chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID vaccine breakthrough case. Pfizer 4/2/21 ER8730, 4/23/21 EW0162, 12/17/21 33130BA, 5/25/22 FN2908, and 11/23/22 bivalent GJ3274
Shot was on 2/15. No adverse until about 9 pm on 2/19 when started having. Neuropathy in feet, legs and mouth started to burn.  This burning and tingling has happened every night since. Was hoping would clear up on its own. Had some neuropathy before but nothing like this.  Went to Dr on 3/1. This was first appointment. I could get. He did number of tests should hear from them soon. At the present time of typing this I have some tingling and burning and numbness. But is extremely bad at night
About a month after my vaccine I noticed small red dots on my arms. They were sure itchy and I rubbed them and did that for several days and they started to spread and get more itchy and were inflamed, after a few more weeks they started to appear on my legs. I then saw the dermatologist and they took some blood to do a biopsied and they all came back clear. The doctor gave me some medicated lotion and they started to go away.
feels like I get COVID all over again, She gets so many symptoms for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feels like I get COVID all over again, She gets so many symptoms for 3 days) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, METOPROLOL, SIMVASTATIN, AMLODIPINE, VERAPAMIL, CHONDROITIN SULFATE SODIUM, GELATINE HYDROLYSATE, GLUCOSAMINE SULFATE, HYALURONIC ACID (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GELATINE HYDROLYSATE;GLUCOSAMINE SULFATE;HYALURONIC ACID]), RISEDRONATE SODIUM (RISEDRONATE) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (feels like I get COVID all over again, She gets so many symptoms for 3 days). At the time of the report, VACCINATION COMPLICATION (feels like I get COVID all over again, She gets so many symptoms for 3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-378251, MOD-2021-378338 (Patient Link).
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: When patient received her Pfizer doses, she had the same reaction. Patient was given 2 zyrtec and 2 benadryl to take when patient gets home. Patient will call if anything changes.
dizziness; chills; severe fatigue; temperature was 102 degree Fahrenheit; feeling spacey and wonky; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (feeling spacey and wonky), DIZZINESS (dizziness), PYREXIA (temperature was 102 degree Fahrenheit), CHILLS (chills) and FATIGUE (severe fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to levofloxacin), Drug allergy (lisinopril), Drug allergy (septra), Drug allergy (Victoza), Type 2 diabetes mellitus since 2010 and Hypertension since 1978. Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) for Clotting disorder, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for GERD, METOPROLOL and LOSARTAN for Hypertension, DULAGLUTIDE for Type 2 diabetes mellitus.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FEELING ABNORMAL (feeling spacey and wonky) and PYREXIA (temperature was 102 degree Fahrenheit). On an unknown date, the patient experienced DIZZINESS (dizziness), CHILLS (chills) and FATIGUE (severe fatigue). At the time of the report, FEELING ABNORMAL (feeling spacey and wonky), DIZZINESS (dizziness), PYREXIA (temperature was 102 degree Fahrenheit), CHILLS (chills) and FATIGUE (severe fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature increased: 102 (High) temperature was 102 degree Fahrenheit. On 04-Mar-2021, Body temperature increased: 99.5 (High) normal for the rest of the day.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Outcome of the event given as recovered and resolved on 05-mar-2021 but didn't specify the event took 3 grams on Tylenol at 5pm on 3Mar2021, the day after being vaccinated her temperature was 102 degree Fahrenheit.  Action taken with mRNA-1273 in response to events were not applicable.   This case was linked to MOD-2021-055186 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Added patient details, medical history, concomitant medications and events. Updated event outcome.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown) 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), 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) 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 EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022).    No concomitant product use was reported. Patient received half dose. The vial was initially stored in the refrigerator on 4Jun2022. Vial did not undergo any temperature excursions.  No treatment information was provided.
Headache still on going after 7 days. Lethargic, Low energy still on going for 7 days. Weak.
pt recv vax 23JAN96 & 16JUN97 pt devel a classic case of chickenpox consisting of lesions around face, eyes, vagina, etc.;pt was covered w/chickenpox;
This spontaneous report as received from a Registered Nurse refers to a 26 year old female patient with no pertinent medical history and no drug reactions or allergies. On 08-JUN-2013 the patient was vaccinated with VARIVAX (Merck) (lot # H018976, expiration date 24-OCT-2014) 0.5 ml, once, subcutaneous for company requirement. Concomitant therapies included amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, ADDERALL TABLETS, desogestrel,RECLIPSEN and simvastatin (manufacturer unknown). The Registered Nurse reported that on 09-JUN-2013, patient went to work stating she had sore throat. The next day, on 10-JUN-2013 the patient had cellulitis at the injection site. The Registered Nurse reported that an unspecified physician in the office gave the patient a shot of ROCEPHIN and oral sulfamethoxazole and BACTRIM. Registered Nurse reported that two other patients, experienced adverse reactions after receiving a dose of VARIVAX (Merck) from this lot # (MARRS # 1306USA009129 and 1306USA009130). Nurse was requesting a lot check for this VARIVAX (Merck). At the time of the report the outcome sore throat and cellulitis at the injection site was unknown. This one of several reports from the same source. Additional information has been requested.
2 hours after injections in upper left arm, patient started experiencing a 6-8" area of redness around injection site, pain, hardness & itching. She applied ice to area on 7/27/2020.  These symptoms lasted approx. one week- Today 8/5/2020 Symptoms have subsided with  slight redness remaining
My neck progressively hurts worse and worse. I am in extreme pain if I try to straighten or move my neck. My arm where the shot was given is knotted but not too sore. My pain kept me from sleeping. I tried heat, Tylenol, and Ibuprofen. I am setting a doctors appointment now. Pharmacy has instructed that do so.
Patient received DTaP #5, IPV #4 and MMR #2 on 08/16/2006.  08/17/2006 developed hard, red, hot lump 10 centimeter erythema upper left arm.
This is a spontaneous report from a contactable consumer reporting on behalf of her husband. A 73-year-old male patient of unknown race received PREVNAR 13 on 27Feb2018 10:30 via unspecified route in the left upper arm at single dose. Relevant medial history included Blood disorder, Blood cholesterol abnormal, allergic to shellfish, and nuts, the patient cannot take Calcium or Fish oil because he has had reactions to them. Concomitant medications included Hydroxyurea 500mg every other day he takes 2, and the opposite days he takes one for blood disorder, ongoing and Gemfibrozil 600mg takes one half of a tablet by mouth once a day, for blood cholesterol abnormal and ongoing. The patient had a regular pneumonia shot about 5 years ago and had no symptoms whatsoever. The patient did not know if he took 23 or 13. On 27Feb2018 the patient felt like he had full blown pneumonia, totally congested and very back headache. All events were recovering.  Information on the batch number has been requested.
The following day after the vaccine I experienced chills w/o a fever.  My temp actually dropped to 96degrees.  I experienced anxiety as well.  These symptoms lasted for about 3 weeks and I was prescribe Mirtazapine for my anxiety.
Pain at the injection site; Redness at the injection site; High temperature; A spontaneous report was received from a Consumer concerning a 50-years-old female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at the injection site, redness at the injection site, high temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date, patient experience pain at the injection site,redness at the injection site, high temperature.  Treatment details were not provided.    Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, pain at the injection site, redness at the injection site, and high temperature was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Approximately 6 hour post vax, the pt felt feverish, had a fever of 102, left arm was sore tot he touch. The next evening (1/10/01) the pt noticed a 3 inch whelp on the left arm. Treated with Tylenol. Fever abated after 36 hours.
Information has been received from a nurse practitioner concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date in August 2014, the patient was vaccinated with a first dose of GARDASIL (dosage schedule, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. On an unknown date in March 2016, the patient was vaccinated with a second dose of GARDASIL (lot # L039066 with expiration date 19-MAR-2017). No adverse effects were reported. Additional information is not expected as there is no consent to contact the reporter.
Information has been received from a physician concerning an 11 year old female patient who on 22-JUN-2009 was vaccinated IM with a 0.5 ml first dose of GARDASIL (Lot number 662300/0100Y). Subsequently, on 31-AUG-2009 the patient was vaccinated IM with a 0.5 ml second dose of GARDASIL (Lot number 663454/0672Y). Concomitant therapy included MENACTRA on 22-JUN-2009 and influenza virus vaccine (unspecified) on 31-AUG-2009. The physician reported that the patient became diaphoretic, pale, experienced low blood pressure and severe stomach pain immediately after receiving the first and second doses of GARDASIL. The patient recovered about 15 minutes after receiving the first and second dose of GARDASIL respectively. The patient sought  medical attention at the physician's office. Additional information has been requested.
developed COVID symptoms with mild flu-like symptoms; developed COVID symptoms with mild flu-like symptoms; developed COVID symptoms with mild flu-like symptoms; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative. The reporter is the parent.  A child patient received bnt162b2 (COMIRNATY), administration date Nov2021 (Batch/Lot number: unknown) as dose number unknown , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), INFLUENZA LIKE ILLNESS (non-serious) all with onset Jan2022, outcome "recovered" (Jan2022) and all described as "developed COVID symptoms with mild flu-like symptoms". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective, covid19 cannot be totally excluded.,Linked Report(s) : US-PFIZER INC-202200056534 same vaccine, similar AE, different patient
administration via IV administration versus IM administration; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe (batch number Unknown, expiry date unknown) for prophylaxis.   On 7th April 2021, the patient received Boostrix (intravenous) and Boostrix Pre-Filled Syringe Device. On 7th April 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On 7th April 2021, the outcome of the intramuscular formulation administered by other route was not recovered/not resolved.   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 reported as follows: The age at vaccination was not applicable for this report. The pharmacy manager reported that Boostrix vaccine was administered via Intravenous administration instead Intramuscular administration, which led to intramuscular formulation administered by other route. At the time of call, the patient was in Emergency room( ER ) at hospital. The reporter consented to follow up.
Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a non health professional. This case involves an Adult patient of an unknown age and gender who may had received vaccine IPOL (formulation Suspension for injection) (lot number, expiry date, dose, dose in series, route, site of administration were not reported). The vaccine exposed to a temperature excursions above 46 degrees Fahrenheit on 26-Nov-2018 between 4:41 AM to 5:41 AM at 47.3 degree F. On 27-Nov-2018 between 9:11 PM to 9:56 PM at 46.9 degree F and again at 1:26 AM to 2:26 AM at 47.1 degree F. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of actual medication error due to incorrect product storage because IPOL was exposed to temperatures greater than 46F for almost 2 hours. It was not reported if any adverse event occurred or not following the vaccination. 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. Documents held by sender: none.
14MAR94 stiff neck, visual distrubances, swollen tongue; 4ASPR94 treated res, propoxyphene nap/APAP 100/650, poly-histine elixir;
In March, April and May 2021, after receiving her 2nd Covid-19 vaccination, began having her period twice per month which are very heavy and painful.
the patient became dizzy during her 30-minute post-vaccination observation. Hypertensive state and dizziness continued for over 1-hour post-vaccination. pluse remained within normal range and the patient reported no other symptoms
Malaise, chills, fever 101.5 degree, nausea, vomiting, itching, lost of appetite
Quickly after receiving the second dose I experienced numbness in my right big toe. That went on for at least a couple weeks. Then this month I experienced pain around my upper right leg and hip area and thought initially that it was bursitis or arthritis in my hip. However, a rash then broke out and I was diagnosed Sunday with shingles.I have read extensively that incidence of shingles have increased following the COVID-19 vaccine especially those with autoimmune issues like me where I have Raynauds.
As the day went on I began to feel more tired. I felt that I just wanted to lay down and sleep.
Dizziness, nausea, vomiting for 1 day duration; no fever; no treatment;
Did not use diluent in the box/I am assuming they uses sterile diluent that we keep on the counter; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The reporter reported that someone at their clinic had given a Menveo vaccine without using the diluent in the box. The reporter assuming they used sterile diluent that they kept on the counter. The reporter asked for guidance to know how that affects the individual receiving it. Additional supportive information: The patient had Menveo reconstituted with sterile diluent, instead of the supplied diluents, which led to wrong solution used in drug reconstitution. The follow-up could not be possible as no contact details were available. This is 1 of 4 linked cases reported by same reporter for different patients. Conservatively case was processed with event wrong solution used in drug reconstitution considering the sterile diluent was used in vaccine reconstitution.; Sender's Comments:  US-GSK-US2023AMR032664:Same reporter US-GSK-US2023AMR032644:Same reporter US-GSK-US2023AMR032665:Same reporter
Dry, itchy scalp and large amounts of hair loss beginning 4 days after 1st dose of Moderna COVID vaccine.
fever; headache; chills /teeth chattering so strong thought that her teeth may crack; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and CHILLS (chills /teeth chattering so strong thought that her teeth may crack) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). 21-Feb-2021, the patient experienced CHILLS (chills /teeth chattering so strong thought that her teeth may crack). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, PYREXIA (fever), HEADACHE (headache) and CHILLS (chills /teeth chattering so strong thought that her teeth may crack) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: 101 (Inconclusive) 101 F. On 23-Feb-2021, Body temperature: 103 (Inconclusive) 103 F. On 24-Feb-2021, Body temperature: 103.6 (Inconclusive) 103.6 F. On 25-Feb-2021, Body temperature: 101 (Inconclusive) 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.