chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 06/Jul/2006 from a health care professional.  Three, five-year-old patient's had received a subcutaneous dose of IPOL, lot number Y0324-2; an intra-muscular dose of Tripedia, lot number U1342BC; and a dose of Measles Mumps and Rubella vaccine (manufacturer reported), lot number 0603R on varies dates.  Approximately 24-48 hours post-immunization, the patient's all experienced a local reaction on the arm were the IPOL and Tripedia injections were administered.  All three patient's required emergency room visits.  The patient's may have received treatment with with IV antibiotics, oral antibiotics, or other unspecified treatment.  The reported did not specify which patient received what treatment.  The recovery status of the patient's was reported as unknown.  The reporter for this case in the same as for case 2006-01717, where a four-year-old patient experience a similar local reaction requiring an emergency room visit.
I experienced swelling of knuckles in my right hand and cannot make a fist that night, and every night since.  It dissipates approximately 10-15 minutes every morning.  The psoriatic arthritis has affected my skin & toes, but never my hands.
Anaphylactic reaction. treatment with EpiPen. patient treated with own EpiPen. EMT called and was retreated with EpiPen. Also given Benadryl by RPh on duty. given IM Benadryl by EMT. Throat swelled up and pt has trouble breathing
per mother, developed dizziness and had low BP 100/60.  Symptom started on 6/11/21.  Child only had soreness at sight prior to development of dizziness.  Saw medical care physician on 6/15/21 due to persisting dizziness and low BP.   Symptoms lasted for 2 weeks then resolved.
Shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-Nov-2022 Reporter's comment: The patient contracted shingles, the day after received Shingrix vaccine. The reporter agrees to follow up from GlaxoSmithKline. Additional supportive information: This case has been linked to the case US2022AMR160156 reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR160156:Same reporter
Ldeltoid and below red and warm to touch  Bruised area size of half dollar.  Child fussy and crying.  Mother has to hold child while nurse examed L arm.  Instructed to apply warm compresses to arm no improvement see the doctor.
Pt states she had flu shot on Monday, 11/19/01 and chills started on that evening and has persisted along with weakness from 11/19/01 to 11/23/01. No topical reaction. Informed pt that she was most likely exposed prior to vaccination. Recovery in process.
Irregular menstruation - menstruation began on June 3rd even though patient's cycle had ended two days prior to receiving the vaccine.
PMH:  coronary disease, DM, CKD, COPD; presented to ED with SOB; positive for COVID; unable to have hemodialysis due to hypotension; given steroids, IV fluids, Levophed; pt's condition worsened and he was transferred to ICU; condition continued to deteriorate and family decided to not escalate care; pt died in the hosp
Arm started hurting 2 days after shot, got so bad couldn't lift arm. Still hurting feels like nerve pain.
10/19/2023  am   Extremely  sore left shoulder cap area.   Lasted 24 hours.   Did stretches and massage to try to relieve 10/19/2023 am    GI distress,  gas, frequency, discomfort, etc.   Lasted 8 days.    Used probiotics, careful diet. 10/20/2023 pm     Quarter size rash appeared on inner left forearm 2 inches below elbow area .    Extremely itchy, painful, red, hot.                                          Lasted about 7 days. Used Hydrocortisone cream.
Fever of 103.0 on 18NOV90 - lasted 1/2 days at the most joint pains, generalized weakness. tx - none.
6/8/18- vaccinations given. 6/13/18- became febrile 102-103; redness to injection site. 6/14-  continued to be febrile; redness to leg continued. 6/15- afebrile; redness to injection site worsens 6/16- rash to bridge of nose and under eyes, spreading to trunk and limbs as day progressed; injection site red and warm to touch; evaluated in ER.
Moderna COVID-19 vaccine inadvertently administered to a 17-year-old patient, despite approval for vaccine being for patients 18 years or older.
2-4 hrs after vaccine administration, the pt developed gradually worsening chest pain and dyspnea. Eventually admitted and dx with non-malignant, large, bloody pericardial effusion. Discharge summary states abdominal pain, anemia. msv
This is a spontaneous report received from contactable reporter. The reporter is the patient. A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Dec2020 (Lot number: EK5730) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported.  The following information was reported: COVID-19 (non-serious) with onset Dec2020, outcome unknown. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient did not receive other vaccine in four weeks. Patient had other medications in two weeks which included Aleve. The patient had no covid prior vaccination.   Follow-up attempts are completed. No further information is expected.
Ongoing severe left arm pain, loss of mobility, muscle weakness tendonitis, bursitis. Rule out Parsonage-Turner syndrome. Currently seeing neurology for workup and referred to another location for specialty care.
severe peripheral neuropathy; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (severe peripheral neuropathy) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (severe peripheral neuropathy) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (severe peripheral neuropathy) outcome was unknown.            Concomitant medications were not reported.  On unspecified date patient administered MODERNA COVID-19 VACCINE 2nd booster. It was reported the patient had a negative reaction (severe peripheral neuropathy).   Treatment information was not provided.  Company comment: This is a spontaneous case concerning a male patient of unknown age  with no reported medical and vaccination history. The patient experienced the unexpected serious (medically significant) event of severe peripheral neuropathy. The event occurrence was unknown with respect to the second booster dose of mRNA-1273.222 vaccine administration. No further clinical information was available for medical review. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a male patient of unknown age  with no reported medical and vaccination history. The patient experienced the unexpected serious (medically significant) event of severe peripheral neuropathy. The event occurrence was unknown with respect to the second booster dose of mRNA-1273.222 vaccine administration. No further clinical information was available for medical review. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Oral bleeding; Toothache; Chest pain; Leg pain; Fever 101F; This case was reported by a physician via call center representative and described the occurrence of mouth hemorrhage in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number PH2R2, expiry date 5th October 2023) for prophylaxis.   Concurrent medical conditions included obstructive sleep apnea syndrome and irritable bowel syndrome. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 17th October 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 17th October 2022, less than a day after receiving Shingrix, the patient experienced mouth hemorrhage, toothache, chest pain, leg pain and fever. On 20th October 2022, the outcome of the mouth hemorrhage, toothache, chest pain, leg pain and fever were recovered/resolved.   The reporter considered the mouth hemorrhage, toothache, chest pain, leg pain and fever to be possibly related to Shingrix.     Additional Information: GSK receipt date: 02-FEB-2023 Reporter's comment : The patient had received the second dose of vaccine via intramuscular route.  The patient height was 69 inch and weight was reported as181 pounds. The patient had experienced mouth hemorrhage, toothache, chest pain, leg pain and fever  Additional supportive information: Adverse event (AE) outcome captured conservatively as recovered/resolved based on the event outcome date provided and AI was raised to confirm the same.  The reporter had consented to follow-up.
Pt recvd Engerix-B on 30ARP90, 5JUN90, 29OCT90 subsequently was found neg Anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Dizzy, light headed, tingly lips and arms, tight chest, bright red hot rashy face.  It started Friday night and is still continuing today (Monday).
Information has been received from a consumer concerning her 12 month old son who on 29-MAY-2008 was vaccinated with ZOSTAVAX (Merck) instead of with VARIVAX (Merck). There was no adverse event reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved.
Never been so sick; This serious initial spontaneous safety report was received by Novavax on 03-DEC-2022 from a consumer via social media monitoring.  An 85 year-old individual of an unspecified race and sex was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine unspecified dose on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the individual had never been so sick (PT: Illness) (Serious: Hospitalization). The individual was hospitalized for 10 days.  At the time of reporting, the event outcome of Illness was unknown.  Lot number was not provided in the report.; Sender's Comments: This 85 year-old individual of an unspecified sex experienced: Illness after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Illness was reported as serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported event is considered Possible.
Patient received Moderna and still contracted COVID-19; Lack of effect / Adverse effect; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Patient received Moderna and still contracted COVID-19) and DRUG INEFFECTIVE (Lack of effect / Adverse effect) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient received Moderna and still contracted COVID-19) and DRUG INEFFECTIVE (Lack of effect / Adverse effect). At the time of the report, COVID-19 (Patient received Moderna and still contracted COVID-19) and DRUG INEFFECTIVE (Lack of effect / Adverse effect) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant drug information was provided. Patient's year of birth was 1938 It was reported by the reporter that the patient was not the only one included who got sick. No treatment drug information was provided.  Company comment: This spontaneous case concerns a male patient of about 8 decades old, with no reported medical history, who experienced the non-serious unexpected AESI of COVID 19 which occurred unknown days after administration of a dose of mRNA-1273 vaccine. Drug ineffective was also reported as an event. Further details are not mentioned in the report. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of about 8 decades old, with no reported medical history, who experienced the non-serious unexpected AESI of COVID 19 which occurred unknown days after administration of a dose of mRNA-1273 vaccine. Drug ineffective was also reported as an event. Further details are not mentioned in the report. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
This case was reported by a pharmacist and described the occurrence of hive in a 21-year-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  On 1 July 2005 at 11:58, the subject received 3rd dose of ENGERIX B, (1 ml, unknown, left arm).  On 1 July 2005, less than one day after vaccination with ENGERIX B, the subject experienced hive and welts all over body.  The pharmacist reported that a male subject received his 3rd dose of ENGERIX B and developed large welts all over his body.  The subject went to the emergency room and was treated with epinephrine for hives.  The symptoms resolved within 24 hours.  No further information was available at the time of the report.  The pharmacist considered the events were clinically significant (or requiring intervention).  The subject was treated with adrenaline (Epinephrine).  On 2 July 2005, the events were resolved.  The pharmacist considered the events were possibly related to vaccination with ENGERIX B.
This spontaneous report as received from a nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number not specified). Route was not reported. No other co-suspects were reported. NO concomitant medications were reported. On an unknown date the patient experienced pain and weakness in her vaccinated arm. The patient also had a thickened area in the deltoid region of her arm, with a 2 inch circumference. The patient sought medical attention by visiting the office. No treatment information was reported. At the time of report the patient had not recovered. Additional information has been requested.
severe daily headaches, episodes of sudden onset tachycardia possible SVT for less than 15 min.
severe vertigo after the first dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81 year-old female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) at the age of 81 years as single dose for covid-19 immunisation. Relevant medical history included: "arm swelled up" (unspecified if ongoing), notes: I've had flu shot, a little reaction with the adult one my arm swelled up twice the size for about a week. That was 2 to 3 years ago, the adult stronger one. The patient's concomitant medications were not reported. Vaccination history included: Flu shot, for immunisation, reaction(s): "arm swelled up twice the size ". The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "severe vertigo after the first dose".  No follow-up attempts are possible. No further information is expected.
Patient developed dizziness and fell face first approximately 10 minutes after receiving vaccine.  EMS called.  Blood pressure normal.  Heart rate 54. Blood sugar normal.  Patient stated loss of consciousness.  Patient refused to go to the hospital.
Both have now got the Delta strain, both very sick; Both have now got the Delta strain, both very sick; Both have now got the Delta strain, both very sick; This is a spontaneous report from a contactable consumer reported for a patient. This is one of two reports (No. 1 got Delta strain). A patient of an unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included virus (covid-19) and DD (Dercum's disease) both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated for the patient as "I am 75yrs, have a rare disease, DERCUMS, it is progressive with no cure. it's a doozie. Last winter I sent an email to the CDC about your shot as this virus would send those of us with DD straight to heaven, we were so compromised. Nice note back, stating they were comfortable with the Pfizer shot. 90% of us wanted the shot. The 2 I know of that got the virus before the shot was available, they were both lucky to be alive, however, Both have now got the Delta strain, both very sick". The patient underwent lab tests and procedures which included sars-cov-2 test: got the delta strain on an unknown date. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101017357 Same reporter/events/product, different patients
Shakes; Low grade Fever 100.3 Fahrenheit/fever an and off; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), PYREXIA (Low grade Fever 100.3 Fahrenheit/fever an and off), HEADACHE (Headache) and FATIGUE (Tired) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced TREMOR (Shakes), PYREXIA (Low grade Fever 100.3 Fahrenheit/fever an and off), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, TREMOR (Shakes) and HEADACHE (Headache) outcome was unknown and PYREXIA (Low grade Fever 100.3 Fahrenheit/fever an and off) and FATIGUE (Tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Body temperature: 100.3 °F (High) 100.3 and 100.1 °F (High) 100.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. The patient took acetaminophen for fever and the fever came down to 100.1 Fahrenheit. Treatment included Tylenol
Pt was given ADACEL with expiration date of 9/6/10 vaccine given on 9/21/10.
Seizures (non-febrile) beginning within hours of the injection. He had dozens of seizures each day for weeks. 4 years later he is still having subclinical and absence seizures daily. He lost all previously gained speech and didn't speak for 3 years. He lost gross and fine motor skills and began losing weight, losing his hair and became severely anemic.
Initial case was received on 22 September 2010 from a healthcare professional. A male patient (date of birth and age not reported) received on 21 September 2010 at 12:30 p.m., an injection of FLUZONE (lot number U3567EA). At 11:30 p.m. on 21 September 2010, he experienced "shaking uncontrollably." No further information was provided and the outcome of the event was not reported. Follow-up information was received from a health care professional on 16 November 2010. The patient had received the FLUZONE vaccine in the left deltoid at 12:30 p.m. At the time of vaccination, the patient could not sleep and had "violent shaking". It was unknown if the patient had any adverse events after prior vaccinations. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Patient stating erythema and swelling to right upper FA, noticed this am; now stating this afternoon decreased swelling and erythema.  Large area still noted to have erythema, swelling; epi compassive most of upper FA (R); denies SOB, CP or difficulty breathing.
This spontaneous report as received from a nurse referring to a 35 year old female patient with asthma. Patient was not pregnant and had no drug reaction or allergies. On 23-FEB-2016, the patient was intramuscularly vaccinated with dose PNEUMOVAX23 (dose and frequency were not reported, lot # L040178 with expiration date: 18-AUG-2017). Concomitant therapies included CIPRO, PENLAC and DIFLUCAN. On 24-FEB-2016, the patient developed swelling and redness at the site PNEUMOVAX23 injection. The patient was not recovered. No treatment was given for adverse event. Lab diagnostic studies were not performed. The patient sought medical attention. A lot check was requested. Causality assessment was not reported. Additional information has been requested.
INJECTION SITE VERY SORE; This spontaneous report received from a patient concerned a 43 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: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced injection site very sore.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site very sore was not reported. This report was non-serious.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Said after around 15min that he was dizzy. Wasn't getting better after sitting a bit longer and said he felt like it was sort of a fog in his head. His wife was also there. They waited a bit longer and then the wife wanted a wheel chair from store. They brought him one and he and his wife wanted to leave and did not want to wait any longer. He got into the electric wheel chair himself and seemed to be doing better. He operated the wheel chair himself with his wife next to him.
2nd Shingrix vac at 1 year; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. It was reported that the patient was improperly instructed to get 2nd Shingrix vaccination at 1 year, which led to lengthening of vaccination schedule.  The patient asked if he/she need a 3rd shot.
2/9/21 - pain/soreness injection sight afternoon, from 9 pm on flatulence  2/10/21 - in bed around 12am chills on and off, woke up with headache, body aches and general malaise,                   cramps and diarrhea around 4pm, 6 pm severe chills, could not stop and started hyperventilating, used paper bag and after about 15 minutes got breathing under control and got in bed fully clothed with 2 blankets and with heat turned up finally stopped shaking. 2/11/21 - fatigue, cough 2/12/21 - fatigue, cough 2/13/21 - better, normal bowel movement