chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Swollen, painful injection site; Painful injection site; "knot" at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In January 2020, less than a week after receiving Shingrix, the patient experienced injection site lump. On 17th January 2020, the patient experienced injection site swelling and injection site pain. On 20th January 2020, the outcome of the injection site swelling and injection site pain were recovered/resolved. On 21st January 2020, the outcome of the injection site lump was recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain and injection site lump to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on left arm. After receiving 1st dose, on same day developed a swollen, painful injection site which resolved 2-3 days later. The patient reported that, 1-2 days after her first dose she developed at knot at the injection site that lasted for 2 days and then resolved. The reporter did not consent to follow-up. This case has been linked with US2020159648, same patient, 2nd dose of Shingrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159648:same reporter
Sex: M
Vaccine: PNC13
Symptoms: Neuropathy peripheral, Swelling
Clinical narrative: peripheral neuropathy; swelling; This is a spontaneous report from a contactable consumer (patient). This male patient of unspecified age received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on Dec2017 at single dose for immunization. Medical history and concomitant medications were unknown. In Apr2018, the patient experienced initial signs of swelling, a problem later pinpointed as peripheral neuropathy. He was supposed to "receive part A" (first dose of pneumococcal 13-val conj vac (dipht crm197 protein)) in Dec2017 and "part B" (a second dose) a year later, but he didn't because of the neuropathy issue. The patient said during trials to complete the study or during the trial process for drugs approved for the general population, there should have been results three to five months later, and information may be available about side effects after receiving the product. Patient said that on some government agencies websites he had seen peripheral neuropathy listed as a side effect for the vaccine, but not on Pfizer websites. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Injection site discolouration, Injection site rash
Clinical narrative: rash on leg that lasted for a month; injection left a brown spot on left thigh; This is a spontaneous report from a contactable physician (the prescribing physician) via a Pfizer sales representative. A female patient of unspecified age received the 2nd dose of meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration on 26Apr2019 at single dose at left thigh for physical. The patient's medical history and concomitant medications were not reported. The reported was reporting an adverse event regarding meningococcal group b rlp2086. She was made aware on 06Aug2020. The reporter did not have the product with them at the time of reporting. It was reported that a couple of years ago, a patient received the 2nd dose of meningococcal group b rlp2086 and developed a rash on her leg that lasted for a month. The injection also left a brown spot on her left thigh. The outcome of the event "rash on her leg" was unknown, for event "injection also left a brown spot on her left thigh" was recovered on an unspecified date.  No follow-up attempts are needed. Information on Lot/Batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Feeling hot, Injection site swelling, Nausea, Swelling, Tenderness
Clinical narrative: Tenderness and swelling at injection site; Tenderness and swelling at injection site; neck swelling; heat to neck; nauseous; This is a spontaneous report from a contactable nurse via Pfizer Sales Representative. A 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, lot number: CW2843, strength: 0.5 ml) via an unspecified route of administration on 11Aug2020 at single dose for immunisation. Medical history and concomitant medications were unknown. On 11Aug2020, the patient experienced tenderness and swelling at injection site, neck swelling and heat to neck a few hours later, nauseous. No other vaccine was given. Event took place after use of product. Outcome of all events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Laboratory test, No adverse event
Clinical narrative: The patient was given 3 doses of Imovax after 2 months, no AE; Initial information was received on 05-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a male patient (age unspecified) who was given three doses of RABIES (HDC) VACCINE [IMOVAX RABIES] after 2 months (Inappropriate schedule of product administration)  Medical history included animal bite (unknown date in June). Past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IMMUNOGLOBULIN HUMAN ANTI-RABIES (IMOGAM) for post exposure immunisation.  On 03-Aug-2020, the patient received a first dose of suspect RABIES (HDC) VACCINE (lot 120D1H20KFMG76, expiry: 30-Apr-2021) via unknown route in unknown administration site for post exposure immunisation.  On an unknown date, the patient received two doses (second and third) of suspect RABIES (HDC) VACCINE (lot number: not reported) via unknown route in unknown administration site for post exposure immunisation.  This was a case of an actual medication error due to drug dose administration interval too long.  The laboratory test (unspecified) was inconclusive.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: dizziness immediately after injection, lasted 2-5 minutes, patient stayed in room for an additional 15 minutes for observation and was released.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Varicella post vaccine
Clinical narrative: Chicken pox spots appeared on the left thigh (site of varicella immunization) 6 days after injection. Family was told to keep child away from daycare or anyone who is immunosuppressed.
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: She developed a "hard ball" at the injection site; He states the area is slightly warm to the touch; Slightly red; Slightly raised; When you press on the side of the injection, it feels like a bruise; This spontaneous report was received from a pharmacist concerning to an approximately 20-year-old female patient. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 22-JUL-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly on her left deltoid (strength, dose, lot # and expiration date were not provided) for prophylaxis.         On the same date (reported as "after receiving the vaccine injection"), the patient developed a "hard ball" at the injection site (injection site induration). Moreover, the pharmacist also reported that the patient stated that, since an unknown date in 2020, the area was slightly warm to the touch (injection site warmth), slightly red (injection site erythema) and slightly raised (injection site mass). Furthermore, she stated that "when she pressed on the side of the injection, it felt like a bruise (contusion). The patient did not seek for medical attention. At the time of this report, the hard ball was still present; however, no abscess was noted in the area. The outcome of the events of injection site induration, contusion, injection site mass, injection site erythema and injection site warmth was reported as recovering.   The causality assessment between the reported adverse events and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional adverse events; An adult patient was administered a pediatric dose of VAQTA; This spontaneous report was received from a Licensed Practical Nurse referring to an approximately 56-year-old patient. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 27-JUL-2020, the patient was vaccinated with a pediatric dose of hepatitis A vaccine, inactivated (VAQTA) (dosage regimen, route of administration, lot # and expiration date were not provided) for prophylaxis. No adverse events were experienced by the patient.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Syncope, Urticaria
Clinical narrative: Fainting and welts on arm post dose; Fainting and welts on arm post dose; This is a spontaneous report from a contactable nurse via Pfizer Sales Representative. A 20-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced fainting and welts on arm post dose on an unspecified date. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 6.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Adacel was given to a 6 year old instead of Daptacel, No AE; Adacel vaccine was given to a 6 year old patient, No AE; Initial information received on 04-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a six-year-old female patient who was vaccinated with a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6706AA and expiry date: 03-Jul-2022) via unknown route in the left thigh for prophylactic vaccination on 29-Jul-2020 instead a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.   At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given a dose of Menactra that had expired, no AE; Initial information received on 07-Aug-2020 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 11-year-old female patient who was inadvertently vaccinated with an expired 0.5 mL first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]  (lot U6219BA and expiry date: 16-Jun-2020) via an unknown route at an unknown administration site for prophylactic vaccination on 24-Jul-2020.  The patient's medical history, past medical treatment, past vaccination and family history medication were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation.  It was an actual medication error case due to expired vaccine used.  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site induration, Pyrexia, Skin warm
Clinical narrative: Localized induration, approximately 3.5 inches by 3.5 inches across the LEFT deltoid. No reaction on the right. Slight erythema and slight warmth. Mother of child also reports a tactile fever, which was brought to a normal range by Tylenol. MOC presented two days after vaccine date to clinic to report reaction. Consulted with Nurse Practitioner onsite. Recommended Ice and Ibuprofen. Reviewed red flag indications for which she should call the clinic.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Coating in mouth, Dysgeusia, Heart rate increased, Throat irritation
Clinical narrative: METALLIC TASTE IN MOUTH, FILM IN MOUTH, SCRATCHY THROAT, AND INCREASED HEART RATE
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching were reported.  Benadryl and calamine were used to alleviate symptomes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: SIGNIFICANT INDURATION AND ERYTHEMA ON THE LEFT ARM
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lethargy, Myalgia, Neck pain
Clinical narrative: Patient reports pain in head and neck, muscle aches throughout body, severe lethargy
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: For the first few days after felt fine and then a few days after developed a charley horse-like sensation in his upper arm.  There is no swelling or redness or warmth.  This has persisted.  With occasional numbness and tingling in his forearm as well.  Has never had a reaction like this to vaccines.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Patient received the wrong TDap for his age. He should have received the Vaccine for ages 11yrs and up.
Age: 2.0
Sex: F
Vaccine: RAB
Symptoms: Injection site rash
Clinical narrative: About an hour after vaccination, Mother contacted the clinic and sent a photo of a rash on the BACK of leg - not at the injection site.  She was examined by Drs.   Accurate injection site (left vastus lateralis) confirmed .  A couple of hours later the rash resembled a tree, as though it were along a nerve patch, again, on the back of her left upper thigh.   Received oral benadryl administered by the doctors.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Pruritus, Skin warm
Clinical narrative: Patient presented with complaints that 3 days after she received the vaccine her arm became red, warm to the touch and itchy and has not improved. At todays visit her left arm exhibited redness for about 2/3 of the area from the shoulder to the elbow.    Patient was prescribed : cephalexin 500mg tablet take 1 tablet by mouth every 12 hours for 10 days Benadryl 25 mg capsules take 2 capsules by mouth every 4-6 hours as needed for 3 days
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Malaise, Myalgia, Pyrexia
Clinical narrative: weakness, high fever, chills, muscle pain, malaise increased to md/severe after 2 hours. Improvement in pain and fever after 24 hours. Still weak and sleepy.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: weakness, high fever, chills, muscle pain, malaise increased to md/severe after 2 hours. Improvement in pain and fever after 24 hours. Still weak and sleepy.
Age: 94.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient developed swollen arm with pain and hot to touch. Diagnosed with cellulitis ~24 hours after injections administered. Patient was evaluated and treated with cephalexin.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Itching, swelling with blanchable erythema, and localized warmer skin near site of injection with a downward spread w/o signs of acute allergic reaction.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Biopsy skin, Rash, Rash pruritic
Clinical narrative: 3 days after the shot I got a rash on my chest and neck. I sent a message to the Doctor and she referred me to dermatology. The rash has spread all over my body. They have done multiple biopsies. They said it was something I came in contact with. We have nothing in our house and didn?t come into contact with anything new. The only new thing I came into contact with was the shot. I am still dealing with this horrible itchy rash.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Large area of the deltoid, red, warm to the touch, raised na and very swollen.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Burning sensation, Computerised tomogram normal, Full blood count
Clinical narrative: Apparently, at baseball practice, just coming off routine drill he experienced an episode where he felt his vision when dark and immediately was followed by a popping sensation at the top of his head. At the time he was stationary waiting in line, It was a mild day (temp low 80's, no humidity). Sx resolved and he returned to practice, later after practice while sitting, eating lunch with his mom, the "exact same" episode occurred but this episode was more progressive, HA worsened, vision changed (saw red), he began to experience numbness symmetrically down both arms (elbows down) and tingling. No reported change in his visible appearance per mom. Arms became extremely sensitive to even light touch, felt like "fire" R arm improved first but L arm felt as if it was burning. Sx completely resolved while in ED. He was evaluated in Hospital ED CT/CTA (stroke protocol) was normal -transfered to Pedi ED, MRI brain w and w/o contrast was normal, Labs normal except CPK 880
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Head discomfort, Hyperaesthesia, Hypoaesthesia, Magnetic resonance imaging brain normal, Metabolic function test normal
Clinical narrative: Apparently, at baseball practice, just coming off routine drill he experienced an episode where he felt his vision when dark and immediately was followed by a popping sensation at the top of his head. At the time he was stationary waiting in line, It was a mild day (temp low 80's, no humidity). Sx resolved and he returned to practice, later after practice while sitting, eating lunch with his mom, the "exact same" episode occurred but this episode was more progressive, HA worsened, vision changed (saw red), he began to experience numbness symmetrically down both arms (elbows down) and tingling. No reported change in his visible appearance per mom. Arms became extremely sensitive to even light touch, felt like "fire" R arm improved first but L arm felt as if it was burning. Sx completely resolved while in ED. He was evaluated in Hospital ED CT/CTA (stroke protocol) was normal -transfered to Pedi ED, MRI brain w and w/o contrast was normal, Labs normal except CPK 880
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Paraesthesia, Visual impairment
Clinical narrative: Apparently, at baseball practice, just coming off routine drill he experienced an episode where he felt his vision when dark and immediately was followed by a popping sensation at the top of his head. At the time he was stationary waiting in line, It was a mild day (temp low 80's, no humidity). Sx resolved and he returned to practice, later after practice while sitting, eating lunch with his mom, the "exact same" episode occurred but this episode was more progressive, HA worsened, vision changed (saw red), he began to experience numbness symmetrically down both arms (elbows down) and tingling. No reported change in his visible appearance per mom. Arms became extremely sensitive to even light touch, felt like "fire" R arm improved first but L arm felt as if it was burning. Sx completely resolved while in ED. He was evaluated in Hospital ED CT/CTA (stroke protocol) was normal -transfered to Pedi ED, MRI brain w and w/o contrast was normal, Labs normal except CPK 880
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Induration, Paraesthesia, Swelling
Clinical narrative: Redness Swelling (egg-shaped, hard raised area) of arm, tingling, warmth
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness
Clinical narrative: Patient's parent states that 2 weeks after receiving vaccine, the child experienced muscle weakness. Parent read an article online and presented today, 08/14/2020 to report reaction.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Patient reports feeling fatigued 6-8 hours post injection, lasting 3 days. He reported this to the pharmacy 7 days later. He is fine now.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, induration and swelling of right middle upper arm-onset 48 hours after injection ; reported chills and body aches; no fever
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain, redness, induration and swelling of right middle upper arm-onset 48 hours after injection ; reported chills and body aches; no fever
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Fall, Syncope
Clinical narrative: Pt fainted when checking out from the office after vaccination, she started to fall towards her mother, who gently lowered her to the floor. Pt awakened within 5-10 seconds and was alert within a few seconds. She remained supine for another 1-2 minutes and drank some water. Pt stated she had not eaten anything since awakening that day. She subsequently was able to get up to sitting for a few minutes, then standing and left the building ambulating on her own without any further symptoms.
Age: 42.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: I see lot of chickenpox like  itchy rashes in my body . I counted around 60+ rashes .   There is no fever  . As of today , the rashed become cloudy .  There is no other symptoms . I am not particularly sure if it is because of this vaccine . I had taken mmr vaccine also on the same day along with varicella vaccine
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Fatigue, Insomnia, Nausea, Pain
Clinical narrative: 5-6 hours after injection I woke up due to shortness of breath, mild nausea, and body ache. Shortness of breath was most concerning. Was awake for several hours trying to find a position that helped my breathing. Used Albuterol inhaler, which is extremely rare for me, and that seemed to help. In the AM I was tired from lack of sleep but symptoms had subsided. I don't think there is a longer term issue, but I have never had an adverse vaccine reaction before and wanted to flag it. This is the first time I have received the High Dose Quad version of flu vaccine, which I try to get yearly.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain, Pyrexia
Clinical narrative: All symptoms were 48 hours, beginning 2 hrs. after shot: Low grade fever 99.6  upper right arm incapacitated, could not move upper arm aches throughout the body
Age: 73.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: The patient complained about the muscle ache in her leg and her back. She did not mention about any pains in her arms and the pain started on August 6 (2 days after getting the injection). As of today 8/14/2020, the pain is still ongoing and I advised her to consult with her PCP.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Haemorrhage, Injection site urticaria, Venous injury
Clinical narrative: After injecting, the patient immediately began to bleed and upon inspection, a large welt (~1.5" diameter, raised ~0.5") had developed at the injection site. The patient stopped bleeding quickly, the area was cleaned with alcohol wipe, and a Band-Aid was applied. Patient did not feel any pain nor was he concerned. Patient was counseled that the needle most likely hit a vein and to reach out to his PCP if he had worsening of symptoms. Patient remained seated for 15 minutes following the injection, reported he felt well, and left.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Hypersensitivity
Clinical narrative: patient had some discomfort .  she went to an urgent care and it appeared to be an allergic reaction. she was advised by the healthcare provider at the urgent care not to take the second dose in the series and was given a steroid
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Dark circles under eyes, Diarrhoea, Erythema, Lid sulcus deepened
Clinical narrative: very high fevers, hives, erratic behavior, black sunken eyes, red periorbital area, red face, then diarrhea x 1 week and 2 days
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Urticaria
Clinical narrative: very high fevers, hives, erratic behavior, black sunken eyes, red periorbital area, red face, then diarrhea x 1 week and 2 days
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness
Clinical narrative: The parent of patient came into the pharmacy after reading an article online regarding vaccines and side effects. She stated her son experienced muscle weakness approximately 2 weeks after receiving the vaccine. Parent stated she was concerned that it was caused by the vaccine and requested we report the event.
Sex: U
Vaccine: VARZOS
Symptoms: Lethargy, Pain in extremity, Sleep disorder
Clinical narrative: Sore arm within minutes  Severe pain and not able to sleep or awake in middle of night. No appetite & lethargic for 3 days. Sore arm after 2 months. Pain reduced.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Rash erythematous, Rash macular
Clinical narrative: Developed a red raised area at MMR injection site 7 days after vaccine was given. Area became indurated 2 days later. 13 days after vaccine was given patient developed a red spotted macular rash on the face and shoulder which rapidly responded to Benadryl.
Age: 1.5
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Injection site swelling, Nasal congestion, Pyrexia, Rash morbilliform
Clinical narrative: Site reaction within 5 minutes of vaccine, swelling taken down with Benadryl. One week (7 days) later she got a high fever that reached 104.3 f, red cheeks, and nasal congestion. The fever lasted 3 days and then a measles-like rash appeared on her back and chest and spread to her face. Currently has rash, day 11 since MMR vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Injected limb mobility decreased, Injection site pain, Nausea
Clinical narrative: Painful at injection site, difficulty raising arm, fever during the night of the injection, body aches, nausea, loss of appetite, lightheadedness.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Painful at injection site, difficulty raising arm, fever during the night of the injection, body aches, nausea, loss of appetite, lightheadedness.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: For approximately 24 hours immediately following the injection, I had no significant side effects, other than some muscle soreness in the left arm. The following day, after a vigorous morning 3.5 mile walk in somewhat hot & humid conditions, 8/12/2020  (11:00 AM) I had fatigue and a headache and low grade fever. The headache and fever subsided somewhat with Ibuprofen.  Fatigue continued throughout the day, even with a 60 minute afternoon nap, where I needed a blanket for warmth. I began with shivering and chills approximately 9:00  PM. At that time, I went to bed with multiple blankets on and had some sweating overnight. I continued with a headache through Friday, 8/14/2020.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Pyrexia
Clinical narrative: For approximately 24 hours immediately following the injection, I had no significant side effects, other than some muscle soreness in the left arm. The following day, after a vigorous morning 3.5 mile walk in somewhat hot & humid conditions, 8/12/2020  (11:00 AM) I had fatigue and a headache and low grade fever. The headache and fever subsided somewhat with Ibuprofen.  Fatigue continued throughout the day, even with a 60 minute afternoon nap, where I needed a blanket for warmth. I began with shivering and chills approximately 9:00  PM. At that time, I went to bed with multiple blankets on and had some sweating overnight. I continued with a headache through Friday, 8/14/2020.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse events occured, patient asked for Prevnar 13, Fluzone HD was given instead.  Patient came to pharmacy on 8/14/20 to find out which pneumonia shot she was given at that time it was discovered that RPH gave a dose of Fluzone HD instead.  No adverse events were noted by patient to the dose of Flu shot.  It was recommended to get the Prevnar 13 shot to patient on 8/14/20, patient declined immunization.
Age: 70.0
Sex: F
Vaccine: FLUA4, PNC13, VARZOS
Symptoms: Dizziness, Fall, General physical condition abnormal, Heart rate decreased, Loss of consciousness
Clinical narrative: After 3 vaccinations. Pt looks delirious and then fainted. I caught pt from falling of the chair. She was out for at least 10-15 seconds. I called for help and the person called for 911.  I (pharmacist) waited till ambulance to come. She was a little out of it. She takes Blood pressure medication. She told me she was afraid of needles after waking up, She was dizziness/nauseous as well. She doesn't give blood anymore before she faints. Ambulance came and pulse was low 45. They took her to the hospital.
Age: 70.0
Sex: F
Vaccine: FLUA4, PNC13, VARZOS
Symptoms: Nausea, Syncope
Clinical narrative: After 3 vaccinations. Pt looks delirious and then fainted. I caught pt from falling of the chair. She was out for at least 10-15 seconds. I called for help and the person called for 911.  I (pharmacist) waited till ambulance to come. She was a little out of it. She takes Blood pressure medication. She told me she was afraid of needles after waking up, She was dizziness/nauseous as well. She doesn't give blood anymore before she faints. Ambulance came and pulse was low 45. They took her to the hospital.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Fever of 101.2, aches and pains throughout whole body, headache.  I feel like I have the flu, got hit by a truck
Age: 93.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Limb mass, Peripheral swelling
Clinical narrative: Patient's left arm instantly swelled up at time of injection. A small lump could be visualized but patient stated she "felt fine" and she denied being in pain.  Pharmacist requested for her to stay in the waiting area for at least 20 minutes after immunization.  After 20 minutes (11:37am), pharmacist examined injection site and it appeared to look the same as 20 minutes prior.  Patient's daughter called pharmacy around 3pm stating the lump had resolved.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Irritability, Vaccination site mass, Vaccination site pain
Clinical narrative: Redness and soreness w/ lump at vaccination side starting day 1-3, lump remained at vaccine site with fussiness and irritability in infant on 8/13/2020 prompting a re-evaluation in clinic
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Myalgia, Nausea
Clinical narrative: Quite sore arm, aching muscles/joints, slight nausea, general fatigue, slight dizziness
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Quite sore arm, aching muscles/joints, slight nausea, general fatigue, slight dizziness
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash on left side of face and neck started about 2 days after injection.  Also developed redness and swelling around the injection site at same time of rash development.  Rash moved to other side of face after about 1 day.  Saw a doctor today, 8/15/20, who prescribed triamcinolone cream and OTC Zyrtec.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Vasovagal syncope.  Patient passed out as she was leaving the building, approximately 5 minutes after vaccination.  Patient was with her relative who says she dropped her phone and just passed out on the sidewalk outside, for approximately 10 seconds, then regained consciousness on her own.  Gave water, checked BP (129/91), recommended rest. Patient says this has happened before, but not recently.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity, Palpitations
Clinical narrative: Patient states he has soreness in the injection arm, which is common. The soreness then moved down his body and into his legs. He said it felt like his legs were dead weight. Then he felt like he was having heart palpitations.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Erythema
Clinical narrative: arm turned red and streaky within a minute or two of the injection. Watched closely for 15 minutes, but no swelling or further irritation occurred. Did apply instant ice bag to help reduce the chance of further reaction
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Erythematous papular rash starting at the site of injection (deltoid) that spread to trunk.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Dermatitis acneiform, Erythema, Feeling hot, Joint swelling, Pain
Clinical narrative: redness, swelling of the front arm, swelling at the elbow. patient states felling warm and painful.  there?s also pimple like that appear 2 days after injection.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: redness, swelling of the front arm, swelling at the elbow. patient states felling warm and painful.  there?s also pimple like that appear 2 days after injection.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: 3 DAYS FOLLOWING VACCINATION PATIENT STARTED TO DEVELOP A BLISTERY RASH ALONG HER TRUNK AND UPPER ABDOMEN
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: High fever, chills, body aches, headache, nausea, fatigue. Took Tylenol for fever. Fever broke 30 hrs after onset.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: High fever, chills, body aches, headache, nausea, fatigue. Took Tylenol for fever. Fever broke 30 hrs after onset.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Head discomfort, Injection site reaction, Injection site urticaria
Clinical narrative: Temperature 102  days 2 & 3 post-vaccine Intense  constant head pressure and vertigo days 2, 3, & 4 post-vaccine inability to focus joint pain arms, hands, hips, legs days 2, 3 & 4 post-vaccine left arm spasms below injection site day 2 to 4 post-vaccine bilateral jaw pain days 2, 3, & 4 post-vaccine nausea urticaria and welt below injection site onset day 4 - ongoing
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Nausea, Pain in jaw, Urticaria, Vertigo
Clinical narrative: Temperature 102  days 2 & 3 post-vaccine Intense  constant head pressure and vertigo days 2, 3, & 4 post-vaccine inability to focus joint pain arms, hands, hips, legs days 2, 3 & 4 post-vaccine left arm spasms below injection site day 2 to 4 post-vaccine bilateral jaw pain days 2, 3, & 4 post-vaccine nausea urticaria and welt below injection site onset day 4 - ongoing
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: Temperature 102  days 2 & 3 post-vaccine Intense  constant head pressure and vertigo days 2, 3, & 4 post-vaccine inability to focus joint pain arms, hands, hips, legs days 2, 3 & 4 post-vaccine left arm spasms below injection site day 2 to 4 post-vaccine bilateral jaw pain days 2, 3, & 4 post-vaccine nausea urticaria and welt below injection site onset day 4 - ongoing
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Patient phoned the pharmacy at 9am Saturday, 8/15/2020 and spoke to pharmacist who was also the vaccine administrating pharmacist. Patient stated that the front bicep portion of her arm was pink, warm to the touch and slightly swollen. She believed she had cellulitis. She had no fever or chills. Pharmacist explained that the vaccine had been administered into her deltoid vs. the front bicep area where she was explaining the redness to be. She stated that the redness and warmth had begun sometime on Thursday, approximately 48 hours after vaccine administration. During vaccine administration, patient's left deltoid area was cleansed well with an alcohol pad, gloves, a KN-95 face mask and a plastic face shield were worn by pharmacist, the vaccine administrator. Pharmacist attempted to contact her primary care physician but she wasn't available on a Saturday. Patient sought care at medical Center (urgent care). There the provider told her he wasn't sure it was cellulitis but would air on the side of caution and prescribe cefuroxime 500mg, BID x7. Patient came to the pharmacy to pick up the cefuroxime. She had the pink area outlined and it was indeed on her front bicep.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Lymph node pain, Pyrexia
Clinical narrative: Patient stated had fever night of but went away (she was counseled on flu like symptoms possible) but more concerned about tenderness/soreness  under left arm in lymph node area. Advised patient to ice area. Still tender 3 days later post imz(today)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pruritus, Urticaria
Clinical narrative: PATIENT RECEIVED SHOT AT 5:07PM 8/13/20. RECALLS BODY ACHES STARTING AROUND 11PM. STATES WAS IN BED ALL DAY 8/14/20 FEELING ACHY AND TIRED. TOOK ADVIL OTC FOR SYMPTOMS. 8/14/20 IN THE EVENING PT STARTED DEVELOPING ITCHING AND HIVES. 8/15/20 AT 9AM CALLED PHARMACY TO REPORT ALL OVER ITCHING AND HIVES. NO BREATHING ISSUES. AT 1:15PM PATIENT REPORTS SYMPTOMS ARE IMPROVING WITH ALLEGRA AND PREDNISONE 10MG.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Limb discomfort, Pain
Clinical narrative: It started hurting the day she got the vaccine. It has the feeling of "having laid on it for a long time". She can't lay on that arm. When she moves her arm a certain way, it hurts more.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: swelling and blistering at injection site
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Blood test, Joint swelling, Muscular weakness
Clinical narrative: Arthritis mainly in hands and wrists. Painful swollen joints in fingers and muscles in hands. Weakness in wrists and hands on both right and left.  Course of prednisone 10mg tablet 1 per day for 10 days started (10 days after worsening of symptoms) Has not subsided yet.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia
Clinical narrative: Arthritis mainly in hands and wrists. Painful swollen joints in fingers and muscles in hands. Weakness in wrists and hands on both right and left.  Course of prednisone 10mg tablet 1 per day for 10 days started (10 days after worsening of symptoms) Has not subsided yet.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Hypoaesthesia, Injection site hypoaesthesia, Oropharyngeal pain
Clinical narrative: Patient received Afluria vaccine intramuscularly on 08-14-2020. Today 08-15-2020, the patient came into the pharmacy to say that beginning last night, she experienced a severe sore throat, severe diarrhea, and numbness in her arm from the injection site all the way down to the tips of her fingers. The numbness is not as severe today, and is only at the injection site now.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event, patient received a 3rd shingrix shot after already receiving 2 shots course
Age: 57.0
Sex: F
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Chills, Insomnia, Lethargy, Malaise, Pyrexia
Clinical narrative: Patient's husband notified the pharmacy roughly around 12:20pm on Saturday 8/15/20 that his wife didn't feel well several hours after receiving IMZ on Friday 8/14/20. Husband mentioned chills, fever, and being lethargic but can't sleep. Patient hasn't eaten since the day before and now she's finally able to sleep. I advised patient's husband to monitor her fever, keep her hydrate and provide apap if she still has fever. If fever and symptoms doesn't get better to call MD/emergency. Patient husband thinks the pneumonia shot made her ill, but that is not 100% because patient received flu, shingrix, and pneumonia all
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Injection site erythema, Injection site inflammation
Clinical narrative: a couple hours after receiving the vaccine, I began to feel very tired and "out of it". I walked around in a mental fog and couldn't seem to focus or concentrate on any given task. Taking a nap helped, but I still felt bad. I woke up this morning to my arm being sore, feeling as though it had been hit with a hard object at the injection sight. My husband noticed a densely packed, red, raised rash at the injection site- hot to the touch, inflamed, but is not seemingly spreading. Im still pretty tired today but more clear headed.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash papular
Clinical narrative: a couple hours after receiving the vaccine, I began to feel very tired and "out of it". I walked around in a mental fog and couldn't seem to focus or concentrate on any given task. Taking a nap helped, but I still felt bad. I woke up this morning to my arm being sore, feeling as though it had been hit with a hard object at the injection sight. My husband noticed a densely packed, red, raised rash at the injection site- hot to the touch, inflamed, but is not seemingly spreading. Im still pretty tired today but more clear headed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Site on arm that was vaccinated Is red hard and swollen. Fever of 100.9
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Gingival disorder, Gingival erythema, Gingival pain, Lymph node pain
Clinical narrative: Body pain extending into severe jaw & gum pain. Temp of 99.9
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in jaw
Clinical narrative: Body pain extending into severe jaw & gum pain. Temp of 99.9
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever (101.5 F), chills, tiredness, redness and pain at injection site.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Rash erythematous
Clinical narrative: Patient got injection on 8/13.   On 8/14, he had flu like symptoms:  fatigue, achy.   On 8/15, he developed red rash on his back.  Rash most prevalent on back on each side next to both arms but it does extend to mid back and near buttocks.  He denied any pain or itchiness.  I recommended for him to watch it and could use hydrocortisone for inflammation or benadryl for  itch.  I also advised to call doctor if symptoms worsen or if it does not improve in 2 days.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Syringe issue
Clinical narrative: This is a prefilled syringe with a round flared end towards the plunger that is used to grip the syringe .  As I began to administer the shot, this flared grip broke off / detached from the syringe.  I immediate ceased administration, removed the syringe (with needle attached) from the patient's arm.  Minimal bleeding (a small speck of blood at site of administration) was noted.   Most, if not all of the vaccine remained in the syringe body.   I re-administered without incident the same vaccine / same lot # shortly after to the left deltoid (she insisted on left arm again) 1 inch from original site.  I notified her primary care provider, Dr's office, of the incident.  Patient had no complaints.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red, Swollen, warm right arm
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Arthralgia, Lip swelling
Clinical narrative: upper and lower lip swelling began around 8 pm on 8/12/2020. joint pain began on 8/12/2020
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Lip swelling
Clinical narrative: PT STATED HE HAD SWELLING IN THE ARM WHERE VACCINE WAS GIVEN AND THAT HIS LIPS STARTED TO SWELL UP. RECOMMENDED PT TO TAKE BENADRYL UNTIL SYMPTOMS RESOLVE, IF NOT GO TO DR.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: patient reported a square area around the injection site became warm to the touch and developed a small welt
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: CSF glucose normal, CSF lymphocyte count normal, CSF protein increased, CSF red blood cell count positive, CSF test normal
Clinical narrative: Fever (103F), chills, encephalopathy (somnolence, large change in mental status compared to baseline). Onset 3 days after immunization. Persisted for 2 more days until spontaneous recovery
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: CSF white blood cell count increased, Chills, Encephalopathy, Mental status changes, Polymerase chain reaction
Clinical narrative: Fever (103F), chills, encephalopathy (somnolence, large change in mental status compared to baseline). Onset 3 days after immunization. Persisted for 2 more days until spontaneous recovery