressure (123/86) and pulse (60). He was clammy and wife stated he looked ashen. Paramedics arrived and took over monitoring his blood pressure and pulse. His pulse was was lower in the 30-40s. He told paramedics he was feeling nauseous. They encouraged patient to be transported to the hospital to be checked out. Wife stopped back in later the same evening and stated he was doing fine and had been released. They were told it was a vagal response.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Mass, Skin warm
Clinical narrative: Patient reported a raised, hard, hot lump approx. 2cm raised by 4cm wide.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Sore arm for over a week after vaccine administration. No swelling or redness. No changing in soreness (same constant soreness, not improving or getting worse). Pt has tried ice and already takes NSAIDS consistently for back pain. Nothing makes the soreness go away. Pt contacted MD for advice. MD said it's not unusual for tetanus shots to cause soreness that lasts over a week. Continue ice and Ibuprofen 600 mg TID.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Dyspnoea, Muscle spasms, Neck pain, Pain
Clinical narrative: The patient states that she reported to pharmacy to receive her Prevnar-13 vaccine and after she received the vaccine she was making her way out of the store when the patient reported severe low back pain localized on the spine that left her breathless.  She states the pain started to radiate up her spine and to her neck.  On physical examination the day she presented to the clinic she had point tenderness to the T12- L1  and evidence of muscle spasm to the low back.  Her VS done on 08/26/2020, the date she sought medical evaluation, were: temp: 97.5, HR 73, BP: 187/95
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Spinal pain, Tenderness
Clinical narrative: The patient states that she reported to pharmacy to receive her Prevnar-13 vaccine and after she received the vaccine she was making her way out of the store when the patient reported severe low back pain localized on the spine that left her breathless.  She states the pain started to radiate up her spine and to her neck.  On physical examination the day she presented to the clinic she had point tenderness to the T12- L1  and evidence of muscle spasm to the low back.  Her VS done on 08/26/2020, the date she sought medical evaluation, were: temp: 97.5, HR 73, BP: 187/95
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: Patient states that he started to have a chicken pox like rash that was very itchy break out on his lower back starting the day after he received the vaccine.  He stated it progressively got worse each day and on day 4 he took an oatmeal bath to help relieve the itching.  He still had a visible rash on his back 5 days post vaccine.