chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left breast has deflated and is not same size; Huge swelling under arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 28Feb2021 13:30 (at the age of 59-years-old) at dose 2, single for covid-19 immunization. Medical history included osteo inflammation and Sjogren's. The patient had no known allergies. Concomitant medications included thyroid; losartan potassium (LOSARTIN); C Zinc D (as reported) elderberry (SAMBUCUS NIGRA); glutathione. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 07Feb2021 12:30 (at the age of 59-years-old) at dose 1, single for covid-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. On 01Mar2021 07:00, the patient experienced huge swelling under arm and 4 days out the left breast has deflated and is not same size. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered for the events. The outcome of the events was not recovered.      No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
30 mins post injection the pt developed chest pain, shortness of breath. Pt later developed nausea and emesis x2 with itching but no hives. Prescribed atara, pepcid, benadryl, pred.
Pt was given MMR vaccine on 12/20/18 but it was discovered to be expired on 12/16/18. CDC was contacted and they stated the vaccine was invalid and pt would need to be re-vaccinated 4 weeks after dose given on 12/20/18. Pt's parents were notified today, 12/26/18, about the error. Pt did not have side effects from this expired vaccine.
Patient developed vertigo and her eyes and lips were swollen. Patient then took Allegra for 3 days until symptoms resolved on 09/22/2015.
Initial misuse report received from a non-healthcare professional on 28 May 2013. It was reported that ACTHIB was mixed with sterile water and given as the third dose in the series. No adverse event was reported. Documents held by sender: none.
fainted; hit head; shivering; flu like symptoms; This case was reported by a consumer via sales rep and described the occurrence of faint in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (on18 October 2019 received 1st dose refer link case US2022AMR189646).   On 13th March 2020, the patient received the 2nd dose of Shingrix. On 14th March 2020, 1 days after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant) and head injury. In March 2020, the patient experienced shivering and influenza-like symptoms. The patient was treated with intravenous fluid (nos) (Iv Fluids (Not Specified)). On an unknown date, the outcome of the faint, head injury, shivering and influenza-like symptoms were unknown.   It was unknown if the reporter considered the faint, head injury, shivering and influenza-like symptoms to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR189646   Additional Information: GSK Receipt Date: 19-DEC-2022 Reporter's Comment: The patient self-reported this case. The reporter reported that after the 2nd dose patient arm was not hurt but, experienced systemic adverse effects of shivering and flu like symptoms, the next morning patient fainted and hit her head. The patient went to a walk-in clinic and received IV (intravenous) liquids. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2022AMR189646:Same reporter
Information has been received from a Registered Nurse (R.N.) concerning a patient who was vaccinated with the second dose of GARDASIL. The patient experienced paralysis on the right side of her face 10 days after receiving the second dose of vaccine provided during a clinical trial. The patient also noted that she has experienced headaches since receiving the second dose. Upon internal review, paralysis on the right side of the face was determined to be an other important medical event. Additional information has been requested.
1st Vaccine 1/8/2021; 2nd Vaccine 1/29/2021; seen at ICC for Diarrhea, nausea onset 1/30/2021
Pt reported episodic palpitations and heart racing for 6 weeks post vaccine. He did not get the second vaccine.
Chest pain, almost like a squeezing sensation on the heart, feels like a heart cramp.
No adverse event: They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    The Beyond use date (BUD) of the vaccine was reported as 21-May-2021. Patient received the vaccine at a Pharmacy.  No concomitant medication reported. No treatment medication reported.   This case was linked to MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up document received on 24-Jan-2023 with no new information.; Sender's Comments:  MODERNATX, INC.-MOD-2023-704416:Master case
This spontaneous report as received from a registered nurse refers to a 15 year old male patient with amoxicillin allergy. The patient has no pertinent medical history. On 22-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot # h016238, expiration date 11-APR-2015) 0.5 ml, intramuscular for immunization. There were no concomitant medications. Nurse reported that a patient came in her office for his second dose of GARDASIL, but she decided not to administer it. The patient stated that in 2013, after receiving his first dose, the injections site swelled to "the size of a soft ball" and was painful. The patient stated that he took over the counter Benadryl and the swelling resolved in an unspecified amount of time. The outcome of injection site swelled and injection site painful was reported as recovered/resolved on an unspecified date in 2013. No lab diagnostic studies were performed. The relationship between GARDASIL and the events was not reported. Additional information has been requested.
I have over a dozen hard knots develop on my face, chest and one on my shoulder. They itched and were  very red.  They had a hole in middle and looked like blood. The right side of my face was swollen where i had 3 bumps. Also the ache in the left arm moved to my left calf. Very sore, felt like a charlie horse but I never developed.  I had to limp on the leg a couple of days. I still have the bumps on my face and chest but the hard knots are gone. Just red bumps now. I never  have acne and never had face fillers.
weakness, nausea, abdominal pain/cramps, fever-temp unknown, rash eyes yellowing
I had burning hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 14:00 (Lot number: fd0810) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Mango skin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious) with onset 03Oct2021 11:00, outcome "recovered" (06Oct2021), described as "I had burning hands". Therapeutic measures were not taken as a result of burning sensation.  Additional information: Facility type vaccine other was Costco. There was no other vaccine in four weeks. There was no other medications in two weeks. 3 days after the first shot I had burning hands for approximately 2 hours and it went away. There was covid prior vaccination. There was no covid tested post vaccination. known allergies was Mango skin  Follow-up attempts are completed. No further information is expected.
Complained of tingling in the left arm. Denies chest and shortness of breath. No dizziness or headache. Observed for an additional thirty minutes to the initial fifteen minutes. Patient expressed relief of tingling at end of observation.
15 mins after had brain fog and felt buzzed. Had night sweats evening of vaccine and for a few days after first one as well. 24 hours later had bone and joint pain. 28 hours later had heart palpitations and increased heart rate.
Information was received on 26-MAY-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with ZOSTAVAX (dose, site, lot and expiration not reported) on or about 07-AUG-2013, at a pharmacy as recommended for routine adult health maintenance 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 08-JAN-2014, the patient was treated by a physician at a office for a vesicular outbreak that was diagnosed as severe shingles. The patient was treated for shingles and residual conditions of nerve pain at a clinic and dermatologist, and was prescribed acyclovir (manufacturer unknown) for management of painful symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Did not sleep well. Awoke with muscle aches, generally very tired all day until approx. 5:00 p.m., absolutely no appetite all day. Did not eat anything until 6:00 p.m. Feeling of nausea most of the day. Slept most of the day.
day p/vax devel large area (4" by phone report) swelling, tenderness & erythema;negative systemic rxn
Nausea almost immediately after injection. Nausea lasted throughout the day. At 4 AM the next day I experienced extreme bodyaches and headaches and fever. Adverse symptoms lasted throughout 02/13/21 until 02/14/21
Shots did not work I still get them/Suspected vaccination failure; Shots did not work I still get them; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. The patient paid 90.00 for Shingles shot but it did not work. After receiving Shingles vaccine, the patient still got shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
Tired looking; Mistakenly given 2 pediatric Ixiaro doses within 3 days; The following information was received from healtcare professional on 02 June 2021.  A vaccinee (no identifiers provided) received two pediatric doses of IXIARO (Japanese encephalitis vaccine, batch number not provided) within three days [instead of 28 days apart, which constitutes an accidential overdose].   ---  Follow up information 1 was received from healtcare professional on 10 June 2021.  Relevant vaccinee information included age and gender.  Relevant current medical history included atopic dermatitis rash.  The 6 month old girl also experienced tired looking one day after vaccination of the second dose (batch number JEV19H22E). Outcome of the event was not provided.; Sender's Comments: Assessment of 22 June 2021:  Causality assessment not applicable, as no adverse event occurred.  ---  Assessment of 20 July 2021:  Causality assessed as possibly related for the newly reported event tired looking, as this event is well known for IXIARO, indicative of a systemic vaccination reaction and the time to onset is plausible.
Extreme fatigue, feverish, coughing. Rotated between acetaminophen and ibuprofen for 48 hours
18 hours after vaccination patient had moderate headache that was not relieved with advil or tylenol. Patient's heart rate increased to at least 117. Bp was in normal range. Over the next 24 hours heart rate continued to increase as well as blood pressure.  Heart rate 130, bp 145/119. Went to emergency room. Waited 8 hours. Was seen by MD. Given fluids, benadryl, toradol, iopamidol, and Reglan.  Heart rate reduced to 96.
I got my Boost shot on 10/21/2021. I was fine after the vaccine but after 5 months later on April 23, I woke up with a sore throat, headache, stuffy nose and a fever of 107. Felt very weak. I didn't know what really happened. I called my PCP and told him about my symptoms he said it was COVID-19. I guess I didn't know I contacted COVID-19 from my neighbor who was COVID-19 positive. My PCP told me I should treat this as a regular flu. I still have fever but the other symptoms are gone.
This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 29-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 144 hours and also at 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for a total of 72 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, jaw pain, influenza-like symptoms, fever, swelling, rash, erythema of extremities and numbness. On an unknown date, the outcome of the pain, jaw pain, influenza-like symptoms, fever, swelling, rash, erythema of extremities and numbness were unknown. It was unknown if the reporter considered the pain, jaw pain, influenza-like symptoms, fever, swelling, rash, erythema of extremities and numbness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The reporting pharmacist stated that she had seen many adverse effects after SHINGRIX. The reporter did not have additional information, including patient information or how many affected patients there were. This case has been linked to US2018GSK185943, reported by the same reporter.
GUILLAIN BARRE SYNDROME 5/28/2021 WEAKNESS PULMONARY EMBOLISM, UNSPECIFIED. 5/28/2021 WEAKNESS ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/28/2021 WEAKNESS HYPOXIA 5/28/2021 WEAKNESS GUILLAIN BARRE SYNDROME 5/28/2021 ABNL PELVIC CT SCAN PULMONARY EMBOLISM, UNSPECIFIED. 5/28/2021 ABNL PELVIC CT SCAN ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/28/2021 ABNL PELVIC CT SCAN HYPOXIA 5/28/2021 ABNL PELVIC CT SCAN GUILLAIN BARRE SYNDROME 5/28/2021 BPH W LOWER URINARY TRACT SYMPTOMS PULMONARY EMBOLISM, UNSPECIFIED. 5/28/2021 BPH W LOWER URINARY TRACT SYMPTOMS ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/28/2021 BPH W LOWER URINARY TRACT SYMPTOMS HYPOXIA 5/28/2021 BPH W LOWER URINARY TRACT SYMPTOMS
Severe pain in right hip down thru leg. Hip is still (2 1/2 months) hurting but not as bad-effects my driving a car-hard to walk and get out of car-joints and muscles.
Rash on chest and abdomen appeared morning following injection. Appearance of sunburn, blanched when touched, second day it was itchy, resolved totally day 4.  Other symptoms included pressure headache which lasted one week. Fatigue and muscle achelasted 2-3 days.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included THYROID for Thyroid dysfunction in pregnancy, BETA GLUCAN (CHOLESTEROL BALANCE [BETA GLUCAN]) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced ARTHRALGIA (sore arm). At the time of the report, ARTHRALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
fever of 101 F; muscle aches; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for 5 patients. This is 5 of 5 reports. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported), administered on an unspecified date as single dose for COVID-19 immunisation. The patient received of second Pfizer - BioNTech COVID vaccine, after 26 hours experienced fever of 101 F and muscle aches. The symptoms lasted approximately 7 hours and symptoms were relieved with one dose of Tylenol. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit. Therapeutic measures were taken as a result of events and treatment with Tylenol. Outcome of the events was resolved on an unknown date.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157330 Same reporter/ drug/ event for different patients
BURN MOUTH SYNDROME; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced burn mouth syndrome. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from burn mouth syndrome. This report was non-serious. This case, from the same reporter is linked to 20220105063.
Treatment of COVID-19/COVID rebound with a thick black line on antigen test; Treatment of COVID-19/COVID rebound with a thick black line on antigen test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Lot number: FH8030), in right 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 and concomitant medications were not reported. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/COVID rebound with a thick black line on antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) a faint line; (Jul2022) thick black line. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: it was reported that Treatment of COVID-19 was started on 23Jun2022 and stopped on 28Jun2022. After starting to feel better and saw a faint line on an antigen test, experienced COVID rebound with a thick black line on antigen test and return of symptoms on 02Jul2022.