chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has felt weak, nauseated and has broken out in hives repeatedly since she received her immunizations 3 days ago. She was given 4 shots in the same day, TDAP, HEP A, HPV, and Meningococcal. She has not had an allergic reaction to any previous immunizations, nor has she had hives or rashes as reactions to any substance in the past. At the outbreak of the hives we have treated her with the maximum dose of Benadryl which has controlled the rash temporarily, however, it has returned twice. On the third day she began complaining of a severe headache, so bad she began to cry uncontrollably. We gave her ibuprofen and within an hour her headache had improved.
Patient described a fever 101-102 the night of receiving the immunization. She felt achy, had difficulty walking due to pain in feet. Bright red lump and swelling at injection site very sore arm. Fever and chills all night. Wanted to stay home from work but couldn't.
Vaccine leaked out while administering; Vaccine ran down arm; leaked out from patient's arm; A spontaneous report was received from a pharmacist concerning an unknown old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and vaccine leaked out while administering.  The patient's medical history and products known to have been used by the patient were not reported.  The patient received their second of two planned doses of mRNA-1273 (Batch number: 029A21A) on 5 Feb 2021,  intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, while administering the Moderna COVID-19 Vaccine the vaccine leaked out, a lot of liquid came out of patient's arm. The patient did not developed symptoms.   No treatment information was provided.    No relevant laboratory details were included.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the even is not applicable.  The event, was considered  recovered/resolved.; Reporter's Comments: This report refers to a case of underdose, exposure via skin contact and device connection issue for mRNA-1273 (lot # 029A21A) with no associated AEs reported.
Rectangular rash below injection site about 3"x4", hot, itchy, remained for three days, outcome good
Menstrual period change; sore arm; fever 101F; chills; This is a spontaneous report from a Non-contactable Consumer (Patient). A 43-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 14Apr2021 at 14:30 (at the age of 43 years old) as a DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications include Zyrtec, Bupropion, Multivitamin taken for unspecified indication, start dates and stop dates were not mentioned. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: ER8727) in left arm on 20Mar2021 at 14:15 (at the age of 43 years old) for covid-19 immunisation and experienced Sore arm and Menstrual period change. On unspecified date the patient experienced that Menstrual period change - arrived day after vaccines (both with 1st and 2nd doses). Sore arm with first dose. Sore arm, fever 101F and chills with second dose (started at 14hrs post vaccine and lasted for 24hrs). The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature 101F on unspecified date. Reporter reported the events as non-serious at the time of this report. The outcome of the events was resolved on unspecified date.  No follow-up attempts are possible. No further information is expected.
Severe nausea, fatigue Tunnel vision, and delayed speech. Lasting 15 min.
LEGS, BACK TINGLING, RED RASH, WARM PRICKLY SENSATION. Patient asked if Benadryl ok I agreed and told her to follow up with her physician.
Patient called the pharmacy to report feeling light dizzy spells on Friday, one day after receiving the vaccine.  Then he said on Saturday night he was very dizzy for most of the night.  After Saturday he has been feeling light headed and intermittently dizzy up until reported day, Monday.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
Patient received second dose of the Moderna COVID-19 vaccine 23 days after the first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine 23 days after the first dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine 23 days after the first dose). On 15-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine 23 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details was not reported by the reporter. Treatment details was not reported by the reporter.  It was reported that the patient was not experiencing any symptoms.
Female with history of COVID-19 in January presents to ER with 1 day of shortness of breath.  Patient reportedly received Johnson & Johnson COVID-19 vaccine last week, states postvaccination she had flulike symptoms for a few days that resolved.  States this morning she woke up feeling short of breath.  Reports associated feeling of anxiety/possible palpitations.  Denies chest pain.  Reports resolution of symptoms at this time.  Patient reports history of ectopic pregnancy while on birth control pills, currently has hormone positive IUD.  Denies smoking cigarettes.
FEVER; ANAPHYLACTIC REACTION (PASSING OUT/ COULD NOT BREATH/ SWOLLEN LIPS AND FACE); LIPS WERE DROOPING TO THE RIGHT SIDE OF FACE; This spontaneous report received from a parent concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma (as a child), non-alcoholic, and cigarettes smoker. The patient experienced drug allergy when treated with Tamiflu (oseltamivir phosphate).  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown, NDC number: 59676-0580-15) dose was not reported, 1 total administered on 14-MAY-2021 at 10:00 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-MAY-2021, as soon as the patient got the shot (within the 15 minutes of wait at the pharmacy), he had an anaphylactic reaction. It was further reported that he could not breath, his lips and face started to swell and then he passed out. The patient was taken to ER (emergency room) and his doctor gave him EpiPen (epinephrine) shot, Medrol (methylprednisolone), Benadryl (diphenhydramine hydrochloride) and IV (intravenous) fluids. The patient's lips were drooping to the right side of his face even after taking the medications. The patient stayed at the ER for 6 or 7 hours then was sent back to home on the same day. On 15-APR-2021 (reported as Saturday), the patient had fever. On 16-MAY-2021 (reported as yesterday from the date of reporting), the patient was much better, and his drooping lips was there a little bit but not as bad. The reporter did not have patient's vaccination card (for lot number or expiration date). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction (passing out/ could not breath/ swollen lips and face) on MAY-2021, and was recovering from fever, and lips were drooping to the right side of face. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210532244-COVID-19 VACCINE AD26.COV2.S-ANAPHYLACTIC REACTION. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). 20210532244-COVID-19 VACCINE AD26.COV2.S-LIPS WERE DROOPING TO THE RIGHT SIDE OF FACE. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Tachycardia (HR of 120 - 140 bpm for 12 hours); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, 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: TACHYCARDIA (non-serious), outcome "recovered", described as "Tachycardia (HR of 120 - 140 bpm for 12 hours)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tachycardia.   Additional Information: Covid prior vaccination: No. covid tested post vaccination: No. Tachycardia (HR of 120 - 140 bpm for 12 hours) the day after all 4 doses of the Pfizer covid-19 vaccine, which was worse after doses 3 and 4. I had the flu shot on the same day as dose 3 in Nov2021. I had the flu shot 01Sep2022, 16 days before I had dose 4 of the Pfizer covid vaccine (17Sep2022) and had tachycardia that was worse (more rapid HR and lasted longer) than after dose 3.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SORE THROAT; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAR-2021 to right arm for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster dose of non-company suspect vaccine included: MRNA 1273 (Moderna) (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 05-DEC-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 26-DEC-2021, the patient experienced sore throat, and headaches (dose number in series 2). On 27-DEC-2021, Laboratory data included: Antigen Rapid test ((BinaxNOW) coded as COVID-19 antigen test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s, and MRNA 1273 (Moderna) was not applicable. The outcome of the headaches and sore throat was not reported. This report was non-serious.
I had a headache and fever of 101.6 the night of the vaccine. I also had fatigue. All that was expected. I am surprised, however, that  I am still feeling very fatigued 19 days later. This is not serious, but I thought that reporting the data could help. My guess is that I am very tired as my immune system is building its immunity, but that?s just a guess.
Case number PHHY2012US053152 is an initial literature report received on 20 Jun 2012. This intent of the article was to discuss on a retrospective cohort study conducted to determine whether individuals who were revaccinated (exposed cohorts) with a second dose of trivalent influenza vaccine (TIV) experienced a higher rate of medically attended events (MAE) than those received only one TIV dose (unexposed cohorts). The designed study had two groups; exposed cohort group who received initial TIV dose between 14 Oct 2008 and 21 Oct 2008 and who were revaccinated within 28 days and unexposed cohort group who received an initial TIV dose between 22 Oct 2008 and 07 Nov 2008. This report refers to a patient whose age, gender, medical history, past drugs, current conditions and concomitant medications were not reported. The patient's vaccination history included administration of a dose of possible temperature compromised seasonal influenza vaccine (manufacturer and batch number: not reported) in Oct 2008 (see related case: PHHY2012US052676). On an unspecified date, the patient received a second dose of seasonal influenza vaccine (manufacturer and batch number: not reported) through unspecified route and site of an unknown date. On an unknown date the patient experienced infection following vaccination. The outcome of the event was not reported. The author concluded the article stating that the study demonstrated no increased occurrence of MAE among patients who received a second TIV dose within 28 days of the first.
Patient received first dose Moderna 4/17/21, second dose Pfizer 5/19/2021. Troubleshooting: Scribe and vaccinator did not look at card to see what was given prior; she did not present card until after vaccine; first vaccine at another location so no clear record. Counseled by staff that she had received two doses of mRNA vaccine and there was no need for a third dose. Possible language barrier, but pt checked Moderna in the computer.
Swelling, erythema, and pain to L deltoid extending to left side of upper and mid back. Also reporting malaise and decreased appetite since had vaccine 6 days ago.
12 days p/ vax pt devel a vesicular rash w/approx 6 lesions
Left leg swelling from knee to ankle thought it was a blood clot. Received antibiotics for 10 days, then went to the arms. Test were negative. Itching, rash, red spots over body like clusters on legs, arms, stomach and feet. Difficulty walking, having pain when walking.
Started to have a fever up to 104, shaking, chills, pain from his neck down his back, trouble standing. Mom called 911, in ambulance O2 sat went down to 76% and BS was 40. Got to hospital and lab work showed dehydration and high lactic acid level. Don't have actual lab work in hand.
Information has been received from a consumer concerning her son who was vaccinated with all the doses of MMR II on unspecified dates.  Subsequently the patient developed asperger syndrome.  No other information provided.  Upon internal review, asperger syndrome was determined to be an other important medical event.  Additional information is not expected.
Chills; Slight headache; A spontaneous report was received from a healthcare professional concerning a 69-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, slight headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events chills, slight headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable. On 18 Feb 2021 the outcome of events, chills was resolved. The outcome of events, slight headache was unresolved, still ongoing.
Chills the first evening starting at around Nd 9:00 PM. At 4:30 in the morning excruciating pain similar to a muscle cramp running down my right leg tried to get up but could not lasted about five minutes. Returned at 2:20 PM. Felt like shock wave traveling through the bone or nerve again lasted for about five minutes. It was like nerve spasms.
Right leg swelling day after immun, then developed knee swelling +pain/limp. Ibuprofen.
Shaking chills, muscle aches, bone ache, sweats, nausea, severe headache, sore arm.
ONSET 1 DAY AFTER VACCINATION. PURITIC. EXTENSIVE SCATTERING OF 1 MM PAPULES OVER CHEST, ARMS AND L LEG EXTENSOR SURFACES. EXCORIATED. RX: BENADRYL PO; TRIAMCINOLONE CREAM AND BACTRABAN OINTMENT TO LESIONS.
No adverse event, pt given FluMist, should have had vaccine. Had Flu vaccine 1yr ago no Adverse effect.
This spontaneous report as received from a 60 years old female patient regarding herself. The patient was allergic to pain killers, codeine, Prednisone (reported as prednizone), penicillin and morphine. On 11-DEC-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose were not reported), subcutaneously. No concomitant medications were reported. On 12-DEC-2012, the patient had a reaction to vaccine at the injection site. The patient experienced headache, left insertion arm was swollen, red, itchy and had a hard lump. Her pharmacist said that it would go away in several weeks but the consumer stated that it was swelling into her arm pit on her left arm. The patient sought no medical attention. No treatment was given. The outcome of all the reported events was unknown. Additional information has been requested.
Swelling, redness and rash starting on day 7 after receiving the COVID 19 Moderna vaccine. It was my first dose.
I felt immediate pain at the injection site, after the shot. While I was still waiting at the site, I felt a hard thump in my chest and my face felt flushed immediately after. I notified the nearby nurses, and they took my vitals, which they considered normal. They asked how I felt, and I said that I still wasn?t feeling great. So, they gave me some water and juice, and I stayed another 15 minutes. Since I was no longer having any heart arrhythmia, I decided to leave, even though I was still feeling ?off.? The arm pain continued throughout the day, and a headache and fatigue began to set in as well. Around 3pm, I decided to rest, as it was getting pretty hard to ignore. I am still breastfeeding my 19 month old daughter, and after my nap, I decided to nurse her. The arm pain began to radiate down my left arm all the way to my wrist. My headache and nausea began to intensify as well. Around 9pm that night, I noticed I was beginning to get hives on my chin. The next morning, the day after the shot, I noticed I had hives all over my face, neck, and upper back. I had intense fatigue, headache, and nausea. My 19 month old daughter also had hives on her face, and she had slept horribly the night prior, waking up about five times and even waking up screaming at times. It has been almost a full week since the first shot, and we both are still not ourselves. I have had intermittent low grade fevers, we both still have hives on our face (and my neck), and I still get bouts of fatigue, intense headaches, and nausea. She also seems to have both headaches and fatigue based on her behavior and sleeping patterns. I have seen my doctor, who is having me follow up with an allergist, and I have been in touch with my daughter?s pediatrician, as well as their leading lactation consultant.  Took Benadryl thinking it was allergy, and it did nothing. Was prescribed prednisone, but never felt I had to take it. I slowed down on how much I was breastfeeding my child, and her symptoms seemed to improve when I wasn?t feeding her and would reappear after feeding her. So, I started pumping the breastmilk.
No adverse effects noted; a patient received improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a male patient of unknown age. The patient's concurrent condition and medical history were unknown. Concomitant medication included sterile diluent. On 30-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) of lot # S011951 with expiry date 16-APR-2021 (dose, frequency, route of administration unspecified) for prophylaxis (product storage error). The diluent used to reconstitute the vaccine was properly stored. On an unknown date, the vaccine was exposed to -12.3 Celsius temperature for 6.05 hours. No previous temperature excursion was reported. Digital data logger was involved. No adverse effects reported (no adverse event). The outcome of the events was unknown.
received expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 12th October 2022, the patient received Havrix. On 12th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-Oct-2022 Reporter's comment: No symptoms were reported. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.