chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After my son received the shot that whole night he was not himself. He began running a high fevers, kept jerking, and would not eat or drink anything. He kept complaining that his legs are hurting and struggled to walk. His fever continued and only came down with medicine. I was alternating TYLENOL and Ibuprofen for fevers. His fevers were a constant 105-106. On Saturday night I checked his temperature and it was 106 I gave him Ibuprofen and he fell asleep so I laid him down were me and my husband were sitting so we can keep a close eye on him because he kept jerking and wasn't himself at all. Within about 15-20 mins later my son woke up and said "mommy" I said we are right here sweetheart, he lifted his head and his head fell back on to the pillow and went unconscious. My husband stayed with him trying everything to get him back up and I ran and grabbed my phone to call 911. EMTs arrived not too long after that and he was taken into hospital. Doctors stated that he had a febrile seizure, they test him for flu and a lot of virus and all test came back negative. The hospital also did a urine test and that as well came back negative. Prior to this my son has never had any types of seizure. After discharge my son continued to have fevers. On Monday I took my son in to his PCP due to the fevers, not eating, and not being himself. He was test again for all types of viruses, flu, and strep all came back negative. On Tuesday I was told by his PCP to take him into hospital to be monitored. Once again at hospital they tested his urine that too showed nothing. They also did more testing and blood work and all came back negative. He received in the hospital IV fluids, TYLENOL, and MOTRIN.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose from a vial past the 30 day use by date) and PRODUCT STORAGE ERROR (Date of refrigeration 24Feb2022 and Date of administration 04April2022) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination. No Medical History information was reported. On 04-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose from a vial past the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date of refrigeration 24Feb2022 and Date of administration 04April2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a dose from a vial past the 30 day use by date) and PRODUCT STORAGE ERROR (Date of refrigeration 24Feb2022 and Date of administration 04April2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details were reported. Reporter stated that the date of refrigeration was 24-Feb-2022 and the vial did not undergo any temperature excursions. And the dose was Patient's booster dose. No treatment medication details were reported.
Since receiving this shot I have had pain in my left arm at the injection site. For 2 months the pain was severe, waking me up at night. Now there is still pain, but it is manageable. I have been getting the flu shot for over 25 year and have never had an issue. This pain has lasted almost 4 months now.
Patient came to employee health for flu vaccine. Patient states she has had a flu vaccine before and has not had any previous reaction. She denies having COVID or being exposed to COVID. Patient received vaccine and approximately 5 minutes later she complained of lightheadedness and dizziness. I had her sit down in a chair. About 15 minutes later, I had her try to stand up and walk along the hallway, using the wall for stability. She was able to get up and walk, but felt wobbly whenever she took her hand off the wall and took a few steps. She sat back down and was told to keep waiting it out to see if it gets better. About 45 minutes after the flu shot, I gave her a bottle of water. 1 hour and 15 minutes after the shot we had her try to get up and walk again, and she still used the wall for stability. Still feeling dizzy. 1 hour and 20 minutes after flu shot, she said she is feeling a little bit better. She drank her whole bottle of water, and at 1130, her supervisor told her to go ahead and go home since she has to stand for her whole shift and is not able to stand for the whole shift.   After complaining of initial symptoms, patient did note that she had episodes of vomiting on 9/28, which she says is possible food poisoning since the fridge has not been working correctly lately. No vomiting episodes since then. She has had only cereal and coffee for breakfast. Also, she says she has a PMH of anxiety.
Injection site reaction (redness, swelling), swollen axilla (painful), and severely red and swollen eyes (no pus or discharge)
DOSE ADMNISTERED AFTER BEING STORAGE FOR 30 DAYS BETWEEN 2-8 DEGREE C
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 83-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). Concomitant products included atenolol, clopidogrel, Levothyroxine and simvastatin. On 20h April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, erythromacular rash and pain. On 24th April 2018, the patient experienced blister. SHINGRIX was continued with no change. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the erythromacular rash, pain and blister were not recovered/not resolved. The reporter considered the injection site pain, erythromacular rash and pain to be related to be related to SHINGRIX. It was unknown if the reporter considered the blister to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of their patients received the SHINGRIX vaccine at the pharmacy. The patient complained of having pain in the arm where she received the injection. The patient also experienced about 4 red spots that are also painful. These symptoms developed the next day after the injection. The patient also said that, at the time of reporting, 4 days after vaccination she woke up with blisters above her lips. The patient thinks it might be the SHINGRIX. The blisters were not open.
Sore throat; Headache; Muscle aches; Fatigue; This spontaneous case was received on 28-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04433) and concerned a male patient of an unknown age.  The patient's relevant medical history and concomitant medications were not reported.  On 20-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location and route of administration: not reported) for influenza prophylaxis. The batch number was not reported.  On 23-Oct-2020, after receiving Flucelvax QIV vaccine, the patient developed headache, sore throat, muscle aches and fatigue.  At the time of initial reporting on 28-Oct-2020, the outcome of the events was recovering.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the events as non-serious.  Company comment: The patient developed all events three days after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. The patient's relevant medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed all events three days after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. The patient's relevant medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3247, expiration date was unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 08:45 at a single dose for COVID-19 immunization administered at the clinic. Relevant medical history included allergies to Penicillin. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date, the patient experienced sore arm, which was assessed as non-serious. The patient did not receive any treatment for the adverse event. The outcome of the event was unknown.
This 19 year old female received the J&J vaccine Monday morning. That afternoon, she experienced uncontrollable crying and then extreme fatigue. As the day went on, she developed the worst headache of her life that made her unable to fall asleep due to the extreme throbbing. She also experienced the chills and vomiting. After a restless night, she felt better the next day besides a minor headache.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 19-FEB-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right  arm on 12Apr2021 at 16:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 22:00 the patient experienced tinnitus. 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 adverse  event. The clinical outcome of the event tinnitus was recovered with sequelae on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Noticed itching with redness approx 2" diameter. No treatment, except Cortaid.
PAINFUL RASH AT INJECT SITE. STARTED 2 WEEKS AFTER INJECTION LASTING 10 DAYS AFTER ON SET.
Sore muscles, whole body Tenderness at injection site Fatigue, general weakness Lack of appetite Slight nausea
My tongue began to burn and it increased in intensity and spread to the back of the mouth and throat.  I had pre-treated with an allegra. I stopped and took a Benedryl capsule and turned around and returned to the health facility. The nurses watched me for another 45 minutes during which time nothing else occured. My blood pressure was slightly depressed but not too much. It was 98/ 76 when normal for me with medication is 116- 128 over about 86=92.  I took another Benedryl when I was close to home. The burning continued but did not progress into swelling. It did feel as if I had sores in my mouth that night but they were gone in the a.m.  I felt like my tongue had been burned by much too hot food and/or beverage.
Moderna COVIS-19 Vaccine EUA - adverse reactions started 7 hours after administration (7pm) on 1/7/21. Severe Chills, Shakes and could not get warm, but no fever until midnight, 100 degrees), when I took 2 NyQuil and went to bed. 6am next morning, no fever but still felt achy and weak. Took naproxen at 2:15. Still achy and temp was up to 100.6 at 4pm and took 600 mg ibuprofen. Temp up to 100.8 at 5:20 and took 1000mg of acetominophen at 5:20. Took Nyquil and went to bed around 10pm. Second morning temp was 99.4 and never went up after that. Tired and achy most of the day but a switch flipped around 4pm and I felt back to normal. Today was day 3 after injection and feeling 100%. Vaccine side affects were worse than when I had COVID in July but will do it again in a month.
Left side of neck felt getting tight, likea constricted muscle; Eyes also became swollen with puffy eyelids; Eyes also became swollen with puffy eyelids.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 18Mar2021 at 13:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient received other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 15:00, the patient felt the left side of his neck getting tight, like a constricted muscle and eyes also became swollen with puffy eyelids. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events neck tightness, swollen eyelids and puffy eyes. The clinical outcome of the events neck tightness, swollen eyelids and puffy eyes was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Acute onset of chest pain, ST wave changes, irregular heart beat and elevated C reactive protein 1-2 days after receipt of first Moderna COVID vaccine
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 15-MAR-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Patient came in 11/28 for Moderna booster after having no issues with first 2 shots. About 24 hours later, her whole upper arm swelled, turned red, became itchy and she got a headache. Today 5 days later, the swelling has subsided but it is warm, itchy and painful still. The headache lasted 2 days. The pain wakes her up at night if she rolls over on that arm.
Tinnitus.  Continuous ringing in ears that will not go away.   I was perfectly healthy before the shot.. then several days after developed an ache in my right abdomen, fatigue and constant ringing in ears that will not go away.  I'm also having a very hard time sleeping.. sometimes only being able to get 2 or 3 hours a night regardless of how tired I am.  I'm very disappointed and not sure if I should get the second shot or not given how I'm feeling now.  Before the shot I was perfectly healthy.  I eat well, exercise and have never in my life experienced tinnitus or any type of hearing problem.  This shot was the ONLY thing that could have caused this.  I'm not sure what to do next or if I should get the second shot which could make it worse.  I'm very worried because the ringing and aches have been constant for 10 days..  some days worse than others.
currently nursing my baby who is 14 months old.; This is a spontaneous report from a contactable nurse practitioner. This nurse practitioner reported information for both mother (Self) and her 14-month-old patient infant. A 14-months-old of an unspecified gender started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), (age at vaccination 14-month-old) transmammary on an unspecified date in Dec2020.  The infant's mother received the vaccine for COVID-19 immunisation. The infant's mother reported she was a nurse practitioner working at a local urgent care center. She was currently nursing her baby who is 14 months old. Due to the high risk of getting COVID19, the mother decided to get COVID 19 vaccination despite lack of data on lactating women. She received my Pfizer COVID 19 vaccination 3 days ago (Dec2020).  Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021001535 mother case
myocarditis; myocarditis; chest pain; shortness of breath; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the second of two reports. A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) as 2nd dose, single dose (at the age of 17-years-old) for COVID-19 immunization. Medical history included myocarditis from 2019 to an unknown date. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. Patient admitted to hospital with chest pain and shortness of breath, diagnosed with myocarditis on 05May2021. The patient was hospitalized for 6 days. Treatment received for the adverse events include metoprolol, amiodarone, ketorolac, IVIG. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 05May2021. The outcome of the events was recovering. The events were considered as serious (hospitalization).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  Information on the lot/ batch number has been requested.; Sender's Comments: Myocarditis is not uncommon disease in young population.  This 17-year-old male patient had medical history of myocarditis from 2019.  Based on information available, the reported recurrence of myocarditis with symptoms of chest pain and shortness of breath was not considered as causally related to the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  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.,Linked Report(s) : PFIZER INC-2021565225 same reporter/AEs/vaccine, different patient.
Patient had redness and swelling in the site of the injection, she aslo had rigors, chills and myalgia.
5.5 x 5.5 red, swollen, warm to touch area on L upper arm. Cool/warm compress. advised not to receive flu vaccine preservative or non preservative vaccine in the future.
Since he received the vaccine I have seen a change in his nervous systems gradually more every day that he no longer has control of his nervous system, before the vaccine he was a great athlete he was in a club and with his classes he was number one in his class, everything began after the shot.
Initial information received on 25-May-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 67 years old male patient who experienced bursitis, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatments, vaccinations and family history were not provided. At the time of the event, the patient had ongoing Neuropathy peripheral. The patient did not have any known drug allergy. Concomitant medications included Gabapentin for Neuropathy peripheral and supplements (not specified). On 27-Aug-2017, the patient received a dose of Influenza USP Trival A-B High Dose Subvirion Vaccine (lot number, expiry date and dose not reported) via intramuscular route in the right deltoid. On an unknown date, few hours post vaccination, the patient developed a non-serious event of decrease in range of motion in his right arm, pain in his right arm and SIRVA (shoulder injury related to vaccine administration) with the diagnosis of bursitis. Relevant tests were not reported. Final diagnosis was bursitis. The patient was treated with Cortisone injection on 17-May-2018. The patient was not recovered from the pain in his right arm and outcome of the other events was reported as unknown. List of documents held by sender: none.