chrisvoncsefalvay/vaers-outcomes huggingface dataset:
knotted up my neck within seconds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1; LOT# UNKNOWN;), for Covid-19 Immunization. The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "knotted up my neck within seconds".  Additional information: Reporter mentioned that after receiving his first dose of the vaccine, he experienced "knotted up my neck within seconds." He also reported that both he and his wife (patient, who is also 61 years old) experienced this same sensation with the second dose, which they both received yesterday.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423328 Same reporter/ drug/ event for different patients.
Patient had swelling of lips 4 days after receiving  second dose of moderna covid 19 vaccine. Stated he had no issues with first dose. He had no other symptoms besides swollen lips. He was advised to take Benadryl to decrease swelling and go to ER if condition worsened.
developed a stye in my eye (note the blisters and stye were both on the same side); fever blisters developed in my mouth and around my lips; strange head ache; face and scalp were sensitive to touch; arm hurt; was slightly numb; This is a spontaneous report from a non-contactable consumer (Patient).  A 47-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 04Mar2021 at 05:45 as single dose for covid-19 immunisation. Medical history included autoimmune disease, asthma, diabetic, heart condition (palpitations) and known allergies for gluten. Concomitant medication included ascorbic acid, herbal NOS, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zin (AIRBORNE), fish oil, elderberry [sambucus nigra], garlic [allium sativum] and VITAMIN D. Patient received no other vaccine in four weeks. Other vaccine in two weeks included airborne, garlic, elderberry, vitamin d, fish oil. Patient did not experience covid prior vaccination. Patient has not been covid tested post vaccination. On 05Mar2021 at 06:00 PM after getting vaccine, the patient experienced had arm hurt and was slightly numb, the next evening she had strange headache where face and scalp were sensitive to touch, next day fever blisters developed in her mouth and around lips. The patient took 2 doses of Benadryl and felt better the next day, the following day she developed a stye in eye (the blisters and stye were both on same side that she received the shot). Other events except "next day fever blisters developed in her mouth and around lips" were not treated. The clinical outcome of events was resolving.                                                No follow-up attempt are possible. No further information expected.
1. Severe reactogenicity after Moderna 1 (facial neuritic pain) 2.  Severe reactogencity after Moderna 2 with fevere 103104 x 2 days then profound constitutional symptoms followed by progressive pain and fatigue that was disabling  Patient is a DVM and was unable to work x 5 months. Extensive workup revealed no end organ disease but does ahve + skin bx for smal fiber neuropathy and symptoms of autonomic dysfunction not previously noted.  While medically unexplained the chronology is compelling
I woke up early in the morning and felt chills. I knew I had a fever. I thought I had strep throat, but I took a home Covid - 19 test and it was positive. I called my doctor who prescribed Paxlovid. I took the Paxlovid for five days starting on Friday night and tested negative on that Tuesday.
I was given the Hep B vaccine. About 2 hours later, I experienced pain from the shoulder blade up through to my head.  I couldn't move, and my hearing was muffled. I couldn't turn my head. The temporary paralysis feeling lasted 4 hours, but the pain lasted 4 days.  The most severe pain was at the top of my spine just before my head.
Arm a little sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 90-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In JUL-2023, the patient received the 1st dose of Shingles vaccine. In JUL-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm a little sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-JUL-2023 This case was reported by a patient via interactive digital media. The patient received 1st dose of Shingles 2 days ago from reporting and had arm a little sore. The patient would receive 2nd dose in 2 months.
Psoriatic arthritis flared; COVID-19 vaccine allergy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4162810-00 (AbbVie).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant) with onset 2021, outcome "not recovered", described as "Psoriatic arthritis flared"; ALLERGY TO VACCINE (non-serious) with onset 2021, outcome "unknown", described as "COVID-19 vaccine allergy". The action taken for adalimumab was unknown. Clinical course: DOSE 2 of BNT162B2 was administered intramuscularly on 16Aug2021 (lot: FC3180) for COVID-19 immunization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had rapid heart beat 145 per min sustained after dose 2 within 1.5 weeks.   it was sustained never ceased to calm. She was breathing heavy, no sleep from rapid heart rate.  Hospital visit within a week of complaints confirmed Hyperthyroidism.  Followup with PA  of an Urgent Care allowed imaging to confirm Thyroid damage.  Folowup with Endocrinologists (2 seperate doctors from 2 seperate offices) confirmed Graves Disease as final diagnosis of the disease which  she now suffers from indefinetly.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-JAN-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous report as received from a 77 years old female patient with diabetes, high blood pressure, cyst and no drug reactions/allergies. The patient was subcutaneously vaccinated with, 0.65 ml ZOSTAVAX on 27-AUG-2009 (lot# was unspecified). Concomitant medications included CEPHALEXIN, heart medication (unspecified) and diabetes medication (unspecified). On 03-JUL-2012 the patient had a rash and has been diagnosed with shingles by her doctor, 1042 days after onset of therapy. Treatment given for AE included ACYCLOVIR, prednisone and GABAPENTIN. The outcome of shingles was reported as not recovered/not resolved. No lab diagnostic study were performed. Additional information has been requested.
Initial pregnancy report received from a healthcare professional on 15 April 2013. A 41-year-old female patient, whose medical history and concomitant medications were not reported, had received intramuscular first dose of ADACEL vaccine batch number C4366AA (anatomical site of vaccination was not reported) on 15 April 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was unknown and the estimated date of delivery (EDD) was reported as 18 June 2013. The patient did not experience any adverse event. Documents held by sender none. Follow-up information received from a healthcare professional on 19 August 2013: The patient and her husband had no ongoing illness. The patient did not receive any treatment for infertility. The patient had no previous pregnancies. The patient had not received any drug during pregnancy or prior fertilization that could remain at the time of fertilization. The patient's risk factors included advanced maternal age at pregnancy. The patients prenatal testing done on an unspecified date was normal. The patient's LMP date was unknown. The patient had received ADACEL in the left deltoid. At 39 weeks of gestation, the patient delivered a female child weighting 3.22 kg without any complications by C-section. The height of the baby was 51 cm and APGAR score at 1 minute and 5 minute was 9. The baby had no any congenital anomaly.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; MILD PAIN IN SITE OF INJECTION; This spontaneous report received from a consumer concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) 1 total dose was not reported, administered on 01-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  The patient did 2 antibodies tests and they were negative. On 28-MAY-2021 his result came out negative. The second test was done on 04-JUN-2021 and test came out negative(confirmed immunological vaccine failure). He took the vaccine, he did not have any side effects. He only had mild pain in the site of injection went away the same day after 4 hours. Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) Negative. On 04-JUN-2021, Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild pain in site of injection on 01-APR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210616495-covid-19 vaccine ad26.cov2. s -confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
2 min after receiving 1st dose of Moderna, pt c/o "funny taste" in her mouth and tingling all over - No LOC.  c/o nausea. No vomiting c/o clammy, warm feeling, warm face, face appeared flushed, progressing chilly, clammy, pale 10:55am BP- 138/82 pulse 68 reg, 11:08am 118/78 pulse 60 reg
After the first dose, next period came 11+ days early; Period lasted eight days; PMS equal to or stronger than normal; Cramping equal to or stronger than normal; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 24Feb2021 at 14:00 (at the age of 35-year-old) as a single dose and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and codeine (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021, after the first dose, the patient's next period came 11+ days early and lasted eight days. The typical cycle, for the patient, was 28-30 days with menstruation lasting about three days. The patient also experienced premenstrual syndrome (PMS) and cramping that were also equal to or stronger than normal, both of which were typically strong, to begin with. After the second dose, the period came 8 plus days early with similar symptoms to the last, though not lasting as long. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event after the first dose next period came 11+ days early, period lasted eight days, PMS equal to or stronger than normal, and cramping equal to or stronger than normal was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
11/1: received flu vaccine. 11/2 developed swelling/ redness of upper extremity proximal to elbow. 11/3 seen with significant swelling proximal upper extremity , erythema and vesicular rash to elbow. Afebrile. Later 11/3 admitted with worsening rash/ swelling and fever to 101. Treated for allergic reaction and cellulitis with IV abx and Benadryl. Slowly improved and was discharged on 11/6. Medical Records received on 1/20/2005 states pt experienced agitation.
Chronic earaches usually beginning mid morning, have come routinely throughout the day ever since receiving the 2nd dose. Read that it could be inflammation so didn't report. It has now been 4 months since that dose, and I still get earaches every day.   Menstrual cycles have shortened from 27 days to 16-20 days. Had been very regular until receiving COVID vaccine,. Figured this might also be due to inflammation, but 4 months out, this seems to be my new normal.
w/in seconds p/vax, body went rigid & unconscious; remembers feeling dizzy prior to loosing consciousness; Ice applied to forehead, legs elevated, & regained consciousness; Diaphoretic, cool skin; lasted 1-1.5 hr; occasional vertigo;
I HAD SHOT AND STILL GOT THE VIRUS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced i had shot and still got the virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of i had shot and still got the virus was not reported. This report was non-serious. This report was associated with a regulatory authority: 90000204289.
Sore throat lasting at least 2 days now Sticky build up of flem in back of throat lasting 2 days now Sharp and strong muscle ache intermittently about 8 hours on Sunday Low grade headache 6 hours on Sunday
Infant cried inconsolably for 1 and 1/4 hours.  Developed indurated, tender, mildly erythematous 2 cm nodule at site of pentacel injection in right thigh.
This case was reported by a physician and described the occurrence of fussy in a 4-month-old female subject who was vaccinated with ROTARIX, (GlaxoSmithKline). Concurrent vaccination included unspecified vaccines given on 2 July 2009. On 2 July 2009 at 16:00 the subject received 1st dose of ROTARIX (oral). On 2 July 2009, less than one day after vaccination with ROTARIX, the subject experienced fussy, clarified as screaming. She also had a fever of 99.6. The subject was treated with unknown medication. At the time of reporting the fever was resolved. The event of fussy was unresolved, and the outcome of screaming was unknown. The vaccination course with ROTARIX was discontinued. 10/07/2009 Follow up information received on 07 August 2009 indicated that in addition to already reported events, the subject developed extreme crampiness, vomiting and decreased appetite following administration of ROTARIX. Low grade temperature, extreme crampiness and vomiting were said to have started two  hours post vaccination with ROTARIX. Resolution of all events was documented as  06 July 2009. It was thought that the events were probably related to ROTARIX since this was the first time this vaccine was given. PEDIARIX, PREVNAR and HIB also given on 02 July 2009 were administered for the second time with no history of reaction following the first of each of these vaccines. TYLNEOL was given for treatment of events.
Couldn?t get out of bed for  3 days.   Chills, fever x2, aches and pains in every spot I have been hurt before.  knees, back, leg, neck, jaw, kidney.  Headaches every day, exhaustion, After I thought I was better, it went again to my back one day, my knees another day, my back another day etc.   General malaise returned! Arm was swollen the size of a baseball, hot, hard like a rock, itchy as well as painful!  That went on for a week!   My reaction was so severe, I am not sure I will want to receive another booster next time.  And I believe thoroughly in shots!
This is a spontaneous report received from a non-contactable reporter A patient (no qualifiers provided) 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 complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
LIVER FAILURE; HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had liver failure, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the liver failure and headaches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210403560-COVID-19 VACCINE AD26.COV2.S-Liver failure. 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 event.
Symptoms and illness lasted for 5 days. Seizures on day 2 (2 within a 2 hour period, paramedics were called. No history of seizures), high fever for 4 days  (103-104.7), delusions on the same day of seizures. loss of appetite (could not keep any food down for 4 days). Severe tiredness (lasted for 5 days). Muscle weakness. Fainting (5 times, occurred on the same day as the seizures and delusions). Heart palpitations.
FLU-LIKE SYMPTOMS; LACK OF SLEEP; LOW GRADE HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included herniated disc, and nerve pain, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A211A, and batch number: 207A211A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for nerve pain, and herniated disc. On 12-APR-2021, the subject experienced flu-like symptoms. On 12-APR-2021, the subject experienced lack of sleep. On 12-APR-2021, the subject experienced low grade headache. On 12-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 13-APR-2021, had not recovered from low grade headache, and tiredness, and the outcome of lack of sleep was not reported. This report was non-serious.
BRONCHITIS; WEAKNESS THROUGHOUT ENTIRE BODY; RIGHT NOSE SWELLED; BONES BEGAN TO ACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included leuprorelin acetate. On 10-APR-2021, the subject experienced flu like symptoms. On 12-APR-2021, the subject experienced bones began to ache. On 13-APR-2021, the subject experienced right nose swelled. On 14-APR-2021, the subject experienced bronchitis. On 14-APR-2021, the subject experienced weakness throughout entire body. On 15-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative, and Chest X-ray (NR: not provided) bronchitis. Treatment medications (dates unspecified) included: salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bronchitis, and the outcome of bones began to ache, right nose swelled, weakness throughout entire body and flu like symptoms was not reported. This report was non-serious.
Received the first shot for Shingrix. I got quite sick in the evening, with flu-like symptoms, vomited 4 times, diarrhea,  shivers, sweats.
Tinnitus in right ear.  Occurred a few hours after shot and has lasted (to date) over 3 days so far.