chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-JUN-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2015, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the 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. Additional information has been requested.
I had a bad reaction and I have been not right ever since then you know; This is a spontaneous report form a non-contactable consumer (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. On an unspecified date, patient had a bad reaction, patient had been not right ever since then. Patient wanted to know how long that thing going to last on me like that, how long I am going to be like this. Why it did not go back to normal because I was not normal. The patient got a card after taking last shot. Patient was informed about Pfizer Medical information department. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 01/08/2021, 01/29/2021, and 10/29/2021. They tested positive for COVID-19 on 02/07/2022 at the long term care facility at which they were a resident. I have no indication this person was hospitalized, but they died on 02/23/2022. COVID-19 is listed on the death certificate.
No adverse events listed - tested positive for COVID-19   03/27/21 0214  COVID-19 (SARS CoV-2,RNA Molecular Amplification)  Collected: 03/26/21 1547 | Final result | Specimen: Swab from Nasopharynx   COVID-19 SARS-CoV-2 Overall Result DetectedCritical
This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 7th December 2018, the patient received the 1st dose of SHINGRIX. On 9th December 2018, 2 days after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was recovered/resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on an unknown arm. Approximately 2 hours later, the patient experienced several bumps on her back which were itchy after receiving a t dose of SHINGRIX. The event resolved after 2 weeks. The patient was seen by a physician, but the reporter didnot know what discussion or diagnosis was made. The reporter consented to follow up. The patient received 2nd dose for tolerance see case US2019032491.
Parents feel that the child's left arm was excessively sore for 2 weeks following the administration of Dtap, IPV, and varicella. The symptoms were relieved by Tylenol which was administered every 4 hours for 2-3 days.  This child was vaccinated through a home visit program. The parents asked that the vaccines administered on 6/29/07 be given in the legs instead of the arms.  I agreed to report the complaint.
This spontaneous report as received from a physician refers to a 4 to 6 year old male patient. About a month ago, on approximately December 2013 the patient was vaccinated with PROQUAD dose 2. A week later, on approximately December 2013 the patient developed red, blotchy rash at injection site, which started across his chest and lasted at least a week. The physician had not heard back from the patient so they were assuming the child was now ok. The causal relationship was not reported. Additional information has been requested.
Small amount of redness to injection sites on right arm. Afebrile. No streaking. No redness to left arm.
Sinus infection  Scratchy throat  Bad cough  Breathing issues Tiredness Not able to eat
almost stumbled; dizzy/lightheaded; felt like my head was swimming/loopy on the head; Arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of FALL (almost stumbled) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FALL (almost stumbled). At the time of the report, FALL (almost stumbled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included ibuprofen.  No concomitant medication was provided.
Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). On 23-Oct-2021, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported. The reporter was going  for booster dose but because of cold she was unable to go.   Reporter did not allow further contact
polymyalgia rheumatica after second vaccination/unable to move without pain/first sign was arm pain; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE , solution for injection, Batch/Lot Number: EL32247), via an unspecified route of administration, administered in left arm on 05Feb2021 (at the age of 69-years-old) as single dose for COVID-19 immunisation. The vaccine was administered to the patient at a workplace clinic. The patient had no other vaccine in four weeks. Medical history included type 2 diabetes and high blood pressure. The patient's concomitant medications were not reported.  The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3247) administered in the left arm on 14Jan2021 at 01:00 pm (at the age of 68-years-old) for COVID-19 immunisation. The patient previously took lisinopril and experienced allergies.  The patient reported he was unable to move without pain. He had polymyalgia rheumatica after second vaccination on 09Feb2021 which resulted in doctor or other healthcare professional office/clinic visit. Patient was given naproxen (ALEVE) as treatment. It was reported that the first sign was arm pain on 09Feb2021. The patient denied COVID prior to vaccination. The patient undergone COVID testing: nasal swab post vaccination on 26Feb2021 and yielded negative result. Outcome of the event was not recovered.
Patient was here for vaccinations. PREVNAR and varicella were administered in right thigh while patient was in arms of mother. Patient began to cry and held her breath for approximately five seconds. Patient began to breath again with stuffy nose. For approximately two seconds, patient became limp with eyes closed. Patient then opened her eyes, muscle tone returned and began to cry. Mother waited in office for fifteen minutes until child was calm, skin tone pink, and patient was alert. Advised to call doctor with any further symptoms.
Day after shot developed high fever (Tmax 104.3F), vomited once, develop rash next day. Fever lasted 3-4 days.
Developed redness, warmth and swelling of left upper arm 1 day after receiving vaccines.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient recieved shot high, having trouble being able to raise arm along with pain, swelling & redness
Within 10 minutes of receiving vaccines, pt had hives from waistline to toes.  No wheezing.  Hives lasted approximately 1/2 hours (hives bilateral).
Adverse reaction or side effect experienced: None; Pneumococcal vaccine administered on 23-MAY-2013 and on 03-AUG-2015; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for Zoster Vaccine Live (ZOSTAVAX) (MARRS# 2008USA002268), concerning a 67-year-old male patient. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 23-MAY-2013, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and on 03-AUG-2015, he received a dose of pneumococcal vaccine 13v (manufacturer unknown) (inappropriate schedule of product administration), both administered as prophylaxis (strength, dosage schedule, route of administration, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported for both doses). No adverse effects were reported.; Sender's Comments:  US-009507513-2008USA002268:
covid 19; sore throat; chills; headache; rash on  arm; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (covid 19), OROPHARYNGEAL PAIN (sore throat), RASH (rash on  arm), CHILLS (chills) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011770A and UNK) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatism (Per source, patient has a syndrome that begins with an "S" and is a form of rheumatoid arthritis.). Concomitant products included AMLODIPINE and VALACYCLOVIR [VALACICLOVIR] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced RASH (rash on  arm). On 13-Jan-2021, the patient experienced COVID-19 (covid 19), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills) and HEADACHE (headache). On 13-Jan-2021, RASH (rash on  arm) had resolved. At the time of the report, COVID-19 (covid 19), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 antibody test positive: positive (Positive) POSITIVE.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.    This case was linked to MOD-2021-016281 (Patient Link).
One month after the second dose I have had significantly increased menstrual cramps and menstrual flow.  My cycle lasts longer and is much heavier. This has been for the past 3 months since I received the final dose.
Patient was joking and laughing an able to communicate. Immediately after shot, patient heaved or turned away, eyes watering and then could only answer in single word answers. Massive change in   "affect". Onsite EMS was called vitals BP 146/84 HR 98 Patient passed out 4 times with eyes rolling back. Ems took patient to the hospital.
pt recvd vax; pt devel hematuria; dizziness; pharyngeal discomfort; fever; infection, respiratory, upper; dysuria; urinary frequency; chills; asthenia/fatigue; pain, ear; pharyngitis;
tinnitus has come back; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus has come back) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus (had an implant last year and it reduced his effects to a tollerable level.).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced TINNITUS (tinnitus has come back). At the time of the report, TINNITUS (tinnitus has come back) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Seizure activity starting after booster dose early the next morning- fell into the bathtub with full body convulsions witnessed by patient's wife followed by brief post-ictal period and 2 additional episodes of convulsions before EMS arrived. Patient was seen at emergency room, had lab work and CT head without acute findings. Normal neuro exam and no further episodes or symptoms other than soreness.
Injection 6:30pm nose/sinuses congested, headache, nausea reaction (9/22/10) 9:00pm was light. Started to recede about noon next day (9/23/10).
rash appeared on upper back; very itchy; This is a spontaneous report from a contactable consumer, the patient. A 80-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in left arm on 25Feb2021 at 10:45 (at the age of 80-year-old) as single dose, for COVID-19 immunisation. Medical history included osteoarthritis. The patient has known allergies to tree fruits and some nuts. The patient neither underwent COVID-19 test nor had symptoms associated with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received PRESERVISION; calcium (MANUFACTURER UNKNOWN) started on unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9261) via an unspecified route of administration in left arm on 04Feb2021, as single dose, for COVID-19 immunisation. On an unknown date in Feb2021, a day or two after 2nd shot, rash appeared on patient's upper back; very itchy; over the past month, rash has moved down her back; on her arms, upper hip, abdomen. Therapeutic measures were taken as results of events and included treatment with Claritin 5mg to reduce itch & putting on gold bond psoriasis relief cream. Event didn't result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome for the events rash appeared on my upper back and itchy was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Low grade fever (99.5 ax) started 12 hrs after dose, continued to breakthrough despite acetaminophen dosing. Max. temp 100.5 ax for 48 hours. She was lethargic, limp, and irritable x 96 hours. One loose stool per day. Poor appetite for solids, but continued to nurse well. At 90 hrs post dose had large emesis with dry heaving. She was back to baseline behavior at 5 days post immunization. No other s/s of an URI or any other infections process.
Patient received Pfizer COVID vaccine on 5/14/21 and 6/11/21. Patient admitted to our facility on 9/29/21  s/p a mechanical fall down 2-3 concrete steps with RIGHT distal radius and ulna styloid fracture and LEFT comminuted patella fracture. Pt underwent ORIF of the RIGHT distal radius and ulna fracture and ORIF of the LEFT patella on 9/30/21. On 10/2/21, patient tested positive for COVID but asymptomatic. As of 10/4/21, patient is still admitted in the med/surg unit post ORIF.
Patient received the initial Pfizer vaccine Dec 29,2021.  He developed new onset seizure 1/14/2022 and had a second seizure on 1/23/2022.  He has no prior hx of seizure disorder and no other cause for seizure.
Information has been received from a consumer concerning her 12 year old granddaughter who on unspecified date, was vaccinated with a dose of GARDASIL (lot number dose, site of administration not reported). Consumer reported that on unspecified date since the administration of the vaccine the patient experienced a rash, tiredness, yellowing of the kin and had missed school for two weeks. Antibiotics (manufacturer unknown) and steroids (manufacturer unknown) were given by her physician as treatment of adverse events. The physician diagnosed the patient  with "mono". The consumer reported that her granddaughter did not have "mono" and that these side effects were related to the administration of GARDASIL. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Patient received flu vaccine on 10/20/18 at 2:43pm and states she experienced whole body rash during the same day in the evening around 7pm. Patient states there was no itching and she's received the flu shot before with no known reaction. Patient took ZYRTEC to help with the rash, but states it did not help and each day since the shot the rash gets worse. Patient states the rash is 5mm-10mm in measurement. Patient has been taking ZYRTEC in the morning and BENADRYL at night since the event. Pharmacist recommended patient see a doctor since antihistamine was not providing any relief and patient mentioned rash keeps getting worse.
This spontaneous report was received from a medical assistant concerning an approximately 10 months old (at the time of medication error) female patient with no drug reaction or allergies. The medical history of the patient included premature birth. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot number, expiry date, dose and route unspecified) when she was born, however, the unspecified hospital had no record of the vaccination. On 11-JAN-1999, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot number and expiry date reported as 627176/1091H and 26-MAR-2001 respectively, dose unspecified), intramuscularly in the left thigh. On 11-OCT-1999, the patient was vaccinated with the third dose of of RECOMBIVAX HB (lot number, expiry date and dose unspecified), intramuscularly in the left thigh. Concomitant medication included iron supplements (unspecified). The patient had blood titers drawn for Hepatitis B surface antibodies on 28-JUN-2013. Approximately on an unknown date in July 2013 (reported as last week), the results were received and the Hepatitis B surface antibodies were low. The reporter stated that they read 8.6 when immunity should be 9.9 or greater. No treatment was provided. The outcome of the event was unknown. The relatedness for the event was unknown for RECOMBIVAX HB. Additional information is not expected.
Fever over 101.6 for over 23 hours, myalgias and malaise, headache
Starting Thursday afternoon, 6 days after my vaccine, my left arm started to hurt and became so sore it was hard to raise my arm.  The following day, I developed a welt in the exact location of my shot and a rash from my elbow up to my shoulder on the same arm I received my vaccine.  The rash is still there as of today (April 7th).  During the same timeframe (Thurs/Friday) 6-7 days post vaccine, I did not feel well and was generally very tired.  I was tested for COVID to confirm I had not contracted it at some point.  The PCR test was negative.
inappropriate schedule of vaccine administered, first dose administered on 17feb2021 and second dose taken on 07mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered, first dose administered on 17feb2021 and second dose taken on 07mar2021) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Clot blood and Leg operation. Concurrent medical conditions included Sensitive skin, COPD, Grass allergy, and Pollen allergy.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered, first dose administered on 17feb2021 and second dose taken on 07mar2021). The patient was treated with TYLENOL at an unspecified dose and frequency. On 07-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered, first dose administered on 17feb2021 and second dose taken on 07mar2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by the reporter.   This case was linked to MOD-2021-409850 (Patient Link).   Most recent FOLLOW-UP information incorporated above included on 13-Dec-2021 the Follow-up document contains no new information.
Redness, swollen, blistered, peeling skin. Called my doctor today 10/25/2021.
Got vaccinated 04/12/21 I had numbing one month later went to Hospital,  I was checked for a stroke and heart issues with no results. No information was available to identify these symptoms. My arm had gottn more weak and numb and my fingers are not functioning, I cant button. I am fairly healthy normal and active prior to taking this vaccine. I am concerned. PLEASE HELP
Moist cough on 12/06.  No elevated temperature.  Moist cough continues today 12/8/11.
Fatigue, nausea, diaphoresis, felt chilled (no rigors). T = 98.5. Myalgia, HA, lightheaded. Arm ok. No redness, no rash. Cough onset 2:30 pm; totally resolved by 7 pm same day.
pt recv vax 22MAY96 inadvertently instead of 3rd dose of Hep B vax & may have been given IM instead of SC;pt exp a large, raised, erythema @ inj site;
Pt had vaccine on 9/9. Four days later he presented at local emergency room with blood clots in both legs. He died at the hospital the same day.