chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cousin got Bell's Palsy from it; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy 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 bell's palsy (Verbatim: Cousin got Bell's Palsy from it) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.     It was unknown if the company considered the bell's palsy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-APR-2023 This case was reported by the reporter via interactive digital media. The reporter reported that his/her cousin got Bell's Palsy after taking Shingles vaccine. This case has been linked to the case US2023AMR049593 and US2023AMR049605 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR049593:Same reporter. US-GSK-US2023AMR049605:Same reporter.
Moderna Covid 19 Vaccine EUA  Rt arm down to fingers hurt about 20 minutes after shot.  BP went to 170/126,  heart racing,  clammy feeling, unwell  2 children's Bendryl taken , I stayed at facility for 1 1/2 hrs until my BP went down, EMT took BP., oxyimetry and heart rate during that time.
Pain in right arm and shoulder with an hour of injection, worsened to where I couldn't raise my arm without much difficulty. Took Ibuprophen and it helped for a few hours. Got somewhat better overtime, thought I was going to recover in time. Still have pain at this time....though not nearly as bad as it was. Was hoping it would be resolve itself over time.
Immediately after injection I experienced sweating, loss of vision, hearing, balance,  Difficulty breathing, urge to vomit followed by sharp headache and a metallic taste in my mouth and sinuses. The nurse noted that I lost all color in my face and expressed concern for my condition. I couldn't walk for 10 minutes and had to rest at the facility for at least 30 minutes.
Ankles, feet, hands and wrists are swollen; Getting a bad rash all over my body/rash in arms and legs/rash is spreading to back and ears; Reaction to the vaccine; Ankles, feet, hands and wrists are swollen; Rash hot; Rash bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to the vaccine), JOINT SWELLING (Ankles, feet, hands and wrists are swollen), SKIN WARM (Rash hot), RASH ERYTHEMATOUS (Rash bright red) and PERIPHERAL SWELLING (Ankles, feet, hands and wrists are swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A, 036A21A and 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION COMPLICATION (Reaction to the vaccine), JOINT SWELLING (Ankles, feet, hands and wrists are swollen), SKIN WARM (Rash hot), RASH ERYTHEMATOUS (Rash bright red) and RASH (Getting a bad rash all over my body/rash in arms and legs/rash is spreading to back and ears). On an unknown date, the patient experienced PERIPHERAL SWELLING (Ankles, feet, hands and wrists are swollen). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Reaction to the vaccine), JOINT SWELLING (Ankles, feet, hands and wrists are swollen), SKIN WARM (Rash hot), RASH ERYTHEMATOUS (Rash bright red), PERIPHERAL SWELLING (Ankles, feet, hands and wrists are swollen) and RASH (Getting a bad rash all over my body/rash in arms and legs/rash is spreading to back and ears) had not resolved.            The patient after getting the booster dose on the next day began getting a bad rash all over their body, which was hot and bright red. The patient reported it started in legs and arms but now it was spreading to back and ears. The ankles, feet, hands, and wrists were swollen. The symptoms were still going on.  Treatment medication reported also included Steroid shot on 22-Nov-2021.
Pfizer-BioNTech COVID-19 Vaccine EUA  Patient had 10 min witnessed seizure 5hrs after receiving vaccine with no personal or family history of seizures.  Patient was given VERSED 3mg by EMS, transported to Emergency Dept and recovered, discharged from ED after several hours of observation without any known residual morbidity.
Patient received COVID vaccine around 3:50 pm and started complaining about sweating, SOB, faintness around 3:53 PM.  I laid patient on floor with feet up on chair and got ice packs. As time progressed patients lips and face started to swell and hives started to show up on face and patient complained of chest tightness. Patient started falling in and out of consciousness.  911 was called and 1 epipen was administered to patient. Patient became completely conscious and stated she could breathe better/chest tightness improved.  Patient was transported to hospital via ambulance.
localized shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not reported. The pharmacist reported the patient experienced shingles after dose one of Shingrix vaccine. The health care professional described shingles as a localized outbreak that began approximately 4-5 days after dose one of Shingrix. The health care professional could not provide lot numbers or expiration dates of the dose given. The reporter consented to follow-up. For tolerance of second dose refer linked case US2021AMR202711, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202711:same reporter
Initial unsolicited report received from a nurse on 27 June 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of Tdap (manufacturer, batch number, dose in series, route and site of administration: unknown, expiry date: not reported) on an unspecified date. The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. On an unspecified date, after vaccination, patient had a reaction to a Tdap vaccine. The patient's laboratory data was not reported. Patient was given unspecified medicine as a corrective treatment. On an unspecified date, the patient recovered from the event. List of documents held by sender: none.
Hives like rash few hours after vaccine given. Hives resolved w/in 30 minutes.
Painful cramping of muscle in upper right back.  Pain 2/10. Pain decreased to 1/10 by the next morning, and was fully resolved approximately 36 hours after onset.
Shivering; Muscles were tensed; Both forearms and hands ached; Great difficulty sleeping; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 12:45 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Feb2021 at 11:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 10Mar2021 at 12:15, at night the patient began shivering and all her muscles were tensed. This shivering lasted at least two hours. Both forearms and hands ached and the patient had great difficulty sleeping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shivering, muscles were tensed, forearms and hands ached, great difficulty sleeping was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported. Patient reported of heartbeat getting high on an unknown date and unknown outcome. Further details were not reported. Treatment medications was not reported.   Reporter did not allow further contact
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-JUL-2016, the patient was vaccinated with a first dose PNEUMOVAX 23, 0.5 ml, subcutaneously. Then, on 01-AUG-2016, the patient again administered with second dose of PNEUMOVAX 23, 0.5 ml, subcutaneously. No adverse effects reported. No further information provided. Additional information has been requested.
Initial case was received on 14 October 2010 from a healthcare professional. The reporter provided individual patient identifiers for a cluster of three patients (previously reported in case 2010-04957 as a cluster of six patients). This case contains information for the third of the three patients who had received on 09 September 2010 an injection of FLUZONE (lot number UH214AB). The patient was a female patient (unknown age) with no known pre-existing medical conditions and no concomitant medications. On 09 September 2010, she experienced a cough, lump feeling in throat and exhaustion. She had no illness at the time of the vaccination, no other vaccinations within 4 weeks and no adverse event following prior vaccinations. The outcome was unknown. Follow-up information was received 28 December 2010 from a health care professional who reported that the patient had not seen by a physician and had not received any corrective treatments. Outcome was recovered. The reporter had no additional information to provide at the time of the report. The reporter for this case (2010-05958) is the same as case number 2010-04957 and 2010-05957. Documents held by sender: None.
This case was reported by a nurse via sales rep and described the occurrence of therapy no-responder in a 57-year-old male patient who received ENGERIX B adult. This case was associated with a product complaint. Co-suspect products included ENGERIX B adult (batch number F3BB3, expiry date 18th April 2017) and ENGERIX B adult (batch number FP393, expiry date 17th August 2015). On 9th June 2014, the patient received the 1st dose of ENGERIX B adult. On 9th March 2015, the patient received the 2nd dose of ENGERIX B adult. On 15th July 2015, the patient received the 3rd dose of ENGERIX B adult. On 15th September 2015, 1 year and 98 days after receiving ENGERIX B adult, 190 days after receiving ENGERIX B adult and 62 days after receiving ENGERIX B adult, the patient experienced therapy non-responder. On an unknown date, the patient experienced drug dose administration interval too long, drug dose administration interval too short and pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long, drug dose administration interval too short and pharmaceutical product complaint were unknown. The reporter considered the therapy non-responder to be possibly related to ENGERIX B adult and ENGERIX B adult. Additional details provided were as follows: This case was one of the seven reports reported by an occupational nurse for patients tested negative for Hepatitis B titers following vaccination with ENGERIX B (see cases US2015135763, US2015GSK136757, US2015GSK136758, US2015GSK136759, US2015GSK136760 and US2015GSK136762). The caller reported that, they had their laboratory equipment recalibrated and the tests were rerun and results were dame or even lower titres. For 2 different batches involved in this case there were 2 different National Drug Code (NDCs). The patient concerned in this case received 1st dose of ENGERIX B adult vaccine on 9th June 2014 at a different hospital and at the reporter's. Any more details about this 1st dose was not available with the reporter. On 9th March 2015, the patient received the 2nd dose, which led to lengthening of the vaccination schedule. On 15th July 2015, the patient received the 3rd dose, which led to shortening of the vaccination schedule. On 15th September 2015, 463 days after receiving 1st dose of ENGERIX B adult, 190 days after receiving 2nd dose of ENGERIX B adult and 62 days after receding 3rd dose of ENGERIX B adult, the patient underwent test  for Hepatitis B antibodies and it was found to be negative with the value of 3.4, causing the patient to be a non-responder to the therapy.
allergic reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of ALLERGY TO VACCINE (allergic reaction) in a female 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 vaccination.     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 ALLERGY TO VACCINE (allergic reaction). At the time of the report, ALLERGY TO VACCINE (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The pharmacist wants to know the molecular weight of polyethylene glycol which is present in the Moderna vaccine.   No treatment medication were provided.   Reporter did not allow further contact
Started symptoms on 11/07/21  was seen in clinic and tested for COVID 11/10  was send out test results were Positive  came to ED 11/18 with low 02 sats and Shortness of Breath, productive cough, fatigue and decreased appetite
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that on an unknown dates an unspecified number of patients received doses of PNEUMOVAX (route. dose, frequency and lot # not reported) that were improperly stored. No adverse experiences reported. No further information provided. This is one of several reports from the same source. Additional information has been requested.
Experienced significant increase in tinnitus issues-louder ringing in ears, noticeable difference in volume and "swooshing" (like air escaping a tire loudly), a sensation of puffiness and impacted hearing, some pain and earaches.  Vertigo issues increased significantly, dizziness and unsteadiness.
Received the vaccine on Friday and broke out in shingles on Monday (3 days later). Nurse practitioner I saw indicated I was not the first patient she'd seen that broke out in shingles within a week of receiving a COVID vaccine.
The day after receiving his COVID booster, patient developed abdominal pain (primarily right upper quadrant with radiation to back). Was initially treated for suspected constipation without improvement. Presented to the ED on 2/3/22 and was diagnosed with acute pancreatitis. He was admitted to the hospital for IV fluids and pain control with subsequent improvement in his symptoms.
I had my 4th vaccination on 03/03/2022. On 07/14/2022 I started to experience loose stool and diarrhea. I have had it for 8 weeks presently. On 07/15/2022 I started to have a runny nose and scratchy cough. I tested COVID-19 and tested positive. I contacted doctors office and prescribed Plaxovid. I am having an ultra sound 09/07/2022 to see if blocked duct causing the diarrhea and bilirubin.
Soreness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066, 013L20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Pain in knee. Concurrent medical conditions included Drug allergy (Lisinopril) and Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE (HCTZ) for Blood pressure high.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness on the arm). At the time of the report, PAIN IN EXTREMITY (Soreness on the arm) outcome was unknown.            The patient had Steroid injected for pain on the right knee and the brand was Kenalog. Treatment details were not given.   This case was linked to MOD-2022-462888, MOD-2022-462970 (Patient Link).
Patient said she started to experience back pain the evening after her injection. She stated it was severe enough to keep her awake at night. Ibuprofen helped to numb the pain slightly, but it was still there.
Pt arrived today for her Pfizer booster. During the 30 minute monitoring period she stated that her throat was itchy. She was provided some water and monitored. After 10 min past initial monitoring period symptom of itchy throat was not worsening or improving. VS 144/83, pulse 59, 99%.O2 sat. Pt denies difficulty breathing, chest pain/pressure, or shortness of breath. Assessed by MD. Pt was offered Benadryl (oral 25 mg), She agreed to take 12.5 mg Benadryl prior to her trip home given she drove herself. Pt was monitored for additional 20 min and reported that symptoms were not worsening. Pt advised to seek urgent medical care if symptoms worsened when she transferred home.
Patient was given two vaccines roughly around 2:30pm after a physical exam. Patient left office and reported back to our office around 5pm with complaints of vomiting that started 30 mins after she left here, felt like her throat was closing and sweating. At this time, employee examined patient who also complained of ABD pain and it was determined that she should receive epi via Epi pen adult. Epi was given to patients left thigh and EMS was called due to worsening symptoms to include blurry vision and continuing of vomiting. EMS arrive roughly at 5:20 and patient was transported to emergency room for possible allergic reaction. She was given Solu-Medrol by EMS enroute and was reporting dyspnea. She was discharged from the ER few hours later with Benadryl.
Child received a dose of PCV13, Pfizer Inc., H45099. IM/Right deltoid on 8/13/2014 at which time the child was 67 months old (and had no risk factors).
tested positive for Covid this morning after being vaccinated and having 2 booster shots/keep getting it when it isn't preventing it?; tested positive for Covid this morning after being vaccinated and having 2 booster shots/keep getting it when it isn't preventing it?; had a runny nose and "fatigue, with an occasional dry cough, which staffed yesterday evening; had a runny nose and "fatigue, with an occasional dry cough, which staffed yesterday evening; had a runny nose and "fatigue, with an occasional dry cough, which staffed yesterday evening; This case has been considered invalid as Reporter with No First-hand Knowledge.Information received PRD 01Aug2022/SRD 02Aug2022. Measurable supplier - Pfizer colleague. Case was conservatively upgraded as valid as a HCP reporter was added. Reporter #31 and #32 added.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician), Program ID: (001774).  A 79-year-old male patient received BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in Jan2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "brain problem" (unspecified if ongoing), notes: he's had brain problem for a year or two now. The patient's concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious), FATIGUE (non-serious), COUGH (non-serious) all with onset 20Jul2022, outcome "unknown" and all described as "had a runny nose and "fatigue, with an occasional dry cough, which staffed yesterday evening"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022, outcome "unknown" and all described as "tested positive for Covid this morning after being vaccinated and having 2 booster shots/keep getting it when it isn't preventing it?". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2022) Positive, notes: President (name) tested positive for Covid this morning after being vaccinated and having 2 booster shots; (19Jul2022) Negative, notes: had last tested negative on Tuesday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  SUSPECT PRODUCT is under agreement with regulatory authority.
Past Friday 1, site red, swollen, hot painful. past Friday 2, area increased to 10 centimeters.