chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rebound COVID; Rebound COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 08Apr2021 as dose 2, single (Lot number: EW0153), in left arm, on 21Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WARFARIN; DILTIAZEM; SPIRONOLACTONE; FLUOXETINE; LANSOPRAZOLE; ROSUVASTATIN, stop date: 28Aug2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (02Sep2022) Negative, notes: Rebound Covid. Tested negative on 02Sep2022; (07Sep2022) Positive, notes: Rebound symptoms started 06Sep2022. Tested positive for Covid on 07Sep2022 & 08Sep2022; (08Sep2022) Positive, notes: Rebound symptoms started 06Sep2022. Tested positive for Covid on 07Sep2022 & 08Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Prescribed Paxlovid to patient.  No follow-up attempts are possible. No further information is expected.
FLU like symptoms - sore throat, body aches, nausea, vomitting
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: ENG6200), in left arm, on 22Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 30Nov2021 as dose 3 (booster), single (Lot number: 30130BA), in left arm and on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Kiwi" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Additional information: patient received BNT162b2 for COVID 19 Treatment.
Patient had a large red, raised, warm to touch rash over each of the injection sites.  The right leg rash measured 7.5cm wide x 4.5cm tall and the right leg rash measured 6cm x 6cm.  The right leg became so swollen through the night there is still an elastic mark on her leg from her sleep wear.  The patient was treated with benadryl and tylenol or motrin for pain.  Told to call if rash or symptoms worsen
about 2wk post @ 14NOV97 p/vax;pt devel a modified measles rxn occurred 9OCT dx german measles;
I witnessed the nurse give the Varicella vaccine with a 1" needle at a 90 angle into the muscle of the patients (L) thigh. Should have been SQ ("5/8" needle at 45 degree angle. Nurse states she gave it with 5/8" needle at 45 degree angle.
Woke up feeling like she had the flu; Fever; had a little nausea; Burning sensation in head and body; Arm pain/bone pain/Pain in head and body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 03-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation in head and body), INFLUENZA LIKE ILLNESS (Woke up feeling like she had the flu), PYREXIA (Fever), NAUSEA (had a little nausea) and MYALGIA (Arm pain/bone pain/Pain in head and body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism since an unknown date and Pre-diabetic. Concurrent medical conditions included Hypersensitivity (allergies to objects around neck). Concomitant products included CETIRIZINE, LEVOTHYROXINE and METFORMIN for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced MYALGIA (Arm pain/bone pain/Pain in head and body). On 02-May-2021, the patient experienced BURNING SENSATION (Burning sensation in head and body), PYREXIA (Fever) and NAUSEA (had a little nausea). On 03-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Woke up feeling like she had the flu). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Burning sensation in head and body), INFLUENZA LIKE ILLNESS (Woke up feeling like she had the flu), PYREXIA (Fever), NAUSEA (had a little nausea) and MYALGIA (Arm pain/bone pain/Pain in head and body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous case reported by a physician, describes the occurrence of underdose (12-month-old received underdosed Moderna vaccine. 0.2 instead of 0.25) in a 12-month-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced an underdose (12-month-old received underdosed Moderna vaccine. 0.2 instead of 0.25). At the time of the report, underdose (12-month-old received underdosed Moderna vaccine. 0.2 instead of 0.25) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Information has been received through the pregnancy registry, for Gardasil concerning a 26 year old female patient who on 03-JAN-2007 was vaccinated with the second dose of Gardasil. Concomitant therapy included prenatal vitamins (unspecified). On approximately 14-FEB-2007, six weeks later she became pregnant. She went into labor on 23-JUL-2007 and the baby passed away (reason unspecified). The patient sought medical attention at the hospital. On 02-NOV-2006 the patient received the first dose of Gardasil and it was required that she will not be getting the third dose. The patient's outcome was unknown. No product quality complaint was involved. Upon internal medical review baby passed away and premature labor were considered to be other important medical events. Additional information has been requested.
Extreme irritability x 2-3hrs, entire rt upper & lower extremity swollen & tender;
4 STROKES; 3 BRAIN SURGERIES; LEARNING TO WALK; This spontaneous report received from a consumer via a company representative concerned an 18 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, and batch number: Unknown and expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had 4 strokes and 3 brain surgeries after vaccination. She was learning to walk and live independently again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from learning to walk, and the outcome of 4 strokes and 3 brain surgeries was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220150514-covid-19 vaccine ad26.cov2.s -4 Strokes, 3 Brain surgeries. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
TESTED POSITIVE FOR COVID-19; DIZZINESS; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 43 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced fatigue. On 22-JUL-2021, the subject experienced tested positive for covid-19. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive, Influenza A virus infection (NR: not provided) not reported, and Influenza B virus infection (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headache, and fatigue on 15-APR-2021, and had not recovered from tested positive for covid-19. This report was non-serious. This report was associated with product quality complaint: 90000186982; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
I had a headache that would not go away. However, the only reason I went to my doctor was to be tested because my husband tested positive the previous day.
On 7/24/01, pt developed a fever. On 7/25/01, his cheeks were bright red with welts. On 7/25/01 and 7/26/01, the rash was over entire body; worse on legs and feels rough. It was lighter on back and chest. The child told mom he was sunburned which was not possible per mom. When sleeping on 7/26/01 AM, his cheeks were not red. When up and about, his cheeks would get very red again. Had a low-grade fever for about 1 week, post vax, which lasted a couple of days and was fine until he had a fever again on 7/24/01.
Moderna Covid-19 vaccine EUA Approx 40 min after injection had trouble swallowing,tingling lips,flushed. Give Benadryl and Pepcid at urgent care, felt better in about 15 minutes. Was at urgent care clinic approx 45-50 min.
UNBEARABLE PAINS; BREATHING PROBLEMS AND NEEDED A TRACHEOSTOMY; TUMOR ON FACE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported and expiry: unknown) dose was not reported, 1 total administered on 03-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On OCT-2021, the patient experienced and developed a tumor the following week on his face that needed to be surgically removed and complicated on the 07-NOV-2021 had breathing problems and needed a tracheostomy and he has unbearable pains daily. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unbearable pains and the outcome of breathing problems and needed a tracheostomy and tumor on face was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220122356-covid-19 vaccine ad26.cov2.s-tumor on face and breathing problems and needed a tracheostomy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
2x2 inch erythematous over anterior right thigh.  No tenderness, no pruritis, a localized reaction.
Sore arm; Headache; Tiredness; Nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) at the age of 69 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Verbatim: Diabetic; "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Feb2021, outcome "recovered" (2021), described as "Sore arm"; HEADACHE (non-serious) with onset 27Feb2021, outcome "recovered" (2021), described as "Headache"; FATIGUE (non-serious) with onset 27Feb2021, outcome "recovered" (2021), described as "Tiredness"; NAUSEA (non-serious) with onset 27Feb2021, outcome "not recovered", described as "Nauseous". Therapeutic measures were taken as a result of nausea.  Additional information: The only thing I took was like ginger ale for the nausea and Pepto-Bismol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Eleven days ( 3/29/2021)   after the second dose (which was 3/18/2021)  , I woke with a fever of 101.2, very dry nose and throat.  Great fatigue so I did not get out of bed for 48 hours.  Muscle pains in lower legs,  and then what I would describe as little lumps, singly and in groups, along down the length of my shin bones.  It looked like a drawing of the lymph system , from knee to ankle.  This disappeared by  April 1.  Fatigue was present for 2 more days..  Some mornings I still feel fatigue on arising.
MUSCLE WEAKNESS; TIREDNESS; UNABLE TO WALK; This spontaneous report received from a patient concerned a white Not Hispanic or Latino female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included MS. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, vaccinated at right arm, once total, administered on 08-MAR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, 09:00 AM the patient received Janssen Covid-19 vaccine and at 16:00 PM, the patient started feeling really, tired and at 21:00 PM feeling not well with muscle weakness. On 09-MAR-2021, at midnight, patient had called to go to the emergency room and patient was unable to get up at all and was hospitalized on 09-Mar-2021 for 3.5 days and on 12-MAR-2021, the patient was discharged from the hospital. The patient had physical therapy coming to house.  The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from tiredness, muscle weakness, and unable to walk. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210342113-COVID-19 VACCINE AD26.COV2.S-Tiredness and muscular weakness. These events are labeled and are therefore considered potentially related. 20210342113-COVID-19 VACCINE AD26.COV2.S-unable to walk. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date, patients were vaccinated with improperly stored VAQTA (dose, frequency, route of administration and indication were not provided). No concomitants were reported. No adverse events were reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
generalized macular papular exanthem head-ankles, palms & soles spared; no apparent & LOM edema;
Information has been received from a licensed visiting nurse concerning three female patient' who were supposed to be vaccinated with a dose of Gardasil. It was reported that when the nurse removed the vaccine from the refrigerator, she picked up 2 doses of Gardasil and one dose of Pitocin. The nurse stated the error was due to the cap colors of Gardasil and Pitocin being similar. No symptoms were noted in any woman. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
patient received Shingrix first, then the Fluad. moments after the Fluad was given she mentioned her left arm felt odd and she began to feel faint. Moments after that, her pupils dilated slightly, she had small tremors and became unresponsive for about 10-15 seconds. She then regained composure and marked that she wasn't expecting this to happen. I asked if she had a known seizure disorder and she confirmed she has had absence seizures in the past, but that these last occurred more than 5 years ago, and she was on no medication to control them. While questioning her and attempting to make her more comfortable, she seized again for another 15 seconds, requiring me to give her support to prevent falling out of the chair. Once that was resolved she was given water.  I allowed her to sit as long as she desired while she recovered which ended up being around 10 minutes. When I went to check on her she had stood up and collected her things. I asked if she would like emergency medical services, and she declined, she indicated she would ask her husband to come pick her up from the pharmacy. She then thanked me for helping her and left on her own accord. This is the last interaction with the patient as of documenting the event.
This case was reported by a consumer via call center representative and described the occurrence of nonspecific reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced nonspecific reaction, erythema, fatigue and chills. On an unknown date, the outcome of the nonspecific reaction, erythema, fatigue and chills were unknown. It was unknown if the reporter considered the nonspecific reaction, erythema, fatigue and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was reporting they had a severe reaction to SHINGRIX 1st dose. The patient had erythema in an oval shape down her arm, about 2 inches wide by 3 inches long. She also had fatigue, and the 2nd day she had chills, but no fever. The patient would not give address or any detailed information about severe reaction. The patient reported that their pharmacy had already reported this adverse event, however no duplicate case could be found.
Pt reported to the clinic on 7/8/2019 after noting a ?slow? spreading of a rash over his left upper extremity on 7/4/2019.  Multiple tiny pustular-like, reddened raised rash extending from original injection site (in the left deltoid) down to about an inch above the AC and minimally spread up to the left chest wall.  A red raised rash in the shape of the two bandaids (in cross) was also noted at the original injection site. Pt reports having used large waterproof bandages over site in an abundance of caution as he works with water. Pt stated site was itchy and denies all other symptoms. Pt was initially assessed by his PCM and a dermatologist was consulted who suggested daily dressing changes be done at the clinic by RN for close monitoring of rash.  Site was covered with telfa dressing and paper tape. Post-smallpox vaccine care instructions reviewed with teach back.
Cold like symptoms; Felt a lot of pain on the right hip prosthesis/ knee pain; Leg tiredness; In menopaused stage; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Leg tiredness), MENOPAUSE (In menopaused stage), NASOPHARYNGITIS (Cold like symptoms) and ARTHRALGIA (Felt a lot of pain on the right hip prosthesis/ knee pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included LANSOPRAZOLE, FLURBIPROFEN, ORPHENADRINE and CODEINE PHOSPHATE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MUSCLE FATIGUE (Leg tiredness), MENOPAUSE (In menopaused stage) and ARTHRALGIA (Felt a lot of pain on the right hip prosthesis/ knee pain). On 15-Apr-2021, the patient experienced NASOPHARYNGITIS (Cold like symptoms). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE FATIGUE (Leg tiredness), MENOPAUSE (In menopaused stage), NASOPHARYNGITIS (Cold like symptoms) and ARTHRALGIA (Felt a lot of pain on the right hip prosthesis/ knee pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
fatigue, nausea, vomiting, cough, shortness of breath, myalgia, chest congestion, chest pain, chest tightness, headache
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# not reported). Approximately two weeks after vaccination, the patient developed shingles on her face. The patient sought medical attention and was seen by a physician. After treating with an unknown therapy, the shingles improved.
21JUN96 itching @ inj site;22JUN96 lt arm swollen, jerking spasms in lt arm;sl discoloration, sl warm to touch;seen @ ER;prescribed DPH, keflex & lorbab;arm put into sling;24JUN96 inc pain to lt arm radiating to lt shoulder blade;
I had a sore arm right after the vaccine and then around 04:00AM on 10/26/2021, shooting pain from my left back to shoulder, I began getting chills, body aches and a bad headache. BP was at 124/80, slightly higher than usual I went to urgent care, and they did not really check anything stating I had the flu. After taking acetaminophen and resting I began to feel better the next day. Pain subsiding and arm is slightly sore.  BP 115/62 normal.