chrisvoncsefalvay/vaers-outcomes huggingface dataset:
collapsed unconscious; collapsed unconscious; some shaking; sweating; walking difficulty; disoriented; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (collapsed unconscious) and SYNCOPE (collapsed unconscious) in a  patient of an unknown age and gender 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 23-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (collapsed unconscious) (seriousness criterion medically significant), SYNCOPE (collapsed unconscious) (seriousness criterion medically significant), TREMOR (some shaking), HYPERHIDROSIS (sweating), GAIT DISTURBANCE (walking difficulty), CONFUSIONAL STATE (disoriented) and VOMITING (Vomiting). At the time of the report, LOSS OF CONSCIOUSNESS (collapsed unconscious), SYNCOPE (collapsed unconscious), TREMOR (some shaking), HYPERHIDROSIS (sweating), GAIT DISTURBANCE (walking difficulty), CONFUSIONAL STATE (disoriented) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.  Company Comment : This case concerns a patient of an unknown age and gender, with no details on relevant medical history, who experienced the unexpected serious events of LOSS OF CONSCIOUSNESS and SYNCOPE. The events occurred after a dose of mRNA- 1273 vaccine.  The rechallenge was not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no details on relevant medical history, who experienced the unexpected serious events of LOSS OF CONSCIOUSNESS and SYNCOPE. The events occurred after a dose of mRNA- 1273 vaccine.  The rechallenge was not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
3pm - trembling and extreme cold and fatigue. 5pm in addition to the above, 102.2 fever and sweating.  7pm - in addition to the above, headache 9pm - headache   Saturday 3/20/21 Headache remains. But the fever subsided, as did the trembling.
3/18, admiteed 2 days after covic vaccine with SOB, rib pain, emesis. Patient had metastatic ovarian cancer on chemotherapy who was admitted to the intensive care unit with severe sepsis with septic shock and acute hypoxemic respiratory failure requiring intubation mechanical ventilation. She was started on broad-spectrum antibiotics, but did not have an obvious source of infection.  She remained on mechanical ventilation, with profound metabolic acidosis.  She required high doses of norepinephrine and vasopressin drips, but on arterial blood gas had a pH of 6.98.  The patient had a cardiopulmonary arrest in the intensive care unit.  1 round of ACLS protocol was performed, with return of spontaneous circulation.  After discussion with the patient's mother by phone, she opted for DNR status, comfort care, and to allow for natural death.  The patient was kept on mechanical ventilation, and she passed away.
Patient reported experiencing pain in left arm, swelling of entire left arm, pain radiating to neck beginning 2-3 hours after injection. Continued with swelling in the upper left arm, warmth to touch, numbness in tingling in the left arm, headache, and intermittent nausea at time of evaluation by Dr on 4/17/18
No additional  adverse effects reported; received one dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and drug reactions/allergies were not reported. On 15-MAY-2020, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously (lot# S022756 with expiration date of 22-JUL-2021 and lot# R020654 with expiration date of 18-JUL-2020) for prophylaxis (Product storage error)(anatomical location was not reported). Concomitant therapies included sterile diluent which was reported to be stored properly. No additional adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 5.7 degree Fahrenheit (F) and had previous temperature excursion from 13.3 degree Celsius (C) to 13.2 degree Celsius (c) for 18 minutes. Data logger was involved. No product quality complaint (PQC) was associated with this report.
Narrative: COVID infection following COVID vaccine series 01/19, Pfizer, dose #1 02/09, Pfizer, dose #2 08/17 COVID swab, result: not detected 10/02 COVID swab, result: detected 10/02 SARS-OV-2 Variant Sequencing result: pending 10/02 pt cc: cough, fatigue, fever, headache, exposure: unknown
pt recvd vax & was crying for 12 hrs - screamed continuously beginning w/in hr of inject;
Within 1-2 weeks after the second shot, I developed sharp shoulder pain during certain activities and shoulder movement was restricted.   Diagnosed with adhesive capsilitus ("frozen shoulder syndrome").   Pain has subsided now but shoulder movement is still restricted.
Tuesday night - fever and diarrhea; Wednesday-Saturday - fever and diarrhea persisted quite extensively (Wed and Thursday I had a lot of chills and body aches). Saturdays diarrhea slowed down - and I went to ER - muscles were pushing - I felt my electrolytes were out of whack. I02 degree fever so they gave me Tylenol. They gave me two bags of fluids. My heartrate was in mid 120s when I went in and after fluids it went down to the 70's. I was discharged after that. I was swabbed for COVID - negative. Sunday I was still lethargic and fatigue; diarrhea slowed down quite a bit and I was able to eat some food. Monday I came back to work - not 100% in health but felt better.
Both times after vaccination the patient had a reaction, further described as she developed hives. Her doctor thought it was the PEG in the vaccine that caused the reaction; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Both times after vaccination the patient had a reaction, further described as she developed hives. Her doctor thought it was the PEG in the vaccine that caused the reaction) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Both times after vaccination the patient had a reaction, further described as she developed hives. Her doctor thought it was the PEG in the vaccine that caused the reaction). At the time of the report, URTICARIA (Both times after vaccination the patient had a reaction, further described as she developed hives. Her doctor thought it was the PEG in the vaccine that caused the reaction) outcome was unknown.            No concomitant medications were reported.  Her doctor thought it was the PEG in the vaccine that caused the reaction. No treatment medications were reported.
presented to EC and admitted to hospital for nausea and vomiting the night she received vaccination, admit to hospital until 4/5 for deconditioned state
Pain, swelling and discoloration in left leg which was later diagnosed as a deep vein thrombosis (DVT). Labs, sonograms and studies were performed and no genetic condition was present.
lt upper arm red,warm to touch & swollen w/knot;would not use arm;t99 used cool compress & APAP;mom states 2/3 of upper arm was red & swollen;5MAR96 nodule quarter to half dollar size,warm to touch,sl pink color,using arm
Pt recv vax on 3/3/99; on 3/4/99 pt exp hard/ red/ hot/ swollen/ painful area on lt leg; tx=cool compress, Tylenol
received a SHINGRIX dose by mistake today when he went for a Covid vaccine; received a SHINGRIX dose by mistake today when he went for a Covid vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-JUL-2023, the patient received Shingrix (unknown arm). On 13-JUL-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: received a SHINGRIX dose by mistake today when he went for a Covid vaccine) and wrong vaccine administered (Verbatim: received a SHINGRIX dose by mistake today when he went for a Covid vaccine). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK receipt date 13 Jul 2023: The reporter was the uncle of a patient and was concerned about possible harm.  The patient received a SHINGRIX dose by mistake when he went for a Covid vaccine. The patient was a healthy 15 year-old. The uncle did not know the pharmacy where the injection was received, nor did he know which arm it was received in. The reporter did not consent to follow-up. The 15 year-old patient received a SHINGRIX dose by mistake when he went for a Covid vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered.
pt recv 2 doses of vax & pt did not seroconvert p/full series;MD commented that pt broke out in a full case of varicella following vax;when nurse obtained pt chart MD commented that there was no rash or varicella;
had a red patch that was hot around the site; The muscles in her entire right arm are very sore and says that it's painful; had a red patch that was hot around the site; red patch on my arm was just red and hot and hard; The muscles in her entire right arm are very sore and says that it's painful; This is a spontaneous report received from contactable consumer (patient). An 80-year-old female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9267, and Expiration date: Unknown), via an unspecified route of administration, administered in upper right arm on 25Feb2021 as 2nd dose, single dose for COVID-19 immunization. The patient's medical history included psoriatic arthritis, Deaf (I am on a 'casting' call phone because I am deaf) and the patient also took Penicillin (I was three years old saved my life). The patient's concomitant medications were not reported. The patient stated that she took lot of medications (unspecified) she had a set of "tremor", it was a long list. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269, and Expiration date: Unknown) in left arm on 04Feb2021 as 1st dose, single dose for COVID-19 immunization. The patient had infusion of Simponi on 04Feb2021 the same day she took first dose of vaccine. No other vaccine was administered prior to first dose of COVID vaccine. It was reported that the patient experienced a side effect after getting the second dose of the Pfizer-BioNTech COVID-19 Vaccine on an unspecified date in 2021. Originally, she had a red patch that was hot around the site in the hand for about two weeks. The muscles in her entire right arm are very sore and said that it's painful when she reached. The entire arm was painful and uncomfortable, and it was getting worse. On an unspecified date in 2021, the patient was recovered from the event "red patch on my arm was just red and hot and hard" and outcome was unknown for the event "the muscles in her entire right arm are very sore and says that it's painful"  Follow up needed, further information has been requested.
Itchy; Red; Rash; Arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), ERYTHEMA (Red), RASH (Rash) and VACCINATION SITE PAIN (Arm was sore at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore at the injection site). On 30-Mar-2021, the patient experienced PRURITUS (Itchy), ERYTHEMA (Red) and RASH (Rash). The patient was treated with CORTISONE at a dose of Cortisone-10 cream and ALCOHOL at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy), ERYTHEMA (Red), RASH (Rash) and VACCINATION SITE PAIN (Arm was sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
The patient was vaccinated with improperly stored vaccine of PNEUMOVAX23; This spontaneous report was received from a nurse, referring to a 24 years old patient of unknown gender. The patient´s pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 01-SEP-2020, the patient was vaccinated with an improperly stored doses of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliters, lot number: T009744 and expiration date: 28-JAN-2022 (dosage regimen, route of administration and anatomical location were not reported) for prophylaxis.  The improperly stored of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) experienced a temperature excursion of 48.39 Fahrenheit degrees (°F) for 1 hour and 45 minutes without a previous temperature excursions. It was confirmed that a digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: T009744; expirationdate: 28-JAN-2022; 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
Patient experiencing itchy rash on arms and back approximately 20 minutes following first dose of Pfizer. Patient given 50mg IM Benadryl at vaccination site. Symptoms resolved about 10 minutes after receiving Benadryl.
PATIENT RECEIVED SECOND DOSE 59 DAYS AFTER FIRST DOSE OF PFIZER
This literature marketed report was received from the authors of the published literature article. The authors performed a retrospective chart review to assess hepatitis B titters in children with celiac disease and whether baseline titers were affected by the presence of other autoimmune diseases, gender or vitamin D levels. 67 children that had a baseline hepatitis B titer after the primary vaccine series for hepatitis B were involved. The average age of diagnosis of celiac disease was 6.74 years. The majority (60/67) were diagnosed via endoscopic biopsy while 10.4% (7/67) were diagnosed via serology based on European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guidelines. Thirty-six (53.7%) were male and 31 (46.3%) were female. 60.6% of children (40/66) had normal vitamin D-25 levels. Of the 67 children, 25 (37.3%) had positive hepatitis B surface antibody levels (greater than 12 mIU) and 42 (62.7%) had negative hepatitis B surface antibody levels. There was no difference in response to the initial primary hepatitis B vaccine (recombinant) (manufacturer unknown) series based on gender. Twenty-three percent of children (6/26) with vitamin D levels <30 ng/mL (considered as low) and 45% of children (18/40) with vitamin D levels greater or equal to 30 ng/mL (normal level), had positive hepatitis titers (p=0.07). Twenty-one percent of children (3/14) with an additional autoimmune disease and 42% in children (22/53) without presence of an additional autoimmune disease, demonstrated hepatitis B immunity following primary vaccination (p=0.22). This literature report refers to 20 children of unknown gender (exact age was not provided) with celiac disease. On unknown dates, the patients were vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) series (dose, route of administration, therapy type, lot# and expiration date were not reported) for prophylaxis. On unknown dates, the patients had negative hepatitis B surface antibody levels. The patients started a gluten free diet on unknown dates. On unknown dates, the patients were revaccinated with one additional hepatitis B vaccine (recombinant) (manufacturer unknown) vaccine. All of the patients showed a positive titer (greater than 12 mIU) following revaccination on unknown dates. The authors considered the event of negative hepatitis B surface antibody levels to be related to hepatitis B vaccine (recombinant) (manufacturer unknown). This is one of several reports received from the same literature article (cross referenced cases: MARRS # 1712USA010740). Sender's Comments: US-009507513-1712USA010740:
Upper (R) arm edema with erythema 10 cm x 7 cm warmth (most around the injection site scratched and 2nd cellulitis developed), distal to injection site redness.
Patient seen in office on 8/28/02 with baseball-sized area of edema, heat, and redness. Patient experiencing exquisite tenderness on light palpitation of the area. Treated with Keflex and medrol dose pack for cellulitis.
Thrombocytopenia- PLT level 9 on CBC - petechial bruising.
Course of the anaphylactic reaction: broke out in hives all over; Course of the anaphylactic reaction: broke out in hives all over; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK8982; Expiration date was not reported), intramuscular on the right arm on 01Feb2021 (10:00) as a 2nd dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 08Jan2021 (10:00) as a single dose, intramuscular on the right arm for COVID-19 immunization. On 01Feb2021, after the second dose of vaccination, the patient had described the course of anaphylactic reaction as broke out in hives all over. The events were reported to be severe (assessed as medically significant). The patient had received treatment with adrenaline, corticosteroids and steroid creams for the events. The outcome of the events was recovered on an unspecified date in 2021. The reporter did not consider BNT162B2 to have a causal effect to the reported events (unrelated).; Sender's Comments: There is a reasonable possibility that the event "anaphylactic reaction as broke out in hives" was related to BNT162b2 based on known drug safety profile and close temporal relationship.  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.
Began 05:00am 3/17/21 until 07:00 am 3/28/21 chills alternating with fever (100.9 max), muscle aches, joint aches, fatigue  3/17/21 to present = painful (L) underarm lymph node
A patient who received the 1st dose of the vaccine last 31Dec2020; was diagnosed with COVID on 06Jan2021; This is a spontaneous report from a contactable pharmacist via the sponsored program. A male patient of an unspecified age received the first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown) via an unspecified route of administration on 31Dec2020 as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2 vaccine on 31Dec2020 and was diagnosed with COVID on 06Jan2021. The patient was scheduled to receive his second dose on 17Jan2021 but this was waived because of the diagnosis of COVID on 06Jan2021. As of the reporting date, the patient has not received the vaccine ever since the diagnosis. Caller is asking if they should restart the vaccination series/should he get second shot or should he start over. The patient underwent lab tests and procedures which included a positive SARS-COV-2/COVID-19 test on 06Jan2021. The clinical outcome of the event COVID-19 was unknown.  Information about lot/batch number has been requested.
Vaccine was given 7 days past beyond use date. Per Pfizer,  their data stated, "Stability assessment indicates there is no product quality impact and the vaccine was suitable for use."
Subsequent to receiving two doses of varicella virus vaccine live in 8/99 had the 2nd dose, the pts laboratory tests revealed negative antibody titer and a lack of response. No further information is available.
After 10 min sitting checked on pt who stated throat felt tight and itchy. At that time assessed the patient's breathing and gave option of Epi. Pt refused stating she could still breathe and offered oral diphenhydramine to pt at that time, after which we would reassess need for epi. Pt took 50mg diphenhydramine w/water at 4:51 pm. Checked BP 114/80 mmHg. Stated nervous about getting vaccine when given shot. Pt monitored and started feeling better, after taking diphenhydramine monitored regularly. Pt left at 5:25 pm stating felt ok to go home (walking). Pt came into store 8/19 stating fever, chills, diarrhea. 8/20 stated headache x 3 days.
Experienced chest pain two days after shot. I did have covid-19 1 year prior to the shot but was sent to the hospital for myocarditis.  I was in the hospital for 2 days, now in unable to exercise and cannot do any harsh work.
Severe (L) deltoid rash and hypersensitivity of skin in (L) deltoid region starting 2-3 hrs after receiving Tdap on 7/26/11. Improving pain, skin feels more itchy than painful currently.
Initial information received on 13-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an adult patient (age and gender not reported) who experienced patient complaining about issues after administration, while he/she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (dose, dose in series, lot number, expiry date, route and site of administration was not reported). On an unknown date ¸the patient developed a non-serious issues (administration related reaction) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. No lab test reported. Final diagnosis was issues after administration. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for the event. List of documents held by sender: none.