chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of hearing two days after vaccine; up for 48 hours after the vaccine; This is a spontaneous report from a contactable consumer (patient). A 95-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6208) via an unspecified route of administration, administered in Arm Right, at the age of 95-year-old, on 20Mar2021 11:30, as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. Concomitant medications included atenolol; dutasteride; apixaban (ELIQUIS); and methenamine.  The patient received amoxcillin and experienced allergy and first dose of of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ENF6200) via an unspecified route of administration, administered in Arm Right on 27Feb2021 11:45, as SINGLE DOSE for covid-19 immunisation.  It was reported that the patient received other vaccine (unspecified) four weeks before receiving the COVID vaccine. The patient was up for 48 hours after the vaccine on 22Mar2021, then loss of hearing two days after vaccine on 22Mar2021. The patient did not receive any treatment in response to the events. The event loss of hearing two days required emergency room visit. The patient was not diagnosed with COVID before vaccination and was not tested since vaccination. Outcome of the events was not recovered.
Patient began to have auditory hallucinations.  It has since advanced to both visual and auditory hallucinations. Her congitive ability has severaly decreased.
Pain, nausea, fast heartbeat, low blood pressure of 98 over 58, weak, heaviness in arms, weakness in legs, pressure in chest, cant think straight and words arent coming out right, very painful at the injection site, stiff and painful arm, I haven't called the doctor yet hoping this will pass, very scared.
Fever 102.9, chills, body aches, pain at injection site, nausea, cough
Pt exp fever, chills, flank pain, nausea, vomiting, dizziness & spilling blood on dipstick on 7MAY92 following 1st dose of Engerix-B; pt was seen by MD;
This spontaneous report as received from a Registered Nurse refers to multiple patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot # M047666, expiry date: 24-OCT-2019; lot # N007750, expiry date: 29-NOV-2019 for prophylaxis (Incorrect product storage). Dosing details and route of administration were not reported. No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of -1°C or colder (-1°C) for 11 hours 29 minutes. No previous temperature excursion were reported. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA006090: US-009507513-1708USA006089: US-009507513-1708USA006091: US-009507513-1708USA006088:
Her husband contracted COVID; Got covid after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Her husband contracted COVID) and VACCINATION FAILURE (Got covid after vaccination) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-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, the patient experienced COVID-19 (Her husband contracted COVID) and VACCINATION FAILURE (Got covid after vaccination). At the time of the report, COVID-19 (Her husband contracted COVID) and VACCINATION FAILURE (Got covid after vaccination) outcome was unknown.            On 06-Nov-2021 they had contact with their niece and patient contracted COVID. The patient started to show symptoms on 09-Nov-2021. The patient had mild symptoms of covid and did not need hospitalization, was treated at home. Concomitant medication was reported by reporter.  Company Comment:  This is a case concerning a 56-year-old male patient with no reported medical history, who experienced the non-serious unexpected AESI event of COVID-19 and non-serious unexpected event of vaccination failure. The events occurred approximately 6 months after the second dose of mRNA-1273 vaccine administration. The patient had mild symptoms of covid and did not need hospitalization, was treated at home. Causality for the event of COVID-19 was not applicable to the product administration and related for vaccination failure event. The rechallenge was not applicable since the events occurred after the second dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2022: Follow-up was received: Included no significant information.; Sender's Comments: This is a case concerning a 56-year-old male patient with no reported medical history, who experienced the non-serious unexpected AESI event of COVID-19 and non-serious unexpected event of vaccination failure. The events occurred approximately 6 months after the second dose of mRNA-1273 vaccine administration. The patient had mild symptoms of covid and did not need hospitalization, was treated at home. Causality for the event of COVID-19 was not applicable to the product administration and related for vaccination failure event. The rechallenge was not applicable since the events occurred after the second dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
His father got his first covid vaccine shot in (place) and 5 days after he was tested positive with covid 19 but did not get any symptoms.; This is a spontaneous report from a non-contactable consumer. This consumer reported on behalf of his father.  A male patient of an unspecified age received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got his first COVID vaccine shot in and 5 days after he was tested positive with COVID 19 but did not get any symptoms. Asking if his father could get the second COVID vaccine shot. Outcome of the event was unknown.   No follow-up attempts are possible, Information about batch/lot number cannot be obtained.
Pediarix given 02/27/2006- Fever increase to 104 degrees early am of 2/28/06 and fever persisted for next 3-4 days 101-102 degrees. Fever decrease with Tylenol drops.
Headache which progressed into a migraine, lasting for 3 days.  Swollen lymph nodes on right side of body, which was the  same side as injection site, lasting about a week.  Extreme nausea, sensitivity to smells and light, weakness and lack of energy.  Pain at the injection site.
Patient reports sore arm and fatigue lasting 3 days post vaccine. On 03/9/2021 associate reports symptoms of headache and runny nose. Been tested for COVID-19 and awaiting results.
Woke with fever 101.1 F. Treated with tylenol which the fever responded to. He complained of feeling sick and didn't eat well during the day. He asked to take a nap (which he hasn't taken regularly for months). I let him sleep about a hour and a half. When I went in to check on him, his eyes were open but he seemed like he wasn't fully awake. His temperature at that time was 99.5 F. After 10 minutes of trying to get him to wake fully and respond to me, I realized something was wrong as he still couldn't respond to my questions. I called for my mom who is a retired FNP. She did a neuro check on him and was alarmed at his confusion, that he appeared to see things that weren't there, he had great difficulty focusing on her and following her commands. He had to be helped into a seated position and manipulated into crossing his legs. She had to hold him from falling over as she gave repeated simple commands to squeeze her hands, etc. It appeared he may have had a non-witnessed seizure and was in a postictal state. (He has never had a seizure before but has a history of staring spells and tremors as an infant and toddler.) We called his pediatrician's office and were advised to take him to an urgent care center for kids.
Systemic reaction urticaria, hives, asthma attack, severe local reaction, chest pain, SOB.
1200 Injection site red, hot and raised at 1630 hives to truck and right arm; had mild facial swelling on 9/2 and 9/3/2016; took Benadryl and loratadine on 9/2. Vaccine-FLUARIX 2016/2017 Formula lot 79PE5 exp 6/15/2017.
No adverse event; Nurse gave expired vaccine to a patient on 22Feb2023.Date(s) of administration of vaccine: 22Feb2023 and Expiry date 12Feb2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse gave expired vaccine to a patient on 22Feb2023.Date(s) of administration of vaccine: 22Feb2023 and Expiry date 12Feb2023) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Prior to vaccination) on 17-Sep-2021.    On 22-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 22-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse gave expired vaccine to a patient on 22Feb2023.Date(s) of administration of vaccine: 22Feb2023 and Expiry date 12Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse gave expired vaccine to a patient on 22Feb2023.Date(s) of administration of vaccine: 22Feb2023 and Expiry date 12Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Nurse gave expired vaccine to a patient on 22Feb2023.Date(s) of administration of vaccine: 22Feb2023 and Expiry date 12Feb2023).    Other relevant medical information included patient had no allergies. No concomitant medications were reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient did not reported nor had side effects after vaccination. Patient received vaccine form individual vial. Vial size was reported as 5.5 mL. Vial was initially stored in the refrigerator on 01-Feb-2023. Vial did not undergo any temperature excursions. No treatment information was provided.
I gave patient Vaxelis and extra dose of Hepatitis B; I gave patient Vaxelis and extra dose of Hepatitis B; This case was retrieved during the  Reporting System monitoring on 12-JAN-2023. The original narrative from the sender is the following:  I gave patient Vaxelis,and an extra dose of Hepatitis B. There were no adverse events other than the dose given twice. Mother of patient stated daughter was doing well. There was no redness on the area and baby is well. I did reach out to manufacture and to system to report the incident as well as to ask if there was harm, or what to look out for. Parent was notified as well.  Overdose event was added due to Hepatitis B vaccine being administered at the same time as Vaxelis.  The causality relationship between Vaxelis and the reported event "Extra dose administered" and "Overdose" is not applicable due to the nature of the event.  No further information is expected.
8/22/08 - am - Noted redness and swelling of L posterior deltoid where varicella vaccine given 8/21/08 (5 cm x 7 cm - mild erythema 3 x 4 cm - mod erythema and edema - centrally).
The injection was given incorrect and placed in my shoulder! I have SIRVA  Infection in my shoulder.
has not gotten his second dose yet/they never came back to give my 2nd shot; experienced a sore arm at the injection site/sore arm at the place they put the needle; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not gotten his second dose yet/they never came back to give my 2nd shot) and VACCINATION SITE PAIN (experienced a sore arm at the injection site/sore arm at the place they put the needle) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced VACCINATION SITE PAIN (experienced a sore arm at the injection site/sore arm at the place they put the needle). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not gotten his second dose yet/they never came back to give my 2nd shot). On 03-Jul-2021, VACCINATION SITE PAIN (experienced a sore arm at the injection site/sore arm at the place they put the needle) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not gotten his second dose yet/they never came back to give my 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow-up received on 30-AUG-2021 contains new event
shingles in same arm as injection; shingles burned; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles in same arm as injection) and SKIN BURNING SENSATION (shingles burned) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Chickenpox.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HERPES ZOSTER (shingles in same arm as injection) and SKIN BURNING SENSATION (shingles burned). At the time of the report, HERPES ZOSTER (shingles in same arm as injection) and SKIN BURNING SENSATION (shingles burned) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The patient went to the Emergency Room because of the blistery looking bites underneath her left arm from her shoulder to her elbow, that's when she was diagnosed. The patient  had 12 bumps total. Concomitant medication information was not reported. Treatment information as not reported.
Pt reported to POD for vaccine very anxious and concerned about her allergies to Nsaids, Morphine and pnc. she reports that her they cause HA and facial swelling. Pt received vaccine at 1405 and went to 30 min observation area. at 1420 this provider was contacted by the patient and she reported that feeling numbness   and drooping to the right eye lid. The patient was then brought for eval by this provider and EMT. The patient continued her observation until 1510 and at that time she reported that she was back to normal and continued to be without HA.
On 7 December, 2019, PT discovered that she was pregnant after testing positive after taking three separate pregnancy tests. 2 of the tests were taken 7 December, 2019; the other was taken 8 December, 2019. All three were tested positive. PT's blood was drawn for HCG testing on 09 December, 2019. Results came back positive for pregnancy. PT expressed she thinks she became pregnant on the 22 November, 2019.
Nurse calling for TE evaluation on frozen products states products have been administered.     Names of vaccines involved (including lot/exp) VARIVAX   U033046   10/20/2023        ?    Temperature 6°F up to 14°F (8F) for 0 hours 18 minutes 0 seco; No additional AE details.; This spontaneous report was received from a nurse referring to a 2-year-old.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U033046, expiration date: 21-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided); which was reconstituted with sterile diluent (STERILE DILUENT)(product storage error).  The administered dose of the vaccine was stored with the lowest temperature of 6 degrees Fahrenheit up to 14 degrees Fahrenheit (mean of 8 degrees Fahrenheit) for 0 hours and 18 minutes 0 seconds; and  with the lowest temperature of 14 degrees Fahrenheit up to 46 degrees Fahrenheit (mean of 18.4 degrees Fahrenheit) for 0 hours and 45 minutes 0 seconds. There was no previous temperature excursion. No additional adverse events.; Sender's Comments:  US-009507513-2206USA002264: US-009507513-2206USA002231:
had wound cut by the accidently where the shot took to ER, required stitches; too tetanus shot about month later had numbness in finger wher recvd shot;
Patient describes feeling light headed since the time of the injection but she thought it was from being hungry, since she did not eat breakfast.  She also described her heartbeat feeling irregular.  After she ate lunch and the symptoms got worse, she was advised to go to the doctor.  An EKG was done and it was noted she had an irregular sinus bradycardia & PVC's.  The clinic doctor sent her to the emergency room for atypical reaction post MMR vaccination.
Full body aching intermittently with in 7 mins of receiving vaccine, Provider saw pt and states that her vitals were normal, within 20 mins pt stated that her symptoms were decreasing.  We feel it mostly likely due to anxiety
she had a bump on her shoulder and it was sore for a couple days; she had a bump on her shoulder and it was sore for a couple days; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who had a bump on her shoulder and it was sore for a couple days (Injection site mass) and she had a bump on her shoulder and it was sore for a couple days (Injection site pain), while she received vaccines MMR, DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Dose and route were unknown) (Lot number and expiry date was unknown) used for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (Dose and route were unknown) (Lot number and expiry date was unknown) used for prophylactic vaccination.  On an unknown date, the patient received a dose of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE not produced by Sanofi Pasteur (Dose and route were unknown) (Lot number and expiry date was unknown) used for prophylactic vaccination.  On an unknown date, (Unknown latency) following the administration of Flublok QIV, MMR and Diphtheria, Tetanus and Acellular Pertussis vaccine, patient experienced bump on her shoulder and it was sore for a couple days (Injection site mass) and (Injection site pain).  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome for event injection site mass was reported as recovered and event outcome was unknown for injection site pain.  Information on the batch number was requested.
I have had extremely painful reaction more than 2 weeks after 2nd shot. Very strong muscle pain especially lower torso, but also shoulders. Lasts ALL day & has continued for eight days now.
This spontaneous report was received from a physician via company representative refers to a 2 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date the patient was vaccinated with a dose of improperly stored ROTATEQ (dose, units, frequency, route, lot number, expiration date not reported) (product storage error). After administration the dose was determined to be invalid by the state (agency unspecified) due to a temperature excursion on an unspecified date before administration of ROTATEQ. No further information was provided. The temperature and time frame was unknown. It was unknown if there was any previous temperature excursion and if the call was because of a data logger. No product quality complaint (PQC) was involved.
Called 10/28 to report "nausea and red bruised arm from rec'ing pneumonia shot 10/26 , also had chills last night" Reported redness to arm with no itching and no fever.  Called 10/29 to report she was seen at a clinic she works at and given cephalexin for potential cellulitis. Had redness from right shoulder to elbow, swelling (mild to moderate), tight skin, and warmth to arm. Very painful to touch and to move.
left arm redness started several days after receiving the vaccine, slightly swollen and itchy. c/w delayed hypersensitivity response.
Diarrhea, malaise, weakness, headache, loss of appetite, zero energy.
acute epiglotitis cellulitis; severe sore throat & neck swollen & red; to ER on 15NOV94 discharged to home 18NOV94;
Patient was vaccinated on 9/27/23 in left deltoid.  Patient was seen in doctor's office 10/17/23 for painful left shoulder.
I was dizzy, extreme fatigue, body aches,  right eye lid was swollen and my left arm was itchy and had a rash at the injection site. I went to see my PCP and was given allergy medication. I went to the eye doctor to  make sure there wasn't anything blocked in my eye. There was no blockage.
All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported. None of the patients have reported side effects, so far