chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea for 2 weeks after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea for 2 weeks after the booster dose) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-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 DIARRHOEA (Diarrhea for 2 weeks after the booster dose). At the time of the report, DIARRHOEA (Diarrhea for 2 weeks after the booster dose) had resolved.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Information was received from a licensed practical nurse who reported that an unspecified patient was administered improperly stored M-M-R II lot #M039904, expiration date 26-SEP-2018, (dose and route of administration not provided) reconstituted with properly stored sterile diluent (MSD) on 04-MAY-2017. No adverse effects reported.  Temperature: 9°C to 25°C Time frame: 3 hours Previous temperature excursion: Yes, 11.4°C for 17 hours on 17-APR-2017; 16°C for 3 hours on 01-MAY-2017. Data logger involved: Yes This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA000340: US-009507513-1705USA006221: US-009507513-1706USA000339: US-009507513-1706USA001007: US-009507513-1706USA000343: US-009507513-1706USA000342:
Client received 0.5 ml dose as booster dose instead of 0.25 ml dose of Moderna on Friday 11/19.
Developed PMR; negative effect; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events( vaccination complication i.e., polymyalgia rheumatica) list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  on unknown date, prior to the onset of the events, the patient received mRNA vaccine for prophylaxis of COVID-19 infection.  on unknown date, the patient experienced the events list (polymyalgia rheumatica) with seriousness criteria.  Laboratory details are not provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
When the event happened I got this feeling to where I cant focus or concentrate on my thoughts. I feel like I almost had tunnel vision. I feel like I am going to pass out. I have to take a minute to stop and take deep breaths. The episodes passes pretty quickly. That happened 5 or 6 times over 5 or 6 months. On December 10, 2021, the same thing happened. I tried to fight coming out of one of my episodes, but then I actually ended up passing out on the floor for a couple of minutes. I never called a doctor until that day when I passed out. That's when I called my doctor and started having things looked at. When my doctor found out I had sinus tachycardia they told me not to be worried about it, but it could be what's triggering these episodes I am having. The doctor wants to make sure that nothing is going on neurologically so I am seeing a neurologist. My baby's estimated due date was September 2, 2021, but I had her early. She was 6 lbs. 1oz. This is my 2nd child.
The same day of vaccine I was sore and having body aches. The next day I woke up at 2:00 am with a bad headache took a Motrin and went back to sleep. Woke up the a few hours later and went to work and headache came back so I kept taking Motrin until I got off. When I got home I was tired and my headache came back so I went to lay down because I was cold as well. I went to bed and woke up really cold and my husband came in to check on me and I was running a fever of 101.5. My body was hurting really bad as well I took another Motrin and went back to sleep. I woke up the next morning a little weak with a fever blister. I was still sore and has a headache as well. I took some more Motrin all day and the pain went away. I didn?t report to any doctor because I thought this may be normal.
stiffness; sore arm; sore shoulder; fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (sore shoulder) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (sore shoulder) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (sore shoulder) and PYREXIA (fever) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-275254.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up document received. .Second dose case created. Action taken updated.
This spontaneous report was received from a pharmacist refers to a 72 year old male patient. The patient's relevant medical history, concomitant medications and past drug history are unknown. On 21-JUN-2013 11:30, the patient was vaccinated with a dose of ZOSTAVAX (lot # H018092,expiry:04-JAN-2014) 0.65 ml, subcutaneously. On 22-JUN-2013, the patient called the pharmacist and complained of swelling and red and blue discoloration at the injection site in the left upper arm that started on an unknown date in June 2013. The pharmacist did not know when the swelling and discoloration started. There was no relevant laboratory data. The pharmacist will have the patient come to the pharmacy to examine the site. As of 22-JUN-2013, the patient has discontinued use of ZOSTAVAX  and continues to experience swelling and red and blue discoloration at the injection site. Additional information has been requested.
This case was reported by a nurse and described the occurrence of not responding to therapy in a subject (s) of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline).  On unspecified dates, the subject (s) received TWINRIX series (unknown).  At an unspecified time after vaccinations with TWINRIX, the subject (s) experienced not responding to therapy.  The nurse reported that they are seeing a trend, she estimated 6 or less subjects at their clinic, that get the TWINRIX series and are positive for antibodies initially and then a couple of years later when tested they have negative antibody titers.  The nurse stated that they do not know why the titers are negative and they do not known whether this is related to the TWINRIX or not.  The TWINRIX series is repeated in the subjects.  At the time of the reporting, there was no further information about the subjects.  At the time of reporting, the outcome of the event was unspecified.
dizziness - pt was given applesauce, cold compress and water.  - able to walk on own accord 30 minutes later
Patient never got 3rd dose; Dose 1 04/26 2018, Dose 2 09/13/2019.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 26th April 2018).   On 13th September 2019, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 13th September 2019, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for 3rd dose of vaccine. The registered pharmacist reported that patient received Twinrix at a different facility and both the first and second doses were off schedule. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. No information of the vaccine was available. The reporter asked whether there was need to repeat series or patient can receive only 3rd dose. The reporter consented to follow up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sleep apnea w" (unspecified if ongoing), notes: sleep apnea w/CPAP. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (vaccine lot number=FF8839, vaccine dose number=3, vaccine location=Left arm), administration date: 08Dec2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (vaccine lot number=EI3302, vaccine dose number=2, vaccine location=Left arm), administration date: 22Apr2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (vaccine lot number=EN5318, vaccine dose number=1, vaccine location=Left arm), administration date: 29Mar2021, when the patient was 61-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jun2022, outcome "recovering" and all described as "Treatment of COVID-19";. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.
On or about 3/20/2021 I noticed a small red spot on my upper left arm. It was itchy and about the size of a quarter. I thought it was an insect/mosquito bite. It was not continuously itchy, only about 4 times per day.  A couple of day later it was a little bigger and becoming slight raised around the outer edge. It was irregular in shape and only itching about 4 times per day. On 3/26/2021, it was noticeably bigger. I looked up the possible reactions to the Moderna vaccine, and saw that the area on my arm now matched what they described as ?delayed cutaneous hypersensitivity?. My husband said to report it as a reaction.
This spontaneous report as received from a physician refers to an unknown number of unspecified patients (information about the patients' gender and age was not reported). Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On unknown dates in 2016 (reported as starting in February 2016), the patient were vaccinated with improperly stored RECOMBIVAX HB (lot # L048849, expiration date: 04-FEB-2018; lot # L048236, expiration date: 31-MAR-2018; doses and routes of administration were not reported). The vaccine was stored at 51 degrees Fahrenheit for a time frame of 126 hours and 34.3 degrees Fahrenheit for a time frame of 19.94 days. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint was not filed. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of somnolence and severe fatigue in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19  vaccine) for COVID-19 immunization. No medical history reported. On Mar 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 22, 2021, patient experienced somnolence and severe fatigue. On Mar 29, 2021, severe fatigue resolved. At the time of the report, somnolence resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
The day following my vaccine, I had bad stomach cramps, which subsided by the following morning. Two days later, and for the past 2 months, I have had CFS -- Chronic Fatigue Syndrome.  I had CFS for a 2 year period -- but this was over 30  years ago.    Because of this, I am afraid to get my second dose.
Pt c/o severe redness, swelling, heat, and inability to fully move arm for about 5 days.
had a heart attack after first dose of COVID 19 vaccine and was treated at hospital; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: had COVID really bad 4 months earlier and then got the vaccine four months. The patient's concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, life-threatening)), outcome "unknown", described as "had a heart attack after first dose of COVID 19 vaccine and was treated at hospital".  Additional Information: Age was reported as "just below 40".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug cannot be excluded and are Related to the suspected drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pregnant patient had the exposure to MENACTRA with no reported adverse event; Initial information was received on 21-Dec-2021 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 17 years old female patient who was pregnant and had the exposure to menactra and meningitis b vaccine with no reported adverse event while being treated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGITIS B VACCINE Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient had the exposure to MENACTRA and MENINGITIS B VACCINE with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past vaccination(s) included MENB in 2015. The patient's past medical history, medical treatment(s) and family history were not provided. The patient had <<XX>> previous pregnancy/ies.   On 21-Dec-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength and formulation: unknown) at the dose of  0.5 ml (once) via route intramuscular (batch number: U69528A, expiry date: unknown) in unknown administration site for prophylactic vaccination.  On 21-Dec-2021, the patient received a dose of suspect MENINGITIS B VACCINE not produced by Sanofi Pasteur (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.   On 21-DEC-2021 the patient developed a non-serious event "pregnant patient had the exposure to menactra and meningitis b vaccine with no reported adverse event" (exposure during pregnancy) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and MENINGITIS B VACCINE  Action taken: applicable.  At time of reporting, the outcome was Unknown for the event pregnant patient had the exposure to menactra and meningitis b vaccine with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot number N022015 with expiration date on 10-MAR-2019 (strength and dose number were not provided), for prophylaxis. The ROTATEQ was stored at a temperature range of 47 degrees Fahrenheit (°F) to 77 °F (55°F), for a time frame of 30 hours and 43 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1808USA002487: US-009507513-1808USA002488: US-009507513-1808USA002490: US-009507513-1808USA002491: US-009507513-1808USA002453.
36 AFTER INJECTION - LEFT SIdE OF body NUMb - Including NOSE AND CHEEK. CALLED DR. 12 HOURS LATER - SAId TO go TO EMERGENCY ROOM
Pt. became flushed, light headed, and felt like he was going to faint. Blood pressure was measured and was low. Pt. ate a snack, drank some orange juice, had a fan blowing on him, and rested in the pharmacy before leaving.
Only continued reactions have been from 1st dose my left arm is sore and hard to raise my arm.  It pops when I move it around it is painful and just sore.  After a few days became weeks I was concerned, but not knowing how long it should last I didn't ask my physician till today 3/10/2021 I just wanted to know if there are any solutions or if someone knows the duration it should last my 2nd dose was on the 3rd and that arm the right arm only  hurt for a few days.
pt recv vax & devel a gen pruritic rash p/vax;pt has recovered;this is one of two pt from this site;
This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. This pharmacist reported for his son. A male patient of unknown age and ethnicity received, on an unspecified date, TRUMENBA single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced high fever and his arm went limp. Clinical outcome was unknown at this time of this report.
The night of vaccine donor c/o muscle aches on injection site. Woke up the next day w/immediate headache and nausea (0800). 2 hrs. later started vomiting and diarrhea. Visit a health clinic soon after; Dr stated she's having normal s/s of vaccination. Prescribed OTC TYLENOL and cough syrup. Donor stated continuing vomiting approx. x 3 times and diarrhea throughout the day (12 hrs). Woke up next day no s/s.
This spontaneous report as received from a doctor of pharmacy refers to a 62 years old male patient with no pertinent medical history and no drug reactions or allergies, who on 20-JUL-2012, was vaccinated with a dose of ZOSTAVAX (lot number /0257AE, Exp. Date: 13-MAR-2015) (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that on 25-JUL-2012, the patient developed a head cold following vaccination with ZOSTAVAX. The head cold was described as a stuffy runny nose with a possible fever. No lab diagnostics studies were performed. No treatment was given for the experience. At the time of the report, the patient had not recovered. The patient sought medical attention by contacting the pharmacist. The relatedness for patient developed a head cold described as a stuffy runny nose and possible fever was unknown for ZOSTAVAX. Additional information has been requested.
Flushing; trouble breathing; headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing), DYSPNOEA (trouble breathing), BODY TEMPERATURE INCREASED (temperature around 99) and HEADACHE (headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Fracture vertebral. Concurrent medical conditions included COPD and Arthritis. Concomitant products included CARVEDILOL (COREG), CLOPIDOGREL BISULFATE (PLAVIX), OXYBUTYNIN HYDROCHLORIDE (DITROPAN), TIZANIDINE, LISINOPRIL, DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE [DICYCLOVERINE HYDROCHLORIDE]), VITAMIN B12 [VITAMIN B12 NOS], GABAPENTIN, OLANZAPINE (ZOLAPINE), ALBUTEROL [SALBUTAMOL], ASPIRIN [ACETYLSALICYLIC ACID], OXYCODONE, HYDROCODONE and MONTELUKAST for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced FLUSHING (Flushing), DYSPNOEA (trouble breathing), BODY TEMPERATURE INCREASED (temperature around 99) and HEADACHE (headache). On 08-Mar-2021, FLUSHING (Flushing), DYSPNOEA (trouble breathing), BODY TEMPERATURE INCREASED (temperature around 99) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Moderna COVID vaccines received on 02/02/2021 and 03/02/2021 Hospitalized at Hospital on 10/23/2021 Diagnosis of Acute Respiratory Failure, Acute GI bleed, COPD, Atrial Fibrillation with rapid ventricular response, COVID 19 pneumonia, DM II in Obesity, Pulmonary nodule Treatment included: Supplemental Oxygen, CT scan, Labs, Decadron, ceftriaxone, azithromycin, hospitalization Moderna Booster received on 12/7/2021 after the adverse event of 10/23/2021