chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; have phn; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles and post herpetic neuralgia. On an unknown date, the outcome of the shingles was unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to Shingrix.  Additional details were provided are as follows: The case reported by patient himself/herself. The age at vaccination was not reported. The patient received a shot of Shingrix and 3 days after 1st shot, the patient contracted shingles. At the time of reporting, the patient had post herpetic neuralgia. The patient asked that he/she should get his/her 2nd shot. The follow-up could not be possible as no contact details were available.
having uncomfortable time of it with COVID/tested positive for Covid-19; having uncomfortable time of it with COVID/tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "having uncomfortable time of it with COVID/tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: My husband was diagnosed, tested positive for Covid-19 on May 26. He was prescribed Paxlovid for the emergency use authorization. He is 73, his symptoms he was having chills and was having uncomfortable time of it with COVID. He is fully vaccinated and fully boosted but he is immunocompromised. So he has taken the fully course of the Paxlovid and his symptoms began to improve. Everyday he got better for 5 days that he was taking it. The product details of Paxlovid, consumer stated, the LOT number FY6859. Yesterday he was doing well although we certainly quarantine and isolated as much as we can from each other and he has been masked and much of the time. He tested negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
15:30 day of vaccine - hives rash, grade 1 on cheeks, forehead and sides of jaw/neck area with flushing day following vaccine: grade 3 flu-like symptoms including headache, nausea, muscle aches, fever, diaphoresis Treated with oral Benadryl 25mg BID x 2 days Acetaminophen 650mg QID x 2 days Ibuprofen 500mg QID x 1 day  full-recovered 72 hours following vaccination
Patient had vaccine at 1330 on 12/20. At around 1815 she began experiencing heart palpitations. She presented to the ED and she was found to have a heart rate in the 130s. EKG showed junctional tachycardia. She was given 6mg of adenosine and an EKG was repeated and showed sinus tachycardia. Eventually her heart rate decreased to the 70s-90s. She was noted to have a potassium of 3.4 which was repleted. She was admitted overnight for observation. In the morning her potassium was normal and she remained in sinus rhythm. She was discharged later that afternoon.
Severe allergic reaction; Itchiness; Right arm was painful; Felt tired; Itchiness which was bumpy on her back; Almost like shingles; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program, Support. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 19Apr2021 (lot number: EW0169; expiration date: 31Aug2021) as dose 1, single for COVID-19 immunization. Medical history included allergy to and penicillin COVID-19 infection from Jan2019 (as reported). The patient's concomitant medications were not reported. In Apr2021 (between 6 to 9 days after the vaccination), the patient experienced itchiness which she described was "bumpy" on her back and "almost like shingles". The patient also felt tired and her right arm was painful. Due to this severe allergic reaction, she has not had the second dose of COVID vaccine yet. The patient is a flight attendant and her job was forcing her to be vaccinated, she was wondering if she can taken the vaccine because she had a severe reaction. The patient was also considering of getting vaccine from another company and wonder if its allowed. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
I had such a light period it was almost as if I missed it. I have been having periods for 13 years and they have always been very, very heavy. This has never happened. My period returned the next month.
13 years old received Flublok immunization/no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA287209 (same reporter).  This case involves 13-year-old male patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route.  It was of actual medication error case due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced or not.  Information on the batch number was requested.  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.
experience reflux till today; This spontaneous case was reported by a physician and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (experience reflux till today) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (experience reflux till today). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (experience reflux till today) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator
9/17/21 After receiving her  Bexsero on the right deltoid and flulaval on the left deltoid by MA.   Patient fainted and fell down from the exam table, caught by  her mom.  I came to check  immediately and patient at that time was awake, alert and oriented.  Her blood pressure was 120/67, pulse 49. After the resting  for about 10 min and drank  1 bottle of Ensure,  patient reported feeling fine. I re-eval pt:   Normal speech, PERRL, EOMI, OP clear, tongue  was midline.  heart RRR, lungs were clear, CN 2-12 intact, DTR 2/4  and symmetrical, .  Finger to nose intact, .  Negative Romberg.    Normal gait. Patient was discharged home with mom and sister around 5:30pm.
pt recv doses 1&2 vax 1996 & 1998 pt exp weakness in arm & leg & also muscle wasting;pt reported that is not able to lift weights anymore & reported that physically can see the muscle wasting in arm compared to other side;
Ongoing menses since second dose of Pfizer immunization on 9/14/2021.
Pt recvd 3 doses of vax on 20SEP90 & 18OCT90 was determined to have no immunity to hepatitis B.
Initial report was received 22 May 2008 from a health care a 23-year-old male patient had received an intramuscular left deltoid injection of MENACTRA, lot number U2331AA and within 12 hours of vaccination, he developed tachycardia, joint pains, weakness and a high fever. The patient's heart rate and temperature were not reported. The patient was evaluated by a physician on an unspecified date and results from that medical evaluation were not provided. The patient was reported to have had no past medical history and they had not been ill at the time of vaccination. According to the reporter, the event was still resolving at the time of the report. No further information was provided.
URINARY TRACT INFECTION; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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 27-MAR-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 urinary tract infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of urinary tract infection was not reported. This report was non-serious. This case, from the same reporter is linked to 20210406945.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were orally administered the improperly stored doses of ROTATEQ (lot # M019708 with expiry date on 25-OCT-2017; dose was not reported. Administered doses of vaccine experienced the temperature excursion of -0.24 degree Celsius for 285.5 total cumulative hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was 15 years of age and received the first dose of the Pfizer COVID vaccine.
I became nauseous and having body chills for 4-5 hours with 1 episode of vomiting. I then had a sustained headache with nausea until 8:00 am on 1/27/2021.
pt recv vax & exp weakness & numbness of extremities for GBS;pt adm to hosp & given med;dx rt frontal lobe hemorrhage;
Vaccines given on the 21st January. Patient returned 3 days later with erythematous macular rash on the vaccine site with smaller scattered blanching erythematous papules on the trunk oral pred, hydroxyzine and KEFLEX prescribed. Pending follow up visit.
after the second dose apart from other moderate symptoms like chills; head ache; pressure in the ears & back of the head; pressure in the ears & back of the head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 12:30 (Lot number: ER8729) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known Allergy: Sulpha Drugs" (unspecified if ongoing), notes: Known Allergy: Sulpha Drugs; "Diabetes" (unspecified if ongoing), notes: Diabetes. Concomitant medication(s) included: METFORMIN; LEVEMIR. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer, lot number: ER8727, lot unknown: False, administration date: 19Mar2021, administration time: 12:30 PM, vaccine location: Left arm, dose number: 1), administration date: 19Mar2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 11Apr2021, outcome "not recovered", described as "after the second dose apart from other moderate symptoms like chills"; HEADACHE (non-serious) with onset 11Apr2021, outcome "not recovered", described as "head ache"; HEAD DISCOMFORT (non-serious), EAR DISCOMFORT (non-serious) all with onset 11Apr2021, outcome "not recovered" and all described as "pressure in the ears & back of the head". The event "after the second dose apart from other moderate symptoms like chills" was evaluated at the physician office visit. Therapeutic measures were taken as a result of chills, headache, head discomfort, ear discomfort.  Additional information: AE treatment over the counter pain medication. The patient receive other medications within 2 weeks of vaccination included metformin and levemir. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination  No follow-up attempts are possible. No further information is expected.
Abnormal menstruation and vaginal bleeding 5 months straight of bleeding and or spotting
received by error Engerix-B vaccine.; Twinrix-6 months ago, Twinrix today; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix on an unknown date 6 months ago of reporting date).   On an unknown date, the patient received Engerix B. On 18th October 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 18th October 2021, not applicable after receiving Engerix B and unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received Engerix B vaccine instead of Twinrix, which led to wrong vaccine administered. The patient also received 2nd dose of Twinrix after 6 month longer than the recommended interval, which led to lengthening of vaccine schedule. The patient received Twinrix vaccine in order to complete hepatitis A series, and that was the reason why there was an extra hepatitis B. The pharmacist mentioned that patient was around fifties. The reporter consented to follow up.   Follow up information was received by pharmacist on 22nd October 2021: Upon follow up it was unable to contact reporter after corresponding phone attempts. The case classification was changed to follow up no permission denied.
07/31/2022 in the morning around 8:00AM I was tired and weak. I tested positive on 08/01/2022. On Monday I had  severe cough. On the same day I did a telehealth with my doctor who prescribed me Paxlovid for 5 days. I took few over the counter cough medication as well for few weeks and I still have lingering cough till now.
Chills; Achy; Headache; had spasms in her stomach and diarrhea; had spasms in her stomach and diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date for covid-19 immunisation. The patient experienced chills, achy, headache, had spasms in her stomach and diarrhea on an unspecified date. Therapeutic measures were taken as a result of events. It was reported states that she had the vaccine on Wednesday morning at 9am, and for the next 2 days she went through the whole list of side effects; she had chills, was achy, had a headache; she had everything but no fever. States that when she woke up this morning, she felt great. Then about 2 hours after waking up, she had spasms in her stomach and diarrhea; this has happened 4 times so far today and it's wearing her out. States that the last 2 times were very watery. Is there anything she can do for this? Is this usual? She knows it's on the list of possibilities, the diarrhea, but it doesn't say anything about spasms in the stomach. States the she has pressed down all over her stomach and nothing hurts. She took 1 Imodium a little while ago, is there anything else she should do or take.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Patient was seen at the PCP office on 1/5/2021 for dizziness, hypotension, and syncope.  He did report these been having 6 to 7 weeks of low blood pressure and passing out. Patient was fully vaccinated with Pfizer (3/11/21 & 4/1/21). Patient is still admitted with COVID
Immediately after receiving vaccine I had severe body aches, fever, chills, vomiting and was off work for 3 days. Then on 5/29 I started experiencing extreme left side flank pain, chest pain, and shoulder pain. On 6/1 I went to the emergency department for this pain and the dicovered a splenic infarct, with elevated d dimer. I remained hospitalized until today 6/3/2021. May have been caused by a blood clot, but they did not detect a clot in the scans. I am not sure if this was caused by the vaccine or not, but I know other brands have been linked to clot formation.
sore arm; swelling; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 79 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation..Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced sore arm and swelling on an unspecified date with outcome of unknown.  Follow-up attempts are completed. No further information is expected.
I developed a few hives on arm and torso within an hour of receiving the vax. Other than minor soreness at injection site, I've had no other adverse reactions.
"pt recv vax & to ER w/hypotension, fever like sx;pt adm to hosp for observation;sx abated w/time d/c 12JUL97;"
Vomiting, fever of 101.8, swelling/redness all around injection site, fatigue
Breakthrough infection; Breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 18Nov2021 (Lot number: Ew0196) at the age of 45 years as dose 3 (booster), single, administration date 24Mar2021 (Lot number: Ep6955) as dose 2, single and administration date 04Mar2021 (Lot number: El3248) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NAPROXEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Feb2022, outcome "recovering" and all described as "Breakthrough infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: Covid test post vaccination: covid test type post vaccination: Nasal Swab, covid test name post vaccination: Binaxnow, covid test date: 23Feb2022, covid test result: Positive. The patient was not tested positive prior vaccination and got tested after vaccination. The patient did not had any other vaccine in four weeks.  No other vaccine in four weeks. No covid prior vaccination. Patient was tested covid positive post vaccination.
Immediate erythema from injection site down to wrist. Rash on wrist. Resolved in 1-2 hours.
Rashes and  itchiness on both arms, hands and chest.  Patient has a lot of allergies. Offered Benadryl, but patient is allergic to Benadryl. Patient was given Claritin, but rashes was spreading, so patient was eventually given an Epipen. Symptoms improved. Patient refused for us to call 911.
3 Days post 2nd vaccination, widespread urticarial rash over entire body (neck, trunk, arms, legs). Rash did NOT go to face nor mucous membranes (pictures available). Large itchy welts that responded to diphenhydramine 125mg - 175mg (25mg - 50mg per dose) PO per day, which gradually tapered over two (2) weeks. On day 3, took 12mg dexamethasone PO on advice of ER physician. Both diphenhydramine and dexamethasone resolved rash but interesting to note that when diphenhydramine wore off, itchiness, then welts, returned. Learned to take diphenhydramine at first sign of itchiness. Have never experienced such an allergic reaction before, and this was the first time taking diphenhydramine and dexamethasone for such a condition for me. Also, discontinued prescription medications about one week into rash just in case. Restarted medications a few days before complete remission with no adverse consequences (so current medications as a cause were ruled out). Also, took famotidine 40mg PO during last week that also seemed to help a little  but this may have been due to slow resolution of adverse reaction.
After receiving the first shot, I felt a fever and very tired the first night. I took the day off from work and felt very tired still, which I understand is a normal side effect. On March 9th, around 9-10am, I was having breakfast, and the food tasted as if it was rotten. I assumed it was the meat and went on about my day. Later that night, I had more food and it tasted rotten as well. I didn't think much of it, until every where I went, I smelled that same rotting smell. Two days later, I realized it was not the food, but my sense of smell and taste. It's been about 3 weeks and I am still having these side effects. I have struggled eating and sometimes the smell of food is overwhelming.
Developed a fever of 102.1, chills, severe body aches, HA, After about 18 hours after vaccine. The high fevers lasted about 12 hours. symptons are slowly subsiding.
I tested positive for COVID-19 on June 30, 2022 while being seen for a heart attack. I was asymptomatic. I had to have two stents put in my main arteries and I was released from the hospital July 3, 2022.