chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Afib; edema; Muscle Spasm; Burning Sensation from upper extremity to lower extremity; Swelling below her knee; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) and OEDEMA (edema) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criteria hospitalization and medically significant), OEDEMA (edema) (seriousness criterion hospitalization), MUSCLE SPASMS (Muscle Spasm), BURNING SENSATION (Burning Sensation from upper extremity to lower extremity) and PERIPHERAL SWELLING (Swelling below her knee). At the time of the report, ATRIAL FIBRILLATION (Afib), OEDEMA (edema), MUSCLE SPASMS (Muscle Spasm), BURNING SENSATION (Burning Sensation from upper extremity to lower extremity), PERIPHERAL SWELLING (Swelling below her knee) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Concomitant medication information was not provided. Treatment medication information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Patient reported that she was in hospital due to edema and A-fib.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.    Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Case upgraded to serious, new events added, corrected email updated; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Sore Arm and Fatigue Began day after short 4/1/2021 for ONE Day Only
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with the unknown dose of (Oka/Merck) PROQUAD lot number and expiration ate not reported) with unknown therapy route. The reported stated that the administered doses were stored improperly. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
4 Years old  Male with fever x 2 days.  Per father, patient has been feeling unwell.  He had a recorded fever 100 °F at home.  Father mentions that he received 3 vaccinations yesterday.  He is unsure which vaccinations he received.  Symptoms viewed as moderate by parents.  No history of other contacts with same symptoms. No travel overseas. acetaminophen, 300.8 mg 9.4 mL, Oral, every 4 hrs, PRN as needed for pain/fever, X 3 days, # 120 mL, 0 Refill(s), 02/15/23 5:18:00 Pharmacy: pharmacy  "Generic Substitution Permitted", Supply, 20, kg, 02/12/23 4:04:00, Weight Dosing  ibuprofen, 200 mg 10 mL, Oral, every 6 hrs, PRN as needed for pain/fever, X 5 days, # 120 mL, 0 Refill(s), 02/17/23 5:19:00  Pharmacy: pharmacy "Generic Substitution Permitted", Supply, 20, kg, 02/12/23 4:04:00  Weight Dosing  Discharge Patient
REAL ACHY; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced real achy. On MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from real achy, and fever. This report was non-serious.
A spontaneous report was received from physician concerning a 56-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient could not breathe and experienced anaphylactic reaction for which was hospitalized. Treatment for the event included epinephrine. Action taken with mRNA-1273 in response to the event was not provided. At the time of the report, the outcome of the event was recovering. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Stomach ache, headache, fever, exhausted for a week, hallucinations or "crazy" dreaming.
pt recvd vax & 2 days later was found to have antigenemia p/blood donation; 8 wks later Hepatitis B surface antigen test was neg; No further info is available due to confidentialized red cross system;
Patient reports occasional, off and on throbbing in her right arm that did not start until about day 11 after receiving her vaccine. Did not experience any side effects immediately following or within first 10 days of receiving vaccine.
Initial report received from a healthcare professional on 20 Jan 2010: This patient received FLUVIRIN (batch number: unknown), unknown dose, intramuscular on 19 Dec 2009. On an unspecified date, a few hours after vaccination, the patient experienced pain in arm which comes and goes randomly. The outcome of the events was reported as ongoing.
After receiving her flu shot the patient started having left side facial numbness, migraine headaches and right foot numbness.
This spontaneous report as received from a healthcare worker refers to a patients of unknown age and gender. It was reported that COMVAX that was improperly stored since 07-APR-2014 to 22-JUL-2014, was administered to unspecified patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
About 15 minutes after injection patient reporting shortness of breath , difficulty swallowing. throat felt swollen and tingly sensations. On assessment patient clear but diminished breath sounds, thready/weak pulse,  swollen lips , BP 130/80. At 1359 pharmacy gave first dose of Epi in left leg, pt symptoms only mildly improved, then second dose of epi given at 1406. ER rapid response on site to take patient to ER and assume care.
tinnitus; This is a spontaneous report from a contactable nurse (patient). A non-pregnant 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 24Feb2021 at 17:30 (Lot Number: EK9231, unknown expiration) as dose 2, single at the age of 67 years old for COVID-19 immunisation.  The patient medical history was not reported. No COVID prior vaccination and has not been tested for COVID post vaccination.  No other medications in two/four weeks. There were no concomitant medications.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot No: EK9231) on 26Jan2021 at 18:00 in left arm at the age of 67 years old for COVID-19 immunization. The patient previously took codeine and experienced drug allergy. The patient experienced tinnitus in Mar2021, approximately 2 weeks following vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. The physician examined the patient's ears with no signs and symptoms of infection or other cause. The patient received treatment for the event. The patient has not yet recovered from the event. The event was assessed as serious (disability or permanent damage).   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the event "tinnitus" and the suspect drug "BNT162B2" cannot be completely excluded.  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.
memory loss; Brain fog; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207) via an unspecified route of administration in the left arm on an unknown date and month in 2021 as a single dose for COVID-19 immunisation. The patient had not reported any other health issue. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included progesterone (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6203) via an unspecified route of administration in the left arm on 27Feb2021 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced brain fog and memory loss. The patient had a hard time finding words and short-term memory had been affected. The patient does not normally need to make lists or add things to calendar and right now if patient did not do that, patient did not remember at all and could not recall important things for work. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event brain fog and memory loss was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
That swelled up immediately and was very painful; That swelled up immediately and was very painful; This is a spontaneous report received from a contactable consumer (patient herself). A 57-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration, at arm right (at the age of 57-year-old) on 13Mar2021 12:15 as single dose for COVID-19 immunisation. Medical history included: COVID-19 (at New Year but was not tested, spent a few days in bed and was exhausted for all of January). The patient had not tested COVID post vaccination. The patient's concomitant medications were not reported. The patient previously took shingles (Shingrix) as second shot at via an unspecified route of administration at left (at the age of 57-year-old) on 09Feb2021. The patient took some unspecified antibiotics and experienced allergy. The patient had the first Covid shot in right arm. That swelled up immediately and was very painful but started feeling better the next day on an unspecified date in Mar2021. My doctors said she had seen another patient who had a long term reaction to the vaccine like me. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse and refers to a 30-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medication were not reported. On 11-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX injection, lot # M034766, expiration date 26-OCT-2017 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
On 9/18/09 this volunteer for hospital presented with erythema and "tenderness" to her right deltoid, which progressed since receiving seasonal flu vaccine on 9/16/09 at 0930. Denies need for analgesia, full ROM RUE, CSM's adeq RUE. Afebrile. Visible erythema, warm to touch R deltoid area, extends down arm to just above R elbow - exterior only. [TST neg; 0mm; on 9/18/09].
This spontaneous report was received from a healthcare provider and refers to an adult patient of unknown age (reported as over 18-year-old) and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 01-JUN-2017, the patient was vaccinated with VAQTA (route of administration reported as injection, dose and frequency were not provided, lot # M034893, expiration date: 26-MAY-2017). No adverse effect was reported. Additional information has been requested.
21 hours after vaccine she developed a severe headache, dizziness, and light headedness lasting several hours. She also had a few minutes of double vision and belief loss of vision in one eye.
Mother called 6/20/08 with questioning vaccine info from 6/18/08. States pt awoke feeling achy all over and tired, noted low grade temp 99? and pale and nauseated for a day.
Severe shoulder pain. Lack of mobility. It has been 1 month since injection which was very high on shoulder and I believe caused significant injury.  Condition has not improved since injection date. E.R. visits twice and returned to PCP on Feb 2/1/2017.
The patient received expired dose from the lot number 013F21A.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received expired dose from the lot number 013F21A.) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot#013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received expired dose from the lot number 013F21A.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received expired dose from the lot number 013F21A.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.   Health care professional (HCP) mentioned that there was incident because of miscommunication as a coworker said that there were some lot numbers whose expirations dates have been extended. The patient received 2nd Booster expired dose from the lot number 013F21A.  No treatment information was provided.
The patient experienced the following reaction(s) during the immediate   of observation:   1114: 31 y/o  received his first dose of the Moderna vaccine lot # 020B21A in right deltoid.  At 1120 am pt was complaining of feeling light headed, nauseated, diaphoretic.  The patient stated " I feel like I am about to pass out."  Pt was taken to recovery area and vital signs were taken.  Initial vs BP 100/42, P:58, R: 18, 98% Spo2.  Pt no LOC during assessment and while being monitored.  Pt denies any known medical history and no current medications.  NKDA per patient.  1130: BP retaken showing 102/70, P:72, Sp02: 98% R;18.  No change in pt mental status A&O x4.  1145 last set of vital signs taken, pt ambulated prior to vital sign, denies any dizziness.  BP: 118/70 P: 60, R:18, Sp02 98% RA.  Pt advised he was feeling back to baseline prior to vaccine administration.  Pt was monitored for 30 minutes, pt released home.
2.4 hours after immunization, induration to size of egg with pain. 9/25 left upper extremities erythema poorly demarcated, tender. Rx Benadryl and Tylenol and ice.
Muscle pain in the left upper arm after the 2nd dose even though my shot was in the right arm. Adverse effects that started this past summer were nose bleeds which I have never had before, tingling in my arms and numbness in my hands. I have brain fog , weakness and reoccurring pain in my left arm.  Some days I do not feel well and have no energy.  I also got sick with the flu  2 months after the vaccination.
Breakthrough COVID-19 case with symptom onset 9/5/2021: Fever, Aches, Nausea/Vomiting. Hospitalized 9/5/2021 following fall down the stairs. 911 was called as Pt was unresponsive and taken from home address in record to Hosp where she was admitted for possible heart attack. Chest xray was clear.
Had the same thing-losing weight; Could not taste or smell anything; Could not taste or smell anything; dropping my pulse to 41, 40, 42; blood pressure was 100/60 or 90/55; Fever; Inappropriate schedule of vaccine administered; This is a spontaneous report from a non-contactable consumer. This consumer (patient's neighbour) reported for a female patient that a female patient received bnt162b2 (BNT162B2), administration date Apr2020 (Batch/Lot number: unknown) as dose 1, single and administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WEIGHT DECREASED (non-serious), outcome "unknown", described as "Had the same thing-losing weight"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Could not taste or smell anything"; HEART RATE DECREASED (non-serious), outcome "unknown", described as "dropping my pulse to 41, 40, 42"; BLOOD PRESSURE DECREASED (non-serious), outcome "unknown", described as "blood pressure was 100/60 or 90/55"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate schedule of vaccine administered". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CHILLS,SWEATING Narrative: ITCHING FROM TOP OF HEAD TO BOTTOM OF FEET WITH CHILLS AND SWEATING.LASTED 4-5HR
Pt was in clinic for a flu shot, nurse got flu shot out and laid shot on computer. after verifying name and DOB picked up a covid shot off of table where covid shots held and gave covid vaccine. nurse explained to pt that wrong shot was given. Flu shot given in opposite arm. Nurse asked pt if it has been six months since last covid shot , and she said yes. nurse asked for shot record. Pt stated she got her covid shots at a pharmacy and did not have card. nurse asked pt if she had Pfizer or moderna. she stated moderna. nurse filled out the vaccine card with lot number and told pt to keep both cards and let pharmacy know she has had a Pfizer booster. Pt verbalized that she understands.
palpitations; can't breath properly; Patient was crying; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations) and DYSPNOEA (can't breath properly) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016c21a and 036c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced PALPITATIONS (palpitations) (seriousness criteria hospitalization and medically significant), DYSPNOEA (can't breath properly) (seriousness criteria hospitalization and medically significant) and CRYING (Patient was crying). The patient was hospitalized on sometime in September 2021 due to DYSPNOEA and PALPITATIONS. The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of in the hospital. At the time of the report, PALPITATIONS (palpitations), DYSPNOEA (can't breath properly) and CRYING (Patient was crying) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company Comment - This case concerns a 29-year-old female patient with no relevant medical history, who experienced serious, unlisted, events of palpitations and dyspnoea. The event occurred at unknown duration after 2nd dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the 2nd dose of Moderna COVID-19 Vaccine. Event seriousness assessed based on the limited information available, however, more information is expected for further assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 29-year-old female patient with no relevant medical history, who experienced serious, unlisted, events of palpitations and dyspnoea. The event occurred at unknown duration after 2nd dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the 2nd dose of Moderna COVID-19 Vaccine. Event seriousness assessed based on the limited information available, however, more information is expected for further assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.