chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician via a field representative referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unspecified. On an unknown date the patient was vaccinated with a pediatric dose of RECOMBIVAX HB (intramuscular; strength, lot#, dosage and frequency unspecified) for prophylaxis (accidental underdose and drug administered to patient of inappropriate age). Additional information is not expected as the physician refused to be contacted.
Vaccine given on 12/28/20. Arm began to hurt and began experiencing cold like symptoms, ache, and sore arm at 4PM.  Took Tylenol and felt better.  The sore arm remained for 2 days and completely disappeared.  The following week I developed vertigo for 4 days.  I have never had vertigo.
Racing heart beat; He pulse was at 90 and it came down on its own.; This case was reported by a consumer via call center representative and described the occurrence of heart racing in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a day after receiving Shingrix, the patient experienced heart racing and pulse rate increased. On an unknown date, the outcome of the heart racing and pulse rate increased were recovered/resolved.   It was unknown if the reporter considered the heart racing and pulse rate increased to be related to Shingrix.  Additional information received were as follows: On the day of vaccination, the patient was woke up at  the middle of night with racing heart beat. The patient pulse rate  was at 90 and it came down on it own. No further details were provided. Consent to follow up was denied.
Patient initially felt warm , was fussy and restless after the  vaccines later that afternoon.  When he went to bed he started feeling warm. Mother says he woke up at 9 PM "hysterical" and felt warm again. 2.5 hours later he work up again fussy and restless. Around 2:30 AM he started "seizing" and his whole body was jerking and his eyes were rolling back. Mother says he couldn't control his body. The episodes were 5 in total, lasted 5-10 seconds each and occurred over 1 hour. He's had no more episodes since then. He was still fatigued and fussy the next day.  However, mother says he's been playful and appetite is normal for last 3 days.
Vial was exposed to room temperature range for about 25 hours; patient received dose exposed to romm temperature for 25 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose exposed to romm temperature for 25 hours) and PRODUCT STORAGE ERROR (Vial was exposed to room temperature range for about 25 hours) in an 89-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jul-2022 at 12:15 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022 at 12:15 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose exposed to romm temperature for 25 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was exposed to room temperature range for about 25 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received dose exposed to romm temperature for 25 hours) and PRODUCT STORAGE ERROR (Vial was exposed to room temperature range for about 25 hours) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. Pharmacy student administered an expired dose. The vial did not underwent any temperature excursion.  Vial initially stored in the refrigerator19-Jul-2022  First punctured 26-Jul-2022 around 11 AM  No treatment drug were reported.
it was reported that patient experienced: Covid-Pneumonia; it was reported that patient experienced: Covid-Pneumonia; This is a spontaneous report received from a contactable consumer (patient) via Drug Safety. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection), dose 2 via an unspecified route of administration on 07May2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. Medical history included ongoing multiple sclerosis (concurrent condition). Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for Covid-19 Immunization. Concomitant medication included Ocrelizumab (OCREVUS) taken for an unspecified indication, start and stop date were not reported. The patient experienced Covid-pneumonia on 31May2021. The outcome of event was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Based on the limited information in the case report, A possible causal relationship between Covid-19 pneumonia and suspect drug BNT162B2 cannot be excluded..
male patient that was inadvertently administered by a nurse with an undiluted vial; Received six times the dose; undiluted; left foot went numb; chest pain; BP was high; This is a spontaneous report from a contactable pharmacist.     A 41-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Left on 22Oct2021 (Batch/Lot Number: UJ711AB) as single dose for covid-19 immunisation (Age at vaccination 41 years) .  The patient medical history was not reported. Concomitant medications included influenza vaccine inact sag 3v (FLUCELVAX) taken for an unspecified indication from 22Oct2021 to 25Oct2021.  The patient experienced left foot went numb (medically significant) on 27Oct2021 with outcome of not recovered , chest pain  (medically significant) on 27Oct2021 with outcome of not recovered , BP was high  (medically significant) on 27Oct2021 with outcome of unknown , male patient  was inadvertently administered by a nurse with an undiluted vial  (non-serious) on 22Oct2021 with outcome of unknown , received six times the dose; undiluted  (non-serious) on 22Oct2021 with outcome of unknown.  The patient underwent lab tests and procedures which included electrocardiogram: WNL  on 28Oct2021 Comment: Normal.  The patient visited the ER because of the event.  Course of the event. The patient was administered an undiluted vial of Pfizer Covid-19 vaccine on 22Oct2021. No ADE reported on day of event. Flu was done on 23Oct, 24Oct and on 25Oct and no ADEs were reported. He was kept for observation for an hour on 22Oct before he was released. On 27Oct2021 patient stated his left foot went numb while in the shower that night. He also started having chest pains that radiated down his left arm. He reports his BP was high. He awoke on 28Oct2021 and still had some numbness in the left foot and pain down his arm so he went to our clinic for follow up. He had an EKG and it was normal. He had not gone to pick up his BP meds that was sent at his last visit. He was going to pick up when he left the clinic. We will follow up with patient in a week.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events hypoaesthesia, chest pain and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.
The following is reported from the client. She did not want to get the vaccinations, but states "they talked her into it", and did not want to get the nurses at the office in trouble. They did not tell her about the negative effects, or show her the forms until after she received the vaccinations. Client states she went to bed early, feeling tired. Woke up in the middle of night, not feeling well. Feeling cold "freezing", pins and needles throughout whole body, simultaneously, burning feeling throughout whole body, then felt like being electrocuted, crawled to the kitchen, got some chicken broth. Crawled to get phone, to call her friend for help. Wanted to call ambulance, but worried she would take the service from someone else. The following day she went to the Doctor's office for a physical wellness exam. She laid on the floor because she continued to feel poorly. States the staff treated her better the following day and told of about the VAERs program.
This spontaneous report was received from a pharmacist refers to a "28 to 30 year old" female patient. On an unspecified day in August 2014, the patient received the first dose of M-M-R II 0.5 ml, subcutaneous and the patient did not experienced any adverse effects after the first dose. On 29-SEP-2014 (reported as "10 days ago"), the patient was vaccinated with the second dose of M-M-R II 0.5 ml, subcutaneous (lot # reported as K005110; expiration date in April 2014) and the patient experienced headache and a sore throat the day after on 30-SEP-2014 this second dose of M-M-R II was received. It was also reported that the patient experienced on an unspecified date in 2014 acid reflux after getting vaccination and her doctor gave her PRILOSEC for it. The pharmacist stated that, at the time the patient reported the headache and sore throat, she urged her to take ADVIL for her discomfort and to report her symptoms to the health care provider. The patient said, "I did not have time to do that". For this reason, the pharmacist stated that the patient was not incapacitated, nor did she seek medical attention. The reporter stated that three days after the patient first told her about her headache and sore throat, the patient was still experiencing a sore throat but still going to work every day. The outcome of acid reflux, headache and sore throat was unknown. Additional information has been requested.
fainted;hit head on door knob, lt temple c/o dizziness & h/a;fainted approx 5-10sec;PEARL;
Hives all over body, from head to toe began 10 days after vaccination. It has been 2 weeks and the hives are still appearing. The symptoms have not gotten worse, but also have not improved much.
Patient came to clinic with concern of vaccine reaction. Left arm, site of varicella vaccination from 8/2/17, exhibited signs of infection. Small clustered blisters spread approximately a 1 inch diameter surrounded the injection site. Inflammation with redness, swelling, warmth and approximately 6 inches around the site on the arm. Patient states it is sore. Reports temperature of 100.6 on 8/3/17. Given information on local urgent care clinics and Urgent Care and instructed to have it examined for treatment. Patient denies taking TYLENOL /Ibuprofen or using ice for treatment.
all over body aches, low grade fever,chills, headache, extreme soreness to injection site , extreme fatigue x 48 hours
sore throat, dizziness, fatigue, chills, body aches, mild fever,
Pain at injection site that comes and goes; Rash at injection site that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at injection site that comes and goes) and INJECTION SITE RASH (Rash at injection site that comes and goes) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at injection site that comes and goes) and INJECTION SITE RASH (Rash at injection site that comes and goes). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INJECTION SITE PAIN (Pain at injection site that comes and goes) and INJECTION SITE RASH (Rash at injection site that comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reported. Patient received second dose of Moderna vaccine on 4-FEB-2021 with lot number 038K20A.   This case was linked to MOD-2021-116537 (Patient Link).
About 23 hours after shot, I got headache, chills, fever of 101, body aches, dizziness, and fatigue. These all resolved in about 24 hours, then I developed a large, itchy rash on my left arm.
Information has been received from a lawyer regarding a case in litigation concerning an approximately 64 year old male. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 20-JUL-2012, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On or about 06-OCT-2015, the patient was treated by a by a health care provider for the following injury resulting from his use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to himself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
rash on neck 1-2 hrs p/shots; MD dx heat rash & OM; later same day generalized hives; bumps inc in # & size, to ER, dx chicken pox-lymph nodes swollen
At 7:30 PM, 1/31/22, onset of severe pain left arm and shoulder. Pain to "gums".  describes as stabbing pain.  Followed by swelling to left arm with "knot" at left elbow area.  Swelling to left breast on the morning of 2/1/22.  Denies redness or rash
heart attack; kidneys were  compromised; muscles were tightening; could hardly walk; cough; lethargic; chills; reflux in his chest; blood count went down; severe cramping in leg; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Medical history cardiac bypass surgery years ago. The patient's concomitant medications were not reported. The reporter stated that on 14Jan2021, the reporter and the patient had the first Pfizer vaccine dose, their second dose is scheduled on 04Feb2021. She stated that 2 days after the first dose, on 16Jan2021, the patient's muscles were tightening, could hardly walk, had a cough, was lethargic, had chills and was compalaining of having reflux in his chest. She stated that they had appointments that day with their Internist and their Cardiologist. Both physicians felt "all his symptoms" were probably from the vaccine. That night she took him to the ER and he had had a heart attack. They did a cardiac cath and had one of two stents put in. His "kidneys were compromised" and the HCP couldn't give the amount of dye needed to add another stent. So he still needs another stent. Also the "blood count went down." She added that her husband had cardiac bypass surgery years ago. They were concerned that he had a heart attack and asked if he should get the second dose. She added that on 16Jan2021, the patient had severe cramping in the leg, lethargic, chills, and difficulty breathing and he ended up going to the doctor. They had the vaccine on the 14Jan2021. Saturday it just hit him like a ton of bricks. He got worse on Saturday and worse on Sunday and even more worse on Monday. She took him to the Internist and the Cardiologist, they checked him and found he was okay, just lethargic. He also complained of reflux in chest. Around 11:00 that night he had a heart attack and she had to get EMS. He ended up getting a stent and they have to do another one and they had to do something with his kidneys. She wanted to know if he should get the second vaccine. She would hate to put him in a tailspin again. They were trying to get over this huge problem with his heart and then kidneys. They had to hydrate his kidneys in order for dye to go through so it wouldn't damage his kidney during catherization. She knows that one of the things the vaccine does is it activates the immune system to keep you from getting Covid. She wanted to know if it activates other stuff in the body. She asked if it would be recommended for him to slow it down since he just had the first dose. He is going to the Cardiologist and they say to discuss with the Internist, but she would like to speak with someone. She declined report and asked about the wait time to speak with someone since she does not want to leave him alone for long since he just got home from hospital. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Pfizer BioNTech vaccine on 5/22/2021 and 6/13/2021. Admitted 10/10/22 for COVID PNA and respiratory failure. Pt had c/o of productive cough and congestion for one week with increased use of NC O2. Pt also experienced nausea and poor PO intake. During stay pt had worsening of respiratory status and ABG showed severe hypoxemia. Pt was placed on Airvo then progressed to BiPAP. Code blue was called without ROSC and pt expired on 10/14/22. Tx'd with Decadron, solumedrol, remdesivir, doxycycline, and azithromycin.
This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12hours post puncture/ >24 RT and administered.), PRODUCT STORAGE ERROR (Dose administered >12(hours post puncture/ >24 RT and administered.) and NO ADVERSE EVENT (No adverse event) in a 49-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.       On 11-Jan-2023, 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 and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 11-Jan-2023 at 9:26 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture/ >24 RT and administered.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered >12hours post puncture/ >24 RT and administered.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture/ >24 RT and administered.), PRODUCT STORAGE ERROR (Dose administered >12 hours post puncture/ >24 RT and administered.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions. No treatment medications were reported.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and LIQUID PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL and other 18 children received LIQUID PEDVAXHIB. Follow up information has been received from the medical assistant regarding a 13 years old, male patient with no pertinent medical history reported. On 07-DEC-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Other suspect therapies included LIQUID PEDVAXHIB (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). On 15-MAR-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports received from the same source. Additional information is not expected.
Heart attack; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, in the left arm on 29Apr2021 at 13:10 (Batch/Lot Number: EW0167, at the age of 75 years) as a single dose for COVID-19 immunization at a pharmacy drug store. Medical history included knee operation on 09Nov2020 and ongoing high blood pressure. The patient did not receive any other vaccinations within 4 weeks of the COVID-19 vaccine. Concomitant medications included unspecified blood pressure medication from an unspecified date and ongoing, several unspecified pain medications from an unspecified date following the knee surgery and ongoing and other unspecified medications in addition to the pain and blood pressure medications. On 29Apr2021 at 13:10, the patient received the first dose of the COVID-19 vaccine. On 29Apr202 at 13:25, 15 minutes after the vaccination, she experienced a heart attack. She described that it felt like she had very severe heartburn. She also became very weak and felt weak all the time. Her doctor called while she felt like she had very severe heartburn. She reports that her physician heard her panting during the phone call and said she was having a heart attack. She took Tums and the severe heartburn went away. It was a small bottle of Tums and she took half of the bottle. By the time she got home she was ok and didn't believe that she was having a heart attack. One of the physicians came to her home on 29Apr2021. The physician did an EKG and confirmed that she did have a heart attack. The patient stated that she knew the vaccine caused the heart attack and she was not going to get the second dose of the vaccine. The patient stated that she has no medical history or family history of hear attacks. Emergency room visit was not required. The outcome of event heart attack was recovering.
A rash developed  all around the injection site which had been bruised since the shot. It was red raised bumps that was itchy and painful. There were large lumps under the skin. I woke up the next day with a severe headache and extreme fatigue.   The  second day after the rash first appears the symptoms subsided but the rash is still present.
1/21 1:05 pm   throat itchig; had to keep clearing throat   1:10pm Ears hot and itchy Took Benadryl; symptoms subsided after 30 min. 1/22 Headache, body and joint aches, sore arm
Vaccine leaked from the needle hub after less than half a dose was administered.  Patient was successfully vaccinated with another dose.
Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were inadvertently vaccinated with MMR II (lot # J013316 with expiration date 22-OCT-2015 and K002816 with expiration date 25-FEB-2016; strength, dose and route were not reported), which had been improperly stored. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.