chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of dizziness in a 77-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), Flu vaccine. A physician or other health care professional has not verified this report. Concurrent medical conditions included back injury, high blood pressure, high cholesterol, migraine headache and sleep disorder. Concurrent medications included VICODIN, AMBIEN, COZAAR and LIPITOR. On an unspecified date several years ago, the subject reacted to an unspecified flu vaccine, but the reaction was not described (adverse reaction). Later, on 6 December 2011 at 13:30 the subject received booster dose of BOOSTRIX in the right arm. The subject instantly had diarrhea, which was reported to be controlled (improved) at the time of reporting. Events that occurred on the same day of vaccination with BOOSTRIX (06 December 2011) included dizziness and vomiting. Other dates that vomiting occurred were 08 December 2011, sometime between 24 December 2011 and 30 December 2011 and 05 January 2012. The day after receiving BOOSTRIX (07 December 2011) the subject experienced fatigue, which was improved at the time of reporting and she could not move which improved. Three days after vaccination with BOOSTRIX (09 December 2011), the subject experienced migraine headache which was worsening. The subject reported a history of migraine headaches that occurred about once a month prior to receiving BOOSTRIX. Some time during the weeks following vaccination with BOOSTRIX (between 06 December 2011 to the time of reporting 20 January 2012), the subject felt wired (unspecified), experienced memory loss, had hot flashes (unresolved), developed insomnia which was improving, bruised easily and a wart appeared under the subject's left nostril. Some of the subject's treatments included LOMOTIL, PROVIGIL and HALCION. Others were not provided.
Chest started getting tight; Coughing; Fever; Pneumonia; Positive for covid; A spontaneous report was received from Healthcare Professional concerning a 75-year-old, female patient who received Moderna's COVID-19 vaccine and experienced fever/ pyrexia, cough, tested positive for covid/ COVID-19, pneumonia, and chest started getting tight/ chest discomfort.  The patient's medical history was not provided. Concomitant product use was not provided.  On 11 Jan 2021 prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an undisclosed date, the patient experienced fever and cough.  Her chest started getting tight when doing breathing exercises at home.  On 15 Jan 2021, the patient tested positive for COVID-19.   On 18 Jan 2021, the patient also tested positive for pneumonia.  The treatment included bamlanivimib.  The action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, fever, cough, chest started getting tight, tested positive for covid, and tested positive for pneumonia, was unknown.; Reporter's Comments: Although a temporal association exist, based on the known etiology for COVID-19, a causal association between the product use and events of cough, COVID-19, pneumonia and chest discomfort is considered unlikely.  The patient most likely had pre-existing COVID infection and the other events are complications from the disease. Fever is consistent with the safety profile of the product and a causal association cannot be excluded.
Same eye with redness/redness one eye left eye; Conjunctivitis; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6208, Expiration date: Not reported), via an unspecified route of administration in left arm on 14Mar2021 at 11:30 (at the age of 69-years-old) as dose 2, single for COVID-19 immunization in a hospital but not in a facility. There was no patient's relevant medical history/family medical history. There were no concomitant medications reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6200, Expiration date: Not reported), via an unspecified route of administration in left arm on 21Feb2021 at 11:30 (at the age of 68-years-old) as dose 1, single for COVID-19 immunization and woke up with one eye red and allergic conjunctivitis. No prior vaccinations within 4 weeks of COVID vaccine. After the second dose of vaccination, the patient woke up with the same problem with same time frame and same eye with redness/redness one eye left eye and conjunctivitis on 14Mar2021. The physician/doctor wanted to let him know since he was wondering why the events happened after both the vaccinations and let him know if the eye reaction doesn't clear up. The patient had not taken anything for treatment but the patient had over the counter dry eye drops which could be used for it as per the instruction by doctor. It was reported that these events require physician's office visit. There was no investigation assessment and no relevant tests done. The patient asked that these events were related to the vaccine and whether it has been reported. The outcome of the events was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Facial numbness; tingling on the right side of her face; This is a spontaneous report from a contactable other HCP. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Deltoid Right on 09Jul2021 15:00 (Lot Number: EW0161; Expiration Date: 31Jul2021, NDC number of Pfizer Covid shot: 5926710001) at the age of 41-year-old as 0.3 ML single for covid-19 immunisation. Medical history included penicillin allergy (Just to penicillin. It looks like it is on her allergies. It could have been when she was a child, she did not know). Patient's other medical history (including any illness at time of vaccination) reported as none. Family medical history Relevant to AE(s) reported as no. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect reported as no. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as no. Prior vaccinations (within 4 weeks) reported as no. On 09Jul2021, 6 hours after receiving the vaccine, the patient had facial numbness and tingling on the right side of her face, which resolved after 14 hours. She had no other symptoms. She was a healthy 41 year old. The patient ended up in the emergency room(ER) and they did a CT scan at the hospital and everything was clean. She was not admitted to the hospital, it was just to the emergency room. The numbness went away after 14 hours. Caller stated she guesses it was somewhat serious, it was facial numbness. Events required a visit to emergency room and physician office. The outcome of the events was completely recovered on 10Jul2021 11:00. Causality reported as "they think so, that is what they are trying to figure out". Patient was greater than 42 days past her first dose. Caller was asking if it was okay for her to receive the second dose after having some side effects from the first dose, so addressed timing as well.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event hypoaesthesia, paraesthesia and the suspect drug BNT162B2.
This spontaneous case, initially received from other healthcare professional on 27-Sep-2018, concerns a female patient of an unspecified age. On 27-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 6 ml, route of administration: intramuscular, anatomical location: deltoid, batch number; 252226 and expiry date: 31-May-2019). No adverse event was reported. The reporter assessed the case as non-serious. This case: 201804160 was cross-linked to the case: 201804158 reported by the same reporter. Non-significant follow-up received from the reporter on 03-Nov-2018: No new information was available regarding the patient's age and adverse events. Hence, no changes were done in the narrative.
Chest pain - Pt with left sided chest pain with running yesterday, about a mile into the run, jogging on a treadmill.  Sharp pain, severe, had to stop.  Pain resolved within a few seconds when he stopped.  Similar episode the day before but much more subtle mild achy pain.  Has had faster heartrate and out of breath much easier since he received the 2nd COVID-19 vaccine 3 weeks ago.  Dull pain/pressure in his chest has been persistent the last few days since he started running for soccer, club soccer just started.  Rode a long intense mountain bike ride prior to the 2nd COVID-19 vaccine, no problems with that, that was 2 weeks after the first, 1 week before the 2nd shot.  Since the second vaccine has been really fat
I started off with a sore throat and a cough and a bad headache the first night. I also had congestion and a runny nose. The day I tested positive (04/29/2022). I had a virtual visit with my doctor and was prescribed Paxlovid and that helped a lot. I had a low grade fever as well but not too high. I am feeling a lot better now.
Joint pain, fatigue and "tunnel hearing" post each of four anthrax shots. She has been evaluated by the rheumatology service as well as locally for the arthralgias. At the time of evaluation (after the 4th shot) she was no longer experiencing the fatigue or "tunnel hearing" but continued to experience arthralgias. Pt states that the arthralgias subsided early in the summer of 2000, but could not be certain of an exact date. She also stated she was not entirely sure her symptoms were solely caused by the anthrax vaccine that she has no reservations about receiving her next dose.  A follow up report received 6/23/2003 adds: Continues to experience the following chronic problems: Chronic arthralgias - no change as far as intensity, locatino or quality of pain. Does not require medication, except for occasional Tylenol; Fatigue - has never completely resolved. Says she has just learned to "deal with it"; "tunnel hearing" - has never completely resolved. None of the above symptoms interfere with job functioning or activities of daily living. Pt received Anthrax #5 in April 2003. She pretreated with Ibuprofen 800 mg TID two days prior to the vaccination, and continued on Ibuprofen for 7 days after the vaccination, without an exacerbation of symptoms. Pt denies any new chronic symptoms or health problems.
received dose from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from an expired vial) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from an expired vial). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter  Treatment information was not provided   This case was linked to MOD-2021-350883 (Patient Link).
PT received her covid-19 vaccine. approx 5mins into the observation period, pt stood up to use the rest room. PT then had syncopal episode. PT was cared for and placed in a supine position with her legs elevated. PT explained some ABD pain but no other symptoms. Pt was not injured from her standing fall. Vitals were monitored and pt was eventually able to ambulate on her own and care for herself.
After 2 months I started getting heart palpitations, shortness of breath and chest pain. This is months after vaccination. Vaccine was Moderna. Both doses taken.
Seen ER report dated 2-7-08 22:21 and returned to ER 2-8-08 00:13.  Hospital Mon.
This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011a21a) for COVID-19 vaccination. The patient's past medical history included Heartbeats irregular (When she was little). On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HEART RATE INCREASED (fast heartbeat). At the time of the report, HEART RATE INCREASED (fast heartbeat) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Husband of patient reported that the patient continued to have a fast heartbeat and reported that personnel at the vaccine site did not show any concern. No concomitant medication use was provided by the reporter. Treatment of events was not reported.
no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 09-AUG-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA005873: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA010274: US-009507513-2209USA010275:
On 7/25/2022, I was doing errands and felt fine. Later that afternoon, I felt tired, so I took a nap. When I woke up, I was shivering, so I figured I had a fever. I took my temperature, which confirmed that I had a low-grade fever. I took a home antigen test and immediately tested positive.  During my illness, I had a fever that only lasted for about 2 1/2 days. I also had runny nose, cough, and fatigue. It lasted seven days at the most. I may have taken Tylenol, but I don't remember for sure.  My blood oxygen levels remained in the normal range, but I kept coughing, so I had a telehealth visit with my PCP. She offered me Paxlovid, but I declined, because so much time had elapsed. She prescribed me a generic version of Tessalon Perles, which I took for about two days at the most. I was then fine afterwards. I followed the CDC protocols for isolation and masking, and I continued to mask afterwards.
15 year old, received Flu vaccine in nurses room, walked to room and 7 minutes later had syncope,  70 seconds later while sitting had loss of conscious and activity myoclonic in arms, head rolling back and eyes, seizure type activity, lasted 10-20 seconds.  BP and POCT glucose were normal-
Patient was administered a dose of the monovalent COVID-19 vaccines after they were no longer authorized. Patient's parents were notified and reported patient did not have any symptoms.
Episode precipitated by upsetting event-noted to cry, turn red in face, followed by breath holding; stiffness of arms/legs lasting approx 1 min; eval in ER & felt to be consistent w/breath-holding spells; probably not related to vax;
heart failure; got really sick; lungs filled with water; fever; Chills; nauseous; headache; teeth throbbing from headache; blood pressure was skyrocketing; lethargy; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the dose 1 of bnt162b2 for COVID-19 Immunisation and got nauseated, chills, and felt really lowsy, chronic pain went away, sore arm, vomiting, dehydrated, body aches and got pretty sick for about 4 days. Caller stated that she had called the first time after the first shot about bad and good side effects of chills, body aches, vomiting that lasted about four days that began one day after the first shot. In 2021, she had a second appointment and got really sick and was in hospital six days. Patient stated that she woke up the next morning with fever, chills, nauseous, headache, teeth throbbing from headache, lungs filled with water and went into heart failure and had to be put in the hospital. She stated that her blood pressure was skyrocketing and then normal. She stated that every 12 hours that she would go into this Covid reaction. She never had a headache, but it cycled every 12 hours. She was given narcotics for headache and a paracetamol (TYLENOL) IV drip that killed her fever. There was a case that she read about from testing children about myocarditis and she thought that was what she had but she was never diagnosed with this. She had been coming back from the second vaccine for two months with lethargy and was just starting to get back to where she felt normal. She had called previously about another weird side effect. She stated that her husband called and a guy from laundry called about a side effect. Outcome of blood pressure skyrocketing was recovered in 2021, outcome of other events was unknown.  Information on lot number/batch number has been requested.
Client to get TWINRIX - Gave HEP B.  Called CDC and they stated to give HEP A and then in 5 months give 3rd TWINRIX.
Client reports that she received her influenza vaccine in left arm on 10-28-03 ar Dr. office.  She had previous flu shots other years.. states she got sick on 10-30-03 pm. with vomiting, aching, dizziness and swelling of left arm.  She says there is an indention about 4" below shoulder wherelooks like flesh is out as if from surgery.  She says the area is still hard and swollen.  She still complains of headache and dizziness.  She says she has been back to Dr. office twice for the arm and he x-rayed it on 12-09-03.  she saw Dr. on 12-23-03 and he reported it to the Health Dept.  She gave this information per telephone one 01-05-04 and came to Health Dept. on 01-06-04 to show the arm to nurses.  Says it is painful to raise the arm.  The Dept. of Health & Senior Services will be sending via mail a picture of this arm and possibly the x-ray and lab work that was done on her.
pt recv vax & devel an inj site rxn characterized by redness & swelling;pt recovered;
Patient received all 3 vaccines and was fine. a few minutes later she tried to put on her jacket and that was when she went pale, her head and eyes rolled back and she started shaking. Patient was unresponsive to questions. it appeared to be a seizure. We were about to call EMS when the patient returned to normal. We observed patient for 30 minutes and gave her some water. By the end of the 30 minutes she looked completely normal and was acting fine. Patient informed me that this has happened to her before during work or exercise but never when she had a vaccination. I encouraged the patient to seek medical attention and even asked her if she wanted me to call EMS and she declined. I told her she should at least follow up with her doctor.
I woke up the next morning (Thursday) with dizziness, the room spinning.  The dizziness continued for the day with movements of the head.  Fell down from a wave of dizziness when I bent over to put shoes on.  Feel much less dizzy, but still have dizziness today (Sunday).  Stomach a bit agitated as well, but I am able to eat.  Head just feels a bit dizzy.
arm was a little sore; A Spontaneous report was received from nonhealth-care professional concerning a female patient of unknown age who received Moderna COVID-19 vaccine (m-RNA-1273). The patient medical history was nothing significant. No relevant concomitant medications are provided. On prior to the onset of the events the patient received his Moderns covid-19 vaccine with no(lot/batch) to for prophylaxis of COVID-19 infection. The very next day she experienced symptoms like swollen arm red and itchy. She received her second shot on 25-feb-2021 and symptoms started on 26-feb-2021. Action taken with mRNA-1273 in response to the events was reported. The outcome of events received after getting the moderna COVID-19 vaccine is not recovered.
Systemic: Fainting / Unresponsive-Severe, Additional Details: ~2 mins post shot pt became unresponsive/fainted, after ~2 mins regained consciousness, ~20 mins later was back to full awareness
On 3/10/2021 I developed a severe headache and fatigue. I realized I was experiencing reportable symptoms the evening of 3/11/21 when the inkection site swelled, turned red and began itching. The site became painful and felt hot. Today, 3/12/2021, the symptoms persist.  I am fatigued and my arm is still sore and warm, a bit itchy, and the site has a hard lump.  I have taken Tylenol.
4 hours, post vax, the pt states she had difficult breathing and a high fever. Spoke with MD that she had Hep-A vaccine and took antihistamine. Within minutes, condition improved. No further problems.
Pt experienced a persistent fever for 2 days, persistent crying for 2-3 days and refused foods for 2 days.
Redness, itching, hot arm, pain at site & traveling down arm, could not raise arm, lasted 3 days.
Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to concentrate , extreme weakness & fatigue, extreme focused joint pain, headache, coughing and difficulty breathing requiring multiple nebulizer uses every 2 hours over 2 weeks, headache. Face & body rash, .  Persistent exhaustion continues requiring 2-3 hour daily naps & non Fibro brain fog continues at 3 weeks.
Suspected vaccination failure; What a big mistake we both made / We end up giving the shingles to ourselves; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient experienced shingles. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown. This case has been linked with the case US2021AMR063242, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063242:Same reporter.