chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), in right arm, on 08Apr2021 as dose 2, single (Lot number: EW0153), in right arm, on 14Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: BUDESONIDE, stop date: 21Sep2022; OMEPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19; positive, notes: Recurrence if Covid symptoms, positive test results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Anti viral medication received by patient due to the event was Paxlovid, from 21Sep2022 to 26Sep2022. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EP7534 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP7534, fill lot EP7532, and the formulated drug product lot EP7528; lot EW0153, fill lot EP8692 and the bulk formulated drug product EW8071; lot FF8839, fill lot FF8833, and the bulk formulated drug product FA9148; and lot FJ9943, fill lot FJ9942 and the bulk formulated drug product FJ9940. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
This spontaneous report was received from a physician via a company representative refers to a male patient of unknown age. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date, the patient experienced herpes zoster describe as "breakthrough" shingles and rash. The patient sought medical attention and saw Doctor. It was unspecified if treatment was given and if lab diagnostics studies were performed. The outcome of herpes zoster and rash was reported as recovered/resolved on an unknown date. The relatedness between the herpes zoster and rash, and therapy with ZOSTAVAX was not reported. Additional information has been requested.
I experienced tiredness, runny nose, cough and the day after my vaccination my blood sugar was high and would not come down.
This spontaneous report was received from a physician, via a company representative, referring a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque Forming Unit (PFU), subcutaneously, "one time vaccination" for prevention of herpes zoster. (lot # and expiration date were not reported). It was stated that the vaccine was administered incorrectly at the wrong injection site. The patient sought medical attention by visiting doctor's office and was diagnosed with cellulitis; which was treated with unspecified antibiotics.  There was not a product quality complaint (PQC) involved. At the time of reporting the outcome of cellulitis was reported as unknown. The causality assessment between cellulitis and ZOSTAVAX was not reported. Upon internal review cellulitis was determined to be a medically significant event. As of 30-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: , MERCK 1611USA009008:Mfr number.
This is a spontaneous report from a non-clinical study program from a contactable retired physician reporting for herself. A 78-year-old female patient received PREVNAR 13, via an unspecified route of administration in arm, on 08Dec2014, at single dose. Relevant medical history included asthma and osteoarthritis. Concomitant medications included ADVAIR 2x/day, SINGULAIR at 10mg 1x/day and meloxicam at 60 mg. Past drug history included PREVNAR 13 in 1997 or 1998, with no adverse reaction. On 08Dec2014 PREVNAR 13 was given too much in the arm and the patient experienced abnormal reactions to PREVNAR 13. Two days after vaccination the patient experienced inflammation in the deltoid area of her upper arm. She said that on 14Dec2014 it burst in abscesses, her skin was sloughed off and it drained out. The reporter said that when it slowed down she left it open during the day time but at night she had to cover it as it was still draining. She had to change clothes two times a day. Drainage recovered on 28Dec2014. The physician also said her last big scab filled out on 13Jan2015. On 15Dec2014 her doctor put her on KEFLEX 500 mg four times a day for 10 days. The physician said that KEFLEX helped her a lot. Outcome of the other reported events was unknown at the time of this report. The physician assessed all the events as directly connected with the administration of PREVNAR 13 as it was given too much in the arm.
On 10/16/2003 at 13:50, returned phone call to patient's mom who reported that this AM, patient complained of discomfort of left arm.  Describes swelling and redness of upper left arm, shoulder to elbow.  Discomfort with movement. No change in circulation, sensation, or mobility of lower arm.
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm, in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "non hodgkins lymphoma follicular" (unspecified if ongoing), notes: non hodgkins lymphoma follicular. The patient had no Known allergies. Concomitant medication(s)/Other medication in 2 weeks included: LEVOTHYROXINE, start date: 12Jul2006, stop date: 27Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: rebound COVID-19 infection 4 days after testing negative; Positive, notes: rebound COVID-19 infection 4 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Antiviral details-[{Product- COVID 19 Treatment, Brand- Paxlovid, Treatment start date- 14Apr2022, Treatment stop date- 19Apr2022, Indication-Treatment of COVID-19}]. Covid vaccine details: [{Vaccine brand -Pfizer / BioNTech, Vaccine brand unknown- False, Vaccine administration date- Aug2021, Vaccine lot unknown- True, Vaccine lot unknown reason- Not available/provided to reporter at the time of report completion, Vaccine dose number- 3, Vaccine dose number unknown- False, Vaccine location- Left arm}, {Vaccine brand -Pfizer / BioNTech, Vaccine brand unknown- False, Vaccine administration date- Feb2021, Vaccine lot unknown- True, Vaccine lot unknown reason- Not available/provided to reporter at the time of report completion, Vaccine dose number- 2, Vaccine dose number unknown- False, Vaccine location- Left arm}, {Vaccine brand - Pfizer / BioNTech, Vaccine brand unknown- False, Vaccine administration date- 26Dec2020, Vaccine lot unknown- True, Vaccine lot unknown reason- Not available/provided to reporter at the time of report completion, Vaccine dose number- 1, Vaccine dose number unknown- False, Vaccine location- Left arm}]. Adverse event- rebound COVID-19 infection 4 days after testing negative  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Thyroid nodules; This is a spontaneous report received from a contactable Nurse. A 72-year-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number not provided), via an unspecified route of administration on an unspecified date (at the age of 72-year-old) as a single dose for COVID-19 immunization. The patient previously took bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included Lung Cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced Thyroid nodules. she reported that her mother had the same AE after her second dose of Pfizer-BioNTech COVID-19 Vaccine. Her mother is 72 and had lung cancer.The outcome of the event was unknown.  No more information was provided.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
They administered patients and staff from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administered patients and staff from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They administered patients and staff from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They administered patients and staff from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were reported.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# unknown). On an unknown date the patient experienced an unspecified adverse event. The outcome of the event was unknown. Additional information has been requested.
Tingling sensation in extremities followed by an itchy rash, redness, and hives in arms, neck, face, and chest.
cold like symptoms; This is a spontaneous report received from a contactable consumer.  A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 15Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "cold like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
@ 1.30am  chills, low grade fever, weak. Weak and drained for 2 more days but not bad enough to stay home from work.  Reactions come in waves. Extreme for a while then nothing for a while; @ 1.30am  chills, low grade fever, weak. Weak and drained for 2 more days but not bad enough to stay home from work.  Reactions come in waves. Extreme for a while then nothing for a while; @ 1.30am  chills, low grade fever, weak. Weak and drained for 2 more days but not bad enough to stay home from work.  Reactions come in waves. Extreme for a while then nothing for a while; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that,  A 62-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) (at the age of 62 years old), dose 2 via an unspecified route of administration, administered in arm right on 16May2021 11:00 as dose 2, single for covid-19 immunisation, administered in pharmacy or Drug Store. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm right on 25Apr2021 12:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 17May2021 at 01:30 am patient experienced chills, low grade fever, weak. Patient was weak and drained for two more days but not bad enough to stay home from work. Reactions came in waves, extreme for a while then nothing for a while. Treatment was not received for the events. She did not have covid prior to vaccination. The patient was not receive any other vaccines within 4 weeks. She was not tested for covid post vaccination. She had no known allergies. The lab data included low grade fever on 17May2021. The outcome for the events was recovering.  Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
This spontaneous report as received from a nurse refers to a 6 months 8 days old female patient. No concurrent condition, medical history of allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 14-MAR-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008981, 1405USA008982). Additional information has been requested.
Client was only 17 years old when she received single dose Janssen. Client and parent notified. No adverse sided affects noted per parent.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit; 32 to 35 degrees Fahrenheit for 64 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012527: US-009507513-1703USA010513: US-009507513-1703USA012526.
2 days Blood pressure 150/90 (normal 115/70) Heart rate 90 (normal low 60s)  Ongoing Lightheadedness
subjective 50 yo female presenting for 2nd covid vaccine with h/o anxiety a/w tingling in left hand 15 min after first covid vaccination which resolved during a 30 min observations period .  Again, approximately  15min after the 2nd covid vaccination  c/o tingling without weakness in the palm of left hand a/w anxiousness  Pt denies swelling in hand, no rash, no flushing, no swelling sensation in face or neck, no globus no sob no wheezing no chest pain no palpitation no gi sx no headache no altered mentation or brain fog Objective Pulse 63 bp=154/103 rr 12 temp afeb Heent wnl Neck wnl Chest clr p&a Cor rrr Neuro grossly intact Skin clr  Assessment/plan Anxiety with psychosomatic features and elevated bp due to hyperadnergic state from anxiety. Pt reassured being observed by physician and pt reclined in a quiet room. Repeat vital signs were  p 64  bp 150/89 and p 62 bp  120/85 repectively d . pt discharged home with resolution of left hand paresthesia and normalized vital signs
Sore Injection Site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Sore Injection Site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore Injection Site). At the time of the report, VACCINATION SITE PAIN (Sore Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On 01-FEB-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX lot # K020802. Additional information has been requested.
Awake every hour going to the bathroom after 2nd dose; Vertigo after the 2nd dose; Staggering to bathroom like had been drinking after 2nd dose; Dehydrated from going to the bathroom after 2nd dose; Losing balance and hitting the walls after 2nd dose; Puncture area very hard and felt like vaccine stayed there after 2nd dose; Nauseous after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Awake every hour going to the bathroom after 2nd dose), VERTIGO (Vertigo after the 2nd dose), URINE OUTPUT INCREASED (Staggering to bathroom like had been drinking after 2nd dose), DEHYDRATION (Dehydrated from going to the bathroom after 2nd dose) and BALANCE DISORDER (Losing balance and hitting the walls after 2nd dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Awake every hour going to the bathroom after 2nd dose), VERTIGO (Vertigo after the 2nd dose), URINE OUTPUT INCREASED (Staggering to bathroom like had been drinking after 2nd dose), DEHYDRATION (Dehydrated from going to the bathroom after 2nd dose), BALANCE DISORDER (Losing balance and hitting the walls after 2nd dose), VACCINATION SITE INDURATION (Puncture area very hard and felt like vaccine stayed there after 2nd dose) and NAUSEA (Nauseous after 2nd dose). At the time of the report, INSOMNIA (Awake every hour going to the bathroom after 2nd dose), VERTIGO (Vertigo after the 2nd dose), URINE OUTPUT INCREASED (Staggering to bathroom like had been drinking after 2nd dose), DEHYDRATION (Dehydrated from going to the bathroom after 2nd dose), BALANCE DISORDER (Losing balance and hitting the walls after 2nd dose), VACCINATION SITE INDURATION (Puncture area very hard and felt like vaccine stayed there after 2nd dose) and NAUSEA (Nauseous after 2nd dose) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-022025 (Patient Link).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Peanuts" (unspecified if ongoing), notes: Known allergies: Peanuts and tree nuts; "tree nuts" (unspecified if ongoing), notes: Known allergies: Peanuts and tree nuts. The patient's concomitant medications were not reported. No other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 03Aug2023 to 07Aug2023, for Treatment of COVID-19. The patient has not recovered from rebound COVID from 12Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt recv vax 21MAY96 & 4hr later pt exp nausea, & very bad h/a;No further details were provided;
Pruritic rash all over body that started approximately 2 hours after administration, lasted for a few more hours after taking Benadryl and Famotidine.
Dose of Engerix B that expired on Sep 4th 2020; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 70-year-old female patient who received HBV (Engerix B) (batch number 94S22, expiry date 4th September 2020) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Engerix B. On 10th September 2020, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Medical assistant reported that on 10th September 2020 a female patient received 1st dose of Engerix B that expired on 4th September 2020. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter.