chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6/23/2022 I had a scratchy throat that morning then it became very sore. I thought I had strep throat. I had a minor headache, achy, congested and feeling like I was coming down with something. Two days later, I took a home COVID test and it was positive. I went to the health clinic later that day and I was positive for COVID again. I was prescribed oral steroid and antibiotics for my throat. She told me I had a mild case, that my lungs sounded clear. The next day, after taking antibiotics, my throat was much better. It took about three weeks to stop coughing and I continued to feel fatigued about four weeks. I would get tired very quickly and felt out of breath. I feel like I am over it now. I can exercise and get around without being short of breath and have my strength back.
Information has been received from a nurse practitioner concerning a 27 year old female who, on an unspecified date, was vaccinated with a dose of Pneumovax 23.  Immediately following vaccination, the patient's arm swelled up to 3 times the normal size and the patient developed a temperature of 105 degrees.  The patient sought unspecified medical attention.  The patient was not a patient of the reporter at the time the Pneumovax 23 was administered.  At the time of this report, the outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
pt recvd vax; afebrile sz w/ mild v; loose stools for approx 12 hrs;mult brief (<5mins) generalized tonoc clonic sz;
pt. vax'd w/ 1st dose of hepatitis B vac.& recvd meningococcal vac.at same time;& 4 hrs later developed hives,itching of arms & swelling of hands.
CHIEF COMPLAINT:   Pt reports he has chronic pancreatitis. is tearful at triage as he reports abdominal pain, vomiting, and diarrhea for three weeks.Hx DM, has not taken insulin X3 days.   HISTORY OF PRESENT ILLNESS:     Patient is a 72-year-old male who presents with chronic intermittent abdominal pain, states that he has a history of chronic pancreatitis, gastric ulcers has had worsening abdominal pain with vomiting and diarrhea that has been progressive over the past week.  Patient has family members we have been tested positive for Covid, however he denies any fever cough or sore throat.  Denies chest pain or shortness of breath.  Patient states that he had a EGD in October that showed the ulcers, is taking PPI and H2 blocker as directed.  Denies blood in his vomit, or blood in his stool.
I have enclosed 2 different copies. I had requested the flu vaccine not have the preservative as I have the following for 2 weeks severe itching. Swelling in size as large as a baseball I believe I was not given the right vaccine, as I had the same reaction as the above and went back to CVS to show them my right arm.
Symptoms: Nausea, Dizziness, Fever, Extreme Fatigue, Soreness at Injection Site. Lasted approximately 18 hours.
5 days after vaccination (which was administered simultaneously with flu shot) I started having partial numbness over left side of face.  Occurred intermittently over the last 3 weeks.  Primary care provider did not think it needed immediate treatment and advised me to consult my neurologist who manages my migraines.  Is mostly resolved but still occasionally happens.
Pt developed invasive flu disease. Reporter "did not see this as a MFR problem".  Follow up from reporter stated that the pt "had an immunodeficiency - there was no vaccine problems".
hit was head and it was bleeding; hit was head and it was bleeding; dizzy; fell; Nauseous; This is a spontaneous report from a contactable consumer (Husband). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 18:00 on Arm left at single dose (Lot # EL3249) for covid-19 immunisation. Medical history and concomitant medications were none. He did fine right after, his arm wasn't sore, he felt fine. The next day he had nothing, no soreness, nothing, he felt great the next day. Dizziness started in the morning 17Jan2021 when he got up he said good morning and then said he would bring her back a cup coffee then he became very dizzy and leaned against the wall for support and then he fell, he was okay but he fell. He did go the emergency room because he fell and hit was head and it was bleeding. They told him it was not related to the vaccine but it is one of the things that are on the form that could happen. She says it was okay if it caused it she is just looking for a reason.  Now today (18Jan2021) he feels fine she wants to know what causes that side effect. She says she is supposed to be getting her vaccine too. He had one bad dizzy spell and then it went away, and she thinks he got kind of nauseous with it. It says this can happen, it said it could happen right after but in his case it did not, it happened within probably 34 hours or something. Outcome of the event dizziness has recovered completely at this point. Outcome of other events was unknown.
Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Tingling in legs, hands and tongue
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 15May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 16Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 24Jul2023 to 28Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
they confirmed him to be COVID positive; they confirmed him to be COVID positive; 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's wife.   A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 14May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 27Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Chronic lymphocytic leukemia" (unspecified if ongoing). He was not taking any medication for his chronic lymphocytic leukemia (no immunosuppressants). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "they confirmed him to be COVID positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: Before he got his 2nd dose, he got in contact with someone with COVID, and the doctor told him to proceed with the 2nd dose on 14May2021. After his 2nd dose, he never became well and continued to be ill and they confirmed him to be COVID positive. He received monoclonal antibodies on 20May2021.   The lot number for bnt162b2 was not provided and will be requested during follow up.
bowels were loose yesterday; arm sore; 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 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 09:00 (Lot number: EP7534) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "no spleen" (unspecified if ongoing), notes: Verbatim: no spleen; "hocking and spitting up phlegm " (unspecified if ongoing), notes: for the last six months and they are trying to figure out what it is. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "recovering", described as "arm sore"; DIARRHOEA (non-serious) with onset 30Mar2021, outcome "recovering", described as "bowels were loose yesterday". The event did bot require physician office and emergency visit.  No follow-up attempts are possible. No further information is expected.
The patient got FluBlok on 01-Oct-2020 and by mistake a second dose on 09-Oct-2020, no AE; Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00353175).  This case is linked to case 2020SA318070 (same reporter).  This case involves a 60 years old male patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] twice by mistake (Extra dose administered).  Medical history, medical treatment(s), past vaccination(s) and family history was not provided.  The patient did not receive concomitant medications.   On 01-Oct-2020, the patient received a first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported, prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination.  On 09-Oct-2020, the patient received a 0.5 ml second dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2009, expiry date: 30-Jun-2021, prefilled syringe) via intramuscular route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered.  The reporter asked if they should expect any side effects or were there any concerns if a patient got 2 doses of FLUBLOK.  At the time of report, patient was not experiencing any side effects or any symptoms.  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.
Initial onset at time listed- fever, severe myalgias, rigors, sweating, headache, anorexia, thirst, lethargy. Felt like severe flu. No pulmonary symptoms or GI symptoms.  Symptoms improved with first ibuprofen dosing on 6Feb2021. Fever and myalgias recurred after Ibuprofen dosing subsided evening of 6 Feb2021. Full resolutions of symptoms on 8Feb2021
Hot to the touch. Red spot popped up got bigger next day. (Varicella right arm).
Patient received a vaccine that had a manufacturer expiration date of 02/12/2023. The fridge expiration date surpassed the manufacturer expiration and that is where the error occurred. The patient received an expired vaccine per the manufacturer expiration date. No adverse reactions were observed. Follow up phone call to inform family of medication and patient was still without reactions.
Headache, Myalgia, NauseaVomiting, fatigue, weakness Narrative:
Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from other Health Care Professional. This case involves an unknown age and gender patient who received vaccine ACTHIB with diluent of sterile saline from Merck instead of the diluent from Sanofi. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot UI908AAB, expiry date; 10 Nov 2019 via unknown route in the unspecified deltoid. It was a case of actual medication error due to wrong solution used in drug reconstitution. It was unknown if adverse event occurred. 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.
Patient complained of significant left arm pain at site of injection night of 9/22/16 and could not sleep, and shakiness.
Shortly after vaccination administration, patient appeared faint, disoriented. Wife states he appeared the same way recently because of dehydration.  911 called, wife reports paramedics state patient was dehydrated  and given fluids. Followed up with wife next day, patient complained of sore and painful arm, weakness, chills during the night.  Patient fell that morning, 911 called again and patient taken to hospital.
I received my second Pfizer booster for COVID-19 on 4/12/2022. On 7/9/2022, I felt very fatigued, plus I had a cough, sore throat, headache, and body aches. I took an at-home test for COVID-19, and the result was positive. I stayed home from work and stayed in bed. I had a low-grade fever of 99.9. I spent most of the day sleeping. On 7/10/2022, I had the same symptoms, but my fever was at 101. On 7/11/2022, I called my doctor, and we agreed that I would get an infusion of monoclonal antibodies, which I got later that afternoon. I still had all the same symptoms as before, though my fever went down to 100. On 7/12/2022, I had all the same aforementioned symptoms, but the fever went away in the afternoon. At the time of this writing, I still have a cough and a minor sore throat, but all of the other symptoms have vanished.
This case was reported by a healthcare professional and described patient who was inadvertently vaccinated with an expired dose of Pediarix for prophylaxis.  On 18 October 2005 the subject received the first dose of Pediarix.  The expiration date for this Pediarix is 15 October 2005.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:34 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient's age was reported as 37.44  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 03-Apr-2021, At excursion time 09:00 AM temperature was 34, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were moved to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H015749, expiry date 08-JUN-2014). The patient was also vaccinated with a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) on the same day. On an unknown date, the patient experienced severe nasal congestion and loss of appetite. The patient had lost 134 pounds since these vaccines were administered. The outcome of the reported events were not recovered. The patient sought medical attention. This is one of the two reports received from the same reporter. Additional information has been requested.
About 12 hours after first dose of vaccine, patient described extreme weakness and had an episode where he had to lower himself to the ground and could not get up, was very dizzy as well, and had been experiencing diarrhea for about 12 hours as well. Was back to normal after the 12 hours and was instructed to report is this occurs again after second dose.
Redness and swelling in the area of the injection, fatigue, very strong headache now into my third day and fever up to 102.5 F
pt stays in memory care unit; had a positive COVID test in facility; cough, poor oral intake, SOB; O2 supplementation; albuterol inhaler; family requested no aggressive measures; pt passed away in the facility
2.5 x 3 inch 2.4induration and swelling below puncture sites located on left lateral arm
This spontaneous report was received from a physician reports regarding himself, not demographics information was provided. On an unspecified date between 1968 and 1969, the patient received series of RECOMBIVAX HB (dose, Lot # and route were not reported). He stated that he was a non responder to series to vaccine. He never developed antibody. No adverse effects were noted. The outcome of he was a non-responder to series to RECOMBIVAX HB series in 1968 and He never developed antibody was unknown. This is one of two reports from the same source. Additional information has been requested.
Follow up information has been received from a physician's assistant concerning an 18 year old female with no previous medical history, who on 19-DEC-2007 was vaccinated with her first dose of Gardasil (lot number: 659055/1522U). No concomitant medications. On 19-DEC-2007, after the injection the patient got up to check out window and had syncopal episode. She hit her head on the plexiglass partition at the window with a minor laceration and bump. EMS was called second degree to patient hitting head, but the patient refused to go the hospital for evaluation. The physician assistant called the patient the next day and she felt well. No other adverse reactions. No further information is available.
This spontaneous report was received from a registered nurse referring to a unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients' were vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L019298 with an expiration date of 22-JUN-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. At the time of the report, no adverse event was reported. Furthermore, no product quality issue was involved. Additional information has been requested.
Client presented for his second Moderna vaccine in his primary series. Client was given Pfizer in error. Client was observed for required 15 minutes and left asymptomatic.
Patient received 1st dose of the vaccine on 12/15/2021 and received his 2nd dose vaccine on 12/20/2021.
This case was reported by a healthcare professional (medical assistant) and described the occurrence of seizure in a 21-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included autism and seizure. Concurrent medications included CELEXA, KEPPRA and LAMICTAL. The subject had a history of seizures but seizures were under control with medications. On 7 October 2013 at 13:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 8 October 2013, 1 day after vaccination with FLULAVAL, the subject experienced "one" seizure. Per the reporter, the subject did not receive any new medication or treatment of other than the flu vaccine. This case was assessed as medically serious by GSK. On 8 October 2013, the event was resolved. Follow-up information was received on 19 November 2013 via healthcare professional. Additional concurrent medical conditions included seizure disorder and "non-verbal". The healthcare professional reported the seizure was witnessed and occurred on 08 October 2013. The subject did not lose consciousness. It was unknown if the subject remembered the event. The subject is non-verbal so it was unknown if the seizure was preceded by an aura or headache. The subject experienced urine/fecal incontinence during the seizure. No evidence that symptoms were due to withdrawal of alcohol or other psychotropic substances. There was no evidence of neurological lesion, infection or abnormal serum electrolytes. The subject has not received any medication known to reduce the seizure threshold. The subject has a history of seizures as well as a history with cerebral palsy, neurological handicap or congenital abnormality; specific details not provided. The healthcare professional indicated that there was no planned follow-up. The reporting healthcare professional did not consider the seizure serious. The reporting healthcare professional attributed the seizure to medical history/concurrent illness of seizure disorder. No action was taken with FLULAVAL vaccine.
mom stated pt had fever 101 for 24hrs p/vax & that entire lt deltoid area swollen; today 18MAY95 pt is afebrile  T98, there is half dollar size red area on lt deltoid;can move lt arm w/o pain