chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: lmproperly stored, administered vaccine; No symptoms or additional adverse effects reported; This spontaneous report was received from a licensed nurse practitioner and refers to a 4-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included properly stored sterile diluent. On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S031704 has been verified to be a valid lot number, expiration date: 06-APR-2021 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. Albumin status for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) has been verified as recombinant human albumin (rHA). Administered dose of vaccine experienced the temperature excursion of 67 degrees Fahrenheit for 17 hours. Data logger was involved. There were no previous excursions reported. No symptoms or additional adverse effects reported. Action taken with the suspect therapy and the outcome of the adverse event was not provided.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Contusion, Crying, Erythema, Swelling
Clinical narrative: BRUISING SWELLING REDNESS CRYING FOR 3 HOURS
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site pain, Injection site swelling, Lip swelling, Pyrexia, Weight bearing difficulty
Clinical narrative: Child woke up to go to the bathroom, and mom indicated that he didn't want to put weight on the left leg. Fever of 101.7, upper leg down to the knee is swollen and painful, lips appeared swollen as well. Child was given Benadryl  and Motrin.   Advised to monitor for any worsening reaction at the site, redness, red streaking, unresolved swelling.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: very sore arm for 2 weeks around injection site.  Use of arm was severely limited, she could move it but Not use it for around 2 full weeks.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Psychotic disorder
Clinical narrative: Pt had psychotic episode within 24 hrs of vaccines.
Age: 7.0
Sex: M
Vaccine: HEP, IPV, TDAP
Symptoms: Confusional state, Pain, Skin warm
Clinical narrative: Upon waking on 7/9/2020 child felt warm to touch and had body aches. He seemed confused and did not know his mom's name. Parent took child to Hospital ER for evaluation.  PHN attempted a follow up call on 7/13/2020 to ask parent about the child's status.  Left a detailed voicemail message for mother.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site reaction, Injection site scab, Rash pruritic
Clinical narrative: Child developed very itchy scabbed rash over entire right upper arm, from shoulder to elbow.
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Injection site erythema, Rash, Rash erythematous
Clinical narrative: An unspecified rash developed on the chest, stomach and back; unspecified red bumps developed under the right armpit; redness developed at the right at the right deltoid; This spontaneous report was received from a nurse via a company representative and refers to a male patient of unknown age. The patient's pertinent medical history, concomitant medications and previous drug reactions/allergies were not reported.  On 16-JUL-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), in the right deltoid lot # R027576, expiration date was not reported, but upon lot validation process established as 23-JUN-2020 (strength, dose and route of administration were not reported); diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid lot# 92T7J in the right deltoid (strength, dose, route of administration and expiration date were not reported) and meningococcal acyw conj vaccine (carrier unspecified) lot# AMV AZ06A (strength, dose, route of administration, anatomical location and expiration date were not reported) all three for prophylaxis.   In July 2020, the patient developed an unspecified rash on the chest, stomach and back, unspecified red bumps under the right armpit and redness at the right deltoid. The reporter stated that an unspecified parent notified the medical practice but no treatment was provided.  At the reporting time, the patient did not recover from the events. The causality assessment was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R027576; expirationdate: 23-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 1.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse event; the patient was inadvertently administered a dose of VAQTA that was expired; This spontaneous report has been received from a nurse regarding a 12 months old female patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On 22-JUL-2020, the patient was inadvertently vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), lot # S005725, expiration date 10-JUL-2020 (dose, frequency and route of administration not reported) as prophylaxis. No additional adverse event. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S005725; expirationdate: 10-JUL-2020; deviceage and unit: 0 ; operatorofdevice: Nurse; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 13.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Wrong product administered
Clinical narrative: Pt given Trumenba instead of Gardasil. After error realized  Pt then gave Gardasil as well. Parent told at this visit of error
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Patient repots should hurting where injection was given starting the day after injection. The pain continues to this day. Injection give on 6/24/20. No limit in range of motion of arm. Hurts when she moves it. Patient does not want to go to her doctor due to Covid-19. Refuses to call office.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cystitis, Gout, Herpes zoster, White blood cell count decreased
Clinical narrative: Gout in her right toe; Shingles in Mouth; Bladder Infection; This case was reported by a nurse via call center representative and described the occurrence of bladder infection in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included leukemia (her white blood cells are low).   On 28th May 2020, the patient received the 1st dose of Shingrix. On 6th July 2020, 39 days after receiving Shingrix and an unknown time after starting Cipro, the patient experienced bladder infection. On 9th July 2020, the patient experienced shingles. On 11th July 2020, the patient experienced gout. The patient was treated with ciprofloxacin hydrochloride (Cipro). On an unknown date, the outcome of the bladder infection was recovered/resolved and the outcome of the shingles and gout were not recovered/not resolved.   It was unknown if the reporter considered the bladder infection, shingles and gout to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had last week she had a bladder infection.   The reporter also stated that she no longer has a bladder infection, she had shingles in her mouth and stated this was better but they are not completely cleared up.   The patient had gout in her right toe and had not cleared up.   The reporter stated that because she has leukemia, her white blood cells are low but they are lower than normal for her now at 1.8.  The reporter stated that her husband was a physician and prescribed her Cipro that cleared up her bladder infection.   Medical Disclaimer was provided.   PI information and talking points from content provided and gave the caller the number to MI to have her HCP call us and emailed her the Shingrix PI. The reporter consented to follow up.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site mass
Clinical narrative: My son developed a hard lump in his upper right thigh two weeks after both vaccines and a discolor mark on the thigh.  The lump has increased in size.  His doctor told me to report this.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Pallor, Presyncope, Vision blurred
Clinical narrative: Patient experienced vasovagal reaction (dizzy, pale, blurred vision) without loss of consciousness within 2 minutes of receiving immunizations. Patient laid down on exam table with feet elevated, recovered in less than 5 minutes.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: 14 hours following injection, severe pain at injection site, radiating through arm, neck and shoulder. Inability to move shoulder and upper arm independently for 2-3 hours.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Breath sounds abnormal, C-reactive protein normal, Chest X-ray abnormal, Flushing
Clinical narrative: Infant became flushed, then pale; developed raspy sounding respirations, then had bubbled gurgling from her mouth. This lasted 2-5 minutes, then she went limp. The limpness lasted about 45 minutes while they were driving to the ED. Child had no tonic-clonic movements, or opisthotonic posturing. She had no apnea. Upon arrival to the ED, her temp was 102.9, respirations 45, pulse 182, all of which came down with ibuprofen and acetaminophen. Evaluation revealed a bilateral pneumonia.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Full blood count normal, Hypotonia, Metabolic function test normal, Pallor, Pneumonia
Clinical narrative: Infant became flushed, then pale; developed raspy sounding respirations, then had bubbled gurgling from her mouth. This lasted 2-5 minutes, then she went limp. The limpness lasted about 45 minutes while they were driving to the ED. Child had no tonic-clonic movements, or opisthotonic posturing. She had no apnea. Upon arrival to the ED, her temp was 102.9, respirations 45, pulse 182, all of which came down with ibuprofen and acetaminophen. Evaluation revealed a bilateral pneumonia.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pneumonia viral, Polymerase chain reaction, Respiratory syncytial virus test, SARS-CoV-2 test negative, Specific gravity urine normal
Clinical narrative: Infant became flushed, then pale; developed raspy sounding respirations, then had bubbled gurgling from her mouth. This lasted 2-5 minutes, then she went limp. The limpness lasted about 45 minutes while they were driving to the ED. Child had no tonic-clonic movements, or opisthotonic posturing. She had no apnea. Upon arrival to the ED, her temp was 102.9, respirations 45, pulse 182, all of which came down with ibuprofen and acetaminophen. Evaluation revealed a bilateral pneumonia.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Streptococcus test negative, Urine analysis normal, White blood cell count normal
Clinical narrative: Infant became flushed, then pale; developed raspy sounding respirations, then had bubbled gurgling from her mouth. This lasted 2-5 minutes, then she went limp. The limpness lasted about 45 minutes while they were driving to the ED. Child had no tonic-clonic movements, or opisthotonic posturing. She had no apnea. Upon arrival to the ED, her temp was 102.9, respirations 45, pulse 182, all of which came down with ibuprofen and acetaminophen. Evaluation revealed a bilateral pneumonia.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: syncope; This spontaneous report was received via a company representative from a pharmacist who is also a patient's father and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On an unknown date (reported as "unspecified date years ago"), the patient experienced syncope after receiving the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (date of vaccination, dose, route of administration, lot# and expiration date were not reported) and on an unspecified date, she had "worsening syncope" after receiving the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (date of vaccination, dose, route of administration, lot# and expiration date were not reported). The patient sought medical attention. The pharmacist also reported that "even now she still sometimes has syncope, but is fully recovered".  The outcome of syncope was reported as recovered/resolved on an unknown date. The relatedness between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.  Upon internal review, the event of syncope was considered to be medically significant.
Age: 0.5
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient experienced no symptoms.; a dose of PROQUAD was accidentally administered to a 6 month old patient instead of a dose of PEDVAXHIB.; a dose of PROQUAD was accidentally administered to a 6 month old patient; Route of Administration: "intramuscular"; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 20-JUL-2020, the patient at the age of 6 months old, was accidentally administered a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, by intramuscular route as prophylaxis (lot number S035100 which has been verified to be valid, expiration date reported and validated as 03-MAY-2021) (dosage, vaccination scheme, frequency and anatomical site of injection were not reported), instead of a dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (wrong product administered, incorrect route of product administration and product administered to patient of inappropriate age). The reporter did not know if the product confusion contributed to the error. The patient experienced no symptoms.
Age: 66.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: since vaccination, she developed a reaction "one inch below the injection site" where arm is "red, raised and very hot"; since vaccination, she developed a reaction "one inch below the injection site" where arm is "red, raised and very hot"; since vaccination, she developed a reaction "one inch below the injection site" where arm is "red, raised and very hot"; This spontaneous report was received from a pharmacist and refers to a 66 years old female patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 22-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe, 0.5 milliliter once via intramuscular route (lot # S033516, expiration date: 29-JUN-2021) for pneumococcal prevention. On the same date, she developed a reaction one inch below the injection site where arm was red, raised and very hot. On 23-JUL-2020, she returned to pharmacy to consult pharmacist regarding the events. The patient was not hospitalized, she had no cancer or overdose. At the time of this report, the patient did not recover from the events. Causality assessment was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S033516; expirationdate: 29-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse reactions; expired dose of Varivax was inadvertently administered to a patient; This spontaneous report was received from a medical assistant 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 23-JUL-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R020651 was verified to be valid, expiration date rerported and established as 18-JUL-2020 (dose, route of administration and anatomical location were not provided) for prophylaxis. Other suspect therapies included sterile diluent (dose, lot number, expiration date and route of administration were not provided).   The patient did not experience any additional adverse reactions.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Vaccine positive rechallenge
Clinical narrative: side effects with the 2nd shot; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse drug reaction (1st dose received on unknown date, refer case US2020136706).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The reporter is the patient's wife reported on behalf of husband. The age at vaccination was not reported. The patient had some side effects with the 2nd shot. However she provided no additional information. The reporter became irritated because GlaxoSmithKline could not advise her if her husband would ever need to be vaccinated again.
Sex: U
Vaccine: MENB
Symptoms: Local reaction
Clinical narrative: local reaction post meningococcal vaccine; This case was reported by a nurse via other manufacturer and described the occurrence of local reaction in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown.   It was unknown if the reporter considered the local reaction to be related to Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced local reaction post meningococcal vaccine, Bexsero B. The reporter recognized she contacted wrong manufacturer and was looking up GlaxoSmithKline contact information to call to report. No further information provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020133267:
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: side effects with the first shot; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was recovered/resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The reporter is the patient's wife reported on behalf of husband. The age at vaccination was not reported. The patient had some side effects with the first shot. However she provided no additional information. For tolerance to 2nd dose refer linked case US2020AMR138047, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: redness at injection site; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. It was reported that unknown number of patients aged 75 years old or older that had received the Shingrix and developed redness at the injection site which spread down the arm. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Low grade fever; Body aches; This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were unknown.   It was unknown if the reporter considered the fever and general body pain to be related to Shingrix.  Additional details were reported as follows: The nurse reported for herself. The age at vaccination was not reported. The patient received the dose of Shingrix and after this experienced body aches and a low grade fever.  The nurse also mentioned that they say that dose was worst. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Body ache; Headaches; Muscle aches; This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced general body pain, headache and myalgia. Shingrix was discontinued. On an unknown date, the outcome of the general body pain, headache and myalgia were unknown.   It was unknown if the reporter considered the general body pain, headache and myalgia to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had experienced body ache, muscle aches and headaches so patient would prefer not to get the second dose of Shingrix if that's possible.  The patient did not get the first dose at pharmacist's site and pharmacist had limited information for the first dose administered and patient could not provide date of birth.  The reporter consented to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pyrexia, Rash
Clinical narrative: Patient started rash later on same day following the fever of 101F. Pt had rash on right arm and chest and was noticed on right leg yesterday as well.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: High fever; Headache; Vomiting; This is a spontaneous report from a contactable nurse via Pfizer Sales Representative. This Nurse reported similar events for 4 patients. This is report 3 of 4. This Nurse reported that a 16-year-old patient received meningococcal group b rlp2086 (TRUMENBA), intramuscular in arm on unspecified date at single dose for meningitis serogroup B vaccine, and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, injection), intramuscular in arm on unspecified date at unknown dosage for vaccine. The patient was administered Trumenba injection in one arm and Menactra injection in the other arm at the same time. The patient medical history and concomitant medications were not reported. The patient experienced high fever, headache, and vomiting on an unspecified date. Outcome of events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020279270 Same reporter,drug,event/Different patient
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tenderness, Weight bearing difficulty
Clinical narrative: Patient reports ongoing arm tenderness after both  injections 7/17/19 & 9/18/19 to the point where  he was unable to push himself up with arms.  Patient states duration lasted up to 7 months.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Eye pain, Headache, Influenza, Lethargy
Clinical narrative: The night it was administered I had severe pain and swelling in my left arm, febrile (101), headache, nausea. I took acetaminophen and zofran. Symptoms continued throughout the night and the next 3 days I continued to be febrile, pain in my arm (not as bad as first day), headache lethargic. Finally on the 28th of July my temp broke and I feel like I have had the flu. All over muscle pain, pain behind my eyes, and general feeling of being drained.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: The night it was administered I had severe pain and swelling in my left arm, febrile (101), headache, nausea. I took acetaminophen and zofran. Symptoms continued throughout the night and the next 3 days I continued to be febrile, pain in my arm (not as bad as first day), headache lethargic. Finally on the 28th of July my temp broke and I feel like I have had the flu. All over muscle pain, pain behind my eyes, and general feeling of being drained.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Crying, Irritability, Pain, Pyrexia, Rash
Clinical narrative: 102F fever, body aches, fussiness, rash, and excessive crying for 4 days. Also, gave a friend the chicken pox 6 days after vaccination.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pain
Clinical narrative: Chills, headache, body ache and muscle ache
Age: 20.0
Sex: M
Vaccine: ANTH, IPV, TYP
Symptoms: Loss of consciousness
Clinical narrative: Pt received shots walked to waiting room sat down, passed out. A different patient waiting for Radiology saw and helped him to the floor. Code blue was called.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Mobility decreased, Pain in extremity
Clinical narrative: Severe Headache, Painful and very swollen area on arm, Red area on arm approximately 4-5 inches long and 3 inches side.  For two days could hardly move I was so exhausted.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Severe Headache, Painful and very swollen area on arm, Red area on arm approximately 4-5 inches long and 3 inches side.  For two days could hardly move I was so exhausted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Dizziness, Influenza
Clinical narrative: Felt like the flu. By evening I was in bed with high fever (102+), body aches, chills, stomach discomfort, dizziness, weakness
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Felt like the flu. By evening I was in bed with high fever (102+), body aches, chills, stomach discomfort, dizziness, weakness
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Pain erythema itching
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: no adverse event; patient was administered a dose of expired V ARIV AX; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On 16-JUL-2020, the patient was vaccinated with  a dose of properly stored but expired varicella virus vaccine live (oka/merck)(VARIVAX) lot # R013566, expiration date 13-MAY-2020, subcutaneously (vaccination site was not reported), for prophylaxis which was reconstituted with properly stored and non expired sterile diluent.
Sex: F
Vaccine: PPV
Symptoms: Injection site nodule, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: The patient had a significant injection site reaction described as hot, swollen and the size of an orange; The patient had a significant injection site reaction described as hot, swollen and the size of an orange; The patient had a significant injection site reaction described as hot, swollen and the size of an orange; The patient had a significant injection site reaction described as hot, swollen and the size of an orange which lasted a few days with a residual knot lasting for quite a while.; This spontaneous report was received from a Certified Pharmacy Technician a female patient reporting on herself via company representative. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  In June 2020 (reported as "last month"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. After vaccination, the patient had a significant injection site reaction described as hot (injection site warmth), swollen (injection site swelling) and the size of an orange which lasted a few days with a residual knot lasting for quite a while (injection site nodule).          At the time of the report, the outcome of injection site reaction, injection site nodule, injection site swelling and injection site warmth was unknown. The reporter did not mention the causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccination.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: child patient was given an expired Pentacel/ No AE; Initial information was received on 27-Jul-2020 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves a two months old female patient who was vaccinated with 0.5 mL dose of expired  vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ084AAA and expiry date 24-Jul-2020) via intramuscular route in the left thigh for prophylactic vaccination on 27-Jul-2020 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  Case details: Reporter stated that female child was given an expired vaccine during a well-baby visit.   It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event 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 and Module VI of the 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: 65.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Blood pressure decreased, Blood test, Body temperature increased, Cardiac stress test
Clinical narrative: Previous to this I was told to stop Mesalamine and Meloxicam due to high kidney function. Thru this whole ordeal I have been in near constant arthritic pain. My thumbs are barely useable. Switching to Tylenol for Arthritis provided no relief. Prayed for morphine gods to have pity on me. This is dose #1 of 2.  Friday July 17, 2020  Shingles Vaccine #1: left arm sore at injection site  Monday July 20, 2020  Nuclear Stress Test: blood pressure became extremely low 52/46  Tuesday July 21, 2020  Woke up in the middle of the night wringing wet with sweat   Wednesday July 22, 2020  Blood Test 8am no fever. 9:15pm 99.6 and aching all over Temp 100.5 in afternoon Low grade nagging headache and low grade sore throat Can?t breath  Only relief is sleeping all day  Thursday July 23, 2020  Had diarrhea all day temp 98.6 to 99.3 still aching  Aching all over only relief is sleeping all day Low grade nagging headache and low grade sore throat Can?t breath  Woke up middle of night sweating still aching all over  Friday July 24, 2020  Sneezed 5xs in the am temp 98.7 saw respiratory at Hospital. Got Covid test  Aching all over only relief is sleeping all day  Low grade nagging headache and low grade sore throat Can?t breath  Woke up middle of night sweating still aching all over  Saturday July 25, 2020  Still aching all over only relief is sleeping all day  Low grade nagging headache and low grade sore throat  Temp 98.6-99.6  Can?t breath  Woke up middle of night sweating still aching all over  Sunday July 26, 2020  Still aching all over  Low grade nagging headache and low grade sore throat Temp 101.0 in am then 100.3 in pm & 100.0 by eve Still get winded and with minimal exertion Woke up middle of night sweating still aching all over  Monday July 26, 2020  Still sore all over. Get hot flashes. Temp in am 100.2 Covid test is NEGATIVE Still got very sweaty napping on sofa Still get winded and with minimal exertion Maybe not quite so achy and arthritis is a bit more tolerable Thumbs still very painful, still achy all over but not as severe Went to bed feeling like fever shivering was going to happen, it didn?t Injection site still sore   Tuesday July 27, 2020  Woke up in am drenched.  Still not 100% yet
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Diarrhoea, Dyspnoea, Headache, Hot flush, Hyperhidrosis
Clinical narrative: Previous to this I was told to stop Mesalamine and Meloxicam due to high kidney function. Thru this whole ordeal I have been in near constant arthritic pain. My thumbs are barely useable. Switching to Tylenol for Arthritis provided no relief. Prayed for morphine gods to have pity on me. This is dose #1 of 2.  Friday July 17, 2020  Shingles Vaccine #1: left arm sore at injection site  Monday July 20, 2020  Nuclear Stress Test: blood pressure became extremely low 52/46  Tuesday July 21, 2020  Woke up in the middle of the night wringing wet with sweat   Wednesday July 22, 2020  Blood Test 8am no fever. 9:15pm 99.6 and aching all over Temp 100.5 in afternoon Low grade nagging headache and low grade sore throat Can?t breath  Only relief is sleeping all day  Thursday July 23, 2020  Had diarrhea all day temp 98.6 to 99.3 still aching  Aching all over only relief is sleeping all day Low grade nagging headache and low grade sore throat Can?t breath  Woke up middle of night sweating still aching all over  Friday July 24, 2020  Sneezed 5xs in the am temp 98.7 saw respiratory at Hospital. Got Covid test  Aching all over only relief is sleeping all day  Low grade nagging headache and low grade sore throat Can?t breath  Woke up middle of night sweating still aching all over  Saturday July 25, 2020  Still aching all over only relief is sleeping all day  Low grade nagging headache and low grade sore throat  Temp 98.6-99.6  Can?t breath  Woke up middle of night sweating still aching all over  Sunday July 26, 2020  Still aching all over  Low grade nagging headache and low grade sore throat Temp 101.0 in am then 100.3 in pm & 100.0 by eve Still get winded and with minimal exertion Woke up middle of night sweating still aching all over  Monday July 26, 2020  Still sore all over. Get hot flashes. Temp in am 100.2 Covid test is NEGATIVE Still got very sweaty napping on sofa Still get winded and with minimal exertion Maybe not quite so achy and arthritis is a bit more tolerable Thumbs still very painful, still achy all over but not as severe Went to bed feeling like fever shivering was going to happen, it didn?t Injection site still sore   Tuesday July 27, 2020  Woke up in am drenched.  Still not 100% yet
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Hypersomnia, Injection site pain, Middle insomnia, Oropharyngeal pain, Pain
Clinical narrative: Previous to this I was told to stop Mesalamine and Meloxicam due to high kidney function. Thru this whole ordeal I have been in near constant arthritic pain. My thumbs are barely useable. Switching to Tylenol for Arthritis provided no relief. Prayed for morphine gods to have pity on me. This is dose #1 of 2.  Friday July 17, 2020  Shingles Vaccine #1: left arm sore at injection site  Monday July 20, 2020  Nuclear Stress Test: blood pressure became extremely low 52/46  Tuesday July 21, 2020  Woke up in the middle of the night wringing wet with sweat   Wednesday July 22, 2020  Blood Test 8am no fever. 9:15pm 99.6 and aching all over Temp 100.5 in afternoon Low grade nagging headache and low grade sore throat Can?t breath  Only relief is sleeping all day  Thursday July 23, 2020  Had diarrhea all day temp 98.6 to 99.3 still aching  Aching all over only relief is sleeping all day Low grade nagging headache and low grade sore throat Can?t breath  Woke up middle of night sweating still aching all over  Friday July 24, 2020  Sneezed 5xs in the am temp 98.7 saw respiratory at Hospital. Got Covid test  Aching all over only relief is sleeping all day  Low grade nagging headache and low grade sore throat Can?t breath  Woke up middle of night sweating still aching all over  Saturday July 25, 2020  Still aching all over only relief is sleeping all day  Low grade nagging headache and low grade sore throat  Temp 98.6-99.6  Can?t breath  Woke up middle of night sweating still aching all over  Sunday July 26, 2020  Still aching all over  Low grade nagging headache and low grade sore throat Temp 101.0 in am then 100.3 in pm & 100.0 by eve Still get winded and with minimal exertion Woke up middle of night sweating still aching all over  Monday July 26, 2020  Still sore all over. Get hot flashes. Temp in am 100.2 Covid test is NEGATIVE Still got very sweaty napping on sofa Still get winded and with minimal exertion Maybe not quite so achy and arthritis is a bit more tolerable Thumbs still very painful, still achy all over but not as severe Went to bed feeling like fever shivering was going to happen, it didn?t Injection site still sore   Tuesday July 27, 2020  Woke up in am drenched.  Still not 100% yet
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity, SARS-CoV-2 test negative, Sneezing
Clinical narrative: Previous to this I was told to stop Mesalamine and Meloxicam due to high kidney function. Thru this whole ordeal I have been in near constant arthritic pain. My thumbs are barely useable. Switching to Tylenol for Arthritis provided no relief. Prayed for morphine gods to have pity on me. This is dose #1 of 2.  Friday July 17, 2020  Shingles Vaccine #1: left arm sore at injection site  Monday July 20, 2020  Nuclear Stress Test: blood pressure became extremely low 52/46  Tuesday July 21, 2020  Woke up in the middle of the night wringing wet with sweat   Wednesday July 22, 2020  Blood Test 8am no fever. 9:15pm 99.6 and aching all over Temp 100.5 in afternoon Low grade nagging headache and low grade sore throat Can?t breath  Only relief is sleeping all day  Thursday July 23, 2020  Had diarrhea all day temp 98.6 to 99.3 still aching  Aching all over only relief is sleeping all day Low grade nagging headache and low grade sore throat Can?t breath  Woke up middle of night sweating still aching all over  Friday July 24, 2020  Sneezed 5xs in the am temp 98.7 saw respiratory at Hospital. Got Covid test  Aching all over only relief is sleeping all day  Low grade nagging headache and low grade sore throat Can?t breath  Woke up middle of night sweating still aching all over  Saturday July 25, 2020  Still aching all over only relief is sleeping all day  Low grade nagging headache and low grade sore throat  Temp 98.6-99.6  Can?t breath  Woke up middle of night sweating still aching all over  Sunday July 26, 2020  Still aching all over  Low grade nagging headache and low grade sore throat Temp 101.0 in am then 100.3 in pm & 100.0 by eve Still get winded and with minimal exertion Woke up middle of night sweating still aching all over  Monday July 26, 2020  Still sore all over. Get hot flashes. Temp in am 100.2 Covid test is NEGATIVE Still got very sweaty napping on sofa Still get winded and with minimal exertion Maybe not quite so achy and arthritis is a bit more tolerable Thumbs still very painful, still achy all over but not as severe Went to bed feeling like fever shivering was going to happen, it didn?t Injection site still sore   Tuesday July 27, 2020  Woke up in am drenched.  Still not 100% yet
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Friday 7-24-2020, 0800 in AM, client would not bend leg and c/o pain with touch. no redness, no lumps, no swelling, no radiant heat emanating from leg, no fever and is playing with other children.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Child was given an MMR vaccine that was out of date. He did not have any reactions. Mom notified and she has since moved. She will contact  her doctor there and have him revaccinated.
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient began to have whelps and itching all over her body the Sunday after her vaccines were administered.  She began treating with Benadryl and topical Calamine . She does not believe that she was exposed to anything doing yard work. Her itching has improved and is now isolated to her wrists and hands.  Encouraged her to continue using Benadryl and to contact her Physician if symptoms do not improve or worsened
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal discomfort, Pain in extremity, Peripheral swelling, Wrong product administered
Clinical narrative: Patient was given Bexsero in error. Reported to the office the next day complaining of upset stomach and painful/swollen deltoid.
Age: 0.67
Sex: F
Vaccine: HEP
Symptoms: Irritability, Pyrexia, Urticaria
Clinical narrative: fever of 100.1 23 hrs after vaccine. 8am on the 28th of july. broke out in hives all over face, behind ears, neck, back, chest. very irritatable
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Extreme exhaustion, headache, and difficulty raising injection arm more than a few inches, very swollen and red at shot shot site with a wheal that was about 4".  On the 4th day or so, the swollen area shifted down towards the front of my arm about 1/2" and it was like a sagging sack of fluid under the skin.  The worst part of the reaction though, was shooting pains all over my body throughout the night.  Very brief, zapping pains in my head, side of body, feet, ribs cage area, calves....just all over repeatedly.  I was in bed for 2 days miserable.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site oedema, Injection site swelling, Injection site urticaria, Pain
Clinical narrative: Extreme exhaustion, headache, and difficulty raising injection arm more than a few inches, very swollen and red at shot shot site with a wheal that was about 4".  On the 4th day or so, the swollen area shifted down towards the front of my arm about 1/2" and it was like a sagging sack of fluid under the skin.  The worst part of the reaction though, was shooting pains all over my body throughout the night.  Very brief, zapping pains in my head, side of body, feet, ribs cage area, calves....just all over repeatedly.  I was in bed for 2 days miserable.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: Patient had her second shingrix and then that night the patient started to get the chills and her fever got up to 102.7, went down to 101 with tylenol. The patient also had body aches at this time. Patient stated that this prevented her from doing her regular activities and states she was very miserable.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Adverse drug reaction, Anxiety, Blood test, Electroencephalogram, Magnetic resonance imaging
Clinical narrative: I began having seizure episodes, I experienced extreme body pains, then would collapse. Seizures caused anxiety, began different seizure medications, side affects made me too sick. Seizure episodes would leave my body in severe pain for weeks ahead.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Pain, Seizure, Syncope
Clinical narrative: I began having seizure episodes, I experienced extreme body pains, then would collapse. Seizures caused anxiety, began different seizure medications, side affects made me too sick. Seizure episodes would leave my body in severe pain for weeks ahead.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Injection site reaction, Muscle spasms, Nausea
Clinical narrative: dizziness, Nausea, Heachache, muscle spasm at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot, Headache, Influenza like illness, Nausea
Clinical narrative: Beginning at 3:00 in the morning after the shot, it started to feel "flu-like" with body aches, headache, felt like I had a fever (but was only 98.1). I thought these symptoms would go away by morning as with the first Shingrix shot, but they persisted the whole next day. I spent most of the day in bed; because I couldn't really do anything. Was taking acetaminophen, but that really didn't do much. The next day (Tues - shot was Sunday), I could at least function. Got out of bed, tried to go about my normal routine. But mid day started feeling nauseous, a little light headed, a little flu-like again, though not as bad as the first night.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient called pharmacy at 5:25 pm, she stated she was experiencing numbness and pins and needles sensation in face(boyfriend also experiencing same symptoms, he had same vaccination). I asked patient if her breathing was compromised in any way, she said no. I instructed for her and her boyfriend to take a Benadryl and that I was going to contact our clinical department for advice and that I would call her back. I called the help desk, they said it could be possible anaphylaxis or adverse reaction affecting her nerves.  They instructed me to tell patient to go to the hospital.  At 5:35 pm I called patient back, relayed to her what clinical department told me and I instructed for her and her boyfriend to go to the emergency room. Patient said she and her boyfriend wanted to "wait it out" they both took a Benadryl and symptoms were the same. no better, no worse. I told her I would follow up with her in an hour.