chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After vaccination, outbreaks now occur at least every month, sometimes twice a month.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Lot number: EP7533) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Anemia" (unspecified if ongoing); "HSV2", start date: 2005 (unspecified if ongoing), notes: I have had HSV2 since 2005; "Outbreaks" (unspecified if ongoing), notes: have had HSV2 since 2005 with outbreaks occurring every 1-3 years prior to vaccination. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose brand: Pfizer,, Prev dose lot number: EP7534,, Prev dose dose number: 1,, Prev dose vaccine location: Left arm), administration date: 18Mar2021, when the patient was 40-year-old, for COVID-19 Immunization. The following information was reported: HERPES SIMPLEX (non-serious) with onset Apr2021, outcome "not recovered", described as "After vaccination, outbreaks now occur at least every month, sometimes twice a month.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of herpes simplex.  Additional information- Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination  No follow-up attempts are possible. No further information is expected.
5 Blood clots coming from right nostril, headache, fatigue, stomach pains   Nose bleed with clots lasted 15-20 minutes. Headache, fatigue, stomach pains lasted throughout the day.
pt recv vax 20OCT97 & exp inc temp 100, n/v, diarrhea, chills, chest pain & severe h/a x 2 days;
Pt began to have numbness in throat and gums.  Tingling of extremities.
Within 5 minutes, my arm became itchy at the injection site. I don't think that was the shot, more maybe the band-aid. Thought I would mention just incase. The next day when my real symptoms began (9/09) - 10:00/11:00AM-EST: I fell asleep at my computer mid-email. I never do this or get THAT tired, especially after a coffee?!  From there, I started getting intense cramping where I would if I were to get my period or right before getting it. I was experiencing HORRIBLE lower back pain along with the cramping, which is a symptom of pre-period signs for me. I had to lay down in the fetal position for a while to ease the pain, and use a heating pad. I began spotting lightly, not as heavy as the first shot post-symptoms; but it was there and should not have been; based my tight, never changing menstrual cycle schedule. I also never get these cramps, or haven't since I was a bit younger a few years ago. Lastly, my body felt hot to touch. No fever that I noticed/the thermometer caught normal 98 and below all day. My head started to hurt, and progressively went away after a few days.   I had a rash on my arm (right forearm around to the top - itchy. Went away when I put an ointment on it. I have photos as well. Lastly, My arm was horribly sore. Which is common of course.
Pt is a 48 y.o. male who reported that he was bit by a dog on 1/25/10. Pt started a series of rabies vaccine and received his first 2 doses. Pt presented to the emergency dept to receive his 3rd rabies vaccine injection on 2/5/10. Rabies vaccine given 2/5/10. Pt presented to the emergency dept again on 2/6/10 with complaints of palpitations/tachycardia, myalgias, shaking chills, fever and shortness of breath. MD felt patient's symptoms were due to an allergic reaction the rabies vaccine that patient received on 2/5/10. Pt received methylprednisolone 125 mg IV x 1 and his symptoms resolved. Pt was given a prescription for prednisone to take if symptoms returned. He was discharged from the emergency dept. with instructions to discontinue rabies vaccine injections.
I received the first dose of the vaccine on 1/31/21. I was 33 weeks pregnant, with an estimated due date on 3/21/21. This was my first pregnancy and I had no complications up to that point. On 2/2/21 I began experiencing menstrual type cramps, which continued for a few days. On 2/5/21, my OBGYN suggested I be examined in Labor and Delivery, where it was determined I was in pre-term labor. Contractions were temporarily stopped, however my water broke on 2/7/21 and it was suggested that I be induced. I was induced on a later date at 34w1d pregnant and delivered my son, who weighed in at 4lbs. 15oz.
High fever 01 am, notice rashes on the forehead eyes, behind ears, upper cheeks runny nose cough vomit one time.
The patient suffered a myocardial infarction complicated by systolic heart failure and, over the course of 6 months led to cardiac arrest and death.
arm was a little sore from the injection/arm with a little sore for a day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 76-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm was a little sore from the injection/arm with a little sore for a day".  Additional information: Reporter stated: "We have both received the Pfizer Covid 19 vaccine since it came out. Last year we got the Pfizer booster and we have not had any problems at all with it, except arm was a little sore from the injection for one day and it was gone, but nothing else. That happens with anything you get. It wasn't a big deal. We have known people that have had COVID that have been so sick from the vaccine (manufacturer name not provided or clarified) that they are not taking it again, which is a shame. Reporter and her husband have not had any problems with it and have been very lucky that the COVID vaccine from Pfizer has been perfect. This is the only one that we will take will be Pfizer."  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300317117 same reporter/drug/event, different patient;
Routine lab draw 6/3/2021. Lab results: abnormal. Have since returned to normal levels a year after the shots. Shingles started August 28, 2021. Two doctor appointments and 3 visits to ophthalmologist due to shingles getting into my eye.
The pt reported a 1.5cm scaly lesion n shaft of penis 4 days after receiving vaccine. Multiple vesicles appears herpetic  but cannot rule out autoinoculation. Vaccine rec'd 1/30/03
Vaccine expired 1/13/23 with no known extension on the expiration date. Vaccine was administered to patient when it was expired
Racing heart, high blood pressure, dizziness, throbbing head-aches, loss of mobility.
Chills, restlessness, muscle soreness, dizziness Slight fever 100F
Baby no longer had heartbeat on 20-week ultrasound. Was only measuring 15-16 weeks. Second dose of COVID vaccine given around 14 weeks.
On 4/18 had fever and aches, but was better and able to work on 4/19. Rash broke out on 4/20 on R anterior shin (somewhat linear set or erythematous papules - look like broken vessels from when an area is scratched, but she denies scratching; lesions don't blanch), back of neck (wide area of erythematous maculopapules with a hint of some mild swelling/raised appearance), over L hip. Patient reports that it doesn't itch or hurt. She did think they were swollen at a point. Patient is also feeling a bit dizzy, with some nausea and a little diarrhea.
Patient experienced chills the night of, and then syncope the morning after vaccination. Experienced fatigue, then sudden warmth and nausea followed by syncope, urinary incontinence, then confusion and dizziness upon awakening which has resolved.
Approximately 5-10 minutes after injections given, she felt faint, weak and nauseated.  She did not faint, and recovered fully after approximately 10 minutes sitting in a chair and sipping water.
In afternoon was achy and had mild temperature and headache. Problems continued on 29th took advid. Felt better next day.
7 x 4.5 in area of erythema on R thigh F T - P, started on BACTRIM 40 mg/5 1 tbs BID x 10 days. ORAPRED 15 mg/5 - 1/4 tsp BID x 5 days; F/U on 2-1-10
Narrative:  COVID infection after COVID vaccine series 01/14 COVID vaccine dose #1 02/04 COVID vaccine dose #2 08/31 pt seen in ED w/ 1 week c/o vertigo, worsening w/ change of position, meclizine not effective; dx: UTI, clinical dehydration and vertigo, treated with fluids, rocephin 1 gm and d/c home w/ cefdinir and meclizine 11/22 pt seen in ED c/o shortness of breath, chest pain, dizziness, weakness, pain in arms and neck with increased tenderness, and anorexia x 3 days; ?COVID positive; dx: Unstable angina 12/14 pt seen in ED c/o dizziness, nausea, abdominal pain, urinary frequency & chest pain, s/p fall at home, COVID positive; found to be hyperglycemic (BS 584), treated w/ insulin; CXR: patchy consolidation and opacities in bilateral lungs, representing infection including COVID pneumonia and CT A/P suspicious for pneumonia, admitted to hospital due to critically high blood sugar 12/18 discharged from hospital, no further notes or details
I started bleeding under my skin on my right arm. It then moved to my left arm. My left arm is not as severe as my right arm. My right arm is the arm that had the injection. It is somewhat painful to the touch and sensitive. I rub arnica lotion on it to help with bruising which does not do anything. It looks like an injury and the bleeding is blackish/purple in color and is from my elbow to my wrist. The doctors can not explain anything. I have not been on aspirin, blood thinner, and steroids. My face has also got swollen and puffy. I have went to 2 different doctors over this with no explanation.
INTENSE BONE PAIN IN LOWER BODY; ACHES/PAINS; CHILLS; HEADACHE; FEVER OF 100F; TIREDNESS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported.  The patient's past medical history included hormone replacement therapy, and concurrent conditions included tetracycline allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced intense bone pain in lower body. On 01-APR-2021, the subject experienced aches/pains. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fever of 100f. On 01-APR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches/pains, chills, headache, and fever of 100f on 02-APR-2021, and tiredness on 03-APR-2021, and was recovering from intense bone pain in lower body. This report was non-serious.
Sick in bed the next day. I had covid in Dec2020. The 3.5 weeks headache and very tired. The whole arm since the 1st dose is numb, feels like someone had been hitting or punching it. I saw the doctor. I put a pillow on it, pain pills.
Stuffy Nose came on and subsided within 24 hours also have had upset tummy with diarrhea on and off since vaccine
A few minutes after receiving the vaccine I started feeling very dizzy. I then felt nauseous. In about thirty minutes the dizziness improved but several hours later I still feel residual dizziness and minor problems in GI tract. I slept after returning home, drank water and took Pepcid prescribed to me for my IBS
Mom states noted red area lt thigh approx 11MAR93 area swollen; states spoke w/MD who instructed return to clinic for eval; mom states has had temp 100.5; seen in clinic 25MAR92; c/o abscess lt thigh, started getting red, area indurated;
her lip was numb, she had a tight feeling there; she felt tight across her forehead; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (her lip was numb, she had a tight feeling there) and TENSION HEADACHE (she felt tight across her forehead) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (her lip was numb, she had a tight feeling there). 04-Mar-2021, the patient experienced TENSION HEADACHE (she felt tight across her forehead). On 04-Mar-2021, HYPOAESTHESIA ORAL (her lip was numb, she had a tight feeling there) and TENSION HEADACHE (she felt tight across her forehead) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Heart rate: high (High) fast heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Neurological symptoms, nerve tingling, numbness, headache, neck and shoulder pain, pain in right leg first reported on 4/13/21
had the original shot and still got pneumonia.; had the original shot and still got pneumonia.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "pneumonia" (unspecified if ongoing), notes: I've had pneumonia twice. The patient's concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "had the original shot and still got pneumonia.".  Additional information: Open-ended question: Thinking of the [Prevnar 20] advertising you just saw, please enter anything you felt, thought, or were reminded of while viewing it. Everything is acceptable. There are no right or wrong answers, no silly or dumb feelings. Don't worry about spelling, punctuation, or grammar. I've had pneumonia twice. I had the original shot and still got pneumonia. When the latest shot became available, I got that shot. I feel hopeful that I'm better protected this time.  The lot number for pneumococcal 20-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.
She states that the shot did not hurt at the time, and was just mildly tender the next day.  However, since that time she noticed a gradual worsening of a sharp pain deep in her left arm at the injection site. Per pt, she had decreased ROM, and had a very sharp pain with certain movements.  After the pain occurred, it took a while for it to settle back down. She states that, with certain movements, it is actually was so painful it brought tears to her eyes.  The area was not red, swollen, or warm.  Pt immediately cried out in pain when RN pressed on the exact area in which she got the flu shot.  Since pt initially reported this on 11/17/11, she has been diagnosed with impingement syndrome of the left shoulder, adhesive capsulitis of the left shoulder, and neuropathic pain at the injection site.  She has had 2 cortisone injections into the joint, and referrals to orthopedic specialists.  Treated with gabapentin for neuropathic pain.
This spontaneous report as received via agency from a nurse refers to a patient of unknown age (age reported as between 13 years and 18 years old) and gender. The patient was enrolled in a program. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2015, the patient was vaccinated with the improperly stored dose of VARIVAX (lot # K026386, expiration date 15-DEC-2016; dose and route of administration were not reported). It was reported that the vials of VARIVAX underwent temperature excursions as follows: on 07-JUL-2015 8.9 degrees of Celsius for 1 hour and 28 minutes and on 28-JUL-2015 0.4 degrees of Celsius for 1 hour and 25 minutes. The reporting nurse stated that the patient did not experience any adverse events. Additional information has been requested.
Shortness of breath mild to moderate on 1/27/23, lasted few minutes sudden onset with activity 1/28/23 sudden onset of shortness of breath at 8:30 pm.  Called 911 immediately.  Transported via ambulance to Community Hospital, dx Saddle PE.  Percutaneous Thromboectomy.  Per Interventional Radiology doctor large fresh clot.  Was able to remove entire clot
Symptoms began around 10 hours after vaccination. Severe chills, body aches, headache, weakness and mild fever. Arm pain at the sight of the vaccination was severe and was unable to use the arm. Most symptoms subsided 18 hours after vaccination but headache and weakness remained until far into the next day. Approximately of aspirin was taken on day 1 of the vaccination.
felt aching; low white cell count; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt aching), WHITE BLOOD CELL COUNT DECREASED (low white cell count) and PYREXIA (fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03BA21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer, Seasonal allergy, Drug allergy (Allergies to medicines for osteopenia and osteoporosis) and Adhesive tape allergy (allergic to tape). Concomitant products included CALCIUM and PREDNISONE for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (felt aching), WHITE BLOOD CELL COUNT DECREASED (low white cell count) and PYREXIA (fever). At the time of the report, PAIN (felt aching) and WHITE BLOOD CELL COUNT DECREASED (low white cell count) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: low (Low) low.         No treatment medications were reported.   The patient was receiving immune drugs for cancer when she received the first and second doses of the vaccine. She received her Seasonal allergy shot last fall, the caller believes it was on Sep-2021. Height: 5´8.   This case was linked to MOD-2022-527664 (Patient Link).
This spontaneous report as received from a treating physician via a company representative refers to a female patient in her 70's (years). In February 2010 (3-4 years ago), the patient was vaccinated with a dose of ZOSTAVAX, (lot#, dose and route not reported). In February 2010 (3-4 years ago), the patient developed shingles on her head after receiving ZOSTAVAX and also developed a headache that lasted for about 4-5 days. The outcome of the events was unknown. The patient had sought medical attention by office visit. Additional information has been requested.
Twinrix in April 13th 2018 and 2nd dose in June 3rd 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 13th April 2018).   On 03-JUN-2023, the patient received the 2nd dose of Twinrix. On 03-JUN-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix in April 13th 2018 and 2nd dose in June 3rd 2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 2-Aug-2023 The pharmacist had 2 patients. The reporter was in a hurry to provide any other details. The reporter consented to follow-up. This is 1 of 2 linked patients reported by the same reporter for different patient. The patient received second dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.; Sender's Comments:  US-GSK-US2023105227:Same reporter, 2nd patient
Was feeling pain, the spot felt hot. The red spot was 1 1/2 inch, pt also was given Benadryl.
Post vax, the pt had difficulty wakening the child. Eyes dull, not focusing, shoulder jerking. Red spot on cheek. Flaccid left arm, temperature of 100.3. Child seen emergently in office and transported to hospital via ambulance. 60 day follow-up states the pt experienced weakness. She is making progress slowly. Her speech and language skills have significantly improved. She continues to have speech therapy.  Diagnosis: R cerebralvascular accident.
I had an episode of vertigo, dizziness, lightheadedness that lasted two days and prevented me from working as a nurse. I have never felt that way before.
Cellulitis of (L) arm (localized redness/swelling) given KEFLEX 3 x/day for 7 days.
Pain at injection site persisted for ~1 hr; 3 hrs. post vaccine -> mild headache; 6 hrs. post vaccine -> serious migraine with myalgia focused on neck and upper back and chest muscles (muscle knots developed and could be felt) -> slight fever (0.6 degrees F above normal); 7 hrs post-vaccine -> serious chills that shook entire body and would not stop  for 30 minutes (similar to the kind I had when I had hypothermia at age 18); 8 hrs post-vaccine -> nausea;  I took tylenol then and within 45 minutes everything except headache, myalgia and muscle knots, and nausea went away. Vomited in middle of the night.  Felt very drained and tired with myalgia all of the next two days.  Majority of symptoms went away after that but I felt as if I was coming down with a cold for the next 7 days - today my nose has been running all day and I have a stuffed head  (and I have not had a cold since November 2019). I  had a covid test yesterday because I need to accompany my husband for a medical procedure on Friday - that was negative. I have seen no one, gone nowhere, and done nothing different since I received my vaccine than I had beforehand yet I am displaying symptoms normally associated with a cold although I have no fever.
Headache, Myalgia, Arthralgia, SkinRash, Pain/Discomfort at injection site, chills, fatigue Narrative: