chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt stated she developed light headache about 1 hr after getting vaccines lasting about 1 hr. next day rash developed on arms around 10am. & started spreading to rest of body. By 5pm had rash all over body & was taken to the ER. pt was examine & given BENADRYL to take until rash cleared. No other tests done.
Patient c/o nausea and fatigue on 7/15 day after vaccination.  On 7/17 had pain in left axillary area and chest wall, pain in axillary area and left chest wall when lifting left arm, reports swelling in axillary area and to lateral aspect of pectoral muscle.  Presented to clinic on 7/18 with continued pain and tenderness in left axillary area, but no swelling appreciated. No lymph node enlargement.
3.75 cm x 2.75 cm erythematous, induration lesion on upper left thigh, no signs of infection. (1/17/2014) Pt. had received vaccines 48 hours prior (01/15/14). Treatment : Ibuprofen and BENADRYL as prescribed by provider.
Patient is a 63 y.o. male with PMH significant for COPD, PE, DVT, left upper lobe cavitary lesion felt to be aspergilloma as well as chronic biventricular CHF and coronary artery disease who presented to the emergency department with increasing shortness of breath and cough over the last 7 days.  The patient states that he had run out of his albuterol inhaler about 7 days ago.  He states that the sputum is clear. He reports wheezing as well as chronic lower extremity edema.  The patient states that he has received 2nd dose of Pfizer vaccine about 2 weeks ago.   In the emergency department, he initially 3 L nasal cannula.  COVID-19 PCR returned positive, NT proBNP was elevated at 2242. Patient underwent chest x-ray revealed a stable left upper lobe mass, with some small nodules and fibrosis noted at the right base
Pain in right shoulder and arm, limited arm movement and mobility started immediately following vaccination, arm numbness, pain at rest and at use.
A company representative that a pt received an injection of Prevnar and subsequently developed a fever greater than 103. No further information was available at the date of this report. Manufacturers Comment: The reporter indicated that other pts had developed fevers following receipt of Prevnar, however they are not presently identifiable. Additional reports will be generated when identifying information is provided.
I got a very serious skin rash. The only control for some time was prednisone. Since then I have been taking cyclosporine twice a day. The symptoms are now primarily just on my hands and wrists. my dermatologist does not see a connection.
Patient was underage, she reported she was 12 - but was in fact 11 years old.
tachycardia; This is a spontaneous report from a contactable nurse. A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140, expiry date: 31Mar2021), intramuscular on the left deltoid on 17Dec2020 13:22 at 0.3 mL, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient had tachycardia on 17Dec2020 13:25, post vaccine but it went away quickly. Reporter stated that she didn't know if patient was anxious. Outcome of the event of tachycardia was recovered on 17Dec2020.  The reporter assessed the event as non-serious.
A delayed skin hypersensitivity response at the Moderna Covid19 vaccination injection site in a 72 year old woman.  A 3 inch by 5 inch red itchy rash at the injection site appeared 5 days after vaccination.  It has abated somewhat but still persists now 2 weeks after the vaccination.
1/15/2021 11:00 p.m. developed orbital edema took Benadryl 75 mg PO. 1/16/2021 morning orbital edema improved but still present, shortness of breath, lips tingling, swollen tongue, facial numbness around mouth and cheeks. Benadryl 50 mg every 4-6 hours, Prednisone 10 mg, Tagement  1 pill (unknown dose), Afternoon developed GI symptoms cramping diarrhea took Bentil 20 mg 1/17/2021 Continued facial swelling Benadryl 50 mg 1/18/2021 Symptom resolution
EPISODES OF HEADACHES; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high cholesterol, high blood pressure, non smoker, and no alcohol use, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204821A, and expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced episodes of headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from episodes of headaches. This report was non-serious.
Skin Sensitivity; Every side effect mentioned; feeling like I have bronchitis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (Skin Sensitivity), ADVERSE EVENT FOLLOWING IMMUNISATION (Every side effect mentioned) and ADVERSE DRUG REACTION (feeling like I have bronchitis) in a patient of an unknown age and gender 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 ADVERSE EVENT FOLLOWING IMMUNISATION (Skin Sensitivity), ADVERSE EVENT FOLLOWING IMMUNISATION (Every side effect mentioned) and ADVERSE DRUG REACTION (feeling like I have bronchitis). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (Skin Sensitivity), ADVERSE EVENT FOLLOWING IMMUNISATION (Every side effect mentioned) and ADVERSE DRUG REACTION (feeling like I have bronchitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication reported. No treatment was provided.
None until after I go the 2nd shot.  Since then, I have a rash that will not go away. Steroids will make it stop itching, but as soon as I stop the steroids it comes on full force. I have had to be on steroids off and on (since I got the last dose). I have been to dermatologist and several other doctors, but there is nothing. I have been told by people it is a COVID rash. Well if so, mine is so severe that it need to be documented.
Adm dx: ORIF-rt supracondylar fracture, gastric ulcer; final dx cardiorespiratory arrest, acute bronchitis, demantia-alzheimer's type, secondary dx malnutrition, dehydrat, ASCVD, osteoporosis, osteoarthritis;
I notice it on 11/19/2021, it could have started earlier, but I did not notice it. It started as an itch and I did not pay a lot of attention. On 11/19/2021, all across my back was itching and I could not scratch it. It just so bad that I finally got my son to look at my back. He took pictures and I had red welts from where I had been scratching. It kept going. I went to see my ENT on 12/06/2021-and I mentioned it to them and showed them the pictures and they told me it was definitely hives and they referred me to an allergist. On 12/13/2021- I saw my allergist and she told me it was hives. It was big red welts. It did not hurt or anything. She prescribed medication, Zyrtec 10 mg, twice a day, morning and evening and Pepcid 20 mg to take that twice a day for 4 weeks. And I have to do blood work and I have to go back and see her again and she will tell me what to do from there. I just started the medication and the itching is not as bad. The welts will come and go away. I have not been itching as much. The hives and itchiness are on my arms, neck, and back and sometimes my legs are itching.
It was a flu shot, but I'm not sure what kind. I know it was not preservative free because I declined a preservative free shot, and I don't think it was quadrivalent. I was 3 weeks 1 day pregnant, EDD 5/30/2018. Miscarriage began 9/23/2017 and was confirmed by hCG draws and ultrasound.
4SEP rt hand (middle finger throbbing) mild pain;5SEP soreness, calves & thigh joint;achiness & piercing pain throughout legs;hx tick bite-1yr ago w/subsequent arthritis sx;
Patient received dose 2 of the Pfizer COVID vaccine (lot EW0187) at approximately 1445. At 1455, patient reported to Paramedic  that she felt generalized numbness, tingling, and lightheaded. PHN  approached to assess. Vital signs: blood pressure 162/94, pulse 89, O2 98%, respirations 18. Patient reported eating cereal and a banana. PHN offered patient Benadryl but patient refused. At 1500, PHN and Paramedic  assisted patient in transferring to zero-gravity chair and laid patient supine. Patient reported allergy to grass, denied medical conditions and medications. PHN encouraged patient to follow up with provider and when to call 911. Patient reported no history of syncope but experiencing similar reaction to previous injections. At 1505, vital signs: blood pressure 144/86, pulse 80, respirations 16. Patient reported improvement in symptoms. Patient was given juice and goldfish. At 1507, patient reported decrease in pulse, pulse 80. At 1510, patient sat up and reported no symptoms. At 1517, vital signs: respiration 16, blood pressure 132/66, pulse 74. Patient stood up monitored by PHN and Paramedic. Patient left walking with steady gait at 1520.
The caller stated his wife has asthma. She has had all the Pfizer COVID shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "weak immune system" (unspecified if ongoing), notes: he stated they have always thought she had a weak immune system. The patient's concomitant medications were not reported. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "The caller stated his wife has asthma. She has had all the Pfizer COVID shots". Therapeutic measures were taken as a result of asthma.  Additional information: Patient had asthma. Patient received all the doses of the vaccine and the reporter wanted to know if his wife can get the booster dose since his wife was taking Fasenra injection every month. He wanted to know if there was waiting time before taking the new booster dose. She had all the Pfizer COVID shots, the original two Pfizer COVID vaccines and two boosters, and was about to go in for the BA4/BA5 variants, Pfizer BioNTech COVID-19 Bivalent adult booster (gray cap). She also took an injection every other month for asthma, Fasenra and had the last one last Sunday. He wanted to know if there is a period of time she should wait after that injection before getting the COVID booster. They called AstraZeneca since they make that product to check on it for that product. After providing information about immunocompetence he stated they have always thought she had a weak immune system but did not know that she has ever been officially diagnosed as immunocompromised and not on any medication for that condition (altered immunocompetence). She did not had another appointment planned with her doctor for a couple months. His HCP recommended he get the flu shot first, which he did in her office yesterday and then wait two weeks before getting the COVID vaccine. He was not sure why their recommendations would be different than CDC recommendations and wanted to know Pfizer's stance.  Follow-up attempts are completed. No further information is expected.
COVID-19 symptoms started 06/23/22; tested positive 06/23/22. I felt fine the 22nd and the 23rd I felt like I had a head cold. It started out with a headache and scratchy throat and then I felt the sinus pressure and headache later on that day. That night I had fever and chills. I did a telehealth visit on the 23rd and was prescribed Paxlovid which I started that night. That night my fever broke probably in the early hours of the 24th and by the day of the 24th my symptoms were maybe runny nose but it seemed like it cleared up and I had 5 days of the Paxlovid and I finished it out and haven't had any other issues since.
Around 10pm on Tuesday I started to have severe neck pain, headache, fatigue. I ended up going to the emergency room after my shift but due to the physicians recommendations I deferred the lumbar puncture while there. Later Thursday night, the neck pain continued, and I started having fevers with a max of 102.1 so I returned to the ER the following day for the lumbar puncture. I was admitted to the hospital for aseptic meningitis.
Sever pain in injection arm, fever, muscle ache, headache, fatigue.  Started 8 hours after injection.  Bed ridden for 36 hours.  2 days after injection feeling better, fever broke, still fatigued.  No longer have headache
Pt became itchy and red within 10 min of injection- states normal for her after receiving medications - similiar episodes with multiple medicatioons Symptoms became worse and pt transported to emergency department for treatment
PATIENT WAITED 15 MINUTES IN OBSERVATION.  LEFT FACILITY, IN CAR, FELT AS THOUGH SHE HAD TROUBLE SWALLOWING.  HIVE APPEARED ONLY ON NECK.  NOT OTHER SWEELING ITCHING OR BREATHING PROBLEMS.    PT REPORTED THAT SHE WAS FEELING BETTER.  BENEDRYL 50MG PO ADMINISTERED.  VITALS: 97%O2 RA, 105 BPM, BP142/110.  911 CALLED, EMTS TRANSPORTED TO HOSPITAL FOR FURTHER EVALUATION.
This spontaneous report has been received from a physician regarding an 11 year old  twin patient (gender not reported). No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). After receiving the vaccine GARDASIL 9, the patient experienced sleepiness, described as "sleeping off and on for a whole day". The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the event. The next day after vaccination, on an unknown date, the patient recovered from the event. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA010075:
Fever, headache, nausea, rash. Rash became worse over next two days. Went to Urgent Care 11/06/2014. Diagnosed with Cellulitis.
Janssen (J&J) COVID vaccine received on 03/19/2021, Pfizer COVID vaccine received on 12/22/2021 after the recorded adverse event Hospitalization on 11/28/2021 and discharged on12/2/2021. Diagnosis: COVID 19 pneumonia, Coumadin toxicity, Hypoxia, Chronic ulcer of leg,  Treatment: Hospitalization, Decadron, Remdesivir, Supplemental O2, Wound care, cardiology consult
MINOR CHILLS FOR 15 MINUTES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced minor chills for 15 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor chills for 15 minutes. This report was non-serious.
tc from mtr 26AUG states pt had recvd vax 10AUG & morning of 12AUG had sz w/tremors on lt side of body; rt side was rigid; mtr states pt had no fever; no other s/s; being followed by MD;
Shot recvd 9:15 am Approx 10:00 AM began to feel tingling in inner ears and scalp moving to face.  10:15 AM lips begin totreat. Checked into ER 10:40 AM swelling spreads to tongue. 11:00 AM swelling spreads to throat. 12:15 PM Dr gave dose of meds that gradually made the symptoms go away
Jannsen COVID-19 vaccine (adenovirus) use for COVID-19 under Emergency Use Authorization (EUA): inadvertent preparation and administration of expired COVID 19 vaccine.
1st dose in her left arm and the pain at that injection site has never gone away; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (1st dose in her left arm and the pain at that injection site has never gone away) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (1st dose in her left arm and the pain at that injection site has never gone away). At the time of the report, VACCINATION SITE PAIN (1st dose in her left arm and the pain at that injection site has never gone away) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information provided was Compresses.   This case was linked to MOD-2021-346463 (Patient Link).
the patient in question received their first dose of VAQTA in 2017 and did not receive a booster as recommended by the prescribing information; No adverse event; This spontaneous report was received from a pharmacist and refers to a 55-year-old patient. Information regarding the patient medical history, concomitant medications, drug allergies or reactions was not provided.      On an unspecified day in  2017,  the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) dose 1 for prophylaxis (dose, strength, administration route, lot number and expiration date were not provided.).    It was mention that the patient did not received the recommended booster by the prescribing information(vaccine dose omission). Pharmacist stated that the patient came into the pharmacy and received a dose of hepatitis A combination (TWINIRIX) on 17-AUG-2023. No adverse events were reported.
Red rash at injection site, first noticed 10 days after injection. No pain or itching. Sore at injection site for a few days after injection.
This case was reported by a nurse and described a patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). The nurse reported that several patients did not respond to immunization with Engerix B, however, patient identifiers were not provided. On an unspecified date, the patient received the third dose of Engerix B. Approximately four to six weeks after the third dose of Engerix B, on an unspecified date, a hepatitis B surface antibody titer was positive. At an unspecified time following the first antibody titer test, on an unspecified date, a second titer for hepatitis B surface antibody was negative.
At 0938 client c/o H/A, back, neck pain and dizziness. He was clammy. R-18, P-80, at 0940 P-84, BP 70/40, states feeling worse, called 911, at 0943 BP 80/64, P80, drowsy mother at side, at 0946 EMT here transport to Hospital with mother. Client able to walk out (unsteady gait).
8/14/02 seen in ER for "target rash"on legs and fever. 8/15/02 saw private dr. for em rash on elbow and for fever of unknown etiology. 8/17/02 seen by dr for generalized rash. 8/18/02 seen in ER rash spread to entire body with facial swelling and fever 103 not relieved by o.c. meds.
Parent reported redness size of three half dollars on left deltoid, warm to touch. Treatment with Benadryl 1 1/2 tsp PO Q 6-8H PRN next 24 hours use warm compresses.
chest pain in ribs but not like heartburn. checked heart rate, blood pressure at home and pressure was normal but heart rate was low at between 48 and 50 (normal around 60)
Expected sore arm started about 6pm day of injection 10-4.  Brief episode of chills at 4:00 am 10-5.  Fatigue & very sore arm during day 10-5, but went to work. About 7pm on 10-5, painful swelling under right arm noticed.   Swelling spread to encompass right breast tissue by 10-7;  large area still painful.  Pain mostly controlled with Tylenol q 6 hrs.  I have not seen my doctor yet.  Tomorrow will be one week since injection.  I would expect to see some resolution starting within the week.  If not, I will make an appt.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-DEC-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB, (dose, route of administration, injection site, lot number and expiration date were not reported). It was also reported that two consecutive doses of RECOMBIVAX HB, (dose, route, of administration, injection site, lot number and expiration date were not provided) were administered on 24-MAR-2015 and 18-MAY-2015, respectively which was outside the recommended dosing schedule. No adverse effects were reported. Additional information has been requested.
Per nurse call 3/18/18 redness, swelling, hard and tender to touch on (R) deltoid no fever. Stated symptoms began 3/7/18. Saw PCP 3/9/18 with resolving swelling.
Fever up to 102.3 degrees F, rectally. Had low grade fevers up to 101.2 on 9/24/10 and 100.5 on 9/25/10.  Then resolved.  Infant was also fussy but consolable from 9/23/10 through 9/26/10 and then this resolved also.
The child fell down on the floor in the office. Applied cold compress to back of neck and forehead. He looked pale. After about 5 mins, he slowly raised to feet to sit in a chair and was feeling fine.
recovering from COVID; recovering from COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID: (003110). The reporter was patient wife.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "recovering from COVID". Patient was at home and had sniffles, a bit of a cough, and get to take extra naps. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.   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: Linked Report(s) : US-PFIZER INC-PV202200095748 Same reporter/event, different patient;
Nausea, emesis, dizziness immediate post vaccine. Resolved that night, returned to work next day.
Chills, Fever, Sweaty, Lower back pain, headache, general malaise