chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 16:50 1/5/13 gave FLUVIRIN. At 16:55, patient complaining of flushing from her chest going up to her face and dizziness, throat tightening. I called 911 and had her lie down on floor. At 17:00 she said she felt better, but still tight. I administered one 0.3 mg EPIPEN into upper right thigh. At 17:05 paramedics came.
Approx. 1-1 1/2 hrs. after pt. rec'd flu vax., she returned to site w/whelps on both arms. Referred to PMD for evaluation and tx.
Red, itchy, swollen area 8 days after vaccination at the injection site. 1x2 inches when first noticed this evening
Client vaccinated with Moderna vaccine for Covid on 2/25 and 3/26/2021 at public health clinic at   Client started having Covid symptoms (nasal congestion, diarrhea, fever x 1 day, vertigo, sore throat, loss of taste and smell, occasional SOB) on 8/2/2021.  Tested positive PCR on 8/4.  Reported as a case of breakthrough Covid in a previously vaccinated person.
his smell and taste was diminished; his smell and taste was diminished; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiry date: unknown), via an unspecified route of administration on 29Jan2021 (at the age of 75 years old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported on Saturday morning, 30Jan2021, experienced his smell and taste was diminished when he got up. "Now, I do not know what I have gathered, it is not necessarily more of a functional Covid. I just wanted, have you had people reported after having the vaccine?" Outcome of the events was unknown.
Case number PHEH2011US01810 is an initial spontaneous report received from consumer on 10 Aug 2011. This report refers to a 15 years old female patient. She was vaccinated with MENVEO (batch number: A100051) intramuscularly on 08 Aug 2011. But, she received Men A lyophilized powder component which was reconstituted with sterile water instead of Men CWY liquid conjugate. No adverse reaction had occurred following this drug administration error.
Tachycardia HR in. the 140s-150s, midsternal chest discomfort
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX (details unknown). Between 20 minutes and 18 hours after vaccination with HAVRIX, the subject experienced rash and hives. At the time of reporting the outcome of the events was unspecified. This case involves a pharmaceutical product complaint. The healthcare professional reported that there had been 3 incidents of rash and hives following vaccination with HAVRIX within the time frame of 20 minutes to 18 hours following the administration. This is case 1 of 3 (see case IDs A0878505A and A0878506A for the other reports). Follow-up received on 09 September 2010: QA analysis revealed the complaint to be unsubstantiated.
I gained a little weight; Have the same injection one after the other; I have vaccine twice; I am going through lot of problems, a lot of stress right now; completely forgot; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 02Sep2020 at single dose for immunisation. Medical history included high cholesterol from an unknown date, "for the heart" from an unknown date, high blood pressure from an unknown date. Concomitant medication included amlodipine for high blood pressure, metoprolol for the heart, atorvastatin. Patient received Pneumococcal conjugate vaccine 13-valent for immunisation last year on 22Nov2019 when she was 72 years old. The patient reported she run in to a problem, she realized that she had vaccine twice. The Prevnar 13 for against pneumococcal. She had last year but she completely forgot that she was given it last year and she got one on Wednesday, 02Sep. She walked into Rite aid to buy few things and she was thinking that it might be good to have but she completely forgot that she had one last year. she administered it last year and she administered it this year. She had it twice instead of getting 23, she got 13 for the second time. The patient stated it was last year. This year she was 73, last year she was 72. Patient gained a little weight. She was 170 pounds. The Pulmonologist advised patient and last year she was given it in doctor office. So she has nothing to do with patient walking to Rite aid this year and completely forgot. She was going through lot of problems, a lot of stress right now for the last year due to big trouble and patient completely forgot. It scares her to tell the truth. It scares her that she forgot something like that. Last year it was Pneumococcal conjugate vaccine 13-valent and it was given to patient on 22Nov2019. One time shot. The patient stated, probably a month she had lab test, something. The patient asked If she would have an adverse reaction, if she would grow hairs on her eyes. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Left ear and left side of face from my eye toward ear went numb/Numbness; Left ear and left side of face from my eye toward ear went numb/Numbness; hands swelled/Hands are still showing swelling on day 7; terribly sore arm; light headed; chills(but no fever); This is a spontaneous report from a contactable consumer or other non health care professional(Patient herself) of 54-year-old (non-pregnant) female patient received the first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Left arm on 09Apr2021 08:15 (at the age of 54-years-old) at a single dose for covid-19 immunisation at Pharmacy or Drug Store. Medical history included none and Concomitant medications were not reported. No Known allergies reported. No Allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, patient had not been tested for COVID-19. On 09Apr2021, the patient experienced Left ear and left side of face from my eye toward ear went numb, hands swelled, had to take jewelry off. Numbness went away by next morning. Hands were still showed swelling on day 7, still not able to put jewelry on. She had some Normal side effects earlier in the day, terribly sore arm, light headed, chills (but no fever). No treatment was received for the events caused. The outcome of events was recovering.   Information on the lot/batch number has been requested.
Felt tired; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) and PYREXIA (Low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (Felt tired) and PYREXIA (Low grade fever). At the time of the report, FATIGUE (Felt tired) and PYREXIA (Low grade fever) had not resolved. Not Provided          No Concomitant medication were provided
On 4/15/21 came into office with bilateral edema in both lower legs as well as pain  x 2 weeks. sent for doppler- Diagnosed with occlusive thrombus in R lower leg.
BURNING HAND AND FEET; REDNESS HAND AND FEET; WALKING DIFFICULTY; CAN'T TOUCH ANYTHING; TEMPERATURE; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced burning hand and feet, redness hand and feet, walking difficulty, can't touch anything, temperature, tiredness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning hand and feet, headache, tiredness, walking difficulty, can't touch anything, redness hand and feet and temperature was not reported. This report was non-serious.
Information regarding Prevnar was received from a healthcare professional regarding a female patient who received the fourth dose on 22-Jan-2007 at 12 months of age and died from Streptococcus pneumoniae meningitis at the age of 26 months. The patient's concurrent illnesses included nasopharyngitis or viral infection. Concomitant medications were not reported. On an unspecified date in 2008, the patient developed Streptococcus pneumoniae meningitis. On 17-Apr-2008, the patient died. The autopsy cause of death was meningitis pneumococcal. A serotype was not provided. The reporter noted that the patient had "something going on in her system, such as possibly a cold or another type of viral infection, that weakened her immune system." Bacterial culture (results: negative for Haemophilus infection, Group B strep, Neisseria meningitides, and Escherichia coli) and bacterial culture (results: Streptococcus pneumoniae) were done in 2008. No additional information was available at the time of this report.   6/27/08 Autopsy report states COD as bacterial meningitis & streptococcus pneumoniae. States acute bacterial meningitis: purulent exudate of subarachnoid space & meninges; c/s (+) for alpha hemolytic streptococcus; PCR for herpes simplex & enterovirus (-).    7/8/08 Reviewed hospital medical records of 4/16/2008. FINAL DX: Admitted for viral gastroenteritis.  Final Dx: bacteremia. Records reveal patient seen by PCP w/fever, nausea & vomiting x 3 days; diarrhea x 1 day; no oral intake; no further BMs; decreased UO; tired; irritable; excessive sleepiness; minimal nasal congestion.  Tx w/IVF.  Began to become more alert then found unresponsive, cyanotic & no pulse/respirations later in evening.  Resuscitation unsuccessful.
red rash that extended from the shoulder to the elbow,rash is bright red; rash itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash that extended from the shoulder to the elbow,rash is bright red) and RASH PRURITIC (rash itches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red rash that extended from the shoulder to the elbow,rash is bright red) and RASH PRURITIC (rash itches). At the time of the report, RASH ERYTHEMATOUS (red rash that extended from the shoulder to the elbow,rash is bright red) and RASH PRURITIC (rash itches) had resolved. Not Provided          Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up was received on 19 May 2021 included 2nd dose details and event outcome were updated.
Cellulitis at the injection site; Pain at the site; Achiness; Fever; Headache; Extreme effects were the tingling skin; bad sunburn and couldn't put on her shirt; it hurt to put on her shirt; bad sunburn and couldn't put on her shirt; it hurt to put on her shirt; This is a spontaneous report from a contactable consumer (mother) from a Pfizer sponsored program.   A 16-year-old female patient received the 1st dose of meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration at single dose at arm in Aug2019 for immunisation, given at the Physician office.  Medical and family medical history was none. There were no concomitant medications. No history of all previous immunization with Prevenar 13. No prior vaccinations within 4 weeks prior to the first administration date of Prevenar 13. The patient was concomitantly also given another vaccine at that same time, but reporter was unable to provide the name, NDC, Lot, or expiry.  In Aug2019 the patient had the usual pain at the site, achiness, fever, and headache, but her extreme effects were the tingling skin. The reporter thought she had a bad sunburn and couldn't put on her shirt; it hurt to put on her shirt. She ended up with cellulitis at the injection site and was put on antibiotics. She improved after being on the antibiotics 5 days or a week. The event cellulitis at the injection site was considered serious IME, all the other events non serious. No event required a visit to Emergency Room, but all required visit to Physician office. No relevant tests performed. The outcome of bad sunburn and couldn't put on her shirt; it hurt to put on her shirt  was unknown and of all other events was recovering. The patient was coming up for the booster dose. The reporter wanted to know if the side effects were severe enough and if she should get the booster or if it's okay to get it. Caller was unable to provide the NDC, Lot, or expiry for the meningococcal group b rlp2086 since it was given in the doctor's office.  She just knows it was another follow up booster that may have started with "MM".   Information on the batch number has been requested.
blurry / double vision; double vision; Bloodshot eyes; my eyes were burning and felt swollen; my eyes were burning and felt swollen; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old non-female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 21Apr2021 09:15 (Batch/Lot Number: ER8729) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Major depression disorder, bipolar disorder, erythromelalgia, surgical hysterectomy, chronic endometriosis from an unknown date and unknown if ongoing. 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. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021,10:15 A.M. (Batch/Lot Number: ER8730) as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medications included oxcarbazepine; imipramine; hydroxyzine hydrochloride (HYDROXIZINE); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. On 26Apr2021 06:30, On day 5 post-2nd vaccination, the patient experienced, I woke up with blurry / double vision and bloodshot eyes. Within 12 hours of getting the second dose, my eyes were burning and felt swollen. The patient did not receive any treatment for the events. The clinical outcome of the events was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
so sick; can't move my arm after 3 days; vomiting; worst body ache; sweat / sweated; Arm is so painful; heart was racing; had diarrhea; shaking, shivering; every bone in her body aches; there's a big hard lump; lymph nodes are swollen; and slept from 12 PM until 8 AM Sunday; got 1 shot of adjuvant only then immediately; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 50-year-old patient who received Herpes zoster (Shingrix) (batch number 92C34, expiry date unknown) and (batch number 9G44C, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 13th November 2020, the patient received the 2nd dose of Shingrix. On 13th November 2020, the 2nd dose was an unknown dose. On an unknown date, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes, hypersomnia and inappropriate preparation of medication. On an unknown date, the outcome of the sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes, hypersomnia and inappropriate preparation of medication were unknown.   It was unknown if the reporter considered the sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes and hypersomnia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the 1st dose of shingrix on 11 September 2020 and second dose on 13th November 2020. Patient received only adjuvent of second dose which because HCP did not mixed it well and given without adjuvent which led inappropriate preparation of medication. It was reported that after that patient immediately got the second shot with adjuvent and antigen ( replacement dose). It was stated that patient experienced some event like patient was sick and after 3 days patient not able to move arm. Patient also experienced vomiting,worst body ache,sweat and very painful arm. Patient also reported that heart was racing at tha moment. On friday 13th November 2020 in night by 9 PM patient went for dinner and experienced vomiting and had diarrhea. On Saturday AM from 7 AM to 12 PM then lay down with shaking, shivering, sweated through her pajamas and slept from 12 PM until 8 AM Sunday. It was also reported that it was worse than the flu every bone in her body aches (getting slightly better now) also At injection site there was big hard lump and her lymph nodes are swollen. The reporter consented to follow up. The case was considered as medication error with harm.
This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022.  Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted.  The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the CDC and the Department of Public Health and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022.  Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly ?invalid? dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been 8 weeks since that clinic.
This is a spontaneous report from a contactable consumer (patient). A 88-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06Mar2021 as dose 1, single for covid-19 immunisation. Patient has a history of bladder infection due to Stent placement between kidneys and bladder. The patient's concomitant medications were not reported. The patient previously took coumadin. On an unspecified date, after the first vaccination the patient experienced bladder infection. Patient received first dose of the Pfizer Covid vaccine on 06Mar2021 and was scheduled to receive the second dose on 27Mar2021 was asking currently taking Keflex (treatment), will it affect her taking the 2nd dose of the vaccine. Patient states that Bactrim cannot be given to people who take Coumadin as it raises INR. The outcome of event was reported as unknown.No follow up attempts are possible. Information about lot/batch number cannot been obtained.
chills 6 hrs after inj, followed by hallucinations about 12 hrs later with increased  chills and intense headache.  Hallucinations lasted 2-3 hrs.   Next morning all had resolved except extreme lethagy.
Had itching after shot, Next day swollen at injection site and soreness. By day 3 seemed to have gone away. On day 8, swelling / hotness / hardness / itching returned at site of injection. Swelling was size of tennis ball
patient was given 0.5ml instead of 0.25ml is twice the dose for age. no adverse effect at this time.
No additional adverse effect reported.; GARDASIL9 was administered on 22-NOV-2019, two days after the expiration date, which was 20-NOV-2019.; This spontaneous report was received from a Registered Nurse referring to a 22 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 22-NOV-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly, with lot # N009801, two days after the expiration date, which was 20-NOV-2019. No additional adverse effect reported.
cold sore; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date for COVID-19 immunization. Medical history, concomitant medication and past drug history were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date for COVID-19 immunization. On an unspecified date, after second dose of vaccination patient had experienced cold sore (reporter states a lady she was talking to, says she got one (cold sore) after her 2nd one). Outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Dizziness/vertigo, persisted for 3-4 days. some improvement with meclizine. Completely resolved 6 days after vaccination.
6/12 vaccine at 3pm, 10pm started shivering 6/13: headache, sore throat, nausea and fever by the evening 6/14 symptoms continued with the addition of chest pain, brought to the ER.  Troponin 10, transferred to hospital.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium
erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;