chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 sore arms; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine, Influenza vaccine Quadrivalent unspecified season and PNEUMONIA VACCINE. On an unknown date, unknown after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Flu shot, shingles vaccine and pneumonia vaccine and experienced 2 sore arm. It was unknown if the reporter considered the pain in arm to be related to PNEUMOCOCCAL VACCINE . This case was linked with the case US2021AMR219073, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR219073:Same reporter
Developed redness, swelling, pain & itching at injection site where she received varicella vaccine the night she received it.
Patient returned for his second dose of the Covid-19 Moderna vaccine on 11/19/21. Patient stated that he waited so long to get his second dose because he had a bad reaction to his first dose.   Patient stated that immediately following his first dose of the vaccine he felt his heart racing, dizziness, and weakness. Patient stated that he also developed nausea, left sided chest pain. These symptoms were stated to last about a week. During that  time the patient rested in bed but was unable to see his doctor.   Most of his symptoms resolved after about 1 week, but the patient reports that he still had lingering  "brain fog", dizziness, and weakness. These symptoms lingered for about a month. The patient reports that he attempted to contact his primary doctor about the incident and whether he should return for a second dose, but was never able to actually get an appointment.   When the patient came in for his second dose on 11/19/21 he reported that all symptoms had resolved.  After questioning about his reaction to the first dose, we did not give the patient his second dose of Moderna due to concerns of potential myocarditis, pericarditis and/or allergy following his first shot of Moderna. The patient declined receiving the Janssen vaccine. Patient was instructed to follow up with his primary care physician and a cardiologist.
Delayed hypersensitivity reaction, occuring at day 8 after injection, with redness, itchiness and hot to the touch. (No pain).
This spontaneous report was received from a registered nurse, referring to a female patient currently 18 years old. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not unknown. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (strength, dose, lot number and expiration date were not reported), for prophylaxis (reported as "prevention Human papillomaviruses (HPV)"). On an unknown date, the patient experienced an excessive hair loss (alopecia). It was unknown if the patient sought medical attention, if any treatment was administered or if any lab diagnostics/studies were performed. It was reported that the patient completed the vaccination series on unspecified dates and had no problems. The outcome of alopecia was unknown. The causality assessment between GARDASIL 9 and the aforementioned event was not provided.
Red area from neck down body to legs; Looked like someone painted red paint on body; not a rash-lasted about 20-30 min; Called MD who prescribed DPH, t103;
This is a spontaneous report from a non-contactable consumer (patient). A 22-year-old female patient received bnt162b2 (COVID 19 Pfizer), dose 1 via an unspecified route of administration, administered in right arm on 14Apr2021 15:00 (lot unknown, reason: misplaced/discarded) as single dose for COVID -19 immunization. Medical history included known allergies: penicillin. The patient's concomitant medications were not reported. The patient experienced complete loss of hearing in left ear. White noise sound only. Less than 24 hours after administration on 15Apr2021 with outcome of unknown. The patient is not pregnant. No treatment was given for events. The patient has not received other vaccine in four weeks. The patient was not diagnosed with covid prior vaccination has not been tested for covid post vaccination.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
inflammation of the gum line. A hole in his front tooth appeared as well. Narrative: Teeth feel sensitive. Pt scheduled to see dentist.
I came home and didn't feel well. Felt like I had a mild case of COVID for about a week. I couldn't breathe. I was having trouble breathing and before I could do anything, I had an inhaler when I had pneumonia from before and the breathing was better. Daughter said Mom you're not well so she took me to the ER and they kept me there. They said I had double pneumonia in both lungs. I was also on a blood thinner, and I had a GI bleed so my blood count was low. They had to give me extra iron and a blood transfusion. Antibiotics for the pneumonia. Was taken off Xarelto. Had another a-fib attack a week later and went to the ER and was put on Eliquis. Then another week later had a bowel obstruction and was back in the ER for another 3 days. Followed up with PCP and Cardiologist Doctor.
Covid + 8-31-22;  to er with shortness of breath, chest pain, muscle aches .  H/o CHF.   He reported he had + home test for covid.  WBC high 26.3 and placed on remdesivir.  lethargic abd pain but no n/v.  no pneumonia on initial cxr. placed in icu 9/1 and troponin increased on 9/2/22   Intubated for stabilization  Levophed due to hypotension.  Air vac contacted for emergent transfer but code blue was called three times and in spite of ROSC at one time, efforts  were not successful in reviving the patient and he expired 9/2/22.
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EK9231), in left arm, on 26Sep2021 as dose 2, single (Lot number: 30135BA), in left arm, on 21Dec2021 as dose 3 (booster), single (Lot number: EK5730), in left arm and on 09Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 24Mar2023, outcome "recovered", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 24Mar2023, outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Mar2023) Positive; (30Mar2023) Negative; (31Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events drug ineffective, Covid-19 and the suspect  product  BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5).,Linked Report(s) : US-PFIZER INC-202300142924 same reporter/patient, different product/AE;US-PFIZER INC-202300143007 Same reporter/patient, same drug/different dose, different AE;
Staff member's left hand was noted to have a slight twitch about ten minutes after receiving the vaccine.  The twitch became more pronounced and involving the entire left arm and within twenty minutes her fingers had become hyper-flexed and erect (looked like swan neck deformity).  She tried pressing down and stretching the fingers to no avail. 12:40 she was asked to accompany this writer to another observation area for closer monitoring. When she stood up from the chair, she was frozen and unable to move her left leg on command and needed physical assistance from this writer to ambulate.  She became weak and needed the assistance of another nurse to  be laid on the stretcher.  VS were taken 98/64,117,22.  (VS prior to administration of the vaccine  124/89,130,18.     At this time we offered to send her to ED for further evaluation but staff declined stating, "this has happened before, it will go away".   It was agreed upon that if symptoms worsened or showed no improvement in 5 minutes EMS would be activated.  12:50 VS 130/83,89 , tremors dissipating, fingers back in normal position , she was able to move her left leg on command and stand unassisted.   She continued to be monitored and all symptoms gone by 1:10  when she was able to leave the facility on her own.
Patient lost consciousness for a minute while waiting in the pharmacy after her vaccination. She slid down from the chair she was sitting on and recovered consciousness soon after laying down on the floor. She mentioned she was dizzy but otherwise alright. No signs of allergy, had cold hands. Symptoms indicated syncope but witnesses mentioned they saw her having a small seizure, where she threw her hands and head back before sliding down. 911 was called, they checked her and walked her to her car and let her go with a friend.
Left knee discomfort; Left knee has swollen like a balloon; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Left knee discomfort) and JOINT SWELLING (Left knee has swollen like a balloon) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Left knee discomfort) and JOINT SWELLING (Left knee has swollen like a balloon). At the time of the report, DISCOMFORT (Left knee discomfort) and JOINT SWELLING (Left knee has swollen like a balloon) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Head ache first day with weakness and chills. Next day I went to work and since I can?t put weight on, trouble  sleeping, minimal appetite, I have a hoarse voice and it starts to go out.
I wish to inform you that I had a very severe allergic reaction after receiving the first dose of the Pfizer vaccine. I had a dreadful swelling on my face with totally red skin and burning in my face. At first, I did not relate it to the vaccine but thought it was something very rare. I went to my dermatologist and she gave me a number of remedies, including cortisone and other medications. The swelling went down a bit and I received the second dose of the vaccine. At that point the allergic reaction was much more severe, just like the first time but much stronger. I went to an allergist and he confirmed that it was a reaction to the vaccine. It is an extremely rare case because I know many people who have received the same vaccine and no one has had anything happen to them.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; NIGHT SWEATING; This spontaneous report received from a patient concerned a  female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: unknown) dose was not reported, 1 total administered at left arm on 06-MAY-2021 for prophylactic vaccination (Dose number in series 1).  No concomitant medications were reported.  On 20-DEC-2021, the patient experienced sore throat, body ache (suspected covid-19 infection), night sweating that are pretty much gone. On 22-DEC-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive (twice) and had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, night sweating, and suspected clinical vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208226.; Sender's Comments: V0-20211251848 -Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Patient remained in the pharmacy area for observation for 15 minutes. Afterwards she went to her car, and felt the need to use her albuterol inhaler. Later she returned to the pharmacy to report her symptoms. Pharmacist called 911. Fire department said patient vital signs were stable. Fire department still transported patient to emergency room because she felt dizzy.
Pain in arm. Can not lift arm above head without pain.  No pain in body at all before the vaccine.
This case is 1 of a cluster of 2 patients who experienced similar adverse events following vaccination with DAPTACEL. The event for the second patient was captured in case number 2011-00817. Initial report received from a health care professional on 23 February 2011. A 3-month-old female patient received on 07 January 2011 a left thigh injection (route not reported) of DAPTACEL, sanofi pasteur lot number C3577AA. On 07 January 2011, the patient developed inconsolable high pitched screaming for 8-9 hours after the vaccine with swelling and redness on the left thigh. The outcome was reported as recovered. Follow-up information was received from the health care professional on 05 April 2011. The patient was 9 pounds, 9 ounces at birth, and had 2 sisters. No additional new information was reported. Documents held by sender: None.
Patient received a dose of the Moderna Covid-`9 vaccine on 4/21/21. About 10 minutes after receiving the vaccine, she reported that she started to feel "anxious and about to pass out". She was the placed in a chair and given water. Her vitals at the time were BP 126/80mmHg, P 86, R 16, and O2 sat 99. She then proceeded to have a panic attack. She was instructed to take deep breaths. Vitals were re-checked 15 minutes after and were BP 138/90 mmHg, P 87, R 18, and O2 sat 100. Patient's spouse came to take her home. She was feeling much better after about 30 minutes.
body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to explain it very well; change of sense of taste; loss of taste; body rash on upper torso only described as "not bad" and "not itchy" or bothersome; low grade fever 100.3; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left upper arm, on 21Dec2020  06:30 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was  hospital.The patient's weight was 67.13 kg and height was 173 cm. The patient's medical history included nausea and flu like symptoms. Concomitant medications included omeprazole(PROTONIX) from Dec2020 at 40mg once a day for nausea. The patient stated that a week before she received the vaccine she had flu like symptoms and she was tested for COVID-19 and the test result was negative in Dec2020. The patient experienced low grade fever 100.3 which started in the evening of the vaccine(21Dec2020) and she took Tylenol and went to sleep and the next day felt better, which resolved by the next day(22Dec2020). The patient experienced body aches on an unknown date, body rash on upper torso only described as "not bad" and "not itchy" or bothersome which started on 21Dec2020(a few hours after receiving vaccine) and resolved on 23Dec2020. The patient experienced change of sense of taste, "everything tastes metallic and it's kind of hard to explain it very well" on 24Dec2020. The patient experienced loss of tastewhich started on either 23Dec2020 or 24Dec2020. She was starting to be able to taste. She has anything it is bland. She can taste some saltiness. That started coming back on approximately Saturday, 26Dec2020. The patient experienced decreased appetite, "cotton mouth" on an unknown date.  The outcome of the events "low grade fever 100.3", "body rash on upper torso only described as "not bad" and "not itchy" or bothersome", "loss of taste" was recovered and of other events  was unknown.
This spontaneous report as received from a medical assistant refers to a 77 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. The patient did not have any drugs allergies. On 20-APR-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R000579, expiration date 9-SEP-2019, for preventive of pneumococcal disease (strength, dose, route and frequency were not reported). On the same day (reported as "immediately after injection"), the patient experienced severe back spasms and after 10 minutes back spasms were resolved with no intervention. The medical assistant reported that physician was requesting a lot check for PNEUMOVAX 23 lot R000579 expiration date 09-SEP-2019. The causality assessment between back spasm and PNEUMOVAX 23 was not provided. This is one of several reports received from the same reporter; Sender's Comments: US-009507513-1804USA009486.
Awoke 36 hours later with severe vertigo. Could not get out of bed, turn head for 3 days. Severe spinning, naseau and sweating.
Severe lower backache and into buttock, similar to sciatica. Debilitation almost complete for about 48 hours. Moved from initially on right side to left side of lower back. After initially noticed Friday, by Monday marked improvement. Now, 8 days after flu shot, back pain greatly reduced but not gone. Now have serious weakness/ache in right knee, unknown if related.
Day 6 after receiving the second dose of Covid Pfizer vaccine i began to develop hives. Started small like a mosquito bite, within 2 more days hives began to get larger and more intense. Large clusters of 30 hives would develop in different areas of my body. The cluster would last approx. 1 hour and then be completely gone. More would return in the same manner.  Currently I am almost 4 weeks still experiencing hives, however they are beginning to slow down. I have not had a large cluster of 30 hives in 7 days.  Physician advised to treat with witch hazel only. This has helped greatly.
Immunizations MMR, Varicella, Polio, Combivax given 8/23/02. On 8/27/02, patient was stumbling, balance off, falling. Patient taken to MD and a neurologist. She became worse. Admitted to hospital. 60 day follow up states pt recovered. 60 day follow up on 10/27/2003: "Vaccine recipient did recover from the adverse events.  Doctor's should only give 1 shot at a time.  Not 2 or 3 that may cause a problem.  It didn't cost the MD a thing it cost us $5,000.00."
06/06/2017 Received routine vaccine. 06/09/2017 Severe allergies symptoms began, including sneezing, runny nose, itchy eyes/skin, eczema flare ups, and wheezing. These symptoms are not completely, uncommon, however came out of nowhere even though allergies had been previously controlled. The allergies symptoms continued through the month. I believe the symptoms were due to the vaccine I received on 6/6/17. A sinus infection began towards the end of June. 07/3/2017 Dr  diagnosed Sinus Infection which was treated with 875 mg Amoxicillin. 7/13/17 Began to notice heart palpitations, racing heart, shaking hands. These symptoms have never been experienced before. 7/27/17 to 8/1/17 started noticing eyes were more puffy than normal. 8/2/17 Dr. Appointment for swollen eyes. 8/3/17 Lab results showed: Free T4 above high normal, TSH Sensitive Below normal  8/4/17 Was sent to hospital to have a thyroid ultrasound. 8/10/17 Referred to Endocronologist, Dr.  8/16/17 Thyroid Uptake and Scan- Confirmed Diagnosed of Grave Disease. 9/8/17 Dr Endocronologist, follow up for Graves Disease treatment, needle biopsy of Thyroid. 9/22/17 Dr. for treatment of Graves Eye Disease. 11/3/17 Dr, Endocronologist follow up for Graves Disease Treatment. 1/12/18 Dr.  Endocronologist, Follow up for Graves Disease Treatment. Diagnosis:  Graves Disease and Graves Eye Disease.  Long term medical care required.
irritability w/fever to 102 resolved by next day;irritability lasted 6-8hr;
Pt recvd vax in JUL92 & 2 to 3 wks later pt exp coughing, congestion, low grade fever, lightheadedness & joint pain; No further details were provided;
nasal congestion; chills; pyrexia; vaccination site pain; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion), CHILLS (chills), PYREXIA (pyrexia), VACCINATION SITE PAIN (vaccination site pain) and MYALGIA (myalgia) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 041B21A) for COVID-19 vaccination.     No medical history was provided by reporter.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced NASAL CONGESTION (nasal congestion), CHILLS (chills), PYREXIA (pyrexia), VACCINATION SITE PAIN (vaccination site pain) and MYALGIA (myalgia). On 17-May-2021, NASAL CONGESTION (nasal congestion), CHILLS (chills), PYREXIA (pyrexia), VACCINATION SITE PAIN (vaccination site pain) and MYALGIA (myalgia) had resolved.          Treatment medications were not provided by reporter.   This case was linked to MOD-2021-080358 (Patient Link).
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a adolescent female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age of vaccination was not reported. The patient experienced injection site pain which persisted for approximately one week. This case has been linked to the cases US2018GSK164861, US2018GSK164860 and US2018GSK091195. For tolerance of 2nd dose refer case US2018GSK233061.
Initial report received from a healthcare professional on 08 October 2013. A child patient received 0.5 ml FLUZONE instead of 0.25 ml. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
lower extremity numbness, weakness, tingling , ascending, MRI suggested demyelinating disease, IVIG started, work up in progress