chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: muscle aches and pains, low grade fever, extremely tired for 3 days. baseball sized swelling and redness around injection site.
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Hypoacusis
Clinical narrative: PATIENT COULDN'T HEAR AND FELT FAINT AND DIZZY
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: This vaccine requires reconstitution of the powder and liquid in order to be appropriately administered. Only the Liquid portion of the vaccine was provided to the patient. The solid portion was not given.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On or about 15-APR-2009, the patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at a medical clinic by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, the patient was treated by a physician for herpes zoster. As a direct and proximate result of patient's use of the Zoster Vaccine Live(ZOSTAVAX) vaccine, patient would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization (on unspecified dates), physician care, monitoring, treatment, medications, and supplies. At the time of report, the patient was not recovered from herpes zoster. The reporter considered the adverse events to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 1.25
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Patient was suppose to get a dose of VAQTA and was given RECOMBIV AX HB; This spontaneous report was received from a registered nurse and refers to a 15-month-old male patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 27-AUG-2020, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 0.5 milliliter, via subcutaneous (reported as SUB Q) route (lot# 4CL44 upon internal review was established as invalid for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date was reported as 24-JAN-2022) (dose number, anatomical location of administration were not reported) for prophylaxis. The patient was suppose to receive a dose of hepatitis A Vaccine, Inactivated (VAQTA).
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: RIGHT THIGH BEGAN WITH WIDESPREAD REDNESS THE SIZE OF AN ADULT HAND WHICH LATER ENCASED THE WHOLE THIGH.  THIGH WAS WARM TO TOUCH.
Age: 54.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Abdominal pain upper, Asthenia, Chest pain, Chills, Dizziness
Clinical narrative: Headache, dizzy, blurry vision, chest and stomach pain, nausea, drained/no energy, muscle pain, chills, feeling of fever but none. Both times that I had the vacciine, I am 54 years of age.
Age: 54.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Headache, dizzy, blurry vision, chest and stomach pain, nausea, drained/no energy, muscle pain, chills, feeling of fever but none. Both times that I had the vacciine, I am 54 years of age.
Age: 54.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Vision blurred
Clinical narrative: Headache, dizzy, blurry vision, chest and stomach pain, nausea, drained/no energy, muscle pain, chills, feeling of fever but none. Both times that I had the vacciine, I am 54 years of age.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vertigo
Clinical narrative: Shot given on 26th.  Fever around 100F (max 100.4F) lasted about 18 hours, waking me at night about 12 hours after injection.  The following day, (28th) no fever but fairly severe vertigo, so that if I moved my head quickly the world spun badly, persisted through the whole day.   No treatment, but all symptoms gone on the 29th.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effect just vaccination history was showing 1 shot and second dose is due, pharmacist helped pt with second dose she forgot she got it at cvs. After going home they found out that the shot she got with us was her second.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient woke in the middle of the night after receiving the shot earlier the previous morning with considerable arm pain. She noticed when she tried to move her arm, she couldn't. She presented to the pharmacy 5 days later (9/1) and she could not more her arm up past her elbow. She says it's getting better day by day, but wanted to report the adverse event. I counselled her to call us back, or call her doctor, if it does not get better and she was satisfied with that. She thinks she will have full recovery at some point.
Age: 16.0
Sex: M
Vaccine: MENB, HPV9, MENB, MNQ
Symptoms: Arthralgia, Headache, Pain, Pyrexia
Clinical narrative: On the night of the day of vaccine patient experienced head ache fever body ache and joint pain  which was treated with Motrin and bed rest.  Patient followed up with Dr next day still didn't feel better that evening and  was taken to the ER because symptoms got worse and was given stronger Motrin and Tylenol and was sent home. Symptoms continued for about a week and a half before he felt better.
Age: 16.0
Sex: M
Vaccine: MENB, HPV9, MENB, MNQ
Symptoms: Hypersensitivity, Pain, Pyrexia
Clinical narrative: On the night of the day of vaccine patient experienced head ache fever body ache and joint pain  which was treated with Motrin and bed rest.  Patient followed up with Dr next day still didn't feel better that evening and  was taken to the ER because symptoms got worse and was given stronger Motrin and Tylenol and was sent home. Symptoms continued for about a week and a half before he felt better.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient did not experience adverse effects.  Patient was given High Dose vaccine and is not 65.  Reporting to VAERS in case of reaction.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Within 5 hours, had muscle pain, couldn't close my hand, chills, aches and pains over entire body. multiple headaches in different areas of head thru the night. Very tired for next 4 days. After that started upper leg pain, still have it. Went to physical therapy. Didn't help. Doing more testing now. P
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Within 5 hours, had muscle pain, couldn't close my hand, chills, aches and pains over entire body. multiple headaches in different areas of head thru the night. Very tired for next 4 days. After that started upper leg pain, still have it. Went to physical therapy. Didn't help. Doing more testing now. P
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient was given actHib mixed incorrectly. ActHib was inadvertently mixed with sterile water instead of the saline. No adverse reaction noted from patient.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Unresponsive to stimuli
Clinical narrative: gave pt the vaccine and pt did fine. went to give a couple of vaccines to other family members and pt started stating feeling dizzy and helped pt sat down. pt's pulse was fine, was still breathing and was someone alert to voices but not responding. pt was responsive and alert after family member applied some cold water to pt's face and felt fine afterward over the course of 2-4 minutes. pt had same vaccine the previous year with no reaction.
Age: 77.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Headache, Pain, Peripheral swelling
Clinical narrative: Patient stated on Day 2-Day 5 after vaccine, she had swelling in her right arm.  She also had headaches and body aches.  She took Motrin and is doing ok now.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Mild IZ reaction to Tdap - expected and very common Notable achiness in left arm where IZ was given with surrounding redness and firmness of the skin.
Age: 58.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site reaction, Rash maculo-papular, Rash pruritic
Clinical narrative: Erythematous, blanchable, itchy maculopapular rash on left upper extremity and abdomen appeared the following day after vaccine administration. No anaphylactic reaction reported. Treated with Benadryl cream with very mild benefit noted for 4 days. Prescribed triamcinolone 0.1% cream to use BID for 14 days on day 4 of rash.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Moderate fever and redness around area of injection.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: warm to touch, red, swollen
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse event reported; patient was administered a fourth dose of GARDASIL 9.; patient was administered a fourth dose of GARDASIL 9.; This spontaneous report was received from a nurse referring to a  patient of unknown gender, age reported as "16" (units not reported).. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 24-AUG-2020, the patient was vaccinated with the fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (mL) as prophylaxis (frequency, route of administration, and anatomical site of vaccination were not reported; lot number S020254 had been verified to be a valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast), with an expiration date on 09-DEC-2021) (inappropriate schedule of product administration and extra dose administered). It was reported that the patient completed the three-dose series on January of 2017. No additional adverse event was reported. At the time of this report the outcome of inappropriate schedule of product administration and extra dose administered was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S020254; expirationdate: 09-DEC-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Renal impairment
Clinical narrative: is scheduled to receive a kidney transplant on an unknown, future date; This spontaneous report was received from a pharmacist and refers to a 63-year-old female patient. Her current condition included diabetes. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided.  On 21-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) once (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis. On the same date, she developed an unspecified renal function disorder. At the time of this report, the patient did not recover from the event and was scheduled to receive a kidney transplant on an unknown, future date.  The relatedness between the event and the suspect vaccine was not provided.  Upon internal review, the event of renal function disorder was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, in 2014, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation, concerning a patient of unknow age and gender. The patient's concurrent condtions, mediacal history and concomitant therapy were not reported. In 2012, patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) (dose, unit, route of administration, lot # and expiration date were not reported), as prescribed and/or dministered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a physician for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not reported.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Local reaction
Clinical narrative: The patient then had a local reaction and received prednisone for cellulitis; This is a spontaneous report from contactable Physician via Pfizer Sales Representative.   This Pharmacist reported  that an elderly patient (65 year-old or older) of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient  had a local reaction and had to go to urgent care where received prednisone for cellulitis  on an unspecified date with outcome of unknown.  The patient then had a reaction to Prednisone and as a result was then not able to get the flu vaccination.  The information on the batch number has been requested.; Sender's Comments: A contributory role of suspect vaccine PREVNAR 13 could not be completely ruled out for the onset of cellulitis at vaccination site.  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 and Investigators, as appropriate.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pain
Clinical narrative: severe headache; body aches; This is a spontaneous report from a contactable physician. This physician reported same events for 3 patients. This is 1st of 3 reports. A 19-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, Lot Number: CN8296), via an unspecified route of administration on 12Aug2020 at single dose for immunisation. There were no medical history or concomitant medications. The patient experienced severe headache, body aches on 12Aug2020. Event details: The physician was calling to report the patient had experienced side effects after the meningococcal group b rlp2086 shot. Patient experienced severe headache and body aches within hours of receiving the meningococcal group b rlp2086 shot. He had treated the patient with ibuprofen (ADVIL) and diphenhydramine hydrochloride (BENADRYL). When asked about Concomitant products or other medical conditions the physician stated the patient was healthy. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020334218 same reporter/drug/event, different patient;US-PFIZER INC-2020334746 same reporter/drug/event, different patient
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Pain
Clinical narrative: severe headache; body aches; This is a spontaneous report from a contactable physician. A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, Lot Number: AT1920), via an unspecified route of administration on 26Aug2020 at single dose for immunisation. There were no medical history or concomitant medications. The patient experienced severe headache, body aches on 26Aug2020. Event details: The physician was calling to report he had a patient who had experienced side effects after the meningococcal group b rlp2086 shot. He had treated him with ibuprofen (ADVIL) and diphenhydramine hydrochloride (BENADRYL). The patient was not responding to treatment with ibuprofen and diphenhydramine hydrochloride and may require narcotics. The patient experienced severe headache and body aches within hours of receiving the meningococcal group b rlp2086 shot. When asked about Concomitant Products or Other Medical Conditions the physician stated the patient was healthy. The outcome of the events was not resolved.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: injection site pain; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced injection site pain on an unspecified date. The outcome of event was unknown. This was a known side effect and it would have been reported if the pain persisted.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: U
Vaccine: MENB
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Severe headache; Having a reaction with extreme pain and myalgia; Having a reaction with extreme pain and myalgia; This is a spontaneous report from a contactable physician. This Physician reported similar events for four patients. This is report three of four reports.  A 19-year-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA, lot number: S58878, Pfizer product), via an unspecified route of administration on 01Apr2019 at a single dose for immunization. There were no medical history and no concomitant medications. On an unspecified date, the patient experienced severe headache, having a reaction with extreme pain and myalgia. The outcome of events was unknown. The doctor stated this was getting ridiculous 50% of shot causing headache and myalgia. Something must be wrong.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020335485 Same reporter/event different patient
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Myalgia, Pain, Sleep disorder
Clinical narrative: extreme pain; myalgia; really boom sleep; headache; This is a spontaneous report from a contactable physician. This physician reported similar events for four patients. This is the fourth of four reports.   A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, Batch/lot number: CM1494), via an unspecified route of administration on 26Aug2020 at single dose for immunization. Medical history and concomitant medications were none. The patient experienced severe reaction, extreme pain, myalgia, really boom sleep, and headache on an unspecified date with outcome of unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020335485 Same reporter/event different patient
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Myalgia, Pain
Clinical narrative: severe headache; Severe reaction with extreme pain and myalgia; Severe reaction with extreme pain and myalgia; This is a spontaneous report from a contactable physician. This Physician reported similar events for four patients. This is report 1st of four reports. A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, lot# 809020), via an unspecified route of administration on 26Aug2020 at single dose for immunisation. Medical history and concomitant medications were none. The patient experienced severe headache, and severe reaction with extreme pain and myalgia on an unspecified date of Aug2020 with outcome of unknown. The doctor stated this was getting ridiculous 50% of shot causing headache and myalgia. Something must be wrong.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020335060 Same reporter/drug, similar event, different patient;US-PFIZER INC-2020335065 Same reporter/drug, similar event, different patient;US-PFIZER INC-2020335482 Same reporter/drug, similar event, different patient
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Death
Clinical narrative: The patient was found deceased; This is a spontaneous case, initially received from pharmacist via Med Communication (reference number: SEQW20-01021) on 28-Aug-2020 with two additional documents received on 31-Aug-2020 (being processed together), concerning a 78-year-old female patient.  The patient's medical history was not reported.  The patient's concomitant medications included mycophenolate, simvastatin, alopurinol, furosemide, prednisone, gabapentin, Humalog (insulin lispro), Lantus (insulin glargine), Synthroid (levothyroxine sodium), potassium chloride, metoprolol, amlodipine, azathioprine, bumetanide and metolazone, all for an unknown indication.  On 26-Aug-2020, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; batch number: 279734, anatomical location: deltoid, dose: 0.5 ml, route of administration: intramuscular and expiration date: 04-May-2021] for an influenza prophylaxis.  On 28-Aug-2020, two days after taking Fluad (TIV), the patient died. The cause of death was unknown and it was unknown if autopsy was done.  The case was assessed as serious due to seriousness criteria of death and medically significance.  The reporter did not provide causality assessment to Fluad (TIV).  Company comment: A 78-year-old female patient was administered Fluad (TIV) vaccine. Reportedly, the patient died two days after vaccination. The cause of death was not provided. It was unknown if autopsy was performed. Patient's advanced maternal age may have contributed to development of the event. More information regarding medical history and autopsy results is needed. With information available, causality is unassessable.; Sender's Comments: A 78-year-old female patient was administered Fluad (TIV) vaccine. Reportedly, the patient died two days after vaccination. The cause of death was not provided. It was unknown if autopsy was performed. Patient's advanced maternal age may have contributed to development of the event. More information regarding medical history and autopsy results is needed. With information available, causality is unassessable.; Reported Cause(s) of Death: Unknown cause of death
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Rash
Clinical narrative: Rash, what looked like bug bites started around ankles and moved up my legs.  Achy muscles (biceps & quads).  Nausea
Age: 0.75
Sex: M
Vaccine: FLU4, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Hepatitis A given in error as child is 9 months old.  Should have received Hepatitis B Per Dr. no adverse reaction expected.  Parents notified
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Sleep disorder
Clinical narrative: severe pain affecting patient sleep. patient unable to lift arm above head without feeling severe pain.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Injection site pruritus, Pruritus, Skin warm, Swelling
Clinical narrative: Patient reported approx. 10 min. after vaccination - reported itching around injection site and increased heart rate.  Approximately 10 minutes later returned to clinic and reported that itching spread to entire left arm and was noticing swelling and warmth.  Symptoms improved with diphenhydramine (Benadryl) 25 mg PO.  No further issues reported by patient.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Nodule, Pain
Clinical narrative: significant pain last over 2 months, moderate size palpable but not visible nodule (about a quarter size) recommended observation and f/u in 3 mo.
Age: 1.83
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Given incorrect vaccine to child. Contacted mother to inform her. No reported symptoms at this time
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Neck pain and could not turn his head all the way,  left arm pain.  Treated with Tylenol
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Five doses of varivax that underwent the temperature excursion were administered; This spontaneous report has been received from a physician  concerning a 4 years- old patient of unknown gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.  On 28-JUN-2020,  the patient was vaccinated with one of the five doses  that underwent temperature excursion of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous injection 0.5 milliliter once for prophylaxis.  Lot # reported as S026925 (Patient route of administration and expiration date was not reported). No additional adverse events were reported.  The storage temperature was reported  to have been at -9.2 celsius degrees (°C) and in between  -14 celsius degrees (°C) to -10 celsius degrees (°C) (-14.3) for 30 minutes.  There was digital data logger involved and  no previous temperature excursion was reported.  Lot #  S026925 is an invalid lot number for varicella virus vaccine live (oka/merck)  This is one of many reports received from the same reporter about related temperature excursion cases.; Sender's Comments:  US-009507513-2008USA011114:related case # 01687213 US-009507513-2008USA011596:Related case # 01687214 US-009507513-2008USA011552:Related case # 01687189 US-009507513-2008USA011473:Related case #01687223
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: A patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a Licensed Practical Nurse referring to a 3 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 14-AUG-2020, the patient was vaccinated with an improperly stored dose of  hepatitis a vaccine, inactivated(VAQTA) (strength, dose, frequency, and anatomical location were unknown) with lot # S032358, and expiration date 11-JAN-2021, intramuscular for prophylaxis.    The administered dose of hepatitis a vaccine, inactivated(VAQTA) experienced the temperature excursion above of  47 °F degrees Fahrenheit  / 9°C (8.9 °C) Celsius degrees for 33 minutes. There was a digital data logger invloved, but there was no previous temperature excursion. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  manufactureraddress:  manufacturercity:  manufacturerstate: ; manufacturercountry: ; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product storage error
Clinical narrative: Took second dose of Vivotif one day late; Spontaneous report received on 08JUL2020.  A pharmacist reported that a female consumer "took second dose of Vivotif one day late" (PT: Inappropriate schedule of product administration). She was receiving Vivotif for immunisation. On an unknown date, the consumer started Vivotif. She took her second dose of Vivotif one day late. It was reported that she did not know when she took the dose but it was in Jun 2020. Moreover, it was reported that the vaccine was left unrefrigerated at unknown room temperature for 3 hours, 5 hours, 8 hours and according to the temperature excursion, the vaccine was still good to use. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took second dose of Vivotif one day late (Inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of  inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took second dose of Vivotif one day late (inappropriate schedule of product administration) and she also consumed Vivotif dose after it was left unrefrigerated at unknown room temperature for 3 hours, 5 hours, 8 hours (product storage error). Vivotif dose should be taken every other day and Vivotif should be stored in the refrigerator at the recommended temperatures. The causality of  inappropriate schedule of product administration and product storage error is assessed as not applicable to Vivotif.
Sex: F
Vaccine: TDAP
Symptoms: Memory impairment
Clinical narrative: difficulty with short-term memory; Initial information was received on 25-Aug-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a female patient (age was not reported) who had difficulty with short-term memory (memory impairment), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (batch number and other dosing details were not reported) for prophylactic vaccination.  On 25-Aug-2020, the patient had (non-serious) difficulty with short-term memory (memory impairment), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on the batch number for this case.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Injection site swelling, Peripheral coldness
Clinical narrative: Patient came in Monday 8/31/20, after receiving the shot on 8/26/20 to let us know that she had a reaction to her shot after receiving it Wednesday night.  She said that she had very cold feet and was shivering to the point that she needed a blanket.  I asked if she had a fever but, she said that she did not check her temperature.  She also mentioned that her arm swelled up around the injection site.  She said that she gets the flu shot every year and has even had the same Fluzone HD vaccine in previous years without any issues.  She also said that she is not having any complications from the shot at this time and that the swelling has subsided too.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pt is fine, no problems  Extra Pediarix dose given instead of Dtap
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reporting severe soreness in upper arm continuing from day of injection through time of reporting (9/1/20). When lifting anything with arm or even holding anything (stated it was a gallon of milk) reports shooting pains that require him to stop or drop object immediately.  Advised to contact Primary Care Physician for follow-up on 9/1/2020
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: On 08/25/20, mother noticed some redness and swelling at injection site and patient was complaining that it was itchy. The redness and swelling continued to progress and covered majority of the upper half of right thigh. Mother took patient to Urgent Care and was diagnosed with cellulitis and prescribed antibiotics. Patient was seen here in our office on 08/31/20 and the redness and swelling seemed to be resolving.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia, Seizure
Clinical narrative: Patients mother reports shortly after returning home (approximately 10 minutes after vaccination) patient complained of his arm tingling. Mother reports 20 minutes later, Patient began having a seizure.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Dyskinesia, Feeling abnormal, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: At 9 pm the day that the vaccine was given(8/27/2020), patient had an episode of abnormal movements of extremities followed by stiffening of the extremities, not responsive and spacing out. lasted about 1-2 minutes. 911 was called and patient was examined by paramedics. Had returned to baseline soon after incident. Seen in the office 9/1/2020, normal exam.
Age: 65.0
Sex: U
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Gait disturbance, Gait inability, Loss of personal independence in daily activities
Clinical narrative: Box 9 - HCTZ 25mg, Potassium ER 8meq, Estradiol 0.05mg, Metformin ER 500mg, Seroquel 200mg, Atorodrastatin 40mg, Singular 10mg, Narco 10/325  Went home and laid down. Started feeling tremendously painful muscle spasms under breasts, both calves, both hands, all fingers, down lower back. Felt a rush of blood to brain. Current day, gait is uneven and I feel lightheaded when I try to use my legs. Very fatigued and dizzy, unable to shower and have to crawl vs walk.
Age: 65.0
Sex: U
Vaccine: FLU4
Symptoms: Muscle spasms, Pain
Clinical narrative: Box 9 - HCTZ 25mg, Potassium ER 8meq, Estradiol 0.05mg, Metformin ER 500mg, Seroquel 200mg, Atorodrastatin 40mg, Singular 10mg, Narco 10/325  Went home and laid down. Started feeling tremendously painful muscle spasms under breasts, both calves, both hands, all fingers, down lower back. Felt a rush of blood to brain. Current day, gait is uneven and I feel lightheaded when I try to use my legs. Very fatigued and dizzy, unable to shower and have to crawl vs walk.
Age: 17.0
Sex: M
Vaccine: MENB, HPV9, MENB, MNQ
Symptoms: Balance disorder, Dizziness, Headache, Injected limb mobility decreased, Pain in extremity
Clinical narrative: On the day of vaccine patient experienced dizziness, off balance, head ache and L arm pain which he was unable to extend.  He followed up next day with Dr. treated with Benadryl Tylenol and Motrin  today patient is in our office he is still experiencing left arm pain.
Age: 17.0
Sex: M
Vaccine: MENB, HPV9, MENB, MNQ
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain, Swelling
Clinical narrative: On the day of vaccine patient experienced dizziness, off balance, head ache and L arm pain which he was unable to extend.  He followed up next day with Dr. treated with Benadryl Tylenol and Motrin  today patient is in our office he is still experiencing left arm pain.
Age: 46.0
Sex: M
Vaccine: HEP, HEPA, MMR, TDAP, TYP
Symptoms: Arthralgia
Clinical narrative: Patient reports experiencing generalized joint pain with severe joint pain in the knees a few days after receiving immunizations. Pt. reports that the joint pain resolved within a few days of onset without treatment. Patient currently reports no joint pain and reports no other adverse symptoms.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity
Clinical narrative: patient had pain and soreness in upper arm. it increased in the evening after the vaccine administration during her hours of work lifting product.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Gait disturbance
Clinical narrative: Patient described back pain that prevented her from walking.  Reported 1-2 hours after injection.
Age: 71.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: itchy welts appeared on legs and ankles. Patient applied Calamine and the welts disappeared temporarily, for maybe 3 or 4 hours. Still having symptoms as of 9/1/20. When patient took Claritin today the symptoms subsided
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: patient said she developed tinnutis after getting the shingrix vaccine. She called Friday 8/28 to let me know, then on Sunday 8/30, she said she lost hearing in that ear.
Age: 21.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Headache, Injection site pain, Pruritus, Rash
Clinical narrative: About an hour and half after receiving the vaccine  the patient was complaining of dizziness and a headach. I observed the patient and asked if she felt itchy, had a rash, felt like throat was closing or any pain at injection site. Patient denied any of these. I asked her if she would like a dose of Benadry(25mg) and she agreed. I administered Benadryl liquid 10 ml. I also asked her if she had eaten today which she confirmed and also asked her if she would like something to drink. She asked for Gatorade which we gave her. Her Mother arrived and told me she had anxiety when she underwent a  medical procedure because of prior knee arthroscopies. I told her Mother what I had done and she was fine with everything and thanked me for treating  her daughter. I told her the Benadryl would make her sleepy and she told me she would be taking her home shortly. She thanks me again.
Age: 21.0
Sex: F
Vaccine: FLUR4
Symptoms: Throat tightness
Clinical narrative: About an hour and half after receiving the vaccine  the patient was complaining of dizziness and a headach. I observed the patient and asked if she felt itchy, had a rash, felt like throat was closing or any pain at injection site. Patient denied any of these. I asked her if she would like a dose of Benadry(25mg) and she agreed. I administered Benadryl liquid 10 ml. I also asked her if she had eaten today which she confirmed and also asked her if she would like something to drink. She asked for Gatorade which we gave her. Her Mother arrived and told me she had anxiety when she underwent a  medical procedure because of prior knee arthroscopies. I told her Mother what I had done and she was fine with everything and thanked me for treating  her daughter. I told her the Benadryl would make her sleepy and she told me she would be taking her home shortly. She thanks me again.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dizziness, Headache, Pain
Clinical narrative: After vaccine was administered when the patient went home she experienced body ache head ache and dizziness.  She was treated with Benadryl and Advil 800 she felt better after 3 days.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Pain, Vertigo
Clinical narrative: After vaccine was administered when the patient went home she experienced body ache head ache and dizziness.  She was treated with Benadryl and Advil 800 she felt better after 3 days.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: C-reactive protein increased, Chest discomfort, Chest pain, Ejection fraction decreased, Electrocardiogram ST segment elevation
Clinical narrative: On 11 APR 20 (day 11) in the evening he experienced progressing severe chest pain and pressure. ER notes document peak trop of-I on 13 APR of 35.072, ESR 27, CRP 7.4; which corrected to trop -.2 CRP 0.6 & ESR 11 at discharge 16 APR. Echo LVEF 55% 12 APR and 60% 26 MAY 20, no effusion. EKG 11 APR demonstrated diffuse ST elevation and one episode of NSVT 12 APR was treated with amiodarone.  Treatment was Toradol, ibuprofen, colchicine, ASA, Percocet and Protonix. No beta blocker due to low BP. He was discharged on ibuprofen, colchicine and Protonix.   He saw cardiology at 6 weeks for follow-up. He had ETT and repeat echo which were normal. He will see them at 6 months. He is currently on no meds and released to usual activity.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Exercise test normal, Red blood cell sedimentation rate increased, Troponin I increased, Ventricular tachycardia
Clinical narrative: On 11 APR 20 (day 11) in the evening he experienced progressing severe chest pain and pressure. ER notes document peak trop of-I on 13 APR of 35.072, ESR 27, CRP 7.4; which corrected to trop -.2 CRP 0.6 & ESR 11 at discharge 16 APR. Echo LVEF 55% 12 APR and 60% 26 MAY 20, no effusion. EKG 11 APR demonstrated diffuse ST elevation and one episode of NSVT 12 APR was treated with amiodarone.  Treatment was Toradol, ibuprofen, colchicine, ASA, Percocet and Protonix. No beta blocker due to low BP. He was discharged on ibuprofen, colchicine and Protonix.   He saw cardiology at 6 weeks for follow-up. He had ETT and repeat echo which were normal. He will see them at 6 months. He is currently on no meds and released to usual activity.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effects pt forgot they got their 2nd dose with pharmacy and they got an extra dose of shingrix. they discovered after going back home from their immunization records
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: In the right arm, the patient experienced swelling, tenderness and warm to the touch for 4 days following the vaccine administration. Patient did not report having a temperature.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis
Clinical narrative: PATIENT STATED DR DIAGNOSED VIA PICTURE OF ARM HAVING CELLULITIS FROM INJECTION. ANTIBIOTIC GIVEN.
Age: 58.0
Sex: F
Vaccine: FLUR4, MMR
Symptoms: Feeling hot, Nausea, Unresponsive to stimuli
Clinical narrative: Patient received the flu vaccine first and the MMR approximately 3 minutes later.  The patient stated that she was fine after each vaccine but then about 3 to 4 minutes after the MMR she stated that she felt very nauseous and then very hot.  I immediately began to fan her and at first she said she was ok and able to breathe deeply when asked to do so.  Within another minute or so the patient appeared to be losing alertness and I called for assistance. The patient never lost consciousness although seemed unable to respond briefly and at that point I directed my assistant to call 911. At hearing that,  the patient almost immediately became alert and responsive and stated that she was fine and "coming back"  The patient was observed for approximately 15 minutes more, offered further assistance but declined and stated she was OK
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm was swelling and hot to touch on Monday 8/31/20. Arm was hurting. No fever. Flu shot given on Saturday 8/29/20
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Coordination abnormal, Hemiparesis
Clinical narrative: Weakness on right side, loss of co ordination, temp of 103* .
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Ear pain, Fatigue, Headache
Clinical narrative: Chills, Shivering, Nausea, Headache, Muscle Ache, Fatigue, Earache, chest pain The chills, shivering, ear ache and chest pain lasted 12 hours. Nausea, headache, muscle ache and fatigue lasted 24 hours. Treatment was ibuprofen and Naproxen.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Chills, Shivering, Nausea, Headache, Muscle Ache, Fatigue, Earache, chest pain The chills, shivering, ear ache and chest pain lasted 12 hours. Nausea, headache, muscle ache and fatigue lasted 24 hours. Treatment was ibuprofen and Naproxen.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Vaccine was administered subcutaneously rather than Intramuscular and  I have injection site pain, tenderness, swelling, redness and general ill-feeling.
Age: 72.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Chills, Dysphonia, Myalgia, Pyrexia, Vocal cord paralysis
Clinical narrative: Patient received the vaccines on 9/16/2019 at.  on 9/17/2019 patient started  having fevers, chills, myalgia and vocal cord paralysis. After the second shingrix vaccine  was given on 2/20/2020 patient had no issues.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Haemorrhage, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient received vaccination in left arm.  Shot given in correct arm.  There was some bleeding, no pain.  Later that evening, patient's mother stated that the arm was warm, swollen, and itchy.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Patient developed a large circular itching rash on back of left shoulder that looks like shingles.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: NOTATION-both doses included; the 1st dose was 8/23/2018 but with the same reactions.  headache, low grade fever, muscle pain/aches, tired.