chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She says she had itching after the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 09Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing); "Retinopathy of prematurity" (unspecified if ongoing), notes: Was born two months early, and has been blind since birth, she has retinopathy of prematurity.; "COVID" (unspecified if ongoing), notes: had COVID twice and was in the hospital in the ICU the first time; "autoimmune issues" (unspecified if ongoing); "health issues" (unspecified if ongoing); "fluid retention problems" (unspecified if ongoing); "blind" (unspecified if ongoing), notes: she can not read her vaccine card, she is blind and can not read print to provide. There were no concomitant medications. Past drug history included: Gentamicin, reaction(s): "gentamicin allergy", notes: allergic to Gentamicin sometime between 1989-2000. The following information was reported: PRURITUS (non-serious) with onset Nov2021, outcome "recovered", described as "She says she had itching after the first dose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus.  Additional information: Patient had itching after the dose 1 and took Benadryl as a treatment and then it went away after taking Benadryl, she thinks she took two 25 mg tablets at a time, and she also took some Aller-Tec, which was like a version of Zyrtec, she took that two to three times a day as well for about a week or two maybe.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200742828 similar report from same reporter
Approx 10 min after receiving the injection patient c/o dizzyness. No headache, no nausea, no swelling any location of body, no sob. Ice packs applied to back of neck and winter garments removed to aid with cooling. Vitals were WNL. Pt observed until symptoms resolved and patient left clinic.
headache, body ache, upset stomach, tired started on April 8th approximately 11am and persisted through April 9th. I woke on April 10th and all side effects were gone. My treatment was to drink lots of water and resting. I did not call a healthcare provider.
Breakthrough case admission after 2 vaccines Moderna 1/21/21 Lot# 012L20A;  Moderna 2/18/21 Lot# 016M20A
pt recv vax 21FEB95 4Pm; 8PM awakened crying & inconsolable, high pitched; cried 30 mins non-stop then off & on 2-3 hr; no fever; mom paged MD who was on-call; mom states pt was fine by 11PM;
NO PRESCRIPTIONS OR OTC MEDICINES. PT GOT BOTH MMR VACCINE AND MODERNA VACCINE AT THE SAME TIME. INITIALLY, PT WAS REQUESTING FOR MMR AND NOT MODERNA.PT ALREADY HAD GOT JOHNSON AND JOHNSON VACCINE IN APRIL 2021.COVID VACCINE GOT DUPLICATED.
temperature of 101.82 degrees F; pulse of greater than 120; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 14Oct2021 08:00 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 08Jan2021, for COVID-19 immunization, reaction(s): "no side effects with either dose"; Bnt162b2 (Dose 2), administration date: 29Jan2021, for COVID-19 immunization, reaction(s): "no side effects with either dose". The following information was reported: IMMUNISATION (non-serious) with onset 14Oct2021 08:00, described as "booster dose"; PYREXIA (non-serious) with onset 15Oct2021 00:07, outcome "recovered" (15Oct2021 01:07), described as "temperature of 101.82 degrees F"; HEART RATE INCREASED (non-serious) with onset 15Oct2021, outcome "unknown", described as "pulse of greater than 120". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, heart rate increased. Additional information: The patient was the reporter's brother. The patient took ibuprofen 200mg and the temperature was back to 98 degrees F within 1 hour.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Terrible vomiting and diarrhea at the same time and may times very weak! No appetite.
Achy arm; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318), via an unspecified route of administration in left arm, on 16Feb2021 at 10:30 AM (at the age of 39 years), as dose 2, single, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot Number: EN5318) on 26Jan2021 (at the age of 39 years) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a workplace clinic facility. The patient needed clarification on definition of adverse event versus expected reaction such as achy arm and body aches. The patient asked if expected effects need to be reported. In Feb2021, the patient had an achy arm so far after receiving the second dose. No treatment was administered for the adverse event. The patient has not been tested for COVID-19 post vaccination. The patient was recovering from the event.  No follow-up attempts are possible. No further information is expected.
Tight throat, heavy chest, increased heart/breathing rate, whole body felt very hot.  Lasted 5-6 minutes then slowly eased up.
Headache that night of the vaccine and for the last seven days I have been taking 2000 mg of Tylenol every day for seven days and 220-440 mg of Naproxen for the headache pain. I found out that is too much Tylenol. It took the edge off the headache. The next day after vaccine, I felt like I had the flu - like every muscle in my body ached really, really bad. That lasted one day. I do still have fatigue. I also have dizziness and feeling spacy for about eight days. My arms and legs feel really heavy now too. I went to the doctor's office on the 20th I have had doctor visit. I was going to go in to get a shot for my headache but my headache kind of eased up just a little. My body is building immunity to the vaccine - the doctor said it could take some time before it to go away and said it would not be permanent. But it feels permanent. He said to diet, exercise and push a lot of fluids. I took a Naproxen 220 mg last night which did not help my help my headache but I am not taking Tylenol anymore. If the doctor's office would have been open last night I would have gone for a shot for it because it was bad enough. I also notice that my pulse is running a little higher  - mid 90's to 103. And my blood pressure is running a little higher - 129/88 one day which is higher for me. At the doctor's  visit it was 130/82 which is higher for me.  Note (I had the 1st Moderna vaccine on April 2nd - I waited because I was nervous about getting the 2nd one.)
Chills Body ache Low-grade fever Headache Sore arm Congestion Running nose  Week After last shot  Sore throat & Headache.  Had a COVID test to be sure and test was negative
Patient reports increased pain in left shoulder one day after receiving injection.  Previously did have diagnosed tendinitis in left shoulder.  Pain and tenderness now subsiding.
Moderna COVID-19 Vaccine EUA Rash below vaccine site - oval shape, center clear, red slightly raised rim, slightly warm. No pain, itching. No other symptoms. First noticed 1/21/2021.
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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: tomatoes" (unspecified if ongoing), notes: known allergies: tomatoes. Concomitant medication(s) included: PRAVASTATIN, start date: Dec2021, stop date: 19May2022; VITAMIN D [COLECALCIFEROL]; CLARITIN [LORATADINE] and also reported as, other medications/products within 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Had two negative COVID tests after initial infection; (2022) Positive, notes: Positive COVID test after symptoms recurred; (2022) Negative, notes: Had two negative COVID tests after initial infection. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (start date: 19May2022, stop date: 23May2022). Clinical course was reported as, The patient had positive COVID test after symptoms recurred. congestion, cough, headache. Had two negative COVID tests after initial infection. Patient was not recovered from symptoms and no treatment received for symptoms. Vaccine lot number was not available/provided to reporter at the time of report completion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient stood after giving vaccine and fainted. he never lost consciousness or complained of pain. he was able to sit up without feeling dizzy and moved to chair to rest further.
rash at injection site; feverish; remained in bed sleeping on and off; left arm was sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (remained in bed sleeping on and off), VACCINATION SITE PAIN (left arm was sore at injection site), VACCINATION SITE RASH (rash at injection site) and PYREXIA (feverish) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01021A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disorder. Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) and ASA for an unknown indication.   On 28-Feb-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced MALAISE (remained in bed sleeping on and off). 28-Mar-2021, the patient experienced VACCINATION SITE PAIN (left arm was sore at injection site). On 29-Mar-2021, the patient experienced PYREXIA (feverish). On 30-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at injection site). On 29-Mar-2021, PYREXIA (feverish) had resolved. At the time of the report, MALAISE (remained in bed sleeping on and off), VACCINATION SITE PAIN (left arm was sore at injection site) and VACCINATION SITE RASH (rash at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: 101 (abnormal) Fahrenheit Feverish and 98.6 (normal) Fahrenheit  end of the day normal.         Additional concomitant medication includes statins, heart medication and diabetic medication multi vitamin.  There were not further specified in initial source document.  treatment information was not provided   Treatment information was not reported.   This case was linked to MOD-2021-041102.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: added patient demographic details new lab data. added new events pyrexia malaise and injection site rash
2nd Pfizer shot on 09/29/2021 about 3:25pm. About 11:40pm right arm began itching in and around shot area and a knot developed. Within 30 minutes all of upper right arm breaking out in hives, itching constantly, and swelling. As of 10/02/2021 still having all the above symptons.symptoms. Also got Flu shot at same date and time of 09/08/2021, 3pm that I got 1st vaccine.
chills; muscle aches; fatigue; a fever of 103 F; currently breastfeeding mother received the vaccine; currently breastfeeding mother received the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported information for both mother and baby. This is the maternal case.   A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3246), via an unspecified route of administration in the right arm, on 08Jan2021 at 05:45 (at the age of 32-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension, non-ongoing COVID-19 from Apr2020 to an unspecified date (1.5 weeks with symptoms at 28 weeks pregnant; recovered), and breastfeeding from an unspecified date and ongoing. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included labetalol (MANUFACTURER UNKNOWN) and an unspecified postnatal vitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced chills, muscle aches, fatigue, and a fever of 103 F on 08Jan2021 at 19:00. The events were reported as non-serious. The currently breastfeeding mother received the vaccine on 08Jan2021 at 05:45. The clinical course was reported as follows: Approximately 12 hours (as reported) after the vaccine, the patient developed chills, muscle aches, fatigue, and a fever and body temperature of 103 F on 08Jan2021 at 19:00. The patient was treated with an unspecified antipyretic and the fever and body temperature spiked to 103 F again during the night. The next day (24-48 hours post vaccine), the patient had a fever and body temperature of 100-101.7 F on 09Jan2021, intermittently while treating with ibuprofen (MANUFACTURER UNKNOWN). The chills were not as bad as before, but body aches and fatigue were still present. On 10Jan2021, over 48 hours post-vaccine, the patient felt mostly fatigued with body temperature of 99 F. At 13:00 on 10Jan2021, the fever came back at body temperature of 101.6 F, which was treated with ibuprofen. Therapeutic measures were taken as a result of chills, muscle aches, fatigue, and a fever of 103 F as aforementioned. The clinical outcome of chills, muscle aches, fatigue, and a fever of 103 F was recovering and of currently breastfeeding mother received the vaccine was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021022120 same reporter, different patient/event (baby case)
Pt history of mitral valve prolapse not identified to Dr at time of vaccine administration. On Aug 24th experienced some chest pain and discomfort which she expressed happened regularly about 3x a month. After being stung by a bee experienced increased chest pain visited ER, no EKG changes.
Patient presented to the ED within 6 weeks of receiving covid vaccine and was diagnosed with UTI.
Shortness of breath, dizziness, light headness,  possible constant headache did not connect these to adverse effects until talking to  person phone who recommend I file a report.
Lot of pain in the upper arm; Pain radiating to my back; Struggle to sleep; Port wine birth mark - red and purple has disappeared; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Port wine birth mark - red and purple has disappeared), PAIN IN EXTREMITY (Lot of pain in the upper arm), PAIN (Pain radiating to my back) and INSOMNIA (Struggle to sleep) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Birth mark (port wine birth mark). Concurrent medical conditions included Migraine since 1980. Concomitant products included ESTRADIOL for Hormone replacement therapy, CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) for Routine health maintenance, MULTIVITAMIN [VITAMINS NOS] and CALCIUM for Vitamin supplementation.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Port wine birth mark - red and purple has disappeared). On an unknown date, the patient experienced PAIN IN EXTREMITY (Lot of pain in the upper arm), PAIN (Pain radiating to my back) and INSOMNIA (Struggle to sleep). In March 2021, THERAPEUTIC RESPONSE UNEXPECTED (Port wine birth mark - red and purple has disappeared) had resolved. At the time of the report, PAIN IN EXTREMITY (Lot of pain in the upper arm), PAIN (Pain radiating to my back) and INSOMNIA (Struggle to sleep) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment Information was not provided.   This case was linked to MOD-2021-136043 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Patient demographics were updated.Concomitant product details were updated. Added new events pain in upper arm, radiating to back and struggled to sleep.Causality of event unexpected therapeutic benefit was updated.
Information has been received from a healthcare professional, concerning a 23 year old female patient with drug hypersensitivity to MACROBID and a history of a colposcopy and abnormal Papanicolaou smears (2005 and 2006), who on 03-JAN-2008 was vaccinated with IM in the left shoulder with a dose, 0.5 ml, of Gardasil (lot #659439/1267U).  Concomitant therapy included YASMIN.  In January 2008, the patient developed hives over her whole body, and scheduled an appointment to visit for evaluation.  At the time of this report, the outcome of the event was not recovered.  Additional information has been requested. 02/10/2010 Lab testing was not performed. Treatment included Benadryl and Medrol dose pack. The patients resolved without further complaints, however the date of recovery was unknown.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 43rd of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Patient received a Pfizer Covid-19 booster on 12/20/2021. The pharmacist later discovered on 12/21/2021 that the vaccine given was expired. The vaccine expired 12/18/21 and according Pfizer manufacturer excursion chart the vaccine was expired by 1 day.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, fever, injection site warmth, injection site cellulitis and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, injection site warmth, injection site cellulitis and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, injection site warmth and injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced cellulitis, redness, hot, swelling at injection site along with a fever. The healthcare professional would like recommendations for the 2nd dose or not. The patient received SHINGRIX subcutaneously instead of intramuscular route, which led to intramuscular formulation administered by other route. No additional information provided.
Approx 1 mon p/vax, pt devel an erythematous nodule @inj site. Pt seen by MD & tx w/Benadryl.