chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up on the morning of February 1st with a rash, itching, and swelling at the injection site. It was in the shape of the oval that was at the site for several days after the injection, but the mark had cleared from my skin prior to this reaction. I used Benadryl and hydrocortisone cream for three days to soothe the itching. The swelling cleared after approximately five days and the rash after a little over a week. I still have a slightly darkened oval shaped marking at the injection site but there is no longer any swelling or irritation.
This case was reported by a other health professional via call center representative and described the occurrence of itchy rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced itchy rash and skin irritation. The patient was treated with hydrocortisone. On an unknown date, the outcome of the itchy rash and skin irritation were unknown. It was unknown if the reporter considered the itchy rash and skin irritation to be related to SHINGRIX. Additional details were provided as follows: This case was reported via webform email. The age at vaccination was not reported. The healthcare professional reported that the patient came to their store for the 2nd dose of SHINGRIX and reported an event happened to her after her 1st dose of SHINGRIX. The patient stated that mosquito bites never bothered her before, but since she had received 1st dose of SHINGRIX, she felt that mosquito bites had been very irritating. The patient used hydrocortisone to relieve the itchiness. No further details were reported regarding the event. The healthcare professional did not consent to follow up.
2 days after shop was at doctor could not walk on feet (pain) gave me medicine that cover it up for a while then went to knees , went away then hips,went away, elbows,wrists,and shoulders.
The cough started Tuesday night all night long. It made my throat really scratchy and my chest was painful. I also slept with VICKS vapor rub on my chest and throat. The next day when I got up, my eyes were so glassy. I took my allergy medication and the symptoms alleviated a little bit, but the cough persisted. I felt a little achy and stiff, but I thought I was fine. I have some nasal congestion and pressure on my forehead, like sinus pressure. I do not have a fever or sore throat, but I do some have energy. Every day I feel a little bit worse. When the doctor called, she told me to get DAYQUIL and NYQUIL. I took NYQUIL and I was able to sleep much better because it suppressed the cough. When I went to the doctor Wednesday, they tested for flu and COVID-19 and those came back negative. We also did a panel for other respiratory viruses, and she said I came back positive for metapneumovirus. I am fully symptomatic today, but I started full symptoms on Wednesday. Today is my third day staying home sick. I wasn't sure if this vaccine had weakened my immune system or I'm not sure what happened. I'm just concerned. I've also been taking some ADVIL daily to help with symptoms. Treating it with over the counter medication.
p/vax inject site swollen, red, itching & tender; treated w/benadryl, atarax, ibuprofen, prednisone
Mother phoned with report of child up all night crying and swelling with redness in a 1"x 3/4" area on right thigh. Pt was not seen.
Felt really tired; fever; Muscles hurt; Joints hurt in his quad muscles; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2020 01:00, the patient received the 1st dose of Shingrix (intramuscular). On 9th August 2020 05:00, 4 hrs after receiving Shingrix, the patient experienced tiredness, fever, muscle pain and joint pain. On an unknown date, the outcome of the tiredness, muscle pain and joint pain were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the tiredness, fever, muscle pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at 1:00 pm and around 5:00 pm felt tired and had a fever. The Fever had resolved but still feels tired, muscles hurt and joints hurt in quad muscles. The reporter consented to follow up and could follow up with the patient directly.
covid-19; Runny nose; Nasal congestion; Joint pain; Nausea; arm extremely painful to touch; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19), RHINORRHOEA (Runny nose), NASAL CONGESTION (Nasal congestion), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K02A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2020, the patient experienced COVID-19 (covid-19), RHINORRHOEA (Runny nose), NASAL CONGESTION (Nasal congestion), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and PAIN IN EXTREMITY (arm extremely painful to touch). On 31-Dec-2020, PAIN IN EXTREMITY (arm extremely painful to touch) had resolved. On 01-Jan-2021, RHINORRHOEA (Runny nose) had resolved. On 02-Jan-2021, ARTHRALGIA (Joint pain) had resolved. At the time of the report, COVID-19 (covid-19) outcome was unknown and NASAL CONGESTION (Nasal congestion) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. treatment  for the symptoms Tylenol. Convalescent plasma for blind study, so she doesn't known if she got the antibodies or not
Received my second shot on Friday 4/30/21 at 12:15pm, had chills and body aches that night and felt fatigue through to Sunday morning 5/2/21. On Sunday morning when I woke up my vagina felt sore, later in the day the pain intensified and was extremely painful Sunday night, barely slept because of constant burning and itching feeling. There was also a brownish discharge leaking out. Monday morning I made an appointment with my gynecologist, and a nurse practitioner did an exam showed me the genital ulcers and told me it was most likely herpes. They swabbed one of the ulcers and gave me a prescription for Valacyclovir for 10 days. I also took a blood test for HSV1/HSV2 IGG and IGM the next day. For the first 5 days the pain was horrible, worst pain I've ever felt, couldn't walk, stand, sit or sleep. I got my period Wednesday morning which made it even worse.  On Friday morning 5/7/21 I got a call from the nurse practitioner and she said the swab and blood test came back negative, I went back the same day so the doctor could look. They still thought it was herpes and told me to take another blood test in a month. I did not have a prior diagnosis of herpes and showed no symptoms before. My partner of the past 1.5 years got tested for herpes and was also negative. After a month I went took another blood test and it came back negative again for HSV-1 and HSV-2.  The only thing different in my medical history is that I got the vaccine and 36-48 hours later I had herpes symptoms.  These symptoms lasted for 2.5 weeks until I started to no longer feel any pain.
Pt is 26 yo female employee at this institution. She is s/p Moderna COVID-19 full vaccination: first dose on 12/31/2020, second dose on 1/26/2021. Underwent voluntary COVID-19 rapid testing on 7/15 after experiencing symptoms including chills, new onset cough, fatigue, muscle/body aches, sore throat, headache, and congestion/runny nose. She reported possible exposure to someone else with COVID-19. PCR test resulted positive.
Second dose Not received >60 days post first dose; Pregnant after First Shot and denied Pregnancy Registry sign up; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant after First Shot and denied Pregnancy Registry sign up) and PRODUCT DOSE OMISSION ISSUE (Second dose Not received >60 days post first dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant after First Shot and denied Pregnancy Registry sign up). On 17-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose Not received >60 days post first dose). On 13-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant after First Shot and denied Pregnancy Registry sign up) had resolved. On 17-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Second dose Not received >60 days post first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The doctor advised not to get the second dose if the patient wants to. The patient is two and a half month pregnant. No relevant concomitant medications were reported. No treatment information was reported.
A report was received from a health care professional on 8OCT2003 concerning a vaccinee of unknown demography who experienced pain at the injection site and supraclavicular lymph node sweling and pain an unspecified length of time after receiving Fluvirin vaccine on an unspecified day in October 2003. On an unspecified day in October 2003 the vaccinee experienced pain at the injection site that radiated up tot he shoulder and neck area, and supraclavicular lymph node sweling and pain after receiving Fluvirin. The pain occurred on the same side of the body as the injection site. The outcome of the event was not reported. The reporter had administered approximately 80 Fluvirin injections to date this flu season. There was insufficient information to determine the reporter's causality assessment. Update 1, 10NOV2003: Further information received from a health care professional on 10NOV2003 indicated that the vaccinee was a 24 year old male. The vaccinee experienced supraventricular lymphadenopathy approximately 1 to 2 days after receiving Fluvirin on 3OCT2003. The vaccinee previously received a flu vaccination without any adverse effect. The supraventricular lymphadenopathy was assumed to have resolved 5 to 7 days following vaccination. The reporter had assessed the relationship of the vaccine  to thesupraventricular lymphadenopathy as probable. No follow up pending . Cross reference with : RJP200300827.
Feeling unwell day one of vaccine. Continue to feel worse every day with muscle aches, pains, severe headaches, light headed dizzy, difficulty walking standing, feeling freezing cold, feeling hot and sweaty, total exhaustion. Tried going to work and collapsed into a co-workers arms and ended up going to the emergency room. Could not walk or stand without assistance. Severe headache, red eyes, chest pain/discomfort started a couple of days after the vaccine.
PATINET RECEIVED TDAP AND PREVANAR 20 ON 05/22/22. PATIENT CAME TO GET SECOND DOSE OF SINGLES AND TECHNICIAN ASKED ABOUT PREVNAR 20 AND TETANUS AGAIN AND PATIENT GAVE APPROVAL TO GIVE IT. VISITING PHARMACIST DID NOT REALIZE PATIENT HAD IT 3 MONTHS AGO AND GAVE ALL VACCINES AGAIN. PATIENT HAS NO SYMPTOMS AND DOING FINE.
w/in 24hr devel redness, swelling @ vax site;tender;duration 3-4 days;
Redness; swelling the size of tennis ball; itching; warm; tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), SWELLING (swelling the size of tennis ball), PRURITUS (itching), FEELING HOT (warm) and TENDERNESS (tenderness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ERYTHEMA (Redness), SWELLING (swelling the size of tennis ball), PRURITUS (itching), FEELING HOT (warm) and TENDERNESS (tenderness). At the time of the report, ERYTHEMA (Redness), SWELLING (swelling the size of tennis ball), PRURITUS (itching), FEELING HOT (warm) and TENDERNESS (tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included Put Benadryl and cortisone cream.   Reporter did not allow further contact
This spontaneous report as received from a medical assistant and a nurse refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot# M049123, expiration date 13-JUN-2018; lot# M048201, expiration date 05-JUN-2018 and reported as lot# N012490 expiration date 17-OCT-2018 (requires lot# verification) and reported as lot# N002325, expiration date 19-JUL-2018 (requires lot# verification) (doses and routes of administration were not reported for all) reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -14 Celsius degrees to -10 Celsius degrees for 16 hours. Data logger was not involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA002187.
Vaccine expired 11/5/21, given 11/10/21 no adverse events reported.
I had all the flu like symptoms like most people have, but I also had heart palpitations on and off for about 24 hours consisting of a palpitation ever 4th heart beat. Would last maybe 10-20 minutes then go away for a few hours. Didn?t affect me very much but I wanted to report in case it would affect someone with a heart condition or something.
positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (who is also the patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0150), via an unspecified route of administration in the arm, on 02Apr2021 16:15, as single dose, for COVID-19 immunisation, at a pharmacy/drug store. There were no medical history and concomitant medications. The patient did not receive other vaccines on the same day as BNT162B2 and did not receive prior vaccinations (within 4 weeks). On 13Apr2021, the patient tested positive for COVID-19 (reported as "8 days after, maybe 10 days after received the first dose of the vaccine"). The patient clarified that she had symptoms before but tested positive on 13Apr2021. The event required physician office visit (medical office visit). The patient finished quarantine on 18Apr2021 and would like to know if she can get the second dose. The outcome of the event was unknown.
Nausea and stomach pain, in waves similar to food poisoning, but not as severe, and without vomiting. Also headache.
MMR II was reconstituted with normal saline instead of the supplied Merck Diluent; This spontaneous report as received from a office manager referring to a patient of unknown age and gender.  The patient's medical history, concomitant medications, drug allergies, or reactions were not reported    On 16-APR-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # S035356 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA), expiration date 05-NOV-2021) for prophylaxis(strength, dose, administration route and frequency were not provided) . It was reported that the vaccine was reconstituted with Normal saline 9%( sodium chlorine) instead of merck sterile diluent (product preparation error).
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an unspecified doses of RECOMBIVAX HB (route, lot numbers and expiration dates not reported) which were improperly stored at 55.9 degrees F for 2 hours. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left Arm is still sore; Swelling in his left arm after the booster dose.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left Arm is still sore) and PERIPHERAL SWELLING (Swelling in his left arm after the booster dose.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 037C21A and 037C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 antibody test positive on 05-Dec-2021. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Left Arm is still sore) and PERIPHERAL SWELLING (Swelling in his left arm after the booster dose.). At the time of the report, PAIN IN EXTREMITY (Left Arm is still sore) had not resolved and PERIPHERAL SWELLING (Swelling in his left arm after the booster dose.) outcome was unknown.            No treatment medication was provided by reporter.   This case was linked to MOD-2022-458714 (Patient Link).
Lost 40 pounds; Allergies; This is a solicited report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier: 2K-163-4391676-00.  A 68-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "When Patient Knit And Crochet Hands Hurt /Its Painful" (unspecified if ongoing), notes: When patient knit and crochet hands hurt /its painful. The patient's concomitant medications were not reported. The following information was reported: WEIGHT DECREASED (medically significant), outcome "unknown", described as "Lost 40 pounds"; HYPERSENSITIVITY (non-serious), outcome "not recovered", described as "Allergies". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Never tested positive; Weight: Lost 40 pounds. It was unknown if patient was enrolled in a Covid-19 vaccine trial. Causality assessment was not provided. The reporter's causality assessment between the events and suspect drugs was not reported.   The reporter's assessment of the causal relationship of "lost 40 pounds" and "allergies" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
One week after vaccination a slightly raised, red welt, approximately 3-4 cm in diameter appeared at the site of the injection with localized tenderness returning at the site (sore arm from the injection had completely resolved 24hrs after injection, this was new "pain" that returned at the surface of the skin, not in the muscle, feels like a slight bruise). Today (the next day) the red blotch is much bigger and slightly more tender. It is now red, asymmetric blotch that is 8cm x 4.5cm.
No adverse event; Customer states she called yesterday 5/24/2022 to report a TE but they just found out they had another TE 1 week ago and they need to report that at this time.; This spontaneous report was received from a costumer referring to an unknown age and gender patient.  The patient's concurrent conditions and medical history were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On an unknown date in May 2022 (between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U039949 has been verified to be valid, expiration date 16-DEC-2023) (dose regimen, route of administration and anatomical location were not reported), for prophylaxis that underwent a temperature excursion (TE) (Product storage error). The time frame of the temperature excursion was -14 degree Celsius (C) up to -10C for 2 hours 5 minutes 0 seconds; -10C up to 8C (-0.4C) for 1 hour 25 minutes 0 seconds. A previous temperature excursion occurred with temperatures of -14C up to -10C (-12C) for 0 hours 50 minutes 0 seconds. No adverse event occurred.   This is one of 13 reports received from the same reporter.
After 30 minutes arm started getting sore which was expected. At dinner several hours later, eating was extremely painful and then I noticed that my gums were swollen to the distance of my teeth so I was chewing on my gums. My mouth was swollen and very sore. I woke up during the night with extreme dryness - used a mouth moisturizer. On waking the following morning, my entire mouth was coated, my tongue was swollen and I had sores on the inside of my lips and cheeks from where teeth were rubbing. My mouth was swollen overall and very sore. Symptoms started subsiding after 24 hours.
1/23/21 - After 1st Vaccine patient experienced extreme sleepiness for two days. (Fells asleep sitting up and with limited noticed for a few hours a time)   2/13/21 - After 2nd Vaccine patient experienced similar symptoms for the 1st two days. On day 3 at 10am patient began experiencing stabbing pain in base of skull. Stabbing pain bony pain radiated down spinal column down to bra strap. Pain continued until about 4pm when, patient took Claritin and pain dissipated (Ibuprofen and Acetaminophen where taken and did not help). Patient continued to take Claritin with pain 3 out of 10 constantly. By 4/1/21, pain increased to a 6 out of 10.  Patient began seeing Dr. for pain management. (call patient more info.)
Convulsion, diaphoretic, approximately 5 minutes. Client and mother were advised to follow up at nearest ED.