chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got covid omnicrom the Monday after Christmas I have not had my booster dose of Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (got covid omnicrom the Monday after Christmas I have not had my booster dose of Moderna) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got covid omnicrom the Monday after Christmas I have not had my booster dose of Moderna). At the time of the report, COVID-19 (got covid omnicrom the Monday after Christmas I have not had my booster dose of Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. It was reported that the patient got COVID omicron the Monday after Christmas had not received booster dose yet.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred on 23-Jan-22, an unknown duration after the unknown dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. At the time of report outcome of the event was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred on 23-Jan-22, an unknown duration after the unknown dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. At the time of report outcome of the event was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
RabAvert was given on the left gluteal area; Case reference number US-BN-2022-001790 is a spontaneous case report initially received on 05-Aug-2022 from consumer (reference number: USBAV22-0827) and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of RabAvert (rabies virus (inactivated, strain flury LEP); batch number: unknown) at an unknown dose or route, administered in the left gluteal regional, for post-exposure immunisation (post-exposure rabies treatment) due to possible bat exposure (explicitly coded as 'vaccine administered at inappropriate site').  On unspecified dates, the patient was vaccinated with two doses of Human Rabies Immunoglobulin (HRIG) (immunoglobulin human anti-rabies; batch number: unknown) at an unknown dose, route or site of administration, for an unknown indication.  At the time of this repot, it was unknown it the patient experienced any adverse event or how any doses the patient received.  The case is linked to the case US-BN-2022-001789 concerning the same reporter.  Additional information received on 09-Aug-2022 included local case ID.; Reporter's Comments: A female patient of unknown age was vaccinated with a dose of RabAvert at an unknown dose or route, administered in the left gluteal regional, for post-exposure immunization (post-exposure rabies treatment) due to possible bat exposure, which is considered as vaccine administered at inappropriate site. No associated adverse events have been reported with the reported medication error. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with a dose of RabAvert at an unknown dose or route, administered in the left gluteal regional, for post-exposure immunization (post-exposure rabies treatment) due to possible bat exposure, which is considered as vaccine administered at inappropriate site. No associated adverse events have been reported with the reported medication error. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
second dose 4/26/21, first dose was in may 2018; This case was reported by a nurse and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (1st dose received in May 2018).   On 26th April 2021, the patient received the 2nd dose of Shingrix. On 26th April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional case details were reported as follows: The patient received 2nd dose of vaccine later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter asked whether this dose would be counted as valid or the series need to be restarted. The reporter consented to follow up.
Information has been received from a physician concerning an approximately 64 year old male with no drug or other allergies who on 28-NOV-2007 was vaccinated with  0.65ml dose of ZOSTAVAX (Merck). On 03-MAY-2011 the patient might have a mild case of shingles. The physician stated that if the patient had the shingles virus it was a very mild case and had already crusted over and "It was too late to give the patient anything to help, like an antibiotic." Unspecified medical attention had been sought. The patient was treated with prednisone and LIDODERM for rash. No blood work was done. At the time of the report, the patient's outcome was unknown. The patient currently being treated for gastrooesophageal reflux disease, hypertension and hyperlipidaemia. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2016, the patient was inoculated with ZOSTAVAX, at a pharmacy (by an unspecified health care professional)  as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at a medical center emergency department (ED) (by an unspecified health care professional) for the onset of a severe vesicular rash, which was diagnosed as Herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Difficulty walking began within 10 days of the immunization with leg weakness making walking difficult. Slowly began having signs of arm weakness, slurred speech and difficulty swallowing, vision problems. Symptoms intensified over the course of the next 15 months, in June 2021 diagnosis of ALS.
severe fatigue (so tired that he felt like he was going to pass out); myalgia that resulted in him feeling muscle pain from his feet up to his neck; his arm was sore; he felt like he was going to pass out; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: severe fatigue (so tired that he felt like he was going to pass out)), myalgia (Verbatim: myalgia that resulted in him feeling muscle pain from his feet up to his neck), pain in arm (Verbatim: his arm was sore) and presyncope (Verbatim: he felt like he was going to pass out). The outcome of the fatigue, myalgia, pain in arm and presyncope were resolved (duration 4 days).   It was unknown if the reporter considered the fatigue, myalgia, pain in arm and presyncope to be related to Shingrix.     It was unknown if the company considered the fatigue, myalgia, pain in arm and presyncope to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JUN-2023 Consumer was the reporter.  The reporter stated that after receiving first dose of Shingrix he experienced severe fatigue so tired that he felt like he was going to pass out and myalgia that resulted in him feeling muscle pain from his feet up to his neck.  The reporter also reported that his arm was sore.  Took him about 4 days to get over the adverse reaction. The reporter consented to follow up.
Noticed red welts ("hives") on arms about 7:30-8:00pm 12/5-spread to trunk, hands, neck and scalp. Took Benadryl resolved am 12/6. Reoccurrence of "hives," about 7:30pm 12/6-took more Benadryl-resolved by 12/7 am-no reoccurrence.
Information has been received from a registered nurse reporting on a 59 year old female patient. The patient's concurrent conditions include congestive heart failure, Hodgkin's disease, hypothyroidism and allergy to sulfa. The patient's concomitant medication included acyclovir (ZOVIRAX), bupropion hydrochloride (WELLBUTRIN), cyclobenzaprine hydrochloride (FLEXERIL) acetaminophen, hydrocodone bitartrate (NORCO), levothyroxine sodium (SYNTHROID) and meloxicam. There was noinformation about the patient's medical history. On 06-OCT-2017, the patient received an unspecified dose of PNEUMOVAX 23 lot # N014946, epiration date 01-FEB-2019, intramuscular, in the leftoid area (unspecified arm) for prophylaxis. On the same date, the patient received on the same area a dose of FLUZONE (dose, route of administration, lot number and expiration date were not reported). On 08-OCT-2017, the patient developed "cellulitis like symptom" from the area below the injection site down to the elbow. The nurse indicated that the patient sought medical attention and received treatment for the adverse event. No lab diagnostics/studies were performed. The outcome of the event cellulitis and its causal relationship with PNEUMOVAX 23 or FLUZONE were not reported. Upon internal review, cellulitis was considered to be a medically signifcicant event.
Feeling of sudden faintness with increased heart rate and breathing rate, and feeling of inflamed sinuses. Faintness, heart, and breathing lasted acutely for  about 30 minutes. After that sore arm, weakness, tiredness, and headache lasted for several days. Inflamed sinuses and sinus pressure recurred for more than a week after the shot.
This spontaneous report as received from a Nurse refers to a patient of unknown demographics. The patient's current conditions or medical history were not repotted. On 26-SEP-2013, the patient was vaccinated with the first dose of VAQTA (dose, route, lot number and expiration date were not reported). On 06-MAR-2014, the patient was vaccinated with the second dose of VAQTA (dose, route, lot number and expiration date were not reported). No adverse effect were reported. Additional information is expected.
Information has been received from a health professional concerning a 10 year old female, with no medical history or no allergies, who on 20-FEB-2001 was vaccinated with a dose of Varivax. Subsequently, the patient experienced mild, breakthrough chickenpox. At the time of the report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a health professional indicated that on 15-MAY-2006 the patient came into the office with a chief complaint of a rash on her belly and back that began "approximately 2 days ago", on approximately 13-MAY-2006, on the back. It was reported that the rash was blister-like and was crusting. The patient was instructed to continue calamine lotion and could return to school since all lesions were crusted. It was reported that the patient had recovered. Additional information is not expected.
massive heart attack; This is a spontaneous report from a contactable consumer or (patient's daughter-in-law).  A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9267) via an unspecified route of administration at single dose in right arm on 19Feb2021 3:30PM for COVID-19 immunisation. Medical history included diabetes, high blood pressure. Concomitant medications included meloxicam at 15 mg one tablet per day in morning by mouth, metformin at 1000 mg twice daily by mouth, hydrochlorothiazide, valsartan (VALSARTAN + HIDROCLOROTIAZIDA) at 320 mg/12.5 mg once a day in morning by mouth, all from unspecified date and ongoing for unknown indication. On 03Mar2021, the patient experienced massive heart attack with outcome of unknown. The event required a visit to the emergency room. The patient was hospitalized for massive heart attack from 03Mar2021 to ongoing. Reporter stated that "Patient is in the hospital right now as he had a massive heart attack on Wednesday 03Mar2021. She reports they do not think its an adverse event related to the COVID-19 vaccine because 3 of his 4 valves were clogged, but she did fill out a form online with the state of (state withheld). The patient's second COVID-19 vaccine was rescheduled to 13Mar2021 and she is asking if the second COVID-19 vaccine can be rescheduled to the 31Mar2021, since the patient will have a long recovery. She's not sure how far they can go with the scheduling of the second vaccine before the 1st one will expire and he will have to start the series all over again".
Patient experienced flushing and anxiety after vaccination. Placed in a recumbent position, given water and observed 30 mins
RECEIVED REPEAT VACCINATION DUE TO USER ERROR/MALFUNCTION OF RETRACTABLE NEEDLE UPON INJECTING VACCINE., AND MAJORITY OF VACCINE NOT BEING INJECTED. UNSURE OF AMOUNT INJECTED ON FIRST ATTEMPT, SO POSSIBLY RECEIVED GREATER THAN RECOMMENDED DOSE.
employee forgot her vaccination card and 2nd booster was administered prior to her 4 months from booster shot back in 01/20/22. No reactions to report
Moderate to sever pain on left side of body - chest and upper back pain, arm pain and tightening down through left leg.  The waves of pain last for an hour before relief and then return in another wave about every hour or so.  Blood pressure very high - 170/77 when I am usually 110/70.  Tylenol did little to resolve the pain.  Went to ER twice due to level of pain.  Heart assessment checked out ok.  Was sent home and instructed to take tylenol.  Took tylenol, benadryl and zyrtec for several days and inflammation and pain continued, but the severity has lessened.  Day 8, pain waved continue.  I went to Urgent care and they prescribed prednisone 40 mg  for five days.  First dose helped, but the flare up occurred again about 20 hours after first dose of prednisone.
Patient received one injection on each side about 4 pm on December 11, 2018. At about 9pm she noticed her face was swelling and she had some numbness. She didn't have any problems at injection sites other than normal soreness. She took TYLENOL PM because she knew there was BENADRYL in it. She slept all night. When she woke up it was more swollen and she said she looked like a cartoon character. She took BENADRYL at 8am and 10 am. She said swelling had gone down some. She had she takes flu shot every year and this was first SHINGRIX. I told her to call her physician to see if he wanted to see her. I called her back at 630pm and she said she had talked to MD and he felt like it was SHINGRIX vaccine and for her not take second one. He told her if she was still having trouble to call back in morning and he could give her a steroid shot.
20 mins after flu shot I had tightness in my chest. My breathing felt short. 3 days later in the roof of my mouth felt like a sore throat. Called Dr. next day. I had yellow color come up when I cough. I continued to cough and wheeze so then I went to my lung Dr. and he gave me Prednisone and antibiotics. I am taking Tussin DM cough medicine my self.
Extreme fatigue,  daily extreme vertigo,  extreme loss of cognitive recall,  achy lower back,  achy legs
severe allergic reaction to the Pfizer vaccine; This is a spontaneous report from a contactable physician. A non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included COVID-19 infection on Mar2020. The patient's concomitant medications were not reported. The patient with previous COVID-19 infection experienced severe allergic reaction to the Pfizer vaccine on an unspecified date. The patient and her husband had COVID-19 infections in Mar2020 and patient's reaction to the vaccine occurred much later. It was unknown if treatment was given in response to the event. The outcome of the event was recovered on an unspecified date.
she has lost 2 lbs since she started with all this.; get tested and got her results back early on Monday and it was positive; This is a spontaneous report from a contactable consumer. A 71-year-old female consumer (patient) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration on 13Feb2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the first Pfizer shot on 13Feb 2021, soon after shot patient had chills but ignored it most of the time until Sunday and tested again and resulted as positive. They are scheduled to have the second on 06Mar2021. Both her husband and herself got the shot on 13Feb2021. On an unspecified date, the patient lost 2 lbs since she started with all this. On 21Feb2021, the patient underwent lab test and procedure which include  tested Covid test and resulted positive. The patient assessed the events as non-serious. The outcome of the events were unknown.  No follow up attempts are possible. No further information is expected.
big red circle on injection side; itchy injection side; sore on the injected arm; hurting too bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (big red circle on injection side), VACCINATION SITE PRURITUS (itchy injection side), VACCINATION SITE PAIN (sore on the injected arm) and PAIN IN EXTREMITY (hurting too bad) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for an unknown indication.     The patient's past medical history included No adverse drug reaction.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (big red circle on injection side), VACCINATION SITE PRURITUS (itchy injection side), VACCINATION SITE PAIN (sore on the injected arm) and PAIN IN EXTREMITY (hurting too bad). At the time of the report, VACCINATION SITE ERYTHEMA (big red circle on injection side), VACCINATION SITE PRURITUS (itchy injection side), VACCINATION SITE PAIN (sore on the injected arm) and PAIN IN EXTREMITY (hurting too bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
People lost their appetite within  24 hours; 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 DECREASED APPETITE (people lost their appetite within  24 hours) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (people lost their appetite within  24 hours). At the time of the report, DECREASED APPETITE (people lost their appetite within  24 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  Concomitant medications were provided.  No Treatment medications were provided.
Feeling queasy; headache; malaise; pain; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration on unspecified date in Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the covid vaccination was reported as unknown. Covid tested post vaccination was reported as unknown. On an unspecified date the patient experienced feeling queasy, headache, malaise, pain. The clinical outcome of the event was unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.
began with Sharp shooting pain in shoulders, then Shoulder blades, lower calves ankles and feet. Numbness, tingling stabbing pain for 2 months in calves and ankles and feet. Loss of vision in lower right eye on March 19th.