chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had reddening/red splotches of skin on arms and neck. Patient felt clammy.  Patient had shortened breathing and shaky voice.  Patient did not have any difficulty breathing or swelling.
Resident received Pfizer COVID-19 Vaccination on April 29.  When entering the information into the Registry, it was noted that the resident had completed the Moderna COVID-19 series in March.
Went to bed around 9:00 to 9:30 PM and he woke up around 11:00 PM; Couldn't even move; Whole body is aching; Sweating; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0170), via an unspecified route of administration in left arm, on 29Apr2021 at 03:00 PM (15:00), as first dose, single, for COVID-19 immunization. The patient's medical history included blood pressure, atrial fibrillation, cholesterol, and heart problem. The patient's concomitant medications included metoprolol and acetylsalicylic acid (BABY ASPIRIN); both were ongoing. The patient takes acetylsalicylic acid because he can't take blood thinners because he works with sharp objects all day. The patient had no prior vaccinations within 4 weeks; and he didn't know adverse events following prior vaccinations as he received vaccines as a child. The patient received his first COVID-19 vaccine in his left arm (because he's right-handed) yesterday (29Apr2021) and his whole body is killing him, it's aching, and he's sweating. The patient was asking if his symptoms are normal. Last night (29Apr2021) when the patient was sleeping, he went to bed around 9:00 to 9:30 PM and he woke up around 11:00 PM and he couldn't even move. The patient got up this morning and took 2 paracetamol (TYLENOL) for the events. The patient was sweating like there's no tomorrow, but he thinks that paracetamol is working. The events did not require a visit to the emergency room and physician office. The patient's second COVID-19 vaccine is scheduled for 20May2021. The patient had not recovered from "Whole body is aching" and "Sweating". The outcome of the other events was unknown.
Area around vaccination is bruised and red. Advised pt to take ibuprofen for pain and swelling.
Itchy runny nose; Itchy runny nose; cough; fatigue; headache; This is a spontaneous report from a contactable healthcare professional. A 45-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on her left arm on 23Jan2021 09:15 at a single dose for COVID-19 immunization. Medical history included Covid-19 at an unspecified date. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient experienced Itchy runny nose, cough, fatigue, headache; all on 24Jan2021 07:00 AM. No treatment was received for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
IM influenza vaccine was mistaken for Flumist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 09-JUN-2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-NOV-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles and post-herpetic polyneuropathy, a chronic condition of nerve damage and ongoing pain. The patient has been prescribed acetaminophen-codeine, gabapentin and valacyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review post-herpetic polyneuropathy was considered a medically significant event. Additional information has been requested.
I had fever for 72 hours. I had headache and body ache for 5 days. I had nausea and diarrhea for about about 6 days.  The diarrhea is still ongoing. I had sore throat and congestion for about 8 days. I had severe fatigue for about 2 weeks. I also had a cough for about 2 weeks. I tested positive for Covid-19 on Dec 3rd.
I recievwd my 2nd dose of Pfizer Covid vaccine on 01/06/2021. I started feeling sick on 01/07/2021 early morning. I had a fever (ranging between 99.7 to 100.1), had chills, bodyache, and a headache. I did not have the strength to get out of bed all day (on 01/07/2021). Today my symptoms have improved to some extent but I still have a bodyache and headache.
Patient was dizzy and slight disorientation after getting vaccine and was observed on site until 1/22 then she was sent to hospital for stroke like symptoms and is scheduled to return to facility on 1/23.
Received Hepatitis A, Menactra and Gardasil.  Fainted immediately after receiving Gardasil. Regained consciousness promptly; given first aid per protocol; monitored until fully stable; parent notified.
Injection site LD with swelling, pain, warmth and redness with an onset of 1 day.
Information has been received from a nurse practitioner concerning a 25 year old female patient with a bee sting allergy, who on 14-OCT-2008, was vaccinated with the first dose of GARDASIL (lot # 660555/0278X), 0.5 ml, IM. There was no concomitant medication. On 14-OCT-2008, the patient developed a fever of 101 F, stuffy nose, wheezing, itching sore throat, and swollen upper middle lip about 18 hours after receiving the first dose of GARDASIL. The patient took an unspecified amount of diphenhydramine hydrochloride (BENADRYL), and most of the symptoms resolved by the patient phoned the nurse practitioner on 16-Oct-2008. The patient's only remaining symptom was a stuffy nose. The patient sought medical attention by phone. Additional information is expected.
after getting her second dose of COVID vaccine was sick; This is a spontaneous report from a contactable consumer, based on the information received by Pfizer (manufacturer control number: US-AMGEN-USASP2021081162).  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gastroesophageal reflux disease" (ongoing); "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for gastrooesophageal reflux disease, rheumatoid arthritis; TRAZODONE HCL; OMEPRAZOLE; PANTOPRAZOLE; GABAPENTIN; PANTOPRAZOLE SODIUM; PLAVIX; NICODERM CQ; ALCOHOL SWABS [ETHANOL]; VICODIN. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "after getting her second dose of COVID vaccine was sick".  Additional information: This non-serious spontaneous report involves an approximately 62 year old (as reported) female patient who missed a dose of her Enbrel due to developing flu like symptoms [PT: influenza like illness] and after getting her second dose of COVID vaccine was sick [PT: illness] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient missed a dose of her Enbrel due to developing flu like symptoms. On an unknown date, after getting her second dose of COVID vaccine, she was sick and decided not to take Enbrel. Patient stated she has already spoken about it with her physician. No treatment information was received. Action taken with Enbrel and Single Dose Prefilled Autoinjector was temporarily withheld for the event influenza like illness. The causal relationship between the events influenza like illness, illness and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Got 2 vaccines and turned out it was shingles,suspected vaccination failure; Got it, turned out it was shingles, it sent me to hospital; horrible  burning sensation, body was burned all over; coma for 3 months; blisters on buttocks; feel fear,scares me; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization), coma (serious criteria hospitalization and GSK medically significant), burning sensation (serious criteria hospitalization), blister and fear. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, blister and fear were unknown and the outcome of the coma was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, coma, burning sensation, blister and fear to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, blister and fear to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comments: This case was reported via interactive digital media. The patient reported that he/she got it (shingles) and it he/she sent him/her to the hospital it was like if all his/her body was burned all over.  The patient went to the doctor and supposedly they gave him/her the wrong medication and it turned out that they sent him/her to another hospital where patient fell in a coma for 3 months and at the end it turned out that it was shingles.  The patient get blisters from time to time on buttocks and that was it, the patient the 2 vaccines but nothing to worry about, he/she heal quickly because it scares him/her, when they come out the patient thought he/she was in a horrible burning oven. Additional Supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
While waiting during the 15 minute monitoring period patient (17 year old female) fainted in her chair. Mom noticed that patient's arms went rigid right before she passed out. Patient was still breathing and was laid on the ground to her side and 911 was called immediately. Mom was massaging her thighs and arms to increase blood flow and she regained consciousness within a few minutes. She was very pale and felt weak. She was given water and remained laying on the ground for another 10 minutes before EMS arrived. She explained she gets anxiety about any medical procedure, has had history of fainting after shots/blood draw/blood pressure reading. EMS took fingerstick reading and gave her oxygen to ensure she doesn't faint again from blood glucose fingerstick. Vitals came out to be normal. Mom explained this is very normal and she doesn't see the need to take her to the hospital. EMS offered to have patient with them in the ambulance for another 15-20 minutes before she's free to leave.
I had minor hives on my neck and chest. I felt dizzy, foggy, and very fatigued for the rest of the day after getting this vaccine.
Redness and swelling at injection site - which started approx. 24 hours after DTaP injection. Ice to area, Tylenol for discomfort. Is considering Benadryl, but has not given any yet.
I developed short runs of PVST without any exersize or stimulation. sudden onset, lasts 5 minutes to an hour. will spontaneously start and stop. identified in January but actually may have started in July post injection. dizzines was primary indication. no SOB, no Cx pain, tingling in arm at times. occurs every 3 or 4 days.
This spontaneous report was received from a physician and referred to a patient of unknown age and sex. On an unspecified date during childhood, the patient received an hepatitis B vaccine (manufacturer unknown) (lot #, expiration date, strength, dose and frequency were not reported). Then, on an unspecified date, the patient had a titer that was negative for hepatitis B surface antibodies. The outcome of the hepatitis B surface antibody negative was unknown. Action taken with the hepatitis B vaccine (manufacturer unknown) was not reported. The relatedness between the hepatitis B vaccine (manufacturer unknown) and the event of hepatitis B surface antibody negative was not reported. Additional information has been requested.
Over the last month have started having speech issues, not being able to find words, slight stuttering, and a tremor in my hands
patient received Fluzone High-Dose Quadrivalent twice this season 14SEP2022 and 7NOV2022, with no reported adverse event; Initial information received on 10-Nov-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 65-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] twice this season 14sep2022 and 7nov2022, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Sep-2022, on the same day the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE twice this season (strength, formulation, dose: unknown) in unknown administration site and on 07-Nov-2022 at 0.7ml total dose (lot number: UJ924AC and expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for Immunization, with no reported adverse event (extra dose administered).  It was reported, reporter was requesting safety information. This situation is reported as a medication error due to two FLUZONE HIGH-DOSE QUADRIVALENT administrations in this flu season.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was unknown.  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 the 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.
Sore throat Chest and UR congestion Severe coughing and sneezing (48 hrs) Diarrhea Fatigue
I received a TDAP booster but am not certain the brand. I received it on friday afternoon. By friday evening (~5 hours later) I had broken out in hives. I had no other symptoms. The hives lasted about three days before beginning to fade.
lt lower quad pain-devel GBS-ER intubation has not regained motor strength or movement-flacid paralysis
Patient started to have swelling on the injection site.  She states that it happened about a day after immunization was given.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 15Apr2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History of pe" (unspecified if ongoing), notes: History of pe; "Allergy" (unspecified if ongoing), notes: Relevant past drug history: name of drug was not reported, reaction: allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: (Sep2022) Positive, notes: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: history of pe. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient was previously receive a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sudden, severe worst headache of her life, coupled with onset of oral herpetic lesions and inflammation to unrelated body part (belly button piercing) occurred one week after vaccination received. She presented to ED 12/28 noted to have hypokalemia and  head CT showed mild occipital encephalitis, admitted overnight for obs subsequent brain MRI was normal.  She was seen in my clinic 2 days later (1/4/21) and was started on 3 day course of Decadron, topical acyclovir for herpetic lesion.  As she is a nurse, I kept her off work until resolution of symptoms. Seen again on 1/8/21, headache resolved.  She did discuss CT and MRI results with neurologist. He was not convinced this was vaccine related.  She is having 2nd dose of vaccine on 1/11/21.
Presented to ED w/COVID-like symptoms; tx w/ abx, discharged home from ED
After got shot, has had them; Has had them 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: After got shot, has had them) (serious criteria GSK medically significant) and shingles (Verbatim: Has had them 3 times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 The reporter reported the case via interactive digital media. The reporter's brother in law never had them.  After patient got the shot to prevent them, he had them 3 times.  So much for the shot preventing.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
I developed a mild case of shingles on the right side of my abdomen. It sometimes burns. It started around April 17th and is ongoing.
Developed maculopapular rash over face and chest about 1 week after receiving the MMR vaccine.  Also c/o rhinitis, eye irritation and generalized aches.  Some low grade fever-subjective.  No dyspnea or sputum-producing cough.  Also had feared she had mumps on 11/1/06 but had a sebaceous cyst and was given keflex for that.  Reported today.  Complete recovery anticipated.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: Unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). No known allergies. Concomitant medications included: ATORVASTATIN MYLAN, stop date: 17Dec2022; TUMS [CALCIUM CARBONATE]; ADVIL [IBUPROFEN] and daily vitamins. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2022) Negative, notes: tested negative for Covid 8 days ago; (27Dec2022) Positive, notes: test positive again 8 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course:  On 17Dec2022, the patient started Paxlovid for the treatment of COVID-19 and stopped at 21Dec2022. Finished taking Paxlovid on 21Dec2022 (7 days ago) and tested negative for Covid-19 on 20Dec2022 (8 days ago). Sore throat again and home test positive again on 27Dec2022 (8 days later).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Narrative: Pt is a 81y.o. male who died on 03/24/2021 w/ h/o DM, HRN, BPH, HLD, past PE. Pt received Moderna Covid-19 Vaccination 1/2 on 02/26/2021. Pt DIED ON ARRIVAL (DOA) AT HOSPITAL (03/24/2021) PER EMAIL AND CPRS NOTE. Unlikely that Moderna Covid-19 vaccine caused/contributed to pt death.
acute cellular rejection in a liver transplants recipient occuring after the first dose of the mRNA vaccine; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "liver transplant" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TRANSPLANT REJECTION (medically significant), outcome "unknown", described as "acute cellular rejection in a liver transplants recipient occuring after the first dose of the mRNA vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event acute cellular rejection and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
She received her covid vaccine at 1:14pm and within approximately 10 minutes of the vaccine her face became flushed.  She also noted tingling in bilateral upper and lower extremities.