chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). Other case identifier: US-PFIZER INC-202101234704). A 66-year-old female patient received the 1st dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Aug 28, 2021, single dose, for COVID-19 immunisation. Medical history included high blood pressure (ongoing) and cholesterol (ongoing). The patient's concomitant medications not reported. The patient experienced paresthesia (tingling in both legs), with outcome of not recovered; and burning sensation (sort of strange burning in the front of both legs, below knees to the foot of both legs), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. Additional information: This report not related to a study or program. Patient took the first dose; had tingling of both legs and still has it. Symptoms eased up for a little while, but now back. It was like having a low dose of electrical shock. It was intense, but now has eased up. Patient wanted to know does it ever go away and should she take the second shot. This happened within a couple of days or so after vaccination. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The patient experienced flu-like symptoms after receiving the SHINGRIX vaccination. The reporter did not consent to follow-up. The reporter would not provide any additional details. This case was one of the 5 cases, reported by the same reporter.
104.5 fever, chills, uncontrollable shaking, upset stomach, dizzy, out of it feeling, headache, vomited once. Lasted for 3 days.
Nausea; Diarrhea; This spontaneous case from the United States was received on 06-Oct-2022 from other healthcare professional (nurse) via Communications (reference number: SEQW22-04040) with additional information received on 12-Oct-2022 (being processed together) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced nausea and diarrhea.  The outcome of the events was not reported.  The reporter assessed the events of nausea and diarrhea to be related to Flucelvax Quadrivalent. As reported, diarrhea and nausea, both were related to the vaccine as not one else had these symptoms prior to vaccine administration and these only occurred in the patients that received the vaccine.  This case is linked with the cases 202204733, 202204734, 202204735, 202204736, 202204737, 202204738, 202204739, 202204740 and 202205485 (the same reporter).  Company comment: The events of diarrhea and nausea are assessed as unassessable to Flucelvax Quadrivalent due to unclear temporal relationship.; Reporter's Comments: As reported, diarrhea and nausea, both were related to the vaccine as not one else had these symptoms prior to vaccine administration and these only occurred in the patients that received the vaccine.; Sender's Comments: The events of diarrhea and nausea are assessed as unassessable to Flucelvax Quadrivalent due to unclear temporal relationship.
The patient comes in to get Pfizer booster vaccine, and Moderna booster (0.25 ml) was administered by mistake
Information has been received from a physician concerning an 82 year old male with Parkinson's Disease, Carpal Tunnel Syndrome and steroids allergy and a history of hives while taking penicillin (unspecified) and rash while taking BACTRIM who on 21-DEC-2010 was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot # 664275/0960Y) into left arm. Concomitant therapy included aspirin, LIPITOR, NEXIUM and carbidopa/levodopa (MSD). On 22-DEC-2010 the patient woke with swelling in his left wrist over his thumb. At the time of reporting, the patient had not recovered and would see his internist on 23-DEC-2010. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning an 82 year old male with Parkinson's Disease, Carpal Tunnel Syndrome in both wrists who on 21-DEC-2010 was subcutaneously vaccinated with the first dose of ZOSTAVAX (Merck) (lot # 664275/0960Y) into left arm. On 22-DEC-2010 in the morning the patient woke with swelling in his left wrist over his thumb (radial aspect). None tender and it was not treatment reporter, gradually resolved. At the time of reporting, the patient recovered from swelling in his left wrist over his thumb. Additional information is not expected.
1 day after my 2nd dose vaccine - I felt very fatigued and then the next day I felt better and when I got up of my bed I passed out and cut myself (facial area, inside of my mouth) I have pretty severe pain with both of my shoulders and my back. I went to the ER and  they performed an X-Ray and the Doctor advised that there was nothing broken and to take some Tylenol. Then I was released and went home , and up to now I still have problems with my left shoulder and have a bit of difficulty when I move it.
PT STATES SITE OF INJECTION IS STILL ITCHING AND SWOLLEN SINCE 10/19/21
Symptoms of COVID-19 all over again; Symptoms of COVID-19 all over again; Bad fever; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. This consumer reported 2 cases for different patients. This is the 2nd of 2 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history included COVID-19 (not ongoing). Concomitant medications were not reported. The patient experienced symptoms of COVID-19 all over again and bad fever all on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date, body temperature: fever on unknown date.  The information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076695 Same reporter/product/event, different patient
Information has been received from a physician concerning an 18 year old female who on 19-JUN-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast) (route and administrating site not reported) (lot# 660393/0067X). Following her second dose of GARDASIL vaccine (yeast) the patient experienced nausea and vomiting for three hours. Subsequently the patient recovered from the nausea and vomiting. The patient sought unspecified medical attention. Additional information has been requested.   This is in follow-up to report(s) previously submitted on 7/15/2008.  Follow-up information was received from the physician.  The patient had itching around site of IMPLANON for 4 weeks.  She was treated with an antihistamine.  The outcome was not provided.  Additional information is not expected.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# M023169 with an expiration date of 13-JUN-2018 (doses and route of administration were not provided). Administered doses of vaccine underwent the temperature excursion at >46 degrees Fahrenheit but < 77 degrees Fahrenheit for 1 hour and 45 minutes which was detected by a data logger. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009656:
Fever, chills, headache, achy joints, nausea, trouble breathing (have to use inhaler).
Injection site reaction. Red un-raised rash at injection site. Started day after vaccination and lasted for multiple days. Patient also complained of fatigue following vaccination.
suspected pericarditis ~6 wks after second dose in young male, based on clinical diagnosis (positional chest pain, worse supine, diffuse ST elevation/ST depression on EKG, neg troponins, self limited, improved w/ NSAIDs)
Slowly developing, increasingly severe rash, extending from underarm to below waist, on side of vaccination site, consisting of small, red blistered bumps, close together.  No pain, but itching.
Hives - first on left arm then other arm, both thighs, torso to below breasts and down to knees.   Started 1 hour after vaccination, continued to get bad for 1 1/2 hour more, took Benedryl and used B cream.  Hives stabilized but remained for another hour and then slowly went away.  6 hours later there was still redness where the hives had been.  I have photos.
This is one case out of a cumulative total of 239 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 25 November 2014. These 239 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial solicited report was received on 25 November 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 15 month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received four doses of PENTACEL: dose one on 19 August 2013 (lot number C4482AA), dose two on 25 October 2013 (lot number C4478AB), dose three on 26 December 2013 and dose four on 03 October 2014 (lot number C4625AA). Routes and sites of administration for all doses were not reported. The subject developed cough, paroxysmal cough and cold-like symptoms on 08 October 2014, approximately 5 days after the last dose of PENTACEL. The subject also experienced post-tussive vomiting and sleep disturbance on an unspecified date. Laboratory testing included a positive PCR on 17 October 2014. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 17 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 12 November 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 35 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sore arm, was shot high on my deltoid muscle. Immediately the pharmacist said I bled and it was black and blue. Now have weak arm and limited motion ever since that day. It is Dec. 8, 2015.
arthritis flare up; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis flare up) and FATIGUE (tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (arthritis flare up) and FATIGUE (tiredness). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, ARTHRITIS (arthritis flare up) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include on 8-Feb-2021; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Mild headaches; chills; Fatigue; Body aches; fever; running between hot and cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 37 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "chills"; FATIGUE (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "Fatigue"; PAIN (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "Body aches"; PYREXIA (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "fever"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "running between hot and cold"; HEADACHE (non-serious), outcome "unknown", described as "Mild headaches".  Additional information: Reporter clarified that her second son, who is 37 years old, after his second dose of Pfizer Covid-19 Vaccine he thought he was running a fever but he did not check his temperature; but was running between hot and cold and having the chills and also experienced fatigue. She also reported that he also had body aches. These events lasted at least 12 hours, the same day, and then the next day he was ok. She thinks that was back in Aug2021 that he had the second dose of Pfizer Covid-19 Vaccine and these events. She only knows that his Pfizer Covid-19 Vaccines were administered at a withheld where he lives in unknown sub-town of withheld, withheld, like withheld or something like that. She wouldn't know any further information to provide for this son, and declined to provide any further information because he is a grown man and she does not know that he would want her to provide that. Caller mentioned her 37 year old son experienced fatigue, mild headaches, chills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
lump in throat Narrative:  lump in throat lasted about one hour, ED told her it was not an allergic reaction,
Potentially got their doses from vials punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided
Initial medication error report received on 08 October 2013 from a pharmacist. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE (route was intravenous, lot number and site of vaccination was not reported) on an unspecified date.  The dose was given IV, Intravenous. Also reported that before and we are unaware of any associated adverse events. However, probably no immune effect will take place.  Patient did not have any adverse events. List of documents held by sender: none.
I am 48 and received my first dose of shingrix; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles at the age of 46 years old).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter reported for himself or herself. The reporter received a dose of Shingrix at the age of 48 years old, which led to inappropriate age at vaccine administration. The patient asked questions regarding effectiveness of Shingrix since the patient already suffered with shingles.
Information has been received from a registered nurse (RN) and 29 year old white female with endometriosis and allergies to penicillin and aspirin and a history of one previous pregnancy which resulted in a miscarriage at approximately 4 weeks gestation, through a manufacturer pregnancy registry, who in January 2003 was vaccinated with a 0.5ml dose of varicella virus vaccine live (lot # 643822/0866M). There was no concomitant therapy. The patient reported that in January 2003, she received a dose of varicella virus vaccine live (patient was negative for varicella antibodies prior to vaccination). The patient felt that she was vaccinated around the same time of conception. Ultrasounds on 2/11/03 and 2/18/03 confirmed that the patient was pregnant (LMP 12/25/02, EDD 10/01/03). The RN indicated that the patient had no local reaction at the vaccination site, no varciella or herpes zoster symptoms post vaccination. Unspecified medical attention as sought. Follow up information was received from the RN who reported that on 3/12/03, eight week and three days from the LMP, the patient had a spontaneous abortion. The products of conception were examined, but it was unknown if the fetus was normal. Additional information has been requested.
Eyes were red; Blue injection site; elbows to her wrists was red (no rash or itchiness); Broke out on her neck(It was scaly); Injection site hurts; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Eyes were red), VACCINATION SITE DISCOLOURATION (Blue injection site), ERYTHEMA (elbows to her wrists was red (no rash or itchiness)), RASH (Broke out on her neck(It was scaly)) and VACCINATION SITE PAIN (Injection site hurts) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced OCULAR HYPERAEMIA (Eyes were red), VACCINATION SITE DISCOLOURATION (Blue injection site), ERYTHEMA (elbows to her wrists was red (no rash or itchiness)), RASH (Broke out on her neck(It was scaly)) and VACCINATION SITE PAIN (Injection site hurts). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, OCULAR HYPERAEMIA (Eyes were red), VACCINATION SITE DISCOLOURATION (Blue injection site), ERYTHEMA (elbows to her wrists was red (no rash or itchiness)), RASH (Broke out on her neck(It was scaly)) and VACCINATION SITE PAIN (Injection site hurts) outcome was unknown.            Concomitant product use was not provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR has information of events after first dose.
Light headedness; More pain; Little shortness of breath; Tingling sensation in my lip; Funny taste in my mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "autoimmune disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Light headedness"; PAIN (non-serious), outcome "unknown", described as "More pain"; DYSPNOEA (non-serious), outcome "unknown", described as "Little shortness of breath"; PARAESTHESIA ORAL (non-serious), outcome "unknown", described as "Tingling sensation in my lip"; TASTE DISORDER (non-serious), outcome "unknown", described as "Funny taste in my mouth".  Additional information: Patient who is calling to report side effects of the Pfizer Covid vaccine, after taking the booster dose on 10Jan2022. Severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your or your child's vaccination provider may ask you your child to stay at the place where you or your child received the vaccine for monitoring after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.