chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was experiencing migraine on an unknown date, after the first dose and wants to take Tylenol. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health care professional concerning an 11 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. It was reported that the patient called the next day after receiving GARDASIL with complaints of swelling. It was reported that this adverse event occurred four to five months ago (approximately in December 2008). It was reported that two weeks later the patient was at the office and was referred to the Emergency Room and was provided antibiotics. The patient was identified with osteomyelitis and was hospitalized for three to four days. It was reported that the patient had recovered at the time of the report. Additional information has been requested.
Pt reported pain, bruising and heat in area where MMR immunization was given. Called pt on 12/3/02 (previous attempts to reach pt were unsuccessful) and arm is no longer sore, bruise is gone (reported by pt). Doctor's assessment localized reaction.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/1/21 (lot not listed in online system) Pfizer Dose 2 3/30/21 (EN6207) COVID Positive 10/1/21  10/5/21: Patient is a 74-year-old male who tested positive for COVID-19 on 9/30/2021.  He presented to the emergency department today with complaints of increasing shortness of breath, dyspnea on exertion, cough, and nasal congestion. He was noted to be 83% SpO2 on room air.  He was placed on 3L of supplemental oxygen which has kept him greater than 90% SpO2.  He was also noted to have a fever of 101.3° F.   His labs were significant for AST 59, PO2 56, WBC 14.34, but were otherwise unremarkable.  D-dimer was negative when corrected for age.  He had a chest x-ray which suggested viral pneumonitis.  He had a CTA chest which showed ground-glass infiltrates in both lungs consistent with viral pneumonitis, but no PE.   On arrival to the floor, patient is requiring 3L of supplemental oxygen.  He denies fever, chills, chest pain, palpitations, nausea, vomiting, diarrhea .  Biggest complaint is cough with deep breathing and mild shortness of breath at rest.  Says he is feeling much better now with the oxygen.  10/10/21: Patient is a 74-year-old male who was admitted on 10/5/2021 with acute hypoxic respiratory failure, secondary to bilateral COVID pneumonia.  He also had elevated LFTs secondary to COVID and leukocytosis secondary to recent corticosteroid use.  The patient was admitted to the medical floor.  He was started on Remdesivir, Levaquin, and dexamethasone.  He also reported a significant cough, so he was started on Robitussin AC which seemed to help.  His blood cultures have had no growth to date.  He was not able to provide a sputum sample.  He completed his remdesivir course yesterday evening.  He reports today that he is feeling much better.  He is asking to go home.  He denies chest pain or palpitations.  Denies shortness of breath at rest, but does report some dyspnea on exertion.  His oxygen need has significantly improved.  He is currently on room air at rest, but requires 3L by nasal cannula with activity, per the home oxygen walk this morning. Patient is being discharged home with home nursing services for nursing and respiratory therapy due to his need for home oxygen.  He is also being discharged with the at Home COVID care program.  They will follow-up with him after discharge.  He should continue dexamethasone 6 mg p.o. daily x5 days, Levaquin 750 mg p.o. daily x3 days, and Robitussin AC 10 mL p.o. t.i.d. a.c. p.r.n. cough.  His self-quarantine is complete today.  He should continue with home oxygen, on room air at rest, 3L by nasal cannula with activity.  He should follow-up with his primary care provider in 1-2 weeks.  I recommend a chest x-ray in 4-6 weeks to document clearance.  The patient has been provided education for COVID pneumonia, home oxygen, Robitussin AC, dexamethasone, and levofloxacin.  I have answered all of his questions and addressed all of his concerns.  The patient is being discharged in improved and stable condition.
11/21 normal little arm pain stiffness tired aches 11/22 stiff sore tired not well, nausea  and vomiting; took NyQuil and anti nausea meds 11/23 fever 99-102; no appetite, drank, strange hot puffy left upper arm between deltoid and bicep, no bruise; sinus pain but no congestion, overall aches and pains; took NyQuil 11/24 aches pains 99 fever; same weird left arm, tightness ache across top of chest shoulder to shoulder; took 800 my ibuprofen resulting in relief of chest symptoms; able to eat clear liquids and BRAT diet 11/25 much better, ate and drank normal 11/26 normal
got shot and still got them / Suspected vaccination failure; got shot and still got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient had the shot and still got them. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient. A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (unspecified if ongoing), notes: Comments: Asthmatic. Concomitant medication(s) included: BREO ELLIPTA taken for asthma. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "had Covid first week of Aug2022. He had taken first and second Covid vaccine and booster Covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: He had Covid first week of Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received Paxlovid treatment from Aug2022.He had Covid first week of Aug2022 and started Paxlovid on either day 1 or day 2 of Covid. He did finish the complete course. He did say he was on Motrin, Tylenol, and cough medication right at the beginning. He was so nauseated for two weeks. He also had a metallic taste. He didn't mention when the nausea or metallic taste started when on Paxlovid. He had taken first and second Covid vaccine and booster Covid vaccine. They were all Pfizer vaccines. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is: expected. The case will be reassessed further upon receipt of additional information.
No wheal obtained with with first attempt of intradermal vaccine placement.  2nd attempt was successful.
No additional adverse event; patient received the first dose of GARDASIL 9 over a year ago, and the second dose window of 12 months has already passed; This spontaneous report was received from a pharmacist and refers to a 12-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (reported as over a year ago), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unspecified day in October 2022, the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the second dose window was already passed (inappropriate schedule of product administration). No further information was provided. No additional adverse event was reported. No product quality complaint was reported.
She got her vaccine, got up at 1:30 in the morning feeling awful. She had had chills and was very very hot.  She knew she was going to throw up or have diarrhea and got up to use the bathroom.  She had shoulder problems and had diarrhea, and standing there thinking if she stay around and throw up and woke up on the floor.  Does not know if her temperature had gotten really high or what happened.  The coolness of the floor felt good to her.   She was not out for long as when her head hit the floor she woke up.  She got up and went back to bed.   She is still feeling awful, has not felt like she was going to faint anymore but did not feel faint at that time either.  She cannot eat anything, and shivering all of the time.  She thinks that she is running temperature, but does not have a thermometer.  She has not called her doctor.
Immediate shoulder pain, injection given very high in shoulder pain worsened every day got a Kenolog shot no help for pain severe could not sleep could not touch could not raise arm saw Doctor had MRI shows Bursitis and small tear still in pain 2 mos later also took NSAID, iced and heat to area, pain meds nothing helps pain, all this from Flu shot {Senior Dose} apt. next wk with Orthopedic Dr.
Full body ache beginning the night of injection, continuing into the next day; resolved by the morning after that. Received injection at 16 weeks of pregnancy; estimated due date 3/16/22.
it may have been a bad batch; I was about to black out/I passed out; felt very heavy; the bathroom started to spin; my vision started to deteriorate; my legs arms started flailing involuntarily; fell asleep; a bad headache; This case was reported by a consumer and described the occurrence of blackout in a patient who received Herpes zoster (Shingrix) (batch number 2LH9L, expiry date 10th April 2022) for prophylaxis.   On 23rd December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced blackout (serious criteria GSK medically significant), sensation of heaviness, spinning sensation, deterioration of visual acuity, movements involuntary of limbs, sleepiness and headache. On an unknown date, the patient experienced pharmaceutical product complaint. Shingrix was discontinued. On an unknown date, the outcome of the blackout, sensation of heaviness, spinning sensation, deterioration of visual acuity, movements involuntary of limbs, sleepiness, headache and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the blackout, sensation of heaviness, spinning sensation, deterioration of visual acuity, movements involuntary of limbs, sleepiness and headache to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient's doctor recommended him/her to contact GSK regarding an unusual and very scary reaction to the Shingrix vaccine. Less than 24 hours after vaccination, the patient got in the shower and felt very heavy. Within one minute of being in the shower, the bathroom started to spin and patient was about to black out as his/her vision started to deteriorate. The patient stepped out covered in soap and his/her legs, arms started flailing involuntarily so badly that he/she could not dry himself/herself. The patient sat down on the toilet before he/she passed out and after several minutes, it let up a little and he/she dragged himself/herself into bed and fell asleep, woke up with a bad headache. The patient did not call the ambulance or immediately go the physician due to the holiday and when patient followed up with his/her physician, she was surprised and a bit baffled. The patient requested the batch number to ask if it might have been a bad batch and a photo was attached. The patient requested to respond and he/she refused to get the second shot. The consent to follow-up was requested.
DEATH; This spontaneous report received from a consumer concerned a patient of unspecified age and sex, race and ethnicity. 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: Unknown) dose, therapy start date were not reported, 1 total administered 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.  The reporter stated that he had a friend who died shortly after the covid vaccine with no other explanation for death. On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211125834-COVID-19 VACCINE AD26.COV2.S-Death. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
The shot is very painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The shot is very painful) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (The shot is very painful). At the time of the report, VACCINATION SITE PAIN (The shot is very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
17-year old patient received the 1st dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year old patient received the 1st dose of the Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No medical history and concomitant drug information was provided by reporter.     On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year old patient received the 1st dose of the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year old patient received the 1st dose of the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received contains no significant information.
Tested positive for Covid; Tested positive for Covid; This is Spontaneous report from a Non-contactable Consumer reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient and her husband received the Covid vaccine last Friday (08Jan2021) and the patient was positive for Covid 19 on Monday (11Jan2021). She was wondering whether she should get the second shot. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034217 same reporter, diff patient
Approximately 1 hr after vaccine (1630), I began to have mild chest pain on the left side of my body. RHR was fairly steady around 70 bpm. Chest pain steadily became worse. Around 1930, RHR peaked at 117 bpm and remained above 90 bpm. Chest pain was at 7/10 and I went to the ER. ER conducted EKG and chest X-Ray, both normal. Given tramadol and aspirin which dulled pain. Prescribed Ibuprofen and released. Follow up with primary care, prescribed naproxen and acetaminophen. Chest pain still persists
Pt developed auto-immune Diabetes of Adulthood (LADA) GAD-65 Ab +
0835 161/110 125 98% RA RR 20  Vaccine 0830 administration by NP who screened patient.  Allergy history, explained monitoring for adverse event to patient.  Reaction 0835 feeling flush, throat tightness.  First responder called and arrived quickly.  NP examined LS clear No cyanosis No signs angioadema  25 mg Benadryl liquid given at 0843  0845 to ED via wheelchair with first responder and security guard
10/20/2012: Woke up with tingling in my hands and feet. 10/22/2012: Severe tingling and numbness in hands and feet with soreness in back and neck. 10/24/2012: Severe pain in legs which led to trouble walking. 10/25/2012: Pain in legs, neck and back with trouble walking. Doctor told me to take 2 Aleve twice a day for pain for a week. 10/27/2012: Numbness in feet and hands with severe pain in legs. Left side of face started to slowly paralyze at 9:00AM. 10/28/2012: Numbness and Tingling in hands and feet. Pain in legs and total left side of face was paralyzed. 10/29/2012: Numbness and Tingling in hands and feet with severe pain in legs. Total face was paralyzed as of 8:00AM. Emergency Room visit diagnosed it as Guillain Barre Syndome and admitted me to hospital. 10/31/2012: First Plasmapheresis treatment administered. 11/1/2012: Second Plasmapheresis Treatment administered. 11/2/2012: Third Plasmapheresis Treatment administered. 11/5/2012: Fourth Plasmapheresis Treatment administered. 11/7/2012: Fifth Plasmapheresis Treatment administered. During the 12 days in the hospital I received 5 plasmapheresis treatments with physical and occupational therapy sessions.
This spontaneous report as received from a nurse practitioner refers to a 6 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 16-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a 49 year old female patient who on 12-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# 658200/0804U). On 12-NOV-2007, the patient experienced cellulitis like reaction. The patient's entire upper arm from shoulder to elbow was red and hot to touch. Unknown medical attention was sought. At the time of report the patient had not recovered. No product quality complaint was involved. This is one of multiple patient report from the same source. Additional information has been requested.
4 patients administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2022 at 8:22 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 08-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine). On 08-Feb-2022, EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that on 27-Oct-2021 at 10:45 am the date the vial was initially stored in the refrigerator. On 08-Feb-2022 at 7:45 am the vial was first punctured. The vial were stored post puncture at room temperature. The vial was exposed to room temperature range for 1 hour. The vials did not undergo any temperature excursions.  No concomitant and treatment drugs were reported.
This case was reported by a physician's assistant and described the occurrence of dizziness in an 30 year old female subject who was vaccinated with Engerix-B for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not provided. On 26 July 2006 the subject received a dose of Engerix-B (dose number and lot number not provided). On 26 July 2006, two hours after vaccination with Engerix-B, the subject experienced dizziness. The event resolved four hours later after the patient slept. Further information was not provided.