chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt hurt in the right arm and lasted for less than a day.; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (felt hurt in the right arm and lasted for less than a day.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol, Anxiety, Blood pressure, GERD, Thyroid disorder and Sexual dysfunction. Concomitant products included ATORVASTATIN, LORAZEPAM (ATIVAN), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), LOSARTAN, AMLODIPINE, ASA, OMEPRAZOLE, LEVOTHYROXINE SODIUM (SYNTHROID) and TADALAFIL (CIALIS) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (felt hurt in the right arm and lasted for less than a day.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (felt hurt in the right arm and lasted for less than a day.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-077876 (E2B Linked Report).; Sender's Comments:  MOD-2021-077876:second dose
Vaccination site erythema; 3 inch square below injection site which was really red, swollen and tender to touch and gradually; (square) tender to touch and gradually spread to elbow at shoulder; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (3 inch square below injection site which was really red, swollen and tender to touch and gradually) and VACCINATION SITE PAIN ((square) tender to touch and gradually spread to elbow at shoulder) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event (No medical history reported) since an unknown date.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (3 inch square below injection site which was really red, swollen and tender to touch and gradually) and VACCINATION SITE PAIN ((square) tender to touch and gradually spread to elbow at shoulder). On 29-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (3 inch square below injection site which was really red, swollen and tender to touch and gradually) and VACCINATION SITE PAIN ((square) tender to touch and gradually spread to elbow at shoulder) had resolved.            Treatment for the events included paracetamol, Benadryl.    Reporter did not allow further contact
This spontaneous report was received from a nurse practitioner refers to a 33 years old patient who on 03-SEP-2012, was vaccinated subcutaneously with a dose of MMR II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
So it started 10/22/2021 in the AM, the symptoms started the numbness and tingling  in my hands, finger tips, and feet  a little for getting things, anxiety and fatigued. It feels like internal shock on the inside of my body. It's kind of difficult to explain but that's the best I can say. It comes and goes throughout the day. I am still experiencing it today 12/08/2021. Sometimes, I can be walking and I get that feeling and it completely brings me to a halt. It takes me a moment to gather myself. I have to at times, sit down or if I am able, I have to grab hold to something to catch my balance. Since take the vaccine, my memory isn't sharp anymore, I forget a lot of things. I never had this problem before taking the vaccine. It has taken a toll on me and my family. I have had to take off work for some days because of this. These symptoms that I am having has taken away financially as well. My doctor, now want me to see a neurologist. Just waiting on the referral.
about three days aftr the vaccine I had a bmp forming on the right arm and it was starting to hurt.  It is still there and no one can tell me why or what is causing it.
rotator cuff, tendinitis, shot was given to high on shoulder, extreme pain, couldn't raise arm;
I tested positive for Covid-19 on March 11, 2023 I experienced congestion, coughing, and I was taking ibuprofen for my symptoms and I was also prescribed cetirizine for my congestion and I was using FLONASE as well for the stuffy nose.
PHYSICALLY ILL; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer concerned a 53 year old female. The patient's weight was 78.47 kilograms, and height was 160 centimeters. The patient's concurrent conditions included: bacterial vaginosis, and drug allergy (Patient was allergic to generics of Flagyl. Generic gel makes her sick). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer, dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. Non-company suspect drugs included: metronidazole (tablet, oral, batch number: unknown, expiry: unknown) dose, frequency, and therapy dates were not reported, and (gel, route of admin was not reported, batch number: 150405 expiry: FEB-2023) dose, frequency, and therapy dates were not reported for bacterial vaginosis. No concomitant medications were reported.  On an unspecified date in JUN-2022, the patient contracted covid-19 infection (suspected covid-19 infection) (dose number in series 2) and she didn't get to the doctor until AUG-2022. Then she got her prescription. She told her doctor every time she took Metronidazole that made her physically ill (dose number in series 2). Patient went to urgent care after she could not get prescription and she was given another prescription and she was given the Metronidazole gel. She said it had been a long time since she took the pills and she only had the gel. She took one or two application and made her really sick and she discontinued. She only had rest of one gel and she only took one tube of it and the next day she noticed she was sick again and she didn't think something not taken by mouth would make her sick and she was surprised. She was given the Metronidazole gel and she thought because of gel instead of pill and would not cause allergic reaction and she was wrong. She was taking generic for a couple of years without incident and all of a sudden she became allergic. Three months since she had covid and now she can have a booster and the doctor said wait 3 months and she will get the Bivalent booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with metronidazole was not reported. The outcome of the suspected covid-19 infection and physically ill was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Case number PHEH2016US026128, is an initial spontaneous report received from a pharmacist on 06 Oct 2016. This report refers to a male patient. Historical condition was not reported. Current condition included neomycin allergy. Concomitant medication was not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number not reported) at a dose of 0.5 ml intramuscular in the last season 2015-2016. The patient had muscle ache for a couple of months. The outcome of the event was complete recovery. Seriousness of the event was not reported. Causality was reported as suspected.
short term memory loss; Sore arm; feeling very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (short term memory loss), PAIN IN EXTREMITY (Sore arm) and FATIGUE (feeling very fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006m20A and 016B21A) for COVID-19 vaccination.     Patient medical history were not provided.  Concurrent medical conditions included Drug allergy. Concomitant products included COLECALCIFEROL (VIT D3), KRILL OIL and ASCORBIC ACID (VIT C) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (feeling very fatigued). On an unknown date, the patient experienced AMNESIA (short term memory loss). At the time of the report, AMNESIA (short term memory loss) outcome was unknown and PAIN IN EXTREMITY (Sore arm) and FATIGUE (feeling very fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Magnetic resonance imaging head: normal (normal) pretty normal.         Patient reported that few weeks after receiving the vaccine patient was feeling very fatigued. Weak legs and arms. Patient wasTotally not herself. This continued for a couple months and as of the end of July patient noticed her energy coming back. Not completely but better than before. She started going back over the months trying to figure out why she felt this way. She also was very fuzzy headed for the duration of time frame above. Patient couldn't concentrate and read as she could not get her thoughts together. She was even uncomfortable driving because of this. As per patient only thing that stood out that could have caused this was the vaccine. Her Dr even ordered and MRI of my brain which showed pretty normal. She do not know for certain what caused this except the Moderna vaccine was the only thing different that she did and it started after this. Patient stated feeling better and thoughts and focus have returned to almost normal. Patient also takes ginger capsules as concomitant medications. No treatment medication information was provided. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) was Not applicable   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow-up Patient details (gender, race, allergy added), suspect dosage details (dose1 and dose 2, vaccine facility details added), concomitant medications and events added.
(Wrong) pediatric dose Hep A given to 19 yo. Revaccinated same day with appropriate dosage. Adult Hep A.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 12:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 55.39 years.  Concomitant products were not provided.  Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit at 10 AM. Total 150 doses were given for the day. Vials were not frozen. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021. 15 vials were sent to clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient was scheduled to receive 2nd dose of Pfizer.  Patient received Moderna, Lot number 047B21A, Expiration Date 10/09/21.  Nurse failed to verify type of vaccine with the patient, failed to verify CDC card, and with scribe prior to administration.  Scribe was in the process of verifying the type of vaccine in Drive-Thru, scribe tried to input lot number into Drive-Thru, lot number failed to register, scribe turned around to inform the Nurse, Nurse had already administered the vaccine.   Nurse explained the medication error to the patient.  Patient displayed minimal concern about the error.  Nurse recommended for the patient to stay in observation for 30 minutes.  Patient refused.  No adverse effects from the incident.
On 21 Oct 2023, vaccination, his blood pressure went up to 125/83 again on 1Nov2023 it is 132/83; This spontaneous case was reported by a patient and describes the occurrence of BLOOD PRESSURE ABNORMAL (On 21 Oct 2023, vaccination, his blood pressure went up to 125/83 again on 1Nov2023 it is 132/83) in a 63-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 21-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced BLOOD PRESSURE ABNORMAL (On 21 Oct 2023, vaccination, his blood pressure went up to 125/83 again on 1Nov2023 it is 132/83). At the time of the report, BLOOD PRESSURE ABNORMAL (On 21 Oct 2023, vaccination, his blood pressure went up to 125/83 again on 1Nov2023 it is 132/83) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Oct-2023, Blood pressure measurement: 125/83. On 01-Nov-2023, Blood pressure measurement: 132/83.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication and treatment medication were not provided.  Patient states that he received Spikevax on 20OCT2023. His blood pressure is normally at 112-114 over 70. One day after vaccination, his blood pressure went up to 125/83. He checked it again today, 01NOV2023, and it is 132/83. He states that he did not have Myocarditis / Pericarditis symptoms.
A report has been received from a Health Professional concerning unknown number of patients with unknown gender, who received Nasal FLUMIST Quadrivalent, 0.2 milliliters. Once/Single administration. It was reported the patients may have received FLUMIST Quadrivalent during temperature excursion/one patient receive FLUMIST after a temperature excursion which started on 01-DEC-2015. The outcome of the event of patients may have received FLUMIST Quadrivalent during temperature excursion/one patient receive FLUMIST after a temperature excursion is unknown. The report was considered to be non-serious by the company physician.
This spontaneous report was received from an external source (reported as an executive) via company representative referring to a 50 year old female patient. The patient's concurrent conditions and medical history were not provided. On 02-JUN-2016, the patient was vaccinated with ZOSTAVAX (Lot # L046893, expiration date was not reported) dose reported as "19400 PFU", subcutaneous injection. There was not concomitant medication reported. Approximately in 04-JUN-2016 (also reported as "within two days") the patient experienced full blown chickenpox on her trunk. The patient sought for medical attention visiting the physician's office. At time of the report the outcome of varicella was unknown. Additional information has been requested.
ACTHIB was included in an excursion and was not viable anymore but it was administered to a patient before it was pulled out (with no reported adverse event); Initial information received on 05-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves acthib that was included in an excursion and was not viable anymore but it was administered to a 2 months old and unknown gender patient before it was pulled out (with no reported adverse event)   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), pertussis vaccine acellular 3-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid (Pediarix); pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13); and rotavirus vaccine LIVE ORAL 1V (Rotarix) for Prophylactic vaccination.  On 05-Sep-2023, the patient received a dose 1, 0.5 ml of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection lot UJ835AA, expiry- 22-Feb-2024 via intramuscular route in the right thigh for Immunization, acthib was included in an excursion and was not viable anymore but it was administered to a patient before it was pulled out (with no reported adverse event) (poor quality product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
irregular heartbeat; This is a spontaneous report from a contactable consumer or other non-hcp (patient himself). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date in Mar2021 (Lot number and Expiry date was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient previously received bnt162b2 dose 1 via an unspecified route of administration on unspecified date in Feb2021. The patient's concomitant medications were not reported. The patient experienced irregular heartbeat on an unspecified date. The patient underwent lab tests and procedures which included heart rate: irregular. The outcome of the event was unknown.
after the second dose he went to see his doctor and he was palpitating and this was thought to be caused by a stress response; had trouble sleeping; very fatigued/ really fatigued; vomiting; a drastic increase in eye floaters/a huge increase in eye floaters; but I have been like falling asleep really early and then like popping awake really early.; dry heaving; I was 180, but I lost 10 pounds during all this I am 170 right now; appetite is still poor; This is a spontaneous report from a contactable consumer (patient). This 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 06Apr2021 (Lot number: ER8737), as single dose, at the age of 30 years, in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On an unknown date after second dose of vaccine patient experienced palpitating and this was thought to be caused by a stress response, had trouble sleeping, very fatigued/ really fatigued, vomiting every couple days, a drastic increase in eye floaters/a huge increase in eye floaters, patient falling asleep really early and then like popping awake really early, dry heaving, patient was 180, but now lost 10 pounds during all this and 170 right now and appetite is still poor. The events were considered as non-serious. Patient was taking Propranolol for the heart palpitation. On an unknown date patient undergone tests which includes Electrocardiogram (EKG), chest scan and had a full panel blood work results of all were unknown. The outcome of all the events was unknown.   No follow-up attempts needed. No further information is expected.