chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DELIRIUM (hospitalization, medically significant), DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Hospitalized with delirium after I had Covid". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
10:20 AM Emesis liquid mucous. Resp intacr. No food intake today. Initially ringing in ears. 15 mins post vaccine. 10:25 am 136/90-HR 98- R 18- O2 Sat 93% Cont nausea 10:30 am  Cont nausea 10:35 am Nausea easing 10:40 am 122/83- HR 96 - R 16- O2 Sat 94% Pt feels ok to leave and plans to eat. Boyfriend said she may be pregnant. Pt called back to clinic later and said dgt sick and vomting.
8 days later a large hive and redness appeared at the injection site. Itchy. I took a Benadryl and the hive flattened but it is still  red and itchy
Swelling in arm, fever, chills, nausea, headache, extreme soreness in arm.
Severe chest pain, palpitations and rapid heart rate.  Started 7 days post vaccine and continue to have symptoms.
Patient presented to clinic with mother for 2nd dose covid vaccine. Patient was seen by provider before administration of 2nd dose covid vaccine (6months-4yrs). An error occurred when administrating vaccine, patient was given 5-11 dose instead of age-appropriate dose. An error was reported to clinical operation manager, as well as mother of patient, and doctor. Per mother of patient, she was ok, and no issues arose from situation. Dr. stated that since the patient is close to 5 years of age the patient will be fine and will be monitored and appt was scheduled in 2 months to follow up. Pt was monitored in clinic for 1hr, and no signs of adverse effects were noted. Pt was alert and went home w/out complications. Dr also saw a patient before the patient left the clinic. Vaccine was administered by MA.
2/24/09 At 9am Donor started having; headache (pounding), fever, chills, fatigue.  Swollen lymphnodes under L arm.  The L arm deltoid area where injection was given warm to touch.  Donor came to center at 5:20pm.  Vitals taken @ 5:25 BP 120/80, Pulse 112, Temp 101.1 and Resp. 20.  Dr called advised donor to take TYLENOL 2000mg and bed rest.  If donor feels worse to go to HCP/ER.
Information has been received on 26 SEP 2001 from an approximately 56 year old male who in the early 1990s and more recently was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). The patient reported that after the first dose he had an unusual soreness about 2-3 weeks afterward for about 3-4 months. After his booster dose he had the same reaction. The patient sought unspecified medical attention. It was reported that the patient recovered. It was also noted that the patient's wife had similar symptoms after being vaccinated (WAES01093033). Additional information has been requested.
Medical assistant reported that within 24 to 48 hours post immunization the patient developed an injection site reaction characterized by a red, warm, hard welt at the site of Acel-Imune administration. This is 1 of 6 patients from this facility who experienced this event following receipt of 3 different lots of Acel-Imune.
This spontaneous report as received from a registered nurse refers to a neonate female patient. The patient's pertinent medical history, drug reactions/allergies were not provided. On 06-JUN-2014 at 10:23 AM, the patient was vaccinated with the first dose of RECOMBIVAX HB, intramuscular, Lot # J012520 and expiration date on 30-JUN-2016. Co-suspect therapy and concomitant medications were not provided. It was reported that vaccine storage temperature dipped to 0-1 degrees for eighteen different episodes between 14-MAY-2014 and 21-JUL-2014 according to minimal/maximal measures (the reporter was not able to identify how long the temperatures were down because it was not documented accordingly). The reporter did not know that when the temperatures were checked each AM and each PM, all recorded temperatures were within 2-8 degrees. The vaccine was removed once problem was identified and has not been used after 21-JUL-2014. This is one of several reports received from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
had a sore throat; slept for a while; got tired; first dose on 6FEB2021 and second dose on 28MAR2021, more than 35 days between Moderna Covid-19 vaccine primary series; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (had a sore throat), SOMNOLENCE (slept for a while), FATIGUE (got tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 6FEB2021 and second dose on 28MAR2021, more than 35 days between Moderna Covid-19 vaccine primary series) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 prophylaxis.     Concomitant products included FAMOTIDINE, ATORVASTATIN, ESCITALOPRAM and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (had a sore throat), SOMNOLENCE (slept for a while), FATIGUE (got tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 6FEB2021 and second dose on 28MAR2021, more than 35 days between Moderna Covid-19 vaccine primary series). At the time of the report, OROPHARYNGEAL PAIN (had a sore throat), SOMNOLENCE (slept for a while), FATIGUE (got tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 6FEB2021 and second dose on 28MAR2021, more than 35 days between Moderna Covid-19 vaccine primary series) outcome was unknown.            No medical history was provided by the reporter.  Patient does not remember which arm that she received the vaccine No treatment information was provided by the reporter.   This case was linked to MOD-2022-648652, MOD-2022-648682 (Patient Link).
trouble with breathing, breathing difficult, " my breathing went to hell"; Could not sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) and DOXAZOSIN for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") (seriousness criterion hospitalization). On an unknown date, the patient experienced INSOMNIA (Could not sleep). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") had not resolved and INSOMNIA (Could not sleep) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The patient stated that two weeks after the vaccination he went to Emergency room due to breathing difficulty and was admitted.  He reportedly spent two days in the ICU.  The patient continued to have trouble and did not get the second dose due to the breathing difficulty he experienced.  The patient reported that he could not sleep since he could not breathe.    Additional concomitant medications included heart medications and heart burn medications.  Treatment medications included an Albuterol inhaler.  This case concerns an 80-year-old male hospitalized with a serious unexpected event of dyspnea, and nonserious unexpected event of insomnia. Patient treated with antibiotics. Event latency 15 days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Case upgraded to serious, Patient demographics updated, additional event reported (could not sleep).; Sender's Comments: This case concerns an 80-year-old male hospitalized with a serious unexpected event of dyspnea, and nonserious unexpected event of insomnia. Patient treated with antibiotics. Event latency 15 days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Still having side effects after Moderna Vaccination; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Still having side effects after Moderna Vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Still having side effects after Moderna Vaccination). At the time of the report, IMMUNISATION REACTION (Still having side effects after Moderna Vaccination) had not resolved.            No Concomitant product use was reported.  The patient stated that they had 1st, 2nd, and booster shots and was still having side effects from it.  No treatment information was provided.   Reporter did not allow further contact
Within 30 minutes of receiving the vaccine, I started getting a headache, body aches and fatigue. I felt like I had COVID again. I worked part time at the post office and, when I got home,  I took ibuprofen and went to sleep. I slept for several hours. I did work the next day and felt slightly better then. Within 2 more days, I felt normal.
approx 1 hr p/receiving vax 20SEP93 pt lt side of face began to tingle & cont throughout evening; awoke approx 230AM 21SEP93 w/lt side of face numb & hearing in lt ear diminished; seen by MD 21SEP93 who told client probably due to vax;
Reporting an error, not an adverse reaction. Patient was given 3 dose of Moderna (Booster) 0.5 ml. Provider was not aware that the third dose was 0.25 ml at the time. Contacted patient  3 days ago. Patient reports he had a sore shoulder but tolerated dose well. I was not aware at the time that the Moderna Booster was not yet approved.  I stopped the booster doses after this patient, (Second  patient to receive such dose), when  I realized it was not time for Moderna Booster.
Increased weakness, nausea (without vomiting), increased dizzy-ness, loss of appetite
Hives/urticaria. Daily itching and outbreaks. Muscle and arm aches.
Painful left supraclavicular lymphadenopathy developed 2 days after second dose vaccination. Still persistent on day 4; This is a spontaneous report from a contactable physician (patient). A 30-year-old female non-pregnant patient received second dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME, lot/batch number and expiry date unknown), intramuscular on 21Jan2021 at single dose for covid-19 immunization. Vaccine facility type was hospital. Medical history included none. No known allergies. Concomitant medication included ethinylestradiol, norgestimate (MONO LINYAH). No other vaccine in four weeks. No covid prior vaccination and covid was not tested post vaccination. The patient experienced painful left supraclavicular lymphadenopathy developed 2 days after second dose vaccination 23Jan2021. It was still persistent on day 4. The outcome of the event was not recovered. No treatment received.   Information about lot/batch number has been requested.
Pt vaccinated with Meruvax II developed a burning & itching sensation in her earlobes, swollen throat, difficulty in breathing & hives all over body.
COVID 19 Treatment; COVID 19 Treatment; Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Moderna/ Dose #5: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Jan2021 as dose 1, single (Lot number: 041L204), in left arm, on 22Feb2021 as dose 2, single (Lot number: 004M20A), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: 011D21A), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: 027121A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer surgery", start date: Nov2019 (unspecified if ongoing); "known allergies: lactose intolerance" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN, start date: Jan2020. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Sep2022, outcome "unknown", described as "Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Moderna/ Dose #5: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Feb2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2023) Positive, notes: Day 8 tested positive with Faint Line; (14Feb2023) Positive, notes: Day 10 stronger nasal & Upper throat & upper back discomfort, tested positive strong line. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Within 15 mins after receiving Flu shot and #3 Hep B c/o feeling flushed, chills, lightheaded, clammy. Monitored by office MD. BENADRYL 25 mg given and VS monitored. Feeling better within hour of onset.
This is a solicited report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4159698-00 (RA). A 72-year-old female patient received BNT162b2 (BNT162B2), on 12Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), since 2021 (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose; 2, Manufacture: Pfizer, Lot Number: Not Provided, Route of administration: Intramuscular), administration date: 30Mar2021, for Covid-19 immunization; BNT162b2 (Dose; 1, Manufacture: Pfizer, Lot Number: Not Provided, Route of administration: Intramuscular), administration date: 01Mar2021, for COVID-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset Aug2021, outcome "recovered", described as "Sleepy"; KNEE OPERATION (medically significant) with onset 12Oct2021, outcome "recovering", described as "Knee surgery on right knee". The action taken for adalimumab was unknown. Clinical course: She was stopped Humira for six weeks, two weeks before the surgery for four weeks after. She had administered Covid booster 12Aug2021 and had some sleepy side effects of that vaccine. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's assessment of the causal relationship of "knee surgery on right knee" and "sleepy" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event Knee operation and somnolence and the suspect drug cannot be excluded. The case will be reassessed once new information is available. 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.
Water blisters; Swelling in arm; red; Covid arm rash; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Water blisters), PERIPHERAL SWELLING (Swelling in arm), ERYTHEMA (red) and VACCINATION SITE RASH (Covid arm rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLISTER (Water blisters), PERIPHERAL SWELLING (Swelling in arm), ERYTHEMA (red) and VACCINATION SITE RASH (Covid arm rash). At the time of the report, BLISTER (Water blisters), PERIPHERAL SWELLING (Swelling in arm), ERYTHEMA (red) and VACCINATION SITE RASH (Covid arm rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up document was received. Reporter's middle name was updated. It contains Non-Significant information.
Splitting headache, tense muscles in arms and shoulders 3 weeks after first shot. After second shot:  brainfog, terrible headaches, very sore muscles in whole body for first two week and then slightly diminished after that.    After 14 weeks I still have weak and very sore muscles especially in arms, legs and neck.  I take ibuprofen 3 times a day to relieve symtoms.
Myalgia, fatigue, low grade fever. These symptoms have lasted 3 days now and interfered with customary activities.
Swollen lymph node in neck on the same  side of the injection.   After first vaccine the reaction occurred about a week later and took about two weeks for the swelling to decrease. After the second vaccine, the swelling occurred under 24 hours later. The nodule is swollen and painful.
Heavy bleeding with menstrual cycle  occurred 10 days after vaccination. This blessing was off cycle from normal cycle.  Cycle is regulated with birth control pills
GENERALIZED SEIZURE, 3 MINUTES, NEGATIVE E.R. EVAL
Received 2nd Covid-19 vaccination as a RN at a drive through site. About 4 hours post shot had fever of 101 degrees Fahrenheit.  Nausea. Headache.  Body/muscle aches. Information posted in my daily cdc email registration text i received.  Illness lasted 24 hours and I did miss work due to fever. Medcated with over counter tylenol and benadryl.
24 hours post vax, the pt developed an itchy rash on back, chest, and arms. The pt also experienced a quarter sized swelling at the injection site. Pt treated with Benadryl.
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. The listed cause of death was CAD. Patient also had DM, CKD, and bladder cancer along with morbid obesity.
Metallic taste in mouth and tongue numbness. Gets better then starts again. Administered 25mg Benadryl and monitored
bad case of the shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's concurrent conditions and medical history were not provided.  On 26-NOV-2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and prevention of shingles (herpes zoster).   On an unknown date (reported as "shortly after receiving vaccine"), the patient suffered a bad case of the shingles. It was reported that the patient's symptoms had resulted in physical limitations not present before used zoster vaccine live (ZOSTAVAX). Also, the patient sustained severe and permanent personal injuries. Further, the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition.   At the time of the report, the outcome of shingles was reported as not recovered/not resolved.    Upon internal review, shingles were considered to be disabling due to severe and permanent personal injuries.  The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Initial unsolicited valid non-serious case received from a nurse on 20-Sep-2018. This case is linked to 2018SA266203 (same reporter). This case involves a 61 years old female patient who was vaccinated with 0.5 ml first dose of FLUZONE HIGH DOSE (lot UJ004AB, expiry date: 30 Mar 2019 via unknown route in the left deltoid) instead of FLUZONE QUADRIVALENT on 15-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose as it was reported that a 61-year-old patient was accidently vaccinated with FLUZONE HD. This is trivalent. They should have gotten Quadravalent. It was not known whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pt came in approximately 1 week after admin, reported oval-shaped red rash, appx 2" in width, 4" in height, with numbness, at injection site. No swelling, warmth, tenderness. Pt husband noticed last night, so exact onset unknown.
The subject received the H1N1 shot in her right arm, on approx. November 25. At that time. she experienced no pain, local swelling, or difficulty in moving arm. On approx. December 7-8, she developed rashes on her abdomen and was diagnosed with shingles. She had had varicella in childhood, but had no history of shingles. She does not have any chronic medical conditions or history of adverse reaction associated with vaccines.