chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & immed devel swelling @ site of vax;pt devel a lump @ site of vax followed by formation of a pit indentation;the indentation remained @ the date of this report;
Began Kw/pain in the arm after shot. Currently pt. unable to move arm and arm makes clicking sound. Current as of 2/1/2016. MRI scheduled for week of 1/31/2016.
PT RECEIVED PFIZER PEDIATRIC BIVALENT BUT HAD NOT RECEIVED THE PRIMARY SERIES YET (OUTSIDE OF CDC GUIDELINES)
The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes; No adverse event; Adult patients received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Adult patients received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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.   In October 2022, 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. In October 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Adult patients received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Adult patients received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Adult patients received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes).    No concomitant information was reported. It was reported that excursion occurred in refrigerator on 03-Oct-2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes. It was the first time the excursion occurred. It was reported that some of the vials were used and some were discarded. Treatment medications were not provided. This case was reported for patient 7th of 11 adult patients.
Site reaction -> 8 am erythematous, pruritic swelling. No signs of infection. Area tender to palpation. No continuous symptoms.
had both shots and boosters and got Covid and passed away; had both shots and boosters and got Covid and passed away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, medically significant), COVID-19 (death, medically significant), outcome "fatal" and all described as "had both shots and boosters and got Covid and passed away". The patient date of death was unknown. Reported cause of death: "had both shots and boosters and got Covid and passed away". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162B2, BNT162B2 OMI BA.4-5/BNT162B2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: had both shots and boosters and got Covid and passed away; had both shots and boosters and got Covid and passed away
Systemic: Dizziness / Lightheadness-Mild, Systemic: EXTREME THIRST AND PROFUSE OVERALL BODY SEATING-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: GAVE PATIENT GLASS OF WATER AND TURNED ON FAN , HAD PATIENT REMAIN SITTING FOR 30 MINS, REVIEVED SHOT AT AROUND 2:08PM AND COMPLAINED OF SYMPTOMS OUTLINE ABOVE AT 2:15PM. TOOK 1ST BP AT 2:26PM WAS 118/74 PULSE=70, REMAINED SEATED FOR ADDITIONAL 15MINS (TOTAL 30MIN OBERVATION PERIOD) TOOK 2ND BP AT 2:41PM WAS 129/79 PULSE=72, PATIENT OPTED TO LEAVE AND ADVISED PT TO HAVE 24 HR URGENT CARE ON SPEED DIAL IN CASE ANY OTHER SYMPTOMS MAY ARISE AND GAVE PT EUA FACT SHEET WITH SYMPTOMS TO WATCH FOR.
severe nausea and headache followed by 3 episodes of vomiting .  onset 24 hours after vaccine.  Vomiting over period of 15 hours.  Severe body aches, lethargy, no appetite and overall weakness for 2 days .
She also came down with a cold also around that time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 66 years as dose number unknown, single for covid-19 immunisation; The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "She also came down with a cold also around that time". Therapeutic measures were taken as a result of nasopharyngitis. Additional Information: The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. The patient stated that she took her COVID-19 (corona virus disease 2019) shot back in November. The patient ended up flaring because she stopped the medication briefly. The patient also came down with a cold around that time. Subsequently, the patient was prescribed Flonase and an unspecified antibiotic. Treatment for the event nasopharyngitis included Flonase (fluticasone propionate). The outcome of the events condition aggravated and nasopharyngitis was reported as unknown. The causal relationship between the events nasopharyngitis, condition aggravated and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. No follow up attempts are possible. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12/13/05 very tired, coughing, congestion, fever 102 degrees. Biaxin 10 days.
shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.            No treatment was reported. No concomitant medication was reported.
HYPERTENSION (HIGH BLOOD PRESSURE); This spontaneous report received from a pharmacist concerned a 74 year old female of unspecified ethnic origin. The patient's height, and weight were not reported. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported,1 total administered on 14-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-OCT-2021, the patient experienced hypertension (high blood pressure) with blood pressure over 200/100 mmHg and was brought to the emergency room for treatment and was hospitalized for unspecified duration.    The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hypertension (high blood pressure). This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000197924.; Sender's Comments: V0: 20211033134-covid-19 vaccine ad26.cov2.s-Hypertension (high blood pressure). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Within 15 minutes of receiving vaccine patient developed SOB, was put on oxygen initially and O2 sats improved for about 10 minutes until O2 sats began dropping again at which time patient was transitioned to a non-rebreather and given IM epi 0.3mg.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported. On 10-NOV-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K007822, expiration date 15-AUG-2015, dose, strength, vaccination site, route unspecified). The pharmacist stated that, PNEUMOVAX 23 did not have any previous temperature excursions and it was supported with in-house post-expiry data. No adverse symptoms were reported. Product quality complaint (PQC) was not reported. No further information was provided. Additional information has been requested.
TEMPERATURE EXCURSION OCCURRED DUE TO THE PLACEMENT OF HAND WARMERS IN THE INSULATED BAG USED TO TRANSPORT VACCINE. ALL 81 PERSONS RECEIVING VACCINE IN LANES 5 AND 6 AT THE HEALTH DEPT ON 02/15/2021 BETWEEN 14:00 and 16:45 WERE NOTIFIED THEY  RECEIVED VACCINE THAT WAS OUTSIDE OF THE APPROPRIATE TEMPERATURE RANGE AND WERE RECOMMENDED TO BE REVACCINATED.
This spontaneous report was received from a medical assistant and refers to a 4 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 04-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). Then, on 04-APR-2016, the patient was revaccinated with another improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
5 weeks of Tinnitus \ ear ringing \ ear cracking; ear pressure; head pressure; mild headaches in different parts of the head; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (5 weeks of Tinnitus \ ear ringing \ ear cracking), EAR DISCOMFORT (ear pressure), HEAD DISCOMFORT (head pressure) and HEADACHE (mild headaches in different parts of the head) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced EAR DISCOMFORT (ear pressure), HEAD DISCOMFORT (head pressure) and HEADACHE (mild headaches in different parts of the head). On 24-Apr-2021, the patient experienced TINNITUS (5 weeks of Tinnitus \ ear ringing \ ear cracking). At the time of the report, TINNITUS (5 weeks of Tinnitus \ ear ringing \ ear cracking), EAR DISCOMFORT (ear pressure), HEAD DISCOMFORT (head pressure) and HEADACHE (mild headaches in different parts of the head) outcome was unknown.        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.   No concomitant medication was reported. The treatment information was unknown.   This case was linked to MOD21-106101, MOD21-106102 (E2B Linked Report).; Sender's Comments:  MOD21-106101: MOD21-106102:
Patient was looking nervous while waiting to receive vaccine. She moved to a different chair after she got a shot, lifted her arm, and fell off the chair. She hit her head. She was able to understand what we were asking her but unable to clearly answer. She said she would like some water, but did not drink. She also said she felt like throwing up. First aid responders came after a few minutes and took her to the hospital.
Pre-existing condition of kidney failure; Pre-existing conditions of heart failure; Skin rash; A spontaneous report  was received from a 63-year-old male, consumer who received Moderna Covid-19 Vaccine (mRNA-1273) and who experienced pre-existing conditions of heart failure / cardiac failure and kidney failure / renal failure.  The patient's medical history, as provided by the reporter, included preexisting conditions of heart failure and kidney failure. No relevant concomitants were reported.   On unk Feb 2021 (during the first week of February), prior to onset of symptoms, the patient received their first dose of two planned doses of mRNA-1273 (Lot number 026L20A) intramuscularly in the right arm for the prophylaxis of Covid-19 infection.   On unknown date, the patient experienced a rash, but no other reaction. He reported taking no other medication when he had  received his first dose.   On 17 Feb 2021, the patient was hospitalized for his pre-existing conditions of heart failure and kidney failure. He was discharged on 21 Feb 2021. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, rash, pre-existing heart failure and kidney failure red, were not reported.; Reporter's Comments: Based on reporter's causality the serious events kidney failure and heart failure are assessed as unlikely related to mRNA-1273 but possibly related to the consumer's pre-existing conditions of renal failure and cardiac failure, while the non-serious event of rash may be possibly related to mRNA-1273.
Information has been received from an unknown age female consumer referring to himself. Information regarding concurrent condition and medical history was not reported. On 12-FEB-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# not reported). Concomitant therapy was not reported. On an unknown date in 2015, after receiving ZOSTAVAX, the patient experienced numbness, tingling and pain at the injection site, to the tip of her fingers. The patient visited physician office. The outcome of the events was reported as not recovered. Additional information is not expected because no demographics were provided for the patient or physician.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a 72-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received at the age of 65 year without adverse events), Flu vaccine with an associated reaction of pain in extremity and Pneumonia Vaccine with an associated reaction of pain in extremity (experienced arm soreness after receiving Flu vaccine and Pneumonia vaccine, refer case US2018GSK070403). Concomitant products included Atorvastatin, Baby Aspirin, Calcium D, CLARITIN, FLONASE, Losartan, omeprazole, SINGULAIR, ZANTAC, Tumeric. On 12th April 2018, the patient received the 1st dose of SHINGRIX. On 12th April 2018, 7 hrs after receiving SHINGRIX, the patient experienced sickened, sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, leg cramps, abnormal dreams, fear, dizziness and fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the sickness, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, leg cramps, abnormal dreams, fear, dizziness and fever were recovered/resolved and the outcome of the sweating and exhaustion were not recovered/not resolved and the outcome of the headache and neck pain were recovering/resolving. The reporter considered the sickness, sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, abnormal dreams, dizziness and fever to be related to SHINGRIX. The reporter considered the leg cramps and fear to be unlikely related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. On 12th April 2018 at 16:00, the patient received SHINGRIX in the left arm. The patient did not have lot and expiration date of vaccine, the dose or how given other than it was an injection. By 23:00, 7 hours after receiving SHINGRIX, the patient was sick. Less than a day after receiving SHINGRIX, the patient experienced sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, leg cramps, abnormal dreams, fear, dizziness and fever. The patient was waking up having to go to the bathroom with urgency. The patient slept till 12:00 on the day of reporting (13th April 2018) and she was so exhausted. The patient took TYLENOL for the headache and neck pain. The patient was scared of what she was experiencing because she lived alone. Most of the issues from last evening have resolved with just a few lingering symptoms but improvement of the headache and neck ache after TYLENOL was taken. The patient described the hallucination dreams as recurring dreams throughout the night of the same thing. She had been hydrating with juice and teas. The patient was encouraged to discuss the events with her physician. The prescribing information was reviewed for the common side effects reported.
12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have  caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures .
12 hours after flu vaccine, developed weakness in legs-unable to stand pt fell-transported to ER-admitted to ER. Symptoms resolved-discharged 10/29.
This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 17-MAR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 144 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Left arm falls asleep randomly; Bad burning sensation wakes me up in the middle of the night; Bad burning sensation wakes me up in the middle of the night; Still sore when I touch the spot of the injection; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10May2021 16:00 (Lot number: EW0176) at the age of 22 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose dose number=1, dose product=COVID 19, dose brand=Pfizer, dose lot number=EW0161, dose administration date=19Apr2021, dose administration time=04:00 PM, dose vaccine location=Left arm), administration date: 19Apr2021, when the patient was 22 years old, for Covid-19 immunization. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 16Jun2021 21:30, outcome "unknown", described as "Left arm falls asleep randomly"; BURNING SENSATION (non-serious), INSOMNIA (non-serious) all with onset 16Jun2021 21:30, outcome "not recovered" and all described as "Bad burning sensation wakes me up in the middle of the night"; VACCINATION SITE PAIN (non-serious) with onset 16Jun2021 21:30, outcome "unknown", described as "Still sore when I touch the spot of the injection". Therapeutic measures were not taken as a result of limb discomfort, vaccination site pain. Therapeutic measures were taken as a result of burning sensation, insomnia.  Additional Information: No other vaccine in four weeks. Other medications in two weeks was Birth control. No Covid prior vaccination. Covid was not tested post vaccination. Had no known allergies.   No follow-up attempts are possible. No further information is expected.
Received MMR, varicella, DTap, influenza vaccine 10/16/07.  Fever above 101 10/23-10/25.  Developed a classic febrile seizure 10/25.  Seen in ED 10/25/07.
Extreme fatigue and soreness in my right arm came on within a few hours of the Tdap Vaccine. I got the shot on Monday, June 3rd. It is now June 5th and I've had high fever and chills each day. Horrible headache. And I woke up this morning with a painful sore on the bottom left of my tongue. My arm has swollen to the size of a egg (upper arm only). My fever is typically 101.8 and Advil lowers it to 100. I am still waiting to feel better. My body feels achy and it hurts to raise my head. Prior to the shot, I felt absolutely fine and energetic.
Received covid vaccine #2 left deltoid yesterday ~ 9:40 am. Last evening she developed a feeling of  numbness from injection site traveling down into her left thumb and fingers... "faintly feels like it's sleeping" denies discoloration, coolness to touch or difficulty with movement. Had slight localized reaction at injection site.
Client received a dose of Janssen as requested today. Had been given 2 doses of covid vaccine prior to today even (1/19/2021 & 2/18/2021 Moderna)  though reported no previous covid vaccinations. Denied any adverse reaction at this time
Severe pain at injection site starting 8 hours after injection. Still very painful 24 hours later. 3/10 with movement and 6/10 to touch.  Nausea and Diarrhea 17 hours after injection. Resolved 36 hours after injection.