chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse assistant regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with improperly stored PROQUAD (Lot # N013270, Expiry Date: 25-OCT-2018 and Lot # N015631, Expiry Date : 03-AUG-2019) for prophylaxis (dosing details were not reported). Concomitant therapies included sterile diluent. Temperature was reported as 6°F to 14°F (5.5°F) for 6 Hours 20 Minutes and -58°F to 5°F (1.5°F) for 5 Hours 15 Minutes (incorrect product storage). There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the two reports from to the same reporter. Sender's Comments: US-009507513-1708USA009084.
I received the vaccine on 12/29 at approximately 12:30 pm. On 12/31 I woke up with itching in my scalp. On 1/1 the itching started spreading throughout my body. I have continuously been itching since 12/31. The itching is all over my scalp, arms, hands, back, and legs. I have recently developed a pain/pressure in the back of my head, that feels like I have smacked it against a wall. I have also recently developed pain in my chest. I have seen my PCP, dermatologist, and ED drs and no one can find a route cause for my reaction.
Two weeks later I had chills; Two weeks later I had fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Two weeks later I had chills) and FATIGUE (Two weeks later I had fatigue) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 CHILLS (Two weeks later I had chills) and FATIGUE (Two weeks later I had fatigue). At the time of the report, CHILLS (Two weeks later I had chills) and FATIGUE (Two weeks later I had fatigue) outcome was unknown.            No concomitant medication were reported. No treatment information was reported  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Woke up on 2/2/2021 with vaccination site red, warm and itchy.  Started out approximately baseball size.  Today is size of a softball.  Not raised and no bump under the skin.  Was seen by physician and started on on Keflex QID for 7 days today.
Allergic reaction- rash progressed quickly down entire right arm.  Arm tingling in both arms.  Complained of dizziness, blurred vision. Puffy under eyes, unable to walk straight, arm swollen. Contacted ER.  Benedryl 5 mg po given and Epinephrine 0.5 ml given L arm subq.  Pt observed for 40 minutes after epi given.  Symptoms cleared.
Information has been received from an RN concerning a 36 year old female with a penicillin allergy who between 7/01 and 9/01, was vaccinated with the adult series of varicella virus vaccine live. There was no concomitant medication. In 12/01, a titer was done which did not show seroconversion. Unspecified medical attention was sought. Additional information has been requested.
This patient presented to hospital with increased dyspnea and cough. She tested positive for COVID after contracting it from her family. She has been hospitalized with high O2 requirements. She was treated with dexamethasone and had few complications beyond respiratory failure. She transfers for ongoing high O2 requirements. The patient reports ongoing cough, congestion, and dyspnea. The patient continued to require high amounts of 02- 100%/40L Vapotherm and NRB without ability to wean. For several days, the patient expressed that she is ready for transition to comfort care but is "waiting on sign from God" to know when to turn off the Oxygen. The family and patient decided to transition to comfort care. The patient was pronounced deceased at 1446 on 6/17/2023 with family at bedside.
Starting in January, I experienced intermittent numbness/tingling in my fingers and toes. I saw a neurologist who indicated I had small fiber neuropathy in my hands and feet extending up to about my knees. The test she performed on my feet and legs in her office with a metal instrument indicated I could not feel cold up to my knee.  These symptoms seem to have resolved.
Received vaccine on 10/26 hours after stated not feeling well. 10/30 Patient went to school fine, healthy, active  normal self. Came home after school (3:30) stating she was having scary thoughts that she was hysterical about them. Suicidal, hurting herself , hurting her siblings. This was not ever something she had dealt with ever. The next day  10/31 took her to doctor. They sent her to counselor and psychiatrist that day. They gave her meds for anxiety. They did not help. 11/1/2018 we took her to the ER because she was getting worse with the thoughts. They admitted her to a local mental hospital on 11/2 the doctor called me and had diagnosed her with OCD intrusive thoughts. She asked if she had any recent Illness or I fe room because OCD does not appear overnight. I started researching online and found several things about a disorder called PANS ( Pediatric Autoimmune Neuropsychiatric Disorder) . We found a local specialist who specializes in this and got her in to see her on 11/6/2018. She was then diagnosed with PANS/Autoimmune encephalitis, immune dysfunction. We?ve been on 2 year journey and have over 50k in medical bills, she?s been through so many things. Compiling medical diagnosis with no end in sight.
Around 16:30, mom noticed that he had problems with balance while sitting between her legs.  Couldn't sit alone, not able to bring to stand, went to sleep at 19:00.  At 21:00 able to site up by self and acting normal.
08/31/2021: Second dose of COVID19 vaccine received. 10/04/2021: EMS respond to 911 call. Patient was found in car with altered mental status, unable to move left side, experiencing vomiting and diarrhea. 10/05/2021: Brought to ER by EMS as a code stroke. Pt admitted after acute IP hemorrhage (confirmed on ED CT and MRI) involving R thalamus with accompanied hypertensive emergency, AKI, and respiratory failure. No surgical treatment indicated for hemorrhage. Patient intubated, nursing staff suctioning and laid on side as vomiting persisted. Given anti hypertensives and vasopressor. 10/06/2021: Patient pronounced brain dead at 0752. 10/06/2021: consulted and performed routine lab work for organ donation. Patient found to be syphillis positive and COVID positive by tracheal aspirate.
No other AE occurred; expired ROTATEQ administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1742457, expiration date reported as 16-JAN-2022, but upon internal validation stablished as 06-JAN-2022) (strength, dose and frequency not provided) orally (PO) for prophylaxis (Expired product administered).
Myoclonic jerks arms, shoulders - started 4-6 hours after receiving flu vaccine.
On 27-JUN-2019 patient is in office to receive second dose of GARDASIL 9.; This spontaneous report was received from a nurse concerning to a 15 year old patient of unknown gender. The patient's historical conditions, concurrent condition and drug reactions/ allergies were not reported.  On 27-JUN-2019, the nurse reported that the patient at the age of 14 year old was vaccinated with 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration, lot number and expiration date were not reported) as prohylaxis. On 27-JUN-2019, the patient was vaccinated with the 2 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration was not reported; lot number R005341 and expiration date 06-DEC-2020) (experienced inappropriate schedule of product administration) as prophylaxis. No adverse effects reported.  Lot number and expiration date were reported in the source document. But, when entering the lot number in MARRS the system automatically auto-populated the correct expiration date, which sometimes  may differs from the expiration date reported by the source.
No additional AE's; Caller reporting a temperature excursion / ROTATEQ was administered; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 12-APR-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dosage form orally administered, as prophylaxis (lot number 1684149 which has been verified to be valid, expiration date reported and validated as 25-JUN-2021) (product storage error). The administered dose of the vaccine was stored at a temperature of 34.1 degrees Fahrenheit (F), during a time frame of 4 hours 15 minutes, as recorded by a digital data logger. There were previous temperature excursions of 34.8 F, during a time frame of 45 minutes; and 34.7 F, during a time frame of 2 hours and 45 minutes. There were no additional adverse events reported in the patient.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA007436: US-009507513-2104USA007270: US-009507513-2104USA007277: US-009507513-2104USA007276:
Diffuse tremors, dizziness, weakness, pallor. Injection 11:30am, onset symptoms 8pm 8/25/15. 8/26/15 AM weak, headache and very painful arm.
I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION  Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET  Left SMS/VM.
Pt. presented to EC on 04/30/21 c/o SOB for several weeks, progressing, and subjective fever; PMHx significant for COPD, IDDM2; admitted to acute care but subsequently transfered to ICU, intubated on 05/09; developed SVT that had to be cardioverted x1; compassionately extubated and expired 05/11/21.
This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 45, via an unspecified route of administration, left arm, Jun 18, 2021, at 09:30, single dose, for COVID-19 immunisation. The patient did not have any reported medical history. The patient did not receive any concomitant medication. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 45, via an unspecified route of administration, left arm, on May 7, 2021, at 09:45, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On Jun 18, 2021, patient had a strange rash on trunk and legs for several weeks. No therapeutic measures taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has tested for COVID-19. On Jun 28, 2021, patient underwent COVID-19 virus test (nasal swab) with negative result. The outcome of had a strange rash on trunk and legs for several weeks: unknown (at the time of this report). The lot number for BNT162B2 was not provided and will be requested during follow-up.
Seems like he has COVID all over again; Difficulty breathing; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (Seems like he has COVID all over again), DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (14 days post symptomatic COVID-19 positive disease).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced SYMPTOM RECURRENCE (Seems like he has COVID all over again), DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, SYMPTOM RECURRENCE (Seems like he has COVID all over again), DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: Positive. On an unknown date, Pyrexia: 101.1 f Fever 101.1 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
he developed rashes after.; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Covid 19 vaccine, and he developed rashes after on an unspecified date. Got the second dose and still had rashes after receiving the dose. He asked on what to do on this. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 10Jan2021 as dose 2, single (Lot number: FJ1686), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Failure" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown. Not Provided          No treatment  was provided.
From the date of second Covid-19 Pfizer on March 29, 2021 until July 13, 2012, I felt fatigue, lethargy, and "brain fog". After July 13th those conditions abated.
No additional AE.; Patient received extra dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a 6-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 23-MAR-2023, the patient was vaccinated with a first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) single dose, lot # X018576, expiration date 05-JAN-2025 (exact dose, route of administration and anatomical location were not reported). On 24-OCT-2023, the patient received second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, route of administration, anatomical location, lot # and expiration date were not provided) (extra dose administered). Both doses were administered for prophylaxis. There was no additional adverse event reported.
Sore arm. Feeling drowsy and sluggish. Sleepy. Not interested in eating large meals. Desire lots of liquids and small bites of food.
Single swollen Lymph node on left armpit (under arm); I discovered a lump in my left armpit on Friday; This is a spontaneous report from a contactable consumer (patient). Follow-up (23Feb2021) was received from same reporter and processed together with initial information.  A 27-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248 and expiry date was not provided), via an unspecified route of administration, in left arm, on 08Feb2021 at 15:45 PM, as a single dose (at the age of 27-years) for COVID-19 immunization at workplace clinic. Historical vaccine included first dose of BNT162B2 (lot number: EL3248 and expiry date was not provided), via an unspecified route of administration, in left arm, on 19Jan2021 at 15:45 PM, as a single dose (at the age of 27-years) for COVID-19 immunization at workplace clinic. The patient was not pregnant at the time of vaccination. Patient's medical history included known allergies with Benadryl. The patient did not receive any other vaccines within 4 weeks. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that after four days of vaccination, on 12Feb2021 at night, the patient discovered a lump in her left armpit. On 13Feb2021 at 12:00 AM, the patient had single swollen Lymph node on left armpit (under arm). Patient did not receive any treatment for the events. Since the vaccination the patient had not been tested for COVID-19. On 15Feb2021, the patient submitted her COVID-19 Adverse Report. Outcome of the event single swollen Lymph node on left armpit (under arm) was not recovered and for another event, it was unknown.
Had shot, didn not stop it / Suspected vaccination failure; It is unbearable / getting new episodes; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shot, didn not stop it / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: It is unbearable / getting new episodes). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2023 This case was reported by the patient via interactive digital media.  The patient stated that he/she had the shingles shot, it did not do anything to stop it (singles). It was unbearable and keep on getting new episodes. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Hard, small nodule at injection site, mildly sore, pinkness around 6 inches long after 2 days after injection 12/6/11 - counseled pt to use BENADRYL on 12/9/11. Called pt on 12/10 & she says it's almost gone.
Headache; Nausea; Lightheadedness; Lethargy; Sore arm; This is a spontaneous report received from non-contactable consumer from a sales representative. The reporter is the patient.  A 75-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) at the age of 75 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Headache"; NAUSEA (non-serious), outcome "recovered", described as "Nausea"; DIZZINESS (non-serious), outcome "recovered", described as "Lightheadedness"; LETHARGY (non-serious), outcome "recovered", described as "Lethargy"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm". Therapeutic measures were taken as a result of nausea, pain in extremity.  Additional Information: Events took place after use of product. The patient had headache, nausea, lightheadedness, lethargy, and sore arm after both COVID-19 vaccine shots. The adverse events set in hours after shots. Symptoms lasted 24 to 36 hours. Paracetamol (TYLENOL) helped relieve sore arm and famotidine (PEPCID) was used for nausea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.