chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe hip and lower back painactually started after the 2nd dose; Severe hip and lower back painactually started after the 2nd dose; This is a spontaneous report from contactable female consumer (patient) reported for herself. A 62-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EK9231), dose 2 intramuscularly, administered in Deltoid Left on 12Jan2021 14:00 (age at the time of vaccination was 62-year-old) as dose 2, single for COVID-19 immunization. Medical history included ongoing diabetes mellitus, ongoing hyperlipidaemia, ongoing hypertension. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EJ1685), dose 1 via an unspecified route of administration, administered in Arm Left on 22Dec2020 02:00 PM (age at the time of vaccination was 62-year-old) as dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that the patient experienced severe hip and lower back pain actually started after the second dose on 14Jan2021 and was unable to get relief from going to the Chiropractor. She had been seeking care with a chiropractor. Outcome of both the events was reported as recovering at this time of the report.  Device Date : 04Oct2021  Follow-up attempts are completed. No further information is expected.
Vaccine administrator accidentally only gave the diluent portion of the vaccine, resulting in no active ingredient being administered.
Arm hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and since then her arm hurts. No further information was provided.
12 hours after vaccine, near syncope episode, severe muscle aches and chills,severe vomiting low grade fever100.2, unable to sit up for 12 hours without almost fainting or having to vomit
Couldn't raise right arm, was so weak had to use assistant to get up, severe weakness and tiredness, severe right sided chest pain through right shoulder
Rapid heartbeat that lasted one (1) minute +/-. Slight swelling in throat for maybe 45 minutes +/-. Was able to breathe fine.
Patient had a fever, redness and swelling at the injection site reported on 10/31/19, patient went to MD and he diagnosed cellulitis
My side effects were intense.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (My side effects were intense.) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (My side effects were intense.). At the time of the report, VACCINATION COMPLICATION (My side effects were intense.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information was not provided by the reporter.
Within 72 hours of receiving the vaccine, I began experiencing itchiness in random locations on my body.  However, it was intermittent and not too severe - initially.   The itchy rash would pop up and subside, until Weds May 26th.  In the middle of that  night (5/26) I awoke with the most severe itching and discomfort that I've ever experienced, and it was in spots across my arms, legs, abdomen, inner thighs, underarms, soles of feet, wrists, and elsewhere.   The next morning (Thursday 5/27) I began calling dermatology offices and clinics hoping to secure a Doctor's appointment ASAP to get a diagnosis and hopefully some relief.  I was able to secure an appointment at Immediate Care for later that morning.  At that time I received a steroid shot in my arm, and began a cycle of Prednisone to address the rash.  It persisted and was very uncomfortable for the following three days, but thankfully began to subside due to the steroids by Monday 5/31.  I would like to stress that I've had no known allergies in my life, and that this was the most extreme rash and itching I've ever experienced.  If I had it to do over again, I would not get the vaccine.
Covid toes on both feet started 1 month post vaccination; redness; blisters on first 3 toes of each feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jul2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: EW0185, Prev dose lot unknown: False, Prev dose administration date: 08Sep2021, Prev dose administration time: 05:45 PM, Prev dose dose number: 3), administration date: 08Sep2021, when the patient was 74-year-old, for COVID-19 immunization; Covid-19 vaccine (Primary immunization series complete; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 25Aug2022 at 22:30, outcome "recovered", described as "Covid toes on both feet started 1 month post vaccination"; BLISTER (non-serious) with onset 25Aug2022 at 22:30, outcome "recovered", described as "blisters on first 3 toes of each feet"; ERYTHEMA (non-serious) with onset 25Aug2022 at 22:30, outcome "recovered", described as "redness". The events "covid toes on both feet started 1 month post vaccination", "redness" and "blisters on first 3 toes of each feet" required physician office visit. Therapeutic measures were not taken as a result of rash pruritic, erythema, blister.  Additional information: It was reported, on 25Aug2022 10:30 PM Covid toes on both feet started 1 month post vaccination. Started as redness on big and gradually over days to blisters on first 3 toes of each feet. Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient was Recovered. No treatment received. No covid prior vaccination. Covid tested post vaccination: Unknown.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 32  for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE, start date: 25May2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of  COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received Pfizer COVID vaccine on 12/30/20 (lot # EL0140), 1/20/21 (lot # EL3302), and 1/28/22 (lot # FJ6369). Patient resides in (private) and was tested positive for COVID on 1/15/22 externally. On 1/29/22, patient admitted to our inpatient facility with acute respiratory failure with hypoxia s/p fall (COVID status negative on 1/29/22 upon admission). As of today (2/1/22), patient is still admitted in our med/surg unit.
soreness at the injection site; malaise / She felt sick for about 4 days; experienced fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 1st dose of Shingrix. On 17th January 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, malaise and fatigue. On 21st January 2020, the outcome of the malaise was recovered/resolved. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain, malaise and fatigue to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix vaccine nad next day experienced fatigue, malaise and soreness at the injection site. She felt sick for about 4 days and one day she did not get out of bed. The reporter consented to follow up. This case has been linked with US2020081799, reported by same reporter. The outcome for events was reported as recovered/resolved with sequel however it was captured as recovered/resolved in the case.
Patient stated on Sunday 2/4/18 in the evening her arm was sore. She then said she felt like she was coming down with the flu. Her son then rubbed her arm in the area of the vaccination on 2/6/18 and she said since then a rash developed from the top of her arm down her arm. Advised the patient to see her primary care doctor to look at it.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/09/21 Moderna,Lot#012L20A 2nd dose: 02/06/21 Moderna,Lot# 012L20A Diagnosed covid positive:08/10/21 Symptom onset:08/10/21 Exposure: Symptoms:Runny nose
Pt. got his Hepatitis A, Yellow fever, and Typhoid vaccines in Travel Health center on the date mentioned in the form. Pt. became lightheaded initially after the first shot and was asked to lie down on the table. He said he is o.k and put his head between his knees. After getting the subsequent vaccinations, he went "blank" as per the MA. As per his wife who was in the room with him, he had a tonic-clonic seizure and left eye gaze. MA called for help. By the time I saw the pt. he is unresponsive. With the help of his wife, I got him out of the chair on to the floor. After being on the floor for 15 seconds and repeatedly calling his name and tapping on his face he became responsive. Travel Health coordinator called the operator at the hospital for help. His BP is was initially in the 80's and PR in 40's. An Internist who works in the same suite came to help us. After the pt. became responsive, he said he is totally aware of everything that happened and refused our recommendations to go to the ER. He lied down on the floor for 15 minutes. His BP eventually improved to 110/80, PR to 66 and his oxygen saturation was 96% on Room air. His Blood glucose by finger stick was 99. Pt. left the travel health center fine.
HCP states patient received ROTATEQ, PEDIARIX, PEDVAX HIB and VAXNEUVANCE as part of 2 month vaccination series on 7/17/2023.  Per mom, patient developed ileus that same evening, ending up in the ED.  HCP calling today to ask if ileus could be caused; This spontaneous report was received from Other Health Professional and refers to a 4-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, single dose (strength, lot #, expiry date, route of administration, and indication were not provided); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, single dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, single dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unknown date, the patient started therapy with diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX),  (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided).  On 17-JUL-2023, HCP stated that the patient received ROTATEQ, PEDIARIX, PEDVAX HIB and VAXNEUVANCE as part of 2 month vaccination series. Per mom, patient developed ileus that same evening, ending up in the ED. HCP calling today to ask if ileus could be caused. No other reactions or adverse events mentioned. No PQC. At the time of reporting, the outcome of the event ileus was not known. The action taken with ROTATEQ regarding ileus was reported as Not Applicable. The action taken with VAXNEUVANCE regarding ileus was reported as Not Applicable. The action taken with LIQUID PEDVAXHIB regarding ileus was reported as Not Applicable.  The causal relationship between ileus and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown. The causal relationship between ileus and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was unknown. The causal relationship between ileus and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was unknown. Upon internal review, the event ileus was determined to be medically significant.
Patient walked from the pharmacy to the photo department. Passed out at the photo department. Stated he started feeling weak, vision blurry, hearing diminished, feeling hot. Sat down by photo and drank some water. Patient said he started feeling better after sitting down. Walked him back to the pharmacy so could monitor for 15 minutes. Patient denied calling 911. Also stated that he didn't really eat or drink anything all day. This hadn't happened with previous doses. Advised that patient eat and drink next time before vaccinations. Also, if any symptoms worsen or develop, advised to go to hospital. Followed up with patient on 12/22/22 1:22pm, patient reported feeling normal. All symptoms resolved.
Dizziness and weakness; fever of 103.4; confusion/incoherent. Occurred exactly 24 hours post-vaccination.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 10Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Oct2023 at 17:00, outcome "not recovered" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
pt recvd vax; pt broke out pink spots on stomach; became very pale; noticed few whelps;
LEFT FOREARM STARTED SWELLING; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on left deltoid on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 27-MAR-2021, the subject experienced left forearm started swelling. On 27-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left forearm started swelling, and injection site pain. This report was non-serious.
Extreme soreness/pain in muscle in area of shot approximately 4 hours after shot. Could not lift arm or touch injection site due to pain. The following day still had severe soreness in upper arm. The third day- redness, swelling, stiffness of skin and deep itching at injection site.
Diabetic; This is a spontaneous report from a non-contactable consumer (patient's friend). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 1, single and via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diabetic on an unspecified date. The reporter, who was calling for a friend, wanted to know if there were any clinical trials for a third Covid shot. The patient had both doses of the Pfizer shot and he was diabetic. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Lymph Node Swelling-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Patient is experiencing extreme pain and swelling after receiving first dose of Pfizer vaccine on 5/17/21. Went to both the ER and PCP and was informed that it was administered too low and could be a potential for infection.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. On 16-NOV-2015, the patient was vaccinated with the first dose of GARDASIL (dose, frequency, route of administration and indication were not reported). The patient completed GARDASIL series on an unknown dates and on 22-JUN-2016, inadvertently received another dose of GARDASIL 9 (dose, frequency, route of administration and indication were not reported, lot number L044475, expiration date: 12-MAY-2017). No adverse effects reported. Additional information has been requested.
immunothrombosis; A spontaneous report  was received from a Consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the serious, medically significant event of infective thrombosis.  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 their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.    On an unknown date, The patient experienced immunothrombosis ( medically significant)  No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.; Reporter's Comments: This case concerns a patient, who experienced a serious unexpected event of infective thrombosis, after receiving 2nd dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. There are no contact details, so no further information has been requested.
Severe fatigue, nausea, both ongoing at the 24 hour mark. Sleeplessness over night on the day of vaccination, and uncontrollable shivering on the day of vaccination for approximately 2 hours.
severe head ache; body ache; This is a spontaneous report from a non-contactable healthcare professional (patient).  A 36-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, expiry date EJ1685), intramuscular on left arm at 21Dec2020 07:30, intramuscular at a single dose for Covid-19 immunization.  The patient has no medical history.  Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced severe headache and body ache during the first dose. The patient underwent lab tests and procedures which included nasal swab with negative result on 21Dec2020. There was no treatment received for the adverse events. Outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Flu shot almost killed me; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, the flu shot almost killed her.