chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a male of unspecified age. Initial information was processed along with additional information received on 14-JUN-2022. 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, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-MAY-2022, after contracting virus, patient had symptoms of runny nose, sneezing, exhaustion and fever (lasted 3 days). On an unspecified date in MAY-2022, Laboratory data included: COVID-19 virus test positive. Thus patient had confirmed covid-19 infection and confirmed clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000235440. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the evaluation/investigation performed. This case, from the same reporter is linked to 20220607940.; Sender's Comments: -20220647125-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Information has been received from a physician concerning a female patient in her mid teens who in September 2009, was vaccinated with the first 0.5 mL dose of GARDASIL. The patient waited 15 minutes and when she got up to leave she fainted fell and hit her head 'quite hard' on the table. The patient sought unspecified medical attention. No laboratory diagnosed studies were performed. At the same day, the patient had recovered. It was unknown if the patient ever got any more doses of GARDASIL. No further information is available.
transverse myelitis; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "transverse myelitis".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, Transverse myelitis cannot be completely ruled out. 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.
On 12/30/2022 I started having asthmatic bronchitis that lasted one long. I was not able to talk without coughing. I reached out to my doctor 01/05/2023 and started Symbicort twice a day along with Albuterol as needed
3 days after receiving the Tdap vaccine, patient developed severe pain in left upper arm from below the shoulder to approx 3 inches above the elbow. Pain has improved but still persists today.  No other symptoms. Pt with full ROM, no redness or swelling.
Patient fainted several minutes after receiving  Moderna COVID vaccination and became conscious several seconds later.  Sweating, loss of consciousness were the symptoms.  Laid patient on the ground with feet elevated and ice pack on forehead.  He received some water, juice and food and felt better within 30 minutes and was taken home by family members.
After administration, bleeding occurred and stopped after applied pressure. Dime-sized swelling and erythema at injection site. Pt denies pain at injection and any s/sx of anaphylactic reaction. Cold compress applied after 10 minutes and swelling+redness improved.  NP assessed injection site and was recommended to closely monitor and to call clinic if there's new/worsening sxs
Information has been received from a health professional concerning a 14 month old pt who was vaccinated with a dose of varicella virus vaccine live at 12 months of age. Subsequently the pt had breakthrough disease, noted to be less than 50 pox, with no fever. There was no known exposure to chickenpox and no complications. The outcome was reported as recovering. Additional information has been requested.
Patient developed a generalized red rash and hives all over her body that began approximately 30 hours after receiving the immunization. The patient sought medical attention and began taking a Medrol dosepak the following Friday which helped alleviate the immunization reaction.
Pain throughout the body and some weakness Headaches  Pain at injection site on left arm Had symptoms for two full days and treated with ibuprofen and or Tylenol
Pt slept on couch @ home last seen alive 3AM 17NOV91 when mom awakened about 9AM; baby dead;
They were tested positive with Covid-19 10 days after taking the 1st dose; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for her wife. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 17Apr2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller also called on behalf of his wife, they took the 1st dose last 17Apr2021. The 2nd dose will be tomorrow (09May2021) which was more than 21 days. As per the caller, they were tested positive with Covid-19 10 days after taking the 1st dose. He is asking if they need to take the 2nd dose or not. Provided the PMI number. Call transfer to unit and created manual AE form. Medical Information, were any unaddressed medical questions referred or forwarded to Medical Information was yes, Customer and/or medical inquiry forwarded or referred to MI. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache, Myalgia, Fever, pain and swelling at site: low grade fever; body aches, headaches; Narrative:
WEAKNESS OF THE RIGHT ARM; OCCASIONAL PAIN OF  THE SHOULDER DURING THE DAY WORSE AT NIGHT; FEVERISH; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperthyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-AUG-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hyperthyroidism.  On 11-APR-2021, the subject experienced feverish. Treatment medications included: paracetamol. On 25-APR-2021, the subject experienced occasional pain of the shoulder during the day worse at night. On 25-MAY-2021, the subject experienced weakness of the right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish on 11-APR-2021, and had not recovered from occasional pain of the shoulder during the day worse at night, and weakness of the right arm. This report was non-serious.
Arm pain; Little headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and HEADACHE (Little headache) in a 34-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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain) and HEADACHE (Little headache). At the time of the report, PAIN IN EXTREMITY (Arm pain) and HEADACHE (Little headache) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient did not have any pre-existing medical condition.  No concomitant mediations were reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-081274 (E2B Linked Report). This case was linked to MOD-2021-081274.   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081274:
Chills, shakes, nausea, muscle aches and fatigue. No treatment. Has been 16 hours since onset of symptoms. According to patient symptoms are improving. Informed to call back with worsening of symptoms or symptoms that are ongoing 2-3 days after.
Had no initial reaction.  After 10 days site became red, swollen, warm and tender to touch. Also itchy.  All the reactions one would expect to get immediately after administration, not 10 days later
LOW FEVER, MUSCLE ACHES, CHILLS FROM 3AM TO 10AM
Severe pain down right arm from injection site.  Profuse sweating. Body heated up, dizzy, nauseous,  vomiting,  chills, blurry vision. Passed out hitting head on floor. Went to hospital on 5/6 due to dizziness and headache, swollen cheekbone, hip pain. CT Scan and xray showed nothing broken. Rest was prescribed.
Developed focal consciousness impairing seizures on 29Sep2021; This is a spontaneous report received from contactable reporter(s) (Physician).  A 68 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), intramuscular, administered in arm left, administration date 20Feb2021 (Lot number: EN6203) at the age of 67 years 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, Date/Time (24hr): 28Jan2021 , Anatomical site of injection: Upper right arm, Route of administration: Intramuscular, Batch/Lot number: EN9581), administration date: 28Jan2021, when the patient was 67 years old, for COVID-19 Immunization. The following information was reported: PARTIAL SEIZURES (medically significant) with onset 29Sep2021, outcome "not recovered", described as "Developed focal consciousness impairing seizures on 29Sep2021". The patient underwent the following laboratory tests and procedures: electroencephalogram normal: normal; magnetic resonance imaging head: showed stable 1.3 cm right temporal cavernous, notes: malformation without edema or recent hemorrhage. Therapeutic measures were taken as a result of partial seizures.  The reporter considered "developed focal consciousness impairing seizures on 29sep2021" not related to bnt162b2.  Clinical course: Developed focal consciousness impairing seizures on 29Sep2021 (1st witnessed). EEG normal. Brain MRI showed stable 1.3 cm right temporal cavernous malformation without edema or recent hemorrhage. Following that was prescribed medication Levetiracetam to stop seizures. He initially was non compliant and had additional seizures. Subsequently started Levetiracetam and developed side effect of depression and irritability. Subsequently changed to Lamotrigine for seizure prophylaxis which to this date has been helpful in preventing seizures. Reporter did not think patient's seizures are related to his Pfizer covid vaccines that he received 28Jan2021, 20Feb2021 and 01Oct2021. Reporter did not consider Pfizer product had a causal effect to the adverse event.; Sender's Comments: The event focal consciousness impairing seizures  is assessed as likely due to the cavernous malformation and assessed as unrelated to BNT162B2 vaccine administration.
congestion; runny nose; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion) and RHINORRHOEA (runny nose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced NASAL CONGESTION (congestion) and RHINORRHOEA (runny nose). At the time of the report, NASAL CONGESTION (congestion) and RHINORRHOEA (runny nose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Additional information includes for concomitant  product where patient had reported of taking Birth control pills. Treatment information was not provided.
flu-like symptoms; headache; photosensitivity; chills; aches; rash/ spot on her forehead and scalp; neuralgia/ after receiving the Shingrix vaccine the neuralgia has worsened; arm Pain; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9737P, expiry date 19th March 2022) for prophylaxis.   The patient's past medical history included shingles and post herpetic neuralgia.   On 30th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, headache, photosensitivity, chills, pain, rash and post herpetic neuralgia. On an unknown date, the outcome of the pain in arm and rash were recovered/resolved and the outcome of the influenza-like symptoms, headache, photosensitivity, chills and pain were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, headache, photosensitivity, chills, pain, rash and post herpetic neuralgia to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix in right deltoid intramuscularly. She had a history of shingles and postherpetic neuralgia, but stated that after receiving the Shingrix vaccine the neuralgia had worsened and not resolved till the time of reporting. She stated that for one day her arm hurt. She had flu like symptoms, headache, photosensitivity, chills, aches. The patient also had a spot on her forehead and scalp, which was resolved. The reporter did not consent to follow up.
Pt states she awakened morning after getting flu shot with tightness in chest, severe headache and chills for 2 days. Breathing difficulties persisted over the next 30 days. Hospitalized 12/14.
localize reaction; rash on the patient's arm around 3x2 inches; arm was a little sored for a couple of days; felt tired; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sored for a couple of days), FATIGUE (felt tired), LETHARGY (lethargy), RASH (rash on the patient's arm around 3x2 inches) and PRURITUS (localize reaction) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Not reported medical history). Concomitant products included PARACETAMOL (TYLENOL), IBUPROFEN (ADVIL HEADACHE & MIGRAINE) and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (HEADACHE RELIEF) for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was a little sored for a couple of days), FATIGUE (felt tired) and LETHARGY (lethargy). On 17-Jan-2021, the patient experienced RASH (rash on the patient's arm around 3x2 inches). On 18-Jan-2021, the patient experienced PRURITUS (localize reaction). On 15-Jan-2021, FATIGUE (felt tired) and LETHARGY (lethargy) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was a little sored for a couple of days) had resolved and RASH (rash on the patient's arm around 3x2 inches) and PRURITUS (localize reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Localized reaction at site of injection with fever, lots of pain, and swelling around the area. Happened later that night a few hours after vaccination.
Itchy throat, itching from head to toe, whelps, rash, nausea
On 09/28/1999 pt was vaccinated with varicella virus vaccine live. On 10/15/1999 the pt developed enlarged lymph nodes. The pt subsequently developed additional enlarged lymph nodes in other areas.
Gall bladder attack; This is a spontaneous report received from a contactable reporter (consumer or other non hcp). The reporter is the patient.   A 41-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 22May2021 at 09:30 (Lot number: UNKNOWN) at the age of 41 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: CITALOPRAM. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN; Route of administration: unspecified), administration date: unknown, for COVID-19 immunisation.  The following information was reported: GALLBLADDER DISORDER (non-serious) with onset 22May2021 at 14:45, outcome "unknown", described as "Gall bladder attack". Therapeutic measures were taken as a result of gallbladder disorder.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of gallbladder disorder which included treatment with muscle relaxants.  The lot number for BNT162b2 was not provided and will be requested during follow up.
pain on his injection site; it's been spreading and it's like a hardness, a lump he can feel that started in his shoulder and now it's in his arm pit and now seems to have spread into the upper part of his back; sharp pain in the shoulder and the armpit which has now spread into the upper part of his back; sharp pain in the shoulder and the armpit which has now spread into the upper part of his back; sharp pain in the shoulder and the armpit which has now spread into the upper part of his back; This is a spontaneous report from a Contactable consumer. This 46-year-old male consumer (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 28May2021 as dose 2, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date after the vaccination patient experienced a lot of pain on his injection site which, he mentioned was spreading. He also mentioned that he could feel like a hardness, a lump that started in his shoulder and now it was in his arm pit and seemed to have spread into the upper part of his back. He also mentioned that he has a sharp pain in the shoulder and the armpit which has now spread into the upper part of his back. He would like to know if this was normal and for how long should they last. Caller asked was this within the expectations of side effects. He had an appointment at 09:30. Caller was unable to complete report. The event outcome was unknown.  No follow up attempts were possible. No further information was expected.
This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored PROQUAD (Merck) injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
pt complained of nausea and dizziness 5 minutes post injection.  Pt with elevated blood pressure 188/88 decreased mentation
After receiving the first shot, I had a taste of metal in my mouth.  I sat down and in the next 30 minutes passed out.  For the next three weeks, I had migraines more frequently than my usual migraines and a new pain behind my eye.  After receiving my second doses, I felt extremely tired and within 3 hours of receiving  got shooting pain on left side of my face.  I was diagnosed with Trigeminal Neuralgia by Dr on March 22, 2021.  This pain has been constant since receiving the second dose on March 8.
Pain at injection site; This is a spontaneous report received from a contactable consumer, the patient. A 70-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route administration in left arm on 21Mar2021 at 07:15, (at the age of 70-years-old) as a single dose, for COVID-19 immunisation. Medical history includes asthma, prolactinoma, hypertension. The patient was allergic to honey. Concomitant drug includes montelukast (SINGULAIR), clopidogrel (PLAVIX), celecoxib (CELEBREX), atorvastatin (LIPITOR), ZESTORETIC and P (unspecified medication), all drugs started on an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 21Mar2021 at 16:00, the patient experienced severe pain at injection site which began 8 hours after shot and continued about 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for event. The clinical outcome of the event pain at injection site was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information was expected.
Pt developed a sore throat and fever 2 days after receiving the vaccine.  Fever resolved after 1 day, but sore throat persisted for several days.
LD-warm to touch, temp 99.3 with Tylenol, red area, edema-moderate.
Stomach ache and diarrhea began 1st.  Then next day still had more severe abdominal pain followed by diarrhea and then vomiting and dizziness. Abdominal pain lasted all day.  Diarrhea lasted all day.  Vomiting started at 4 PM and occurred several times.  I am submitting this at 7pm my time, and my last vomiting was 6pm. My stomach still hurts but I am no longer dizzy.