chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started feeling a sensation in her skin; she felt itching; she had a few spots she could see ...by the next morning she had a lot of them/hives; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received dose 1 of BN162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8737) via an unspecified route of administration on 01Apr2021 at 10:00 (at the age of 73-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included hormone replacement from an unspecified date for an unspecified indication. On 04Apr2021 the patient experienced feeling a sensation in her skin, itching, and hives. She had not taken any new medications, gone anywhere, or done anything different. She felt itching and thought she must have gotten into bugs. It was her arms and legs. That night she had a few spots she could see and thought they were mosquito bites. By the next morning (05Apr2021) she had a lot of them. She was itching a lot and it kept her up all night. The itching was in her hands. The breakout on her body didn't itch so much and her hands didn't have anything on them. The itching was horrible "yesterday" (06Apr2021) especially during the night; she didn't sleep. On 05Apr2021, the patient visited an urgent care for the events and was diagnosed with hives. The patient was treated with cetirizine (lot number OKE2392A; expiration date Jul2022; strength: 10 mg; tablets) from 05Apr2021 to an unspecified date and a steroid pack for 6 days from 07Apr2021. When the patient took the steroid, the itching went away but the hives were still there. They were everywhere, on her thighs, some on her arms, chest, back, and feet. There were no hives on her face and neck. Her breasts and upper chest were real bad and they were red and coming together to be big areas. On 07Apr2021 the rest of the hives were pink and some had gone away. The itching was gone. The outcome of strange sensation on her skin was unknown. The outcome of itchy was recovered on 07Apr2021. The outcome of hives was recovering.   No follow-up attempts are needed. No further information is expected.
Case number PHEH2014US024356, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 22 Jan 2015. This report refers to a 74 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 14511P expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 20 Nov 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. No adverse event was reported following this maladministration. Follow-up from a nurse received on 22 Jan 2015: Site of vaccination (left deltoid) updated.
feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous out of her chest; feels so tired; no appetite, food doesn't taste right; sweating and chills; sweating and chills; feels weak; extremely sick; joints and arms hurt; joints and arms hurt; doesn't feel like walking around/Lethargic; can't hardly even talk to people; Headache; feels like she has been poisoned; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration on Left arm on 09Mar2021 between 15:00 and 16:00 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient states she took that shot on Tuesday and she is still sick and still doesn't feel good. States that she feels better, but she is coughing and spitting up white mucous started on 10Mar2021. She feels like she has been poisoned in Mar2021. States that she is coughing stuff up out of her chest. States that she took this on Tuesday (09Mar2021) and still feels drugged and tired. She states that it made her extremely sick and she is not taking the second shot. She states she took the shot Tuesday and didn't get sick until three to four hours after, she was down feeling so bad, like an ailment or disease. She states she feels like we gave her the Covid. She states she won't even go to the hospital because can't trust anyone. States that her joints and arms hurt and can't hardly even talk to people on 09Mar2021. States she has fluid in her chest that she didn't have before on 10Mar2021. States that this is the first day she has gotten out of bed. States that she is not taking the second shot. States that she had to sit for fifteen minutes after her shot and she felt fine. Clarified that she couldn't eat, she had sweating and chills for two to three days and she couldn't even get out of bed on 19Mar2021. States she feels better but still feels weak and lethargic on 09Mar2021. States it has improved since yesterday. States that her food doesn't taste right but no appetite on 09Mar2021. States the sweating and chills ended 11Mar2021. She states that she had a headache and it started on 09Mar2021 and it went away 12Mar2021 with treatment of Aspirin. Not sure if she is going to recover. Prior to vaccination, was the patient was not diagnosed with COVID-19. The outcome of events Poisoning; feels drugged, extremely sick was unknown, for Coughing and spitting up white mucous out of her chest was not resolved, for headache it was resolved on 12Mar2021, for feels so tired; no appetite, food doesn't taste right; joints and arms hurt; doesn't feel like walking around; can't hardly even talk to people; feels weak; Lethargic was resolving, for fluid in her chest that she didn't have before was not resolved, for sweating and chills it was resolved on 11Mar2021.   Follow-up attempts are completed. No further information is expected.
Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included CML.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medication reported. No treatment information provided.
I have tingling in my arms from my elbow down and now it?s starting in my ankles and up to my knees . It started in my forearm and is now spreading to my hands and legs . It?s not numbness but it?s a weird feelings and is spreading . It started around 3/4 today and is still happening past 8pm
chills, flu-like symptoms around about 12am midnight on the same day, shot was administered on 10/27/2004. Note : patient administered self injection of Copaxone (SQ) cIDPM on 10/27/04. He takes this daily. Patient stayed home in bed today 10/28/04. Patient returned to work 10/29/04.
This spontaneous report as received from a pharmacist refers to a 68 year old patient of unknown gender with no pertinent medical history, drug reactions or allergies. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX lot number K003598, expiration date 13-MAR-2015. ZOSTAVAX administration was intramuscular versus subcutaneous, inadvertently. There were no concomitant medications. On 16-SEP-2014, the patient contacted pharmacy with complains of pain, swelling and redness at injection site (the exact onset date of the events was not specified). The patient sought medical attention via contacting the pharmacy. No treatment was given at the time of contact and the patient was planning to visit an unspecified family physician on 17-SEP-2014, also reported as today. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown.            No concomitant medications were reported.  No treatment information for the events was provided.   Reporter did not allow further contact
This spontaneous report was received from a pharmacist via company representative concerning three elderly patients (exact age and gender were not provided). There was no information about patients' concurrent conditions, medical history or concomitant medications. In October 2017, the patients were vaccinated with PNEUMOVAX 23 lot # N019348 with expiration date of 08-FEB-2019 or lot # N020501 with expiration date of 03-MAR-2019 (route of administration and anatomical location were not reported), for routine vaccination. It was not reported which patient received which vaccine. On unknown dates, the patients experienced injection site swelling, pneumonia like symptoms, and fever. The outcome of pneumonia and injection site swelling was reported as recovered on unknown date. The causal relationship between the events and therapy with PNEUMOVAX 23 was not reported. Upon internal review the event pneumonia was considered to be medically significant.
Pediatric patient received an adult dose; Pediatric patient received an adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 4-day-old female patient who received HBV (Engerix B adult) (batch number 9AX5P, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st December 2021, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 31st December 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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 health care professional did not have the lot number or expiration date at the time of report. A nurse reported that a pediatric patient was given an adult dose of Engerix which led to overdose and adult product administered to child.  No symptoms were reported. The reporter consented to follow up.
I have five other employees that were given shot same morning all having had adverse side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (I have five other employees that were given shot same morning all having had adverse side effects) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031047) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I have five other employees that were given shot same morning all having had adverse side effects). At the time of the report, IMMUNISATION REACTION (I have five other employees that were given shot same morning all having had adverse side effects) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   This case contains information for the 4th patient out of 5 patients as described by the reporter.  No concomitant medication information was reported.  The reporter said that the reporter had five other employees that were given the shot on the same morning of vaccination and all those had adverse side effects.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748333, US-MODERNATX, INC.-MOD-2023-748215, US-MODERNATX, INC.-MOD-2023-748352, US-MODERNATX, INC.-MOD-2023-748342, US-MODERNATX, INC.-MOD-2023-748404 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2023: Live follow-up received contains non-significant information : secondary reporter added; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748333:Master case US-MODERNATX, INC.-MOD-2023-748215:same reporter US-MODERNATX, INC.-MOD-2023-748352:same reporter US-MODERNATX, INC.-MOD-2023-748342:same reporter US-MODERNATX, INC.-MOD-2023-748404:same reporter
Information has been received from a health professional concerning an 80 year old female with type II diabetes mellitus,  g glaucoma, hypertension, peripheral neuropathy, irritable bowel syndrome, and osteoporosis who on 20 Nov 2006 was vaccinated SC with a 0.65 mL dose of Zostavax. Concomitant therapy included 11 unspecified medications. On 04 Dec 2006, the patient called her physician's office to report that she had experienced a sudden loss of hearing in both ears. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
No additional adverse effect reported.; Caller reported that PROQUAD that underwent a temperature excursion was administered.; This spontaneous report was received from "other" reporter type, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 08-MAR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), as prophylaxis (formulation, strength, dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not provided, lot number T027112, which has been verified to be valid, expiration date reported and validated as 07-FEB-2022). The vaccine administered underwent a temperature excursion from 5 degrees Fahrenheit (F) to 14 F (11.60 F), for a time frame of 1 hour, 0 minutes and 0 seconds, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse events were reported.
This spontaneous prospective pregnancy report was received from a nurse and refers to a 25 year old female patient who had a history of abnormal Papanicolaou (PAP) smears. No information regarding her other pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-FEB-2018, she was vaccinated with a dose of GARDASIL 9 injection, 1 dose, intramuscular, lot # N021733 (also reported as M040146), expiration date 01-FEB-2020 (also reported as 26-DEC-2017) for prevention of HPV. Later on that date, after the vaccination, a urine pregnancy test was administered to the patient, with the result: positive, as "a faint line was present on the pregnancy test, indicating that the patient was pregnant." The date of last menstrual period (LMP) was reported as 23-JAN-2018, and estimated delivery date (EDD) was calculated as 30-OCT-2018. The patient sought medical attention via a physician visit. No treatment was given for the event. On an unknown date, chlamydia and gonorrhea test, HIV test, hepatitis B (Hep B) test, hepatitis C (Hep C) test and rapid plasma reagin test for syphilis (RPR) were performed (results not provided). At the time of the report, the pregnancy outcome was pending.
had my shots but still get them/Suspected Vaccination Failure; still get them/ small spot; Painful; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had my shots but still get them/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: still get them/ small spot) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient interactive digital media. The patient stated that it was painful and had Shingles shots but still got them about once a year.  The patient stated that it was just a small spot now and about the size of a half dollar. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a medical assistant and refers to a 5 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 08-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The infant developed a runny nose and cough a few hours after the vaccination.  The patient also became irritable, developed a fever around midnight. Adverse event resolved by 12/13/00. Prescription: Tylenol.
I had (have) a swollen lymph node near my collarbone on the right side. I had  a doctor visit on January 21st.The doctor chose not to treat it. She wanted me to come back a couple of weeks after my second injection if it hadn't gone down. I Haven't gone back as I researched this can be a lingering symptom. And I do still have the symptom. I had the second vaccine on January 29th.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT OF RIGHT PERONEAL VEIN ACUTE DVT OF LEFT PERONEAL VEIN 7/25/2022 -- RECURRENCE OF SAME SYMPTOMS
Fainted; This spontaneous case was received on 13-Nov-2020 from pharmacist via The Agency (reference number: SEQW20-05088) and concerned a 12-year-old, female patient.   The patient had no relevant medical history and was not taking any concomitant medications.  On 11-Nov-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, indication: not reported). The batch number reported was P100264371 and expiry date reported was 30-Jun-2021.  On the same day, after receiving Afluria Quadrivalent, the patient fainted.  On the same day, the patient recovered from the event as it was reported that she regained conscience immediately after and no further reaction occurred.  The reporter did not provide causality assessment.  The event of 'faint' was considered to be medically significant by a Physician within Company's Risk Management Department.  Company comment:The patient developed syncope on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. The patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed syncope on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. The patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
When I eat raw onions or pickled onions, I have severe stomach pain followed by diarrhea. I have eaten these all my life with no side effect. I know of 3 other people that had the same reaction after their shots.
Report 2001013015-1 describes lack of therapeutic effect in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B). In 1992, the pt rec'd her first, second and third doses of Engerix-B respectively. Recent serological testing revealed that the pt was anti-Hbs A negative. The pt was subsequently administered a dose of hepatitis B vaccine recombinant (Recombivax HB). As of 5/24/01 the outcome of the event was unknown.
With the second COVID-19 vaccine I received the next day I had lymph swelling in both breasts, breast tenderness and aching. I also had tenderness underneath my right arm.  This is not associated with my menstrual cycle.  This also lasted about 10-12 days.  With my booster dose (3rd) vaccine, I felt a little bit of swelling in both breasts that lasted 3-4 days.
Symptoms started the night after he received PNEUMOVAX and flu vaccine. Has had flu vaccine in past. Has noticed overall aches, thinks maybe he might have had some wheezing one night. Symptoms seem worse at night. Has been taking over the counter antipyretics for fever. Denies any cough or congestion.
Syncope: (Paleness, Sweating, Lightheadedness). Treatment: Cold Compresses Applied to patient's head, and neck.
Sleeplessness at night; Tiredness during the day; This is a spontaneous report received from a non-contactable consumer, the patient. A patient of an unknown age and unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 6026199) via an unspecified route of administration in the left arm on 05Mar2021 at 10:30, as a single dose for COVID-19 immunisation. The patients medical history was not reported. Concomitant medications included ozempic (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 05Mar2021 at 22 hours, the patient experienced sleeplessness at night and the patient experienced tiredness during the day since the first dose. No treatment was received for the events. The clinical outcome of the events sleeplessness and tiredness was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
shaking chills, fevers to 101, myalgias, headaches lasting for 18 hours