chrisvoncsefalvay/vaers-outcomes huggingface dataset:
woke up 8AM on 13OCT96 w/t101, very fatigued all day, severe body aches, dry, tight cough, sore throat & dec appetite;sx were worse around noon & gradually dec over next 10-12hr;inj site red, swollen, sore x 36hr p/vax;
Urinary Tract Infection (UTI) after the 1st dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "Urinary Tract Infection (UTI) after the 1st dose".  Additional Information: The patient was asking if she should take the second dose because of her UTI or not. The was also asking if how long should she wait before getting the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Got the shot and had shingles over and over/ suspected vaccination failure; Shingles; Burning; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and had shingles over and over/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and burning sensation (Verbatim: Burning). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved and the outcome of the burning sensation was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and burning sensation to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and burning sensation to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine after cleared previously experienced shingles. The patient stated that after received Shingles vaccine did not stop anything and experienced shingles over and over for long time in the same place and then just stopped. The patient stated that the burning is the word would be used to describe the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
15OCT96 mom stated pt broke out last evening w/chickenpox;MD has not seen;RN encouraged pt be seen by MD;pt seen by MD 15OCT who says uncertain if 9 papular areas are vaccine related or bites;states areas are a little pruritic;
This spontaneous report as received from a pharmacist refers to a 74 year old female patient. The patient had no known drug reactions or allergies. On 11-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX lot # L037790, expiration date 30-DEC-2016 subcutaneous. Concomitant therapies included warfarin and gabapentin. On 13-JUL-2016, 2 days after ZOSTAVAX administration, the patient developed blisters and sores all over her body which itched really badly. The pharmacist reported that the patient was seen on an unspecified date by a physician who prescribed prednisone (manufacturer unknown) 5 mg in a dose pack and hydroxyzine hydrochloride (manufacturer unknown) 25 mg for the itching. The pharmacist stated that the patient reported that everything was ok the first day she took prednisone (manufacturer unknown) and then, everything got really worse. After this, the patient went to a different physician who discontinued the prednisone (manufacturer unknown) and increased the hydroxyzine hydrochloride (manufacturer unknown) to 50 mg. At the time of the report, the patient continued to have the blisters and sore and they were still itching "really badly". The pharmacist did not assess the relationship of the events to ZOSTAVAX. The varicella zoster virus identification program pack was sent to the pharmacist. Additional information has been requested.
I have had a fever that keeps topping 99.5 (avg was 100.1) since Friday night. (It is Monday night) My entire body still hurts. As I write this it is currently 99.3. I normally run low at around 97. 99.3 is high for me and feels pretty crappy.  I have had some heart palpitations. Some of the worst chills I?ve ever had. A few dizzy spells. Fatigue. My arm still REALLY hurts. I?m dehydrated and keep having muscle cramps (I?m drinking lots of water and pedialyte). You need to know how people are reacting to this. This is day 4. I have no energy. I do NOT feel good.
Tested positive for covid on April 12, 2021 after sore throat, fatigue, headache on April 11.  Other family member tested positive on April 9, 2022.  Treatment - paxlovid.  Symptoms were mild after paxlovid, mostly fatigue and cough.  Lasted a few days.  Fatigue lasted a few days longer than cough.
Patient with history of diabetes and Parkinson's. She was seen in the ED on 12/13/22 for evaluation of failure to thrive. Family members reported rapid decrease in patient's health, including increased confusion, cough, decreased appetite, and increased fatigue. Additionally, COVID PCR testing done in the ED returned positive. She was admitted 12/13/22 - 12/16/22 for COVID-19 infection, noted to be mostly asymptomatic, among other discharge diagnoses. Patient has been vaccinated against COVID-19.
Patient mother reports headache , nausea and vommiting. Patient advised to maintain hydration. Acetominophen for headaches.
SYMPTOMS BEGAN THE DAY AFTER VACCINATION.  STARTED WITH NUMBNESS AND TINGLING IN RIGHT FOOT.  PAIN IN SAME AREA THAT DAY.  WEAKNESS OF ARCH IN FOOT.  SAME SYMPTOMS CONTINUED UNTIL 01/14/21.  ON 01/14, BOTH RIGHT AND LEFT FEET, ANKLES, LEGS (ABOVE THE KNEE DOWN).  THESE SYMPTOMS SPECIFICALLY INCLUDE TINGLING, PRICKLY, SLIGHT NUMBNESS.  CONDITION GETS BETTER AND WORSE FOR NO REASON.  ESSENTIALLY FEELS LIKE LEGS ARE WAKING UP AFTER THEY HAVE FALLEN ASLEEP.  ALSO HAS THE SAME SYMPTOMS IN BOTH ARMS (ELBOW DOWN) AND HANDS.  HANDS FEEL VERY COLD.  SAME SYMPTOMS IN RIGHT SIDE OF FACE INCLUDING EAR.  NO SEVERE PAIN PRESENT.  NOT TAKEN ANY ACTION TO RESOLVE AS OF YET.
Syncope within 2 minutes after shot. Excessive forehead sweating and lightheadedness. Did not fall to floor or lose consciousness. Resolved completely in 15 minutes. Gave pt Gatorade and peanut butter crackers. Pt admitted to always getting nervous prior to any medical procedure. Pt visiting.  100% fine when he left.
Tenderness under under right axilla that has began to swell and become very tender to touch.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 38-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 1st February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-FEB-2023 Reporter comment: The reporter reported that, the expired dose of Havrix was administered to a patient. The reporter consented to follow up via email. Additional Supportive Information: The patient received an expired dose of Havrix vaccine which led to expired vaccine used.
This case was reported by a consumer via patient support programs and described the occurrence of sinus infection in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced sinus infection. On an unknown date, the outcome of the sinus infection was unknown. The reporter considered the sinus infection to be unrelated to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was complaining about GSK asking questions of them during an earlier adverse event call. The patient had explained that if they tell us they were sick or went into the hospital GSK would like to follow up with a letter about the event and it was required of me to ask those questions. You do not had to answer if you do not want to. They proceeded to say they do not think their sinus infection had anything to do with the vaccine and ended the call.
Gum infection/Bacterial infection; This spontaneous case was reported by a patient and describes the occurrence of BACTERIAL GINGIVITIS (Gum infection/Bacterial infection) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 025B21A and 012A21A) for COVID-19 prophylaxis.     Concomitant products included LISINOPRIL and SIMVASTATIN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACTERIAL GINGIVITIS (Gum infection/Bacterial infection). The patient was treated with CEFALEXIN SODIUM (CEPHALEXIN [CEFALEXIN SODIUM]) for Gum infection, at a dose of 500 milligram. At the time of the report, BACTERIAL GINGIVITIS (Gum infection/Bacterial infection) had not resolved.            The patient did not have positive covid test or diagnosis. Patient had no allergies.  The patient received 3 doses of the moderna vaccine, 2 primary series doses and 1st booster dose in recommended time frame.  The patient stated that his dentist put him on a broad-spectrum antibiotic called Cephalexin 500mg for 10 days for a gum infection. The patient stated that the infection was still on going and stated that it was a bacterial infection.   This case was linked to MOD-2021-057994 (Patient Link).
pt was given the Pfizer COVID vaccine when she had already received both of the moderna vaccines. NO issues reported, pt had no complaints when discharged.
THE AREA OF INJECTION SITE BECAME RAISED, HOT AND TENDER TO TOUCH. THE PATIENT DESCRIBED THE AREA MEASURING ABOUT 7 INCH. SHE TOOK MOTRIN TO HELP WITH THE DISCOMFORT AND I ALSO RECOMMMENDED PUTTING ICE ON THE AREA. SHE DID NOT EXPERIENCED ANY DIFFICULTY BREATHING OR RASH.
Chills , headache, fatigue Sore, swollen arm with red Mark that is huge
Heart rate of 209, It stayed high for quite a while/ The heart rate is now at 138; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart rate of 209, It stayed high for quite a while/ The heart rate is now at 138) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JJ (Patient received the JJ primary vaccination). Past adverse reactions to the above products included No adverse event with JJ. Concurrent medical conditions included Pulmonary arterial hypertension (PAH).    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced HEART RATE INCREASED (Heart rate of 209, It stayed high for quite a while/ The heart rate is now at 138). The patient was treated with IBUPROFEN for Heart rate high, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Heart rate of 209, It stayed high for quite a while/ The heart rate is now at 138) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Heart rate: 209 (High) 209. On 26-Nov-2021, Heart rate: 138 (High) 138.         No concomitant medications were provided.
Initial information has been received a 60 years old male consumer concerning himself with back pain and not drug reactions / allergies. On 11-JAN-2013, the patient was vaccinated with liveZOSTAVAX(Lot # H019042 exp date 17-JAN-2014)(dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On 13-JAN-2013 the patient developed shingles after vaccination with live ZOSTAVAX, and he developed a headache. On 14-JAN-2013 he developed painful vesicles on his right scalp and forehead and also his right eye. His right eye also was sore. The patient was treated with ADVIL and VALTREX. There were not laboratory studies performed. At the time of report, the patient had not recovered. Due to the patient was a physician, it was reported that the patient sought medical attention. Additional information has been requested.
i feel lousey; My bidy aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (i feel lousey) and MYALGIA (My bidy aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (i feel lousey) and MYALGIA (My bidy aches). At the time of the report, FEELING ABNORMAL (i feel lousey) and MYALGIA (My bidy aches) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.
about 12 hours after, heart rate 20 to 30 bpm higher than normal for 24 hours; Normal resting in upper 60s. Most of the day was between upper 80s and upper 90s.; Fatigue; More thirsty than normal; Arm much more sore after 2nd dose; Mild diarrhea; Mild headache for more than 24 hours starting 6 hours after shot; This is a spontaneous report from a contactable consumer, the patient. A 46-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8737), via an unspecified route of administration in the arm left on 10Apr2021 10:30 as dose 2, single (at the age of 46-years-old) for covid-19 immunization. Medical history included brain tumor, respiratory tract congestion, cough from congestion and bandaid adhesive allergy. The concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6207), via an unspecified route of administration in the arm left on 19Mar2021 07:15 PM as dose 1, single for covid-19 immunization and experienced heart rate was elevated and mild sore arm. On an unknown date in Apr 2021, about 8 hours after the second shot of vaccine, the patient experienced mild headache which was lasted for more than 24 hours, patient got frequent headaches so might or might not be related and about 12 hours after heart rate was 20 to 30 bpm higher than normal for 24 hours: normal resting in upper 60s. Most of the day was between upper 80s and upper 90s. The patient also experienced fatigue, more thirsty than normal, arm much sore after 2nd dose and mild diarrhea on an unknown date in Apr 2021. The patient was not received the treatment for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient not tested for COVID-19. The patient was not received any other medications within 2 weeks while not received any other vaccines within 4 weeks. The outcome of the events heart rate increased and pain in extremity was recovered while outcome of the other events was recovering.  No follow-up attempts were needed. No further information was expected.
pt had t103; seen in ER 5FEB93 & admitted sepsis workup neg; mild non erythematous swelling rt anterior thigh; tx IV; dx fever & vax reaction;
This case was reported in a literature article and described the occurrence of Bell's Palsy in a subject who received Flu seasonal TIV Dresden. Concurrent medical conditions included asthma. On an unknown date, 1 day after receiving Flu seasonal TIV Dresden, the subject developed Bell's Palsy. Serious criteria included GSK medically significant. The outcome of Bell's Palsy was unknown. It was unknown if the investigator considered the Bell's Palsy to be related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of Bell's Palsy in a patient aged between 2 and 18 years of unspecified gender who was vaccinated with unspecified inactivated influenza vaccine (manufacturer unknown). The patient was a part of the study that investigated the safety of live attenuated influenza vaccine (LAIV) administered to children and adolescents with history of asthma and evaluated whether its safety profile varied according to asthma severity. It also compared LAIV versus inactivated influenza vaccine (IIV) with respect to asthma exacerbations and other adverse events in children and adolescents with a history of asthma within a particular part of the country. The study also identified all non-asthma outpatient visits as a "negative control", since such visits were not expected to vary between IIV and LAIV recipients. The patient was a negative control in the study. The patient had a history of asthma, prior to immunisation. No information on patient's family history or concomitant medication or concurrent condition was provided. On an unspecified date between 1 July 2007 and 31 March 2014, the patient received unspecified inactivated influenza vaccine (administration site and route unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, between 1 and 14 days after vaccination with unspecified inactivated influenza vaccine, the patient developed Bell's Palsy. (In this study, 1-14 days period after immunisation was considered as risk window). (In this study, non-asthmatic events like Bell's Palsy were only counted as event if there was no other event of the same kind in the prior 60 days). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of Bell's palsy and unspecified inactivated influenza vaccine. However, the authors stated "The authors concluded, "Among children and adolescents with a history of asthma, we found no evidence that those who received LAIV were more likely to have an asthma exacerbation than those who received IIV, and we found that incidence of such events following immunization with LAIV was relative low regardless of asthma severity. Our findings indicate that use of LAIV in children equal to or more than 2 years old with asthma did not increase the risk of asthma exacerbations. "
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787; US-009507513-1805USA009900:Original Case : 1805USA006787; US-009507513-1805USA009901:Original Case : 1805USA006787; US-009507513-1805USA009902:Original Case : 1805USA006787; US-009507513-1805USA009903:Original Case : 1805USA006787; US-009507513-1805USA009904:Original Case : 1805USA006787; US-009507513-1805USA009905:Original Case : 1805USA006787; US-009507513-1805USA009906:Original Case : 1805USA006787; US-009507513-1805USA009907:Original Case : 1805USA006787; US-009507513-1805USA009908:Original Case : 1805USA006787; US-009507513-1805USA009909:Original Case : 1805USA006787; US-009507513-1805USA009910:Original Case : 1805USA006787; US-009507513-1805USA009911:Original Case : 1805USA006787; US-009507513-1805USA009912:Original Case : 1805USA006787; US-009507513-1805USA009913:Original Case : 1805USA006787; US-009507513-1805USA009914:Original Case : 1805USA006787; US-009507513-1805USA009915:Original Case : 1805USA006787; US-009507513-1805USA009916:Original Case : 1805USA006787; US-009507513-1805USA009917:Original Case : 1805USA006787; US-009507513-1805USA009918:Original Case : 1805USA006787; US-009507513-1805USA009919:Original Case : 1805USA006787; US-009507513-1805USA009920:Original Case : 1805USA006787; US-009507513-1805USA009921:Original Case : 1805USA006787; US-009507513-1805USA009922:Original Case : 1805USA006787; US-009507513-1805USA009923:Original Case : 1805USA006787; US-009507513-1805USA009924:Original Case : 1805USA006787; US-009507513-1805USA009925:Original Case : 1805USA006787; US-009507513-1805USA006787:Original Case : 1805USA006787; US-009507513-1805USA009927:Original Case : 1805USA006787; US-009507513-1805USA009928:Original Case : 1805USA006787; US-009507513-1805USA009929:Original Case : 1805USA006787; US-009507513-1805USA009930:Original Case : 1805USA006787; US-009507513-1805USA009931:Original Case : 1805USA006787; US-009507513-1805USA009932:Original Case : 1805USA006787; US-009507513-1805USA009933.
She has been having some flair ups and lots of inflammation in her arms and elbows; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) at the age of 76 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "She has been having some flair ups and lots of inflammation in her arms and elbows".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Several days after my first Moderna dose, I developed heart flutters or palpitations (like my heart was skipping) that continued for several weeks. I would feel them throughout the course of the day, several times per hour.  After several weeks, they went away completely.