chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent condition is blood pressure, and had not known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total administered on left arm on 22-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced Soreness, Nausea, Diarrhea, Fever, Headaches, Sinus Congestion, and loss of smell (confirmed covid-19 infection). On the same date, COVID-19 virus test result was performed and result was Positive which suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. on an unspecified date patient experienced soreness as well. The outcome of the confirmed covid-19 infection, suspected clinical vaccination failure was not reported. This case, from the same reporter is linked to 20211043553 and 20211043252. This report was associated with product quality complaint.; Sender's Comments: V0: 20211043945-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a health care professional concerned a 54 year old male. The patient's height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced body aches. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210429909.
4 1/2 cm x 4 1/2 cm reaction to (L) thigh, redness. BENADRYL and KEFLEX were given.
Right arm became swollen and red, painful according to husband. Also had alot of nausea.
given a dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received HBV (Engerix B) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   On 12th September 2022, the patient received Engerix B. On 12th September 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comments: The pharmacist reported a patient was given a dose of Engerix-B that had expired the day prior.  The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up via email. Additional Supportive Information: The patient received expired Engerix B, which led to expired vaccine used.
Fever of 99.0+ for over 24 hours and went up to 101.1 . This happened with my first dose as well but the highest it went was 103.6 .  Also had chills and body aches both times as well.   This time I also felt aching through the right side of my body as well as on and off chest pain but only for a short period of time.
noticed two blisters, one below her neck and one on the right side of her back; Suspected vaccination failure; shingles; right sided back pain; right arm pain; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number K2ZY4, expiry date 13th April 2021) for prophylaxis.   On 12th March 2019, the patient received the 2nd dose of Shingrix. On 27th November 2018, the patient received the 1st dose of Shingrix. On 28th November 2020, 627 days after receiving Shingrix and 732 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, back pain and pain in arm. On 29th November 2020, the patient experienced blister. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles, back pain, pain in arm and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, back pain, pain in arm and blister to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had reported the events for herself. The patient started to experience severe right sided back pain and right arm pain and on sunday 29th November 2020, she noticed two blisters, one below her neck and one on the right side of her back and she was diagnosed with shingles. The patient was started on valcyclovir. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow-up.
Pt received MMR and varicella vaccines on 6/12/14 on 6/30/14 pt was seen in office for rash all over body x 1 day. Pt had blood drawn and showed positive for varicella and MMR. Pt symptoms lasted 3-4 days and resolved. No treatment. Rash was vesicular lesions and MD determined was active varicella.
IN BY SELF --STARTED WITH A RASH ITCHY ARMS AND BACK AND STOMACH AREA TOO --TRIED BENADRYL --THEN SPREAD ALL OVER GOT BUMPY ALSO OINTMENT TRIED.. ? C... UNCERTAIN NAME--HELPED .. OF NOT HAD J&J VAC LAT WEEK . NOT BEEN OUT IN WOODS -NO KNOWN EXPOSURE TO POISON IVY ETC.. WORKS WITH MACHINES --DISC'D RISK -  ZYRTEC PRN--OK 2 X A DAY X 3-5 DAYS
Erythema (getting red); Irritability (Irritated); This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Erythema (getting red)) and IRRITABILITY (Irritability (Irritated)) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced ERYTHEMA (Erythema (getting red)) and IRRITABILITY (Irritability (Irritated)). At the time of the report, ERYTHEMA (Erythema (getting red)) and IRRITABILITY (Irritability (Irritated)) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Pt had 2 episodes of Anthrax related adverse reactions after 1st and 2nd shot. Pt reported developing nausea, vomiting, headache, weakness, fatigue and difficulty sleeping with 1st shot lasting 3 weeks and 2nd shot lasting 2 1/2 months. Pt also complained of local swelling of 5cm. Treatment was Tylenol and Phenergan, on 2/2/2000 and Entex LA, Tylenol, Cepacol 1oz, for flu-like symptoms on 1/19/2000. Pt still suffering with the same symptoms and is not completely recovered. Consultation generated to see Internal Medicine.
Patient reports getting hives approximatively 48 hours after receiving Fluad vaccination. Patient reported taking 2 diphenhydramine tablets and hives resolved about 6-7 hours later. Patient also report penis feeling "swollen and twisted" which resolved later after applying a similar type of allergy cream on the area.
Reporting issue with the Pfizer Booster I received on 11/17/2021.  Side effects:  body aches that lasted 3 days. Skin blotched/breakout on right side of face. 1.  I had the original Phizer vaccines in March/April 2;021. NO SIDE EFFECTS. 2.  I had the Phizer booser on Nov 17 and experienced unexpected side effects.  (I am in good health and have not been sick for many years).  Besides Body aches, a rash or skin blotches appeared on the right side of my face. I have NEVER in my life had this type of skin reaction (except for Measles and Chicken Pox).   I AM CONCERNED ABOUT WHAT TYPE OF POISON IS IN THIS BOOSTER.    Certainly something that my body rejected.   I AM CONCERNED ABOUT MORE LONGER TERM SIDE EFFECTS.
Patient returned to pharmacy a couple days later complaining of slight swollen at site of injection, with fevered area and redness. By the time the patient came in the symptoms were dissipating per patient.
Flu like symptoms, body aches, headache, fatigue, bruising amd swelling of arm that the vaccine was in.  Then 4 days after the vaccine I woke up with shingles blisters on the right temple.  Will head to my PC dr tomorrow but cant believe the vaccine caused a shingles outbreak.
shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered to be not recovered. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).
I did not have a direct reaction to any of my 3 Pfizer COVID vaccines.   I just recently happened to realize that in the months preceding my second vaccine in February, I was getting intermittent hives for the first time in my 67 years.  The worst event was in September of 2021 when the hives were  extensive over my scalp, ears, torso, legs, and feet.  I did use a whitening hair product once and only once two days before this occurred.  I went to the OnCall and they gave me prednisone and Benadry.  I have since gotten smaller outbreaks of hives on an intermittent basis (q weekly at this point).  Recently, my daughter commented that I have never had hives before and it seemed to start after my COVID vaccines and it may be related so perhaps I should report it at  the next COVID check in text.   I have no idea if this is related to my vaccines.  It could be coincidental.  There has been no change in meds, soaps, detergents, shampoos or conditioners.  I am pretty set in my ways.   This is no big deal and the hives come and go so I don?t have dates and times, etc.
Nausea, body aches, headache, fever & fatigue.   Started within 24 hours and lasted about 18 hours.  Fatigue and headache lasted 48 hours
Inconsolable Crying; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from  other health professional.  This case is linked to case 2020SA041905 (same reporter).  This case involves a 6 months old male patient who experienced inconsolable crying (crying), while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza Vaccine Inact Split Virion 4v (Fluzone Quadrivalent) for prophylactic vaccination; Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13) for prophylactic vaccination; and Rotavirus Vaccine (Rotavirus Vaccine) by mouth for prophylactic vaccination on 12-Feb-2020.  On 12-Feb-2020, the patient received a third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ190AAA and expiration date 22-Feb-2021) via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date, the patient developed a non-serious inconsolable crying (crying) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  No laboratory data reported.  Final diagnosis was crying.   It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event crying.
fainted twice while visiting the bathroom; BP was 145/85; arm was sore; This is a spontaneous report from a contactable consumer reporting for herself.  A 70-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot_number m000007217771.CSN20 447277212), via an unspecified route of administration in left arm on 11Feb2021 16:45 at single dose for covid-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included hypertension, blood cholesterol increased, anxiety, allergies, allergies to penicillin, Sulfa drugs and Crustacea. The patient previously took tetracycline and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Concomitant medication included olmesartan medoxomil (unknown manufacturer), diltiazem hydrochloride (unknown manufacturer) and sertraline hydrochloride (SERT). On 12Feb2021 her arm was sore but she was not really feeling anything more. On 13Feb2021 morning at 04:45 the patient fainted twice while visiting the bathroom. Upon checking of the BP it was 121/75. Later in the day the BP was 145/85. The patient was completely normal before the shot. It seems that the vaccine affected my BP. The outcome of the events was recovered in Feb2021. No treatment was performed. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
At 9:00 pm I developed a fever, headache and was very tired. Overnight I had to urinate 10 times which is highly unusual. I may get up once a night commonly. In the middle of the night I was sweating and then got chilled and put a blanket on. Mind you it is June and we keep our home at 80 degrees. I took my temperature and it was 101.5. I took TYLENOL 2/500 mg tablets and the fever went down to 100.3. During the day I still had the headache. These symptoms lasted about 24 hours. By the evening of 6-13-18 I felt better.
This initial spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown ages and genders. Pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL injection (Lot# K008931 with expiration date 04-MAR-2017; dose, route and anatomical location were not reported). No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 2 hours after receiving Hepatitis A/Typhoid Vi/ IPV vaccines for travel to foreign country, pt. developed sudden, rapidly enlarging hives in both eyes, expanding to include periorbital area, upper nose & cheeks and a feeling of a lump in her throat. Provider at home thru the emergency service. Pt. did not report swelling to tongue/lips/airway or difficulty with breathing/swallowing when she called the provider on-call (me). She was advised to go to ER & since she called from Pharmacy to my home, I advised her to take BENADRYL 25mg X 2 STAT & have parents drive to ER, (They were with her at time) Pt. ended up not going to ER, but taking the BENADRYL "two or three tablets" and sitting at home with her parents, until symptoms mostly resolved (around 10 pm the same night). Today (2/21) I called pt. for update around 11:45 am. She still has some puffiness around her eyes but otherwise, symptoms have mostly resolved.
When they administered it he felt it was burning; His palm went numb/ was feeling my left arm with pain and also that was like my arm was numb; Pain on the left side of his hand and on the joints/ I was feeling my left arm with pain and also that was like my arm was numb; It was burning like when they put the vaccine; in my body I feel burning right away in the arm, the right one.; Feel some pain like in my chest; He had muscle pain on the left side and "behind the back"/ i  feel some pain like in my chest; muscle what in the heart right there and also in my back.; He felt very hot at the site; I have little pain in my back; This is a spontaneous report received from a contactable consumer or other non hcp. A 34-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown, Expiry Date of Covid 19 Vaccine: Un-known) via an unspecified route of administration in Arm Right on 26Mar2021 (age at vaccination 34years old) as single dose for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced when they administered it, he felt it was burning, his palm went numb/ was feeling my left arm with pain and also that was like my arm was numb, pain on the left side of his hand and on the joints/ I was feeling my left arm with pain and also that was like my arm was numb, it was burning like when they put the vaccine; in my body I feel burning right away in the arm, the right one, feel some pain like in my chest, he had muscle pain on the left side and "behind the back"/ I feel some pain like in my chest; muscle what in the heart right there and also in my back, he felt very hot at the site, I have little pain in my back on Mar2021. He got the first dose of Pfizer's COVID-19 vaccine last Friday on the right arm, but when they administered it, he felt it was burning, he felt very hot at the site. Four hours later he started feeling pain on the left side of his hand and on the joints and his palm went numb. On the chest, he had muscle pain on the left side and behind the back. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
postural orthostatic tachycardia syndrome (POTS); dysautonomia; Autoimmune disease; chronic fatigue syndrome (CFS); migraines; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a teenager female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 27-DEC-2017, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) for preventing cervical cancer. On an unspecified date, within the first three months, she began to experience dizziness, headaches, and fatigue. Plaintiff and her mother did not think much about the symptoms, although the symptoms persisted for the next several months. On 13-NOV-2018, she was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). After the second dose, her symptoms dramatically worsened.  In early 2019, Plaintiff began having trouble walking up the stairs at their house and she would complain about her increased heart rate. Her mother assumed it was simply from exertion. As the months progressed, so did her injuries which now included: chronic fatigue, dizziness, migraines, faintness, and heart palpitations. The patient saw several doctors to determine what might be triggering her symptoms. During this time, she began to have intensified migraines, for which her doctors prescribed her medication. In March 2021, Plaintiff's cardiologist diagnosed her with postural orthostatic tachycardia syndrome (POTS) and dysautonomia. As a result of her post-Gardasil symptoms, patient could not engage in normal activities that a teenager would enjoy or participate in the activities she used to enjoy. Additionally, based upon her chronic and severe post-Gardasil symptoms, patient had been diagnosed with various medical conditions, including, but not limited to, POTs, dysautonomia, Chronic fatigue syndrome (CFS) and autonomic dysfunction. The patient contends that patient human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating injuries, including but not limited to POTS, dysautonomia, CFS, migraines, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her Gardasil-induced autoimmune disorder. Autoimmune Disease and Other Related Injuries and had resulted in her suffering from severe, debilitating, disabling and painful chronic injuries.  The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review the event of Autoimmune Disease was considered as medically significant
Information has been received from a physician concerning a 10 year old female with penicillin allergy and a history of Helicobacter pylori infection who on 13-AUG-2008 was vaccinated with the first dose of GARDASIL.  Suspect therapy included VARIVAX at the same time (unspecified if this was the first dose).  On 13-AUG-2008 the patient experienced abdominal pain the evening that she was given the vaccines.  The patient went to the emergency room on 15-AUG-2008 and was admitted to hospital.  Subsequently, the patient recovered from abdominal pain.  Additional information has been requested.