chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose number=3; I was not due for my period and it came heavy that same evening; I was not due for my period and it came heavy that same evening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 16:15 (Batch/Lot number: unknown) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 34 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), administration date: 23Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "Dose number=3"; MENSTRUATION IRREGULAR (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 02Dec2021, outcome "unknown" and all described as "I was not due for my period and it came heavy that same evening". Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding.  Additional Information: There was no other vaccine in four weeks. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. There were no known allergies to the patient. There were no other relevant history. The reporter assessed the seriousness of the case to be non-serious.   The lot number for BNT162b2 was not provided and will be requested during follow up.
I got shingles on my back and on two places in the chest with extreme pain going all the way into my left foot.
Extreme weakness and full body aches started approx. 8 hours after shot, Arm was very tender for 3 days, very sore. Extreme fatigue for approx. 4 days. This did completely clear up in approx. 5 days, so I didn't feel the need for medical treatment.
Vaccine administered at 4:15 pm went to observation area with mother, 4:20 pm pale, anxious, mom called for help, moved to stretcher, 911 called, pt placed on o2 B/P 92/70 HR 80, EMT arrived and transported to hospital. 1/21/2010 - parent stated child was given prednisone and BENADRYL in ER hx-asthma. Dairy free now.
on Friday 3/12/21 "I had a gout flare up which lasted about 3 days and I saw that there are reported side effects of that nature.  I am fine now but wanted to record it / also report it but the website you gave us (V-safe) on that page will not accept my information to sign up" Pt states symptoms started as pain with range of motion in left wrist, then progressed to erythema and took on symptoms of her previous gout flares
Patient had an allergic reaction , itching and throat irritation , we gave benadryl and epipen and patient was better in about 20 minutes
Dose administered after improper storage and handling; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered after improper storage and handling) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered after improper storage and handling). At the time of the report, PRODUCT STORAGE ERROR (Dose administered after improper storage and handling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  No treatment medications were provided.
2 days, post vax, the baby had a short episode of apnea and went flaccid, pale and clammy. Had ran a temperature of 100-102F following vaccines for 3 days.
Fever as high as 103.7; coughing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 13:30 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 05Jan2022 23:45, outcome "not recovered", described as "Fever as high as 103.7"; COUGH (non-serious) with onset 05Jan2022 23:45, outcome "not recovered", described as "coughing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, cough.  Additional information: No other vaccine in four weeks. Not tested for covid post vaccination. No known allergies. Other medical history was None.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I started having a rash all over my body 7 days after first vaccine. Got a lot worse over 5 days. Woke upon 2/5 to major chest pains, itching all over, and broken blood vessels and bruising all over my body.  I had blood work done and they said it's normal but now I need to see a Hematologist.  It's been 5 days and its not getting better just worse.
After my first shot on 3/8/21 I experienced a very tender arm when I bumped into things.  A big red circle on my shoulder that itched by the injection shot appeared less than a week after the injection.  The red circle (the size of a grapefruit)  went away after 7 days.    I had my second shot on  4/5/21 and my arm was again sore.  Now I have pain whenever I lift my left arm above my head or use my left arm to reach something behind myself.  I have never done anything to injure this arm.  It is almost a month and I am still in pain when  ever I reach my arm up in the air or behind me.  It's a sharp pain.
At approximately 1106 client approached EMT and asked to have his vitals taken stating he felt, "a little weird". Client received a 2nd dose Pfizer COVID vaccine (LOT EW0183, exp 08/31/2021) at 1050 in the left deltoid and was preparing to leave the observation site when he stated he felt like a cold liquid was running down his left thigh and the left side of jaw was a little tense. Client denied any other symptoms such as shortness of breath, chest pain, numbness or tingling of his mouth, tongue, and throat, dizziness or feeling lightheaded. Client denied any allergies to medications/foods/environment and stated he had no pertinent medical history nor did he take medications regularly. Client reported last oral intake was a cup of coffee in the morning before vaccination with last meal being dinner on 07/27/21. EMT took the client's vitals at 1106: BP 140/90, HR 70 skin color normal for ethnicity, warm and dry, A&Ox4. Client stated the feeling of cold running down his leg and his tense jaw had resolved. Client stated he had the same feeling after his first dose Pfizer COVID vaccine on 7/7/21. A second set of vitals were taken at 1115: BP 130/90, HR 69 skins normal for ethnicity, warm and dry, A&Ox4. Client stated the vitals were a little higher than his normal but attributed it to having coffee without food and feeling a little nervous. Client stated he felt better and the symptoms had resolved. At 1120 client left the observation site on his own accord with a steady gait.
Redness and swelling on right deltoid, cold compress, Motrin q 6 hrs for pain.
Information has been received from a physician concerning a 4 year old pt who on 01/06/01 was vaccinated with a dose of varicella virus vaccine live. On 03/10/04 th pt experienced breakthrough case of varicella. There were 13 lesions. Unspecified medical attention was sought, though tx or hospitalization was not required.. the pt recovered. No product quality complaint was involved. This is one pt out of 40 reported. Thirty nine other cases (WAES 0407USA01446 and 0409USA01855 through 0409USA01874 and 0409USA01876 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
Generalize itching; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Generalize itching) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PRURITUS (Generalize itching) and HEADACHE (Headache). At the time of the report, PRURITUS (Generalize itching) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Patient did not provide an exact/accurate timeline but stated she had some pain and swelling starting the day of the administration of the vaccination which progressed up until the date of this report. I recommended the patient see her doctor/provider for assessment and informed her that swelling and pain at the injection site is farely common with the Zostavax but it would be wise to still inform her provider of the swelling and pain. Patient plans on informing her provider on Monday since the providers office is closed this weekend.
a 11 years old patient received Flublock vaccine with no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from nurse. This case is linked to case: 2020SA287061 (15 years old).  This case involves a 11 years old female patient who received 0.5 mL dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2009, expiry date: 06-Jun-2021) via unknown route in left arm on 12-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).   The patient's medical history, medical treatments, vaccinations and family history were not provided.  She didn't receive any other vaccinations or medications on that visit.  It was an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  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.
Pt states it burns, swollen, red, and warm. It is approximately 3 inches in diameter.
I was informed by patient's husband that she was hospitalized about 1 week after second dose and was diagnosed with Guillian Barre Syndrome.
Upper arm and lower left shoulder swollen and tender. Got hit a couple of times this evening in the shoulder (left).
Patient was given an extra dose of the Covid vaccine. She got 2 doses of Moderna in July and August 2022 and was given a dose of Pfizer in December 2022.
Site of injection became swollen the size of a large orange. 50 mg Benadryl PO and ice applied
had some bleedings this week; Pregnant; A spontaneous report was received from a nurse concerning a female patient who experienced had some bleedings this week (haemorrhage in pregnancy) and pregnant.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 11 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   On 11 Jan 2021, the patient found out she was pregnant after the vaccination. Patient also reported that she had some bleedings this week. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events had some bleedings this week and pregnant were unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with an adverse event of bleeding during pregnancy for this female of an unknown age. Patient will continue to be contacted for further monitoring of the AE during the pregnancy. Very limited information regarding the event of Bleeding during Pregnancy has been provided at this time and further information has been requested.
Onset of symptoms were the night of the vaccine.  Mild fever, headache, patient took Tylenol.  Next day fever reached 103.5, patient took Tylenol. Fever returned next day but not measured by patient. Sunday a cough developed but only at night and not productive.  Today on Tuesday (5 days after vaccine) patient reported fever of 101.2 and took Tylenol to treat. Advised patient to call or go to ER if fever reaches 103 and doesn't respond to Tylenol.
Received vaccine on 6-21-07 Shingles outbreak 8-28-07
Light spotting that lasted for about 3 days. It was contained with a thin panty liner. Brown in color. Naturally cleared up on its own.
Tested positive for Covid 19 on a home rapid antigen test, July 19, after feeling quite ill for several days.  (Had 3 negative tests on consecutive days despite worsening symptoms, before finally testing positive early morning on July 19). Did a telehealth appt with PA a few hours later, she called in a prescription for Paxlovid based on my pre-existing lung condition and I started it that evening.  After 2 doses, most of my symptoms resolved (stuffy nose, sinus congestion, low fever, exhaustion, muscle aches all disappeared and pulse ox level was back up).  By Day 5, I really felt fine other than getting winded easily.  At this point, still a bit tired but breathing is okay and I'm back to all normal work and life activities.
Facial swelling, pain and bruising in area where previous received derma-fillers. Injections were over a year ago. Some more that 2.
Patient experienced fever, chills, sweats, total body ache and severe leg cramps (10/10) for approximately 12 hours. She reports pain in the armpit (3/10), lower back pain and experienced a tingling sensation (pins and needles) of the periphery.   She also had a headache, nausea/stomach ache, stiff neck, disorientation/dizziness.  Patient summed it by saying  it was the worst pain she has felt since receiving chemo.
Pressure on the left side of head around ear. Near constant high pitch humming noise in left ear. Tinnitus.  I felt I got ear infection one day after my second vaccine shot, but symptoms haven't gotten any better since then.  The only thing brings some relief is wearing large headphones around my ears.  Pressure from headphone pads helps me.  I also do some reflexology exercises people recommend for tinnitus.
2 days following vaccines developed rash starting on right arm - spread to legs/neck over the following week. Saw a physician on 11/16/12 - prescribed Prednisone.
FEEL BLOOD FLOW THROUGH VEIN IN ANKLE; NO STRENGTH IN LEFT LEG/PARALYSIS; This spontaneous report received from a patient concerned a 60 year white old male of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: 28-JUL-2021) dose was not reported, 1 total, administered on 19-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-JUL-2021, the patient experienced muscle problems in leg, glutes, thigh quad, hard time standing and supporting self. On 07-JUL-2021, the patient experienced paralysis, pain in the hip when standing, no strength in left leg, pain in the thigh and leg when standing. On 16-JUL-2021, the patient experienced feel blood flow through vein in ankle. On 17-JUL-2021, the patient experienced numb around skin, tingly around left ankle. On an unspecified date, the patient experienced no reflex in left leg. On 19-JUL-2021, the patient visited urgent care and physical therapist. Perform first chiropractor on 21-JUL-2021 at after noon and second chiropractor on 22-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel blood flow through vein in ankle, and no strength in left leg/paralysis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210753159;covid-19 vaccine ad26.cov2. s- No strength in left leg/paralysis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Client developed hives on back, chest, arms and legs. Took 2 seperate doses of oral Benadryl 25mg on 5/29 and on 5/30 without relief. Topical steoiod applied to area on back without improvement.
shortness of breath while walking; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath while walking) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Previously administered products included for Drug use for unknown indication: Enbrel. Past adverse reactions to the above products included No adverse event with Enbrel. Concurrent medical conditions included Rheumatoid arthritis.   In September 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath while walking). At the time of the report, DYSPNOEA (shortness of breath while walking) outcome was unknown.        mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. On January 2022, the patient had to go to the emergency room due to her inability to catch her breath. She was diagnosed with 2 blood clots in her lungs. After further testing it was determined that the blood clots were due to the Moderna Covid vaccine. She stated that after her first dose she was having shortness of breath while walking and after the second dose it was much harder to breathe.  No treatment medications were provided by the reporter.   This case was linked to MOD-2022-658035 (Patient Link).
Within a few days of receiving my first COVID-19 vaccine, I experienced painful swelling of my lymph nodes in my left armpit (the same side as the injection site). The tenderness in my lymph nodes lasted several days, but they have remained enlarged. It's now three weeks after my first dose and I haven't noticed much reduction in size yet. My second dose is scheduled for next week on 05/17/21.
No additional AE reported; that V ARIV AX had a temperature excursion on 10 OCT 2020 and was administered; This spontaneous report has been  received from an office manager concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 10-OCT-2020, a temperature excursion occured with the varicella virus vaccine live (oka/merck)(VARIVAX) formulation not reported but defaulted to subcutaneous injection, Lot # reported as T01254, expiration date 09-APR-2022 for prophylaxis.        On an unknown date,  the patient was vaccinated with the aforementioned varicella virus vaccine live (oka/merck)(VARIVAX). No additional adverse event (AE) were reported. The temperature excursion  was reported to had been in between a range of -14°C to -10°C, specifically at -14.3°C for 1 hour and 15 minutes, and also in between  -9°C to 8°C, specifically at -9.3°C for 32 minutes.   The total timeframe was reported as 1 hour and 47 minutes.   There was digital data logger involved and  no previous temperature excursion was reported.  This is one of two  reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA007244:
Fever, Chills for 24 hours  Months of Psoriasis / Dermatitis all over body including face, back, head, genetials, armpits Extreme hair loss
2 wks p/DTP started having "sz"; turned blue, tongue "flopped", limp took to MD constantly had episodes that night & was admitted to Hosp;
Rash from left butt down leg down to behind knee/enclosed treatments since 11-18-14-until present time and continuing nerve treatments deep nerves by neurology-MRI to be given then diagnosis. Enclosed all treatment pain clinic ER-now neurology. History of no chicken pox. Four times at age 70 to get shingle shot. Turned down. At age 77 yearly physical-doctor said I have shingle shot set up. I said no-doctor stated if I get shingles at my age-it would be bad. Took shot-January, 2014. November 18th 2014-got shingles. Doctor diagnosed-took picture stated-"Worse post shot shingles ever saw". The rash left completely January 9th 2015. Now-and onset 11/18/14-pain-a lot of pain continues to date-loss of sleep. Now-taking some toll on other ongoing active problems. Dec. 2014 take gabapentin 300 mg 3x daily. Take morphine 20mg 2x daily 1-AM/1-PM. Taken off-dose nothing for pain December 2014. Put compress 3x daily with Aloe Vera w/oats for two weeks-stop-rash is leaving. Put on tramadol-LYRICA, ointment Lidocaine 5% change to ointment-Lidocaine 2.5% prilocaine 2.5%. Ointments did not help with pain. Was to block nerve pain. Change tramadol-LYRICA-nortriptyline adverse effect when put on methadone 5mg 2x daily-does not relieve pain-stop. Given 4 injection by Dr. Jan. 12, 15. Given 3 injection by Dr. May 20, 15. Given infusion by Dr. (3x in ER Depts). Once given VALIUM shots helped for short period. Now neurology-nerve pain deep in leg nerves.