chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a parent via a company representative concerned a 27year old male. 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 not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-JUL-2021 (Monday), the patient experienced sore throat, body aches with no fever. It was reported that the patient had over the counter medication, but he still felt ill. On 28-JUL-2021 (Wednesday), the patient tested positive for covid-19 infection (suspected covid-19 infection and suspected clinical vaccination failure). Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187932.; Sender's Comments: V0: 20210800788-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
Pt had reported feeling dizzy, then mouth swelling, and nausea.  Pt was treated by ED staff after presenting back to vaccine clinic site.  Pt received Epinephrine, Solu-medrol, and Benadryl, and is no longer experiencing any sxs.
15 minutes after her vaccine she complained that she had blurred vision. She did report that she had a latex allergy so I removed the band aid even though the band aides are labeled latex-free. I checked her vitals and  Her b/p was 114/85 pulse was 84 and respirations 16. Her pulse ox was 95% She was in no apparent distress. The blurred vision resolved in 5 minutes and her vitals remained stable for 30 minutes. I discharged her with no symptoms.
Patient called 10/17/16 says arm has knot the size of an orange, red, swollen, hot to touch, painful. Pharmacist recommend patient see primary care doctor. And Pharmacist call Dr. for Patient.
My son got his vaccinations on Thursday morning. Then on Saturday night he was sleeping, started vomiting, when I went to clean him up he was staring and would not respond to his name or anything. His right arm started jerking so around 11:30 pm we took him to the ER. He was given some medication for seizures and had a catscan. He was flown in the helicopter to hospital. Another catscan and MRI were done to him. The doctors had no logical explanation of why he had gotten the seizure. He was under ICU for several hours and admitted to the hospital until he was released on Monday 5/26/09. A few days after this incident he had fever and vomiting for several days.  6/29/09 Hospital records received DOS 5/24/09 to 5/25/09. Assessment: Seizures associated with new onset L cerebral hemorrhage. Patient presented with vomiting, shaking/twitching in right arm, left arm flaccid,  'glassy look in his eyes', right eye deviation. Body became stiff. Seizure. Does not open eyes. Deep tendon reflexes dimished. Somnolent and does not arouse to voice. Disconjugate gaze. Glasgow Coma Scale of 6. Cafe au lait spot neck. 6/30/09-ICD-9 codes 431, 348.8, 345.90 and 372.30.
bad nose bleed/It's bleeding in the back of my nose; the clots are so big that I gag when I expel them; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 on 01Feb2021 at single dose for covid-19 immunization. Medical history was not reported. Concomitant medications included warfarin sodium (COUMADIN). On 02Feb2021, patient had a bad nose bleed which patient stopped. On 03Feb2021 paitent was ok and on 04Feb2021 patient got a nose bleed that patient could not stop and still have to be careful and not do anything as it starts all over again. It's bleeding in the back of nose also and the clots are so big that patient gag when patient expel them. The outcome of the event was not recovered.   Information on batch/lot number was requested.
Chills with shivering; Body pain all over; Nausea; Vomiting; Fever; Headache; Dizziness; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received bnt162b2 (BNT162B2), administration date 24Jan2022 at 09:15 (Lot number: 33036BD) at the age of 28 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: BUSPIRON and CITALOPRAM. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Lot Number: 330368D, Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: CHILLS (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Chills with shivering"; PAIN (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Body pain all over"; NAUSEA (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Vomiting"; PYREXIA (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Headache"; DIZZINESS (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Dizziness". Therapeutic measures were not taken as a result of chills, pain, nausea, vomiting, pyrexia, headache and dizziness.  Additional Information: The patient had known allergies to Bo. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
pt rcvd vax; devel headache, possible serum sickness & pruritic purpuric dermatosis on feet; legs & forearms;pt seen by MD; biopsy revealed extravasation of red blood cells & scattered nuclear debris consistent w/ leukocytoclastic vaculitis
Reddish, itching, all over face, "feels like sand paper", both arms, legs, chest. Still breaking out through out the body. Round bumps, first appear on the chest, then right arm, then left arm. Feel like round bumps. Prescribed Acyclovir 800mg 5x day x 7 days on 8/13/10. First appeared about 1 week after vaccination.
extreme arm pain/being the same arm that vaccine was administered in; headaches; nausea; generalized body aches; a low grade fever; This spontaneous report was received from an Office Manager referring to a 63 year old male patient. The patient's concurrent conditions included allergy to bee venom and statins. The patient's medical history included atrial fibrillation. The patient was not taking concomitant medications.  On 05-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S013490, expiration date: 06-MAR-2019) intramuscular for shingles prevention. On 06-AUG-2019, the patient experienced extreme arm pain, headaches, nausea, a low grade fever, and generalized body aches after receiving pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). It was reported that the extreme arm pain was the same arm that vaccine was administered in. The patient sought for unspecified medical attention and was instructed to take NSAIDs. No lab diagnostics/studies were performed. On 12-AUG-2019, the patient recovered from the adverse events. The causality assessment betweent therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the adverse events was not provided.
stated that she is having chills; stated that her arm is harsh; stated that her arm is sore; This is a spontaneous report from a contactable nurse reported for herself. A 65-year-old female patient received bnt162b2, via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history included covid-19 from Apr2020 to an unknown date. She further stated that she had COVID back in April and survived. Stated that she had the pneumonia part of it and went back to work in June. The patient's concomitant medications were not reported. On an unknown date, patient was having chills since she had the shot. Stated that her arm was harsh and feels real sore. Patient wanted to know if the chills were common. The outcome of the events was unknown.   Information on Lot/Batch number has been requested.
Pt. states that after receiving the 3rd dose of Phizer 12/14/2021 experienced flu-like symptoms lasting 12hrs, started experiencing symptoms 12/27/2021 of loose stool continuing through current. No noted Primary visit/communications.
Freezer temperature warm by atleast 2 degree C for 4 days; Possible administration of invalid dose to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that there are 4 days temperature data(between 01 Apr 2022 and 04 Apr 2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C.  Between 22 Feb 2021 to 26 Apr 2022 there is no other temperature data available.  Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period. Lot numbers were provided include 057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A. Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit.  Treatment information was not reported.
This initial spontaneous report was received from a registered nurse also reported as from a medical assistant) referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unknown dates, the patients were administered improperly stored doses of ROTATEQ oral solution (lot # L008996 with expiration date 01-DEC-2016, lot# L010126 with expiration date 22-JAN-2017, Lot# K019370 with expiration date 16-JUL-2017; dose was not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
BACK PAIN/SPINE PAIN SECOND TO LAST VERTEBRAE PAIN; TINGLING IN THE LEG; PAIN IN LEG; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-APR-2021, the subject experienced back pain/spine pain second to last vertebrae pain. On 01-APR-2021, the subject experienced tingling in the leg. On 01-APR-2021, the subject experienced pain in leg. On 01-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, back pain/spine pain second to last vertebrae pain, tingling in the leg, and pain in leg. This report was non-serious.
By April 13, I had completely lost the hearing in my right ear. I was diagnosed with SHL, sudden sensorial hearing loss.  No treatment. Permanent deafness. Use of hearing aid will not help.
This spontaneous report as received from a registered nurse refers to a 22 year old female patient with amoxicillin allergy and penicillin allergy. The patient's medical history included tonsils removed. On 14-AUG-2013, the patient was vaccinated with the first dose of GARDASIL (lot number J002641, expiration date 10-DEC-2015) (dose and route not reported). On 13-OCT-2013, the patient was vaccinated with the second dose of GARDASIL (lot number J007354, expiration date 20-FEB-2016)(dose and route not reported). Concomitant therapies included LOESTRIN. On an unknown date, the patient experienced arm pain, following administration of the recalled lot of GARDASIL. The nurse reported that the arm pain developed at an unspecified time frame after the second dose of GARDASIL. On 07-FEB-2014 the patient was vaccinated with the third dose of GARDASIL (lot # H021346, expiration date: 01-OCT-2015)(dose and route not reported). At the time of the report, the patient had not recovered from arm pain. This is one of two reports from the same source. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a 4-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 21-FEB-2019, the 4-month-old patient was vaccinated with 1 dose of PNEUMOVAX 23 (dose, and route of administration were not provided; lot # R021045, expiration date: 14-APR-2020). No adverse effects were reported.
pt recvd vax on 16AUG94 & started w/t103, vomiting & abdo pain 17AUG94 & was taken to ER & MD stated was immun react;
Patient is still feeling chills periodically 4 weeks after 2nd booster dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Patient is still feeling chills periodically 4 weeks after 2nd booster dose) in a male patient of an unknown age 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 CHILLS (Patient is still feeling chills periodically 4 weeks after 2nd booster dose). At the time of the report, CHILLS (Patient is still feeling chills periodically 4 weeks after 2nd booster dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient stated he received 2nd booster shot of Moderna COVID-19 Vaccine, and after 4 weeks and he was still feeling chills periodically. Treatment medication was not reported.
Headache, vertigo, body aches, fever, axillary swelling and pain for 3-4 days immediately following the administration. Headaches and vertigo continued and  became sustained leading to an MRI to be done on 2/1/21 resulting in a neurology consult and high doses of prednisone for short term treatment of symptoms.  Further lab work revealed elevated ANA levels. Now awaiting a rheumatology consult. Although moderately improved, vertigo and disorientation remains, unable to work.
Patient reported at 1210 feeling lightheaded, vision blurred, had syncopal episode and fell from chair hitting L temporal region of head. LOC approx 1 min. VS at 1219 were 134/78 and HR 61, SP02 97%; all while sitting. patient was assessed by nurse and reported a hx of passing out with blood draws. VS at 1225 BP 135/70 and HR 72. Left returned to normal.
- recurring swelling at site lasting 4 weeks - bloating, swelling in stomach - cannot eat properly - weight loss
from telephone call by mother; bumps on face, rash on arms, itching; tx DPH
EXTREME BONE ACHES; EXTREME BODY ACHES; JOINT ACHES; CHILLS; FEVER; This spontaneous report received from a parent concerned an 18 year old male. The patient's weight, height, and medical history were not reported. 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced extreme bone aches. On 09-APR-2021, the subject experienced extreme body aches. On 09-APR-2021, the subject experienced joint aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, extreme bone aches, extreme body aches, and joint aches. This report was non-serious.
"pretty sick for about 3 days"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 19Mar2021, outcome "recovering", described as ""pretty sick for about 3 days"". It was unknown if therapeutic measures were taken as a result of illness. Additional information: If other vaccine in four weeks: Unknown. Other medications in two weeks: Unknown. If COVID tested post vaccination: Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm was very sore red at injection site rash chills fever and vomiting hrs later sleeping more than usual had to repeat the Pfizer booster due to the way it was stored after already having the booster in January that booster did not make me as sick as this one did.
Sore arm Fever of approximately 102F Chills/Sweats Body aches Headache
4 days after the vaccination (96+ hours after the vaccination) on 1/3/2021 pt noticed a rash with hives ("red, splotchy, very itchy") on the back of both hands and around both wrists. By that evening (5 pm on 1/3/2021), she noticed that the rash was on her neck, chest, upper and lower back, and both legs (lower and upper legs). At 6:30 pm on 1/3/2021 she took 1 Benadryl (25 mg) and fell asleep. The next morning (1/4/2021) at around 7 am, the rash had lessened all over her body, but was still the same on her wrists and hands as the prior night. She took 1 more Benadryl (25 mg) and within 2-3 hours the rash had disappeared.
I got my booster shot on 10/25/2021. My adverse event started on 02/06/2022 around 11:00PM I wasn't feeling great, I was nauseas, I was feeling achy. I felt crappy for 2 straight days. On the 02/07/2022 I did a COVID-19 home test and it came out positive. The following day I went to the pharmacy they tested me positive with COVID-19. After my booster shot I contacted COVID-19 on 02/07/2022. When I felt better in the beginning of March the right side of my body including  shoulder, legs, hand, arm were swollen and painful. I started occupational therapy for right side of the body I am 75% better but I can't move my right side of the body the way I use to. I would hurt and the pain comes back again. This pain happened after I was diagnosed with COVID-19. I went to several doctors regarding this issue. I still  have the pain it hurts when I move. Still under doctor's care for it.
Vision, vomiting, balance, chills, fever 3 1/2 hours after shot, lasted 1 day.
her husband felt crappier than she did after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "her husband felt crappier than she did after the first dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (19Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
down and out straight; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (down and out straight) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (down and out straight). At the time of the report, ADVERSE EVENT (down and out straight) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-236634 (Patient Link).
Pt got shots on Thursday and on Sunday, arm was pink. On Monday, he had a circular dark red area but no temperature. Today (Tuesday) left arm is lightening up but still no temperature. Mom said she was going to call MD. Child is recovering.