chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweating; Dizziness; Racing Heart beats; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU6202; first dose via unspecified route of administration in the left arm on 13Mar2021 at 11:15 (at the age of 58-year-old at vaccination) as a single dose for COVID-19 immunisation. Medical history of the patient included Lactose intolerance, Osteo and Rheumatoid arthritis, HBP (High Blood Pressure) and Apnea. The patient was allergic to drugs Irbesartan and Naproxen. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Losartan 100 mg and Hydrochlorothiazide 25 mg from an unknown date, indication and ongoing treatment unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 15Mar2021 at 20:45, the patient experienced racing heartbeat, dizziness and sweating. The patient received treatment as sit up, Aspirin 325 two tablets, dinner meal and fluids. The clinical outcome of the events racing heartbeat, dizziness and sweating was recovering. Since vaccination, the patient was not tested with COVID-19. No follow-up attempts are possible. No further information is expected.
Three days after the first dose of the vaccine, I noticed that not only did I suffer from pain in the arm where the shot was given (which is common), I also noticed that I was suffering from pain/ inflammation in the chest area. It was hard to breathe at times along with the chest pain. I noticed this especially at night. My symptoms would normally subside when I took pain relievers/anti-inflammatory drugs. This side effect lasted beyond 3 weeks. After my second dose of the vaccine,  I also experienced symptoms like a cold or like I was beginning to get sick.
Symptoms after 12 hrs included headache, freezing cold, leg pain, tight chest, high heart rate, cough , lasted 5 - 8 hrs. Next day bad head ache and exhausted. Then on  01/29/2022 3 days later I developed what I know no to be tinnitus of the ear. I also still have a head ache, red itchy swollen eyes, and different muscle aches daily. Treatments are Tylenol,  Motrin, and Lipo Flavonoid.
Pfizer COVID-19 vaccine drawn up 12/3/2021 (more than 6 hours since it was drawn up) given to the patient.
Within 4-5 hours post-IM he developed severe upper posterior torso muscle aches/pains that were worse with movement.  Pain initially was about 5/10 (0=nothing/10=worst), increased to 9/10 by 9am the following morning, interfering with sleep entire interval.  Several hours later pain diminished to about 6-7/10.   IV EGCG and Methylprednisolone treatment initiated ~3pm, which will take a few hours to see notable response.
tingle - nerve sensation;  in left arm from shoulder to fingers- stronger in fore arm and arm, over all surface of the arm. Also a little sore up left side on neck and left shoulder blade but No tingling in these two locations.
HYPOTENSION ACUTE PULMONARY EMBOLISM 11/5/2022  -  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: pt was counseld to reach out to primary care provider during regualr weekdays and if happens during weekend counseled to go to er
This vaccine made me incredibly sick for about 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's comment: This case was reported by a patient via interactive digital media. This vaccine made the patient incredibly sick for about 2 days. Additional supportive information: The follow-up could not be possible as no contact detail were available.
A few minutes after receiving her 1st moderna shot, patient complained of an itchy throat and bad taste in her mouth.  She had visible redness all over her face, neck and shoulders.  She stated she had intense itching all on her neck and face and her voice was sounding a little hoarse.  She did tell me that she had experienced  something like this with her asthma allergies but not with a vaccine. She had her albuterol inhaler with her and took t 2 puffs. She did state that it was a little hard to swallow, but did not feel like her throat was closing up. She stated she did not feel like she was having shortness of breath,  but was felt jittery and didn't know if was from the inhaler or her nerves. I had her lie on the floor.  The intense itching did not seem to be subsiding for her. Aske her if she would like me to call the EMTs  to asses her and she said yes.  I called the EMTs. Once they arrived , they took an assessment and her vitals. After about 20 minutes , she decided she was feeling a little better.  She did not go to the ER , they did wheel her out in a wheel chair and advised her to take some Benadryl.
PMH:  HTN, DM, morbid obesity; pt c/o SOB, fatigue, cough, nausea, anorexia x2wks, worsening past 3 dys; positive for COVID; COVID pneumonia with HRF; placed on BiPAP, remdesivir, dexamethasone, baricitinib; eventually required intubation with mechanical ventilation; pt coded and died in the hosp
Patient developed redness, swelling, warmth, pain, and itching at the site of the injection, this occurred approximately 48 hours after receiving the vaccination.
Dose 1- 16-Jun-2021 Dose 2- 04-Aug-2021; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 16-Jun-2021 Dose 2- 04-Aug-2021) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006821A and 047A21A) for COVID-19 vaccination.     Patient medical history included HLD. It was unknown that the patient was ever been diagnosed positive with COVID-19. Patient had no acute illnesses at the time of vaccination and up to one month before.  The patient's past medical history included Anemia (no recent changes in current condition). Concurrent medical conditions included Penicillin allergy, Hypertension (no recent changes in current condition), Diabetes mellitus (no recent changes in current condition) and Parkinson's disease (no recent changes in current condition). Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL SULFATE HFA), ALENDRONATE SODIUM (ALENDRONATE), AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID], BRINZOLAMIDE (AZOPT), CALCITONIN, SALMON (CALCITONIN-SALMON), BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN), FUROSEMIDE, LATANOPROST, LOSARTAN, BIMATOPROST (LUMIGAN), METFORMIN, ROSUVASTATIN and TRAMADOL from 01-Apr-2022 to an unknown date for an unknown indication.   On 16-Jun-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Aug-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Aug-2021 at 1:30 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 16-Jun-2021 Dose 2- 04-Aug-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 16-Jun-2021 Dose 2- 04-Aug-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not receive dose.4. The formulation of the calcitonin(salmon) 200 unit was actuation  nasal spray No treatment medications were reported.   This case was linked to MOD-2022-544279 (Patient Link).
VOMITING; SEVERE CHILLS; SEVERE  HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced severe chills. On APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe chills, severe headache and vomiting was not reported. This report was non-serious.
This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and same has been requested. No concomitant medications were reported. On APR-2021, the subject experienced shivering chills all night. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shivering chills all night and fever was not reported. This report was non-serious.
Patient woke up around 1 am on March 14th feeling dizzy. He continued to sleep until morning. He woke up with a headache and was not feeling well, so I kept him home from school. He took a nap until about 11:50 am. He came down the stairs and said he was feeling really weird. I felt his head and he was burning up. He took off his sweatshirt so I could take his temperature under his arm.  He again said he was feeling really weird. I asked, "what do you mean weird?" He stared straight ahead and started to walk right into the wall ahead of him. I tried asking him what was going on but he couldn't respond. I held him under his armpits and carefully walked him to our recliner.  Once he sat down, he came back to. He said he saw a bunch of colors and his ears were ringing.  He looked really pale and said he could feel the sweat dripping down his back. His shirt was soaked. I quickly called the doctor's office and got a temperature on him. It was 102.3 (with the point added since it was under his arm). I got his two TYLENOL right away too. Then I took him to the doctor's office. After the doctor visit, he just had low grade fevers 100-101 through the evening and night and felt good Friday, 3-15-19 except for a headache. Patient was completely healthy and feeling fine prior to the flu shot and he has never, ever been unresponsive like this. It was very scary!!!
If she walks little bit then she felt she passed out; After 2 weeks, she had shortness of breath; Dizziness; Vomiting; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (all cillins), Drug allergy (ibuprofen (MOTRIN)), Sulfonamide allergy (trimethoprim/sulfamethoxazole (BACTRIM)), Allergic to cats and Asthma. Concomitant products included DILTIAZEM, LISINOPRIL and ISOSORBIDE MONONITRATE (IMDUR) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021 at 3:00 AM, the patient experienced DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache). On 03-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) (seriousness criterion medically significant) and DYSPNOEA (After 2 weeks, she had shortness of breath). At the time of the report, LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) had resolved and DYSPNOEA (After 2 weeks, she had shortness of breath), DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received her first dose of Moderna COVID-19 vaccine on 20-APR-2021. After two weeks, she had shortness of breath and "if she walks little bit then she felt she passed out." The patient's health care provider did some test (unspecified) and everything came out normal, her lungs are clear and her oxygen level is normal.   Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Pt received DTP & 5 hrs later was brought to Hosp w/generalized jerky movements & rolling of eyes.
a child that is less-than-7 years-old receives a dose of ADACEL instead of DTAP with no reported adverse event; Initial information received on 25-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a child patient that is less-than-7 years-old receives a dose of Adacel (diphtheria-2/tetanus/5 ac pertussis vaccine) instead of dtap with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine suspension for injection (lot number, strength, expiry date, dosage not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the child that is less-than-7 years-old receives a dose of adacel instead of dtap with no reported adverse event (wrong product administered) (unknown latency)  A Medical Assistant (MA,) from Texas Health, asked if there are any concerns if a child that is less-than-7 years-old receives a dose of ADACEL instead of "DTAP?"  RA informed that since an AE occurred, I would like to gather additional information from her to document the call and submit an Adverse Event report to SANOFI PV Team  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Got her shingles vaccine and had tingling on Sunday between her lip and her nose and had gotten a cold sore, and the next day Monday she thought it was a cold sore and was close to the vaccine, and knows that it is not a live virus and she looked at it, and had cold sores years and years ago and they were usually a bubble.  She used a magnifying mirror and was small 3 little bubbles like shingles in this area.  She thought it was weird and wanted to report it and does not know what is going on with her body.   4th time she had shingles, in junior high on her hip diagnosed by a doctor.  She then got them about 10-12 years ago and they were on her buttocks and her groin area.  Then she got them after she had COVID, and then again after she had the booster vaccine, and now again following the shingles vaccine.  She did have a cold sore.  Her doctor moved to another city and did not go and see him as she is almost 92 and in the process of getting another PCP.  She went to the store a couple days later and bout some Lysin and took it once and now they are drying up and going away.   She put coconut oil on it to keep it soft and so that it didn't scab off, she saw on the internet to use Vaseline, but she uses coconut oil and used that.
Elevated heart rate when sitting (sustained 120-125 bpm for a period lasting over 10 minutes); Chills; General feeling under the weather; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 30Apr2021 at 12:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included the patient was allergic to iodine dye. The patient did not receive any concomitant medications within two weeks prior to the vaccination.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 09Apr2021 at 15:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 10:00, the patient experienced elevated heart rate when sitting (sustained 120-125 bpm for a period lasting over 10 minutes), chills and general feeling under the weather. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event elevated heart rate when sitting (sustained 120-125 bpm for a period lasting over 10 minutes), chills and general feeling under the weather were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient had no side effect after the first dose/No adverse event; Patient never received the second dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second dose of the vaccine) and NO ADVERSE EVENT (Patient had no side effect after the first dose/No adverse event) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergies related to medications, food, and other products.  Concurrent medical conditions included Asthma (Patient is asthmatic.). Concomitant products included ALBUTEROL [SALBUTAMOL] and MONTELUKAST for an unknown indication.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second dose of the vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (Patient had no side effect after the first dose/No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second dose of the vaccine) and NO ADVERSE EVENT (Patient had no side effect after the first dose/No adverse event) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was interrupted on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (Patient had no side effect after the first dose/No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second dose of the vaccine).    The reporter was calling on a behalf of a patient. The patient stated he only received the first dose of the Moderna a year ago. The reporter wanted to know if patient need to restart the series or 5 months down the line get the booster shot. The patient height was reported as 5 feet 10 inch.  The patient vaccination location, lot number, and route were unknown.  No treatment information was provided by the reporter.
I had sudden loss of breathe at the onset of the shot. I felt my body go from cold to hot, and I couldn?t catch my breathe. My BP was high. After feeling my stable, I went home. The next day I went to work, my right arm was sore. Saturday night 10/9/2021 I began to be itchy, big hives started near my right arm pit, and then moved to left side of my back and chest, and bilateral thighs. My thighs started getting red, hot and swelling. The rashes were hot to the touch, extremely itchy, and extremely swollen. It would hurt to walk as it felt like my skin was going to explode, a lot of pressure. On Sunday, early morning I went back and got Benadryl and cortisone cream that didn?t help at all. But what was most concerning was just having a normal conversation I was getting out of breathe, and it was hurting to walk. My resting HR was 138, BP 158/110. That evening I went to the ER and was admitted overnight.
Moderate pain left shoulder after shot. After 24 hours pain in shoulder radiating to elbow and swelling of left hand. Pain & swelling for 3 days went to Emergency Room & had ultrasound and x-ray of shoulder (both negative). Tramadol pills for pain from E.R. doctor - pain subsided 3 days later.
Approx 2 1/2 wks post vax pt experienced itching, 5days later developed generalized hives, Seen in Er tx inject of epinephrine; Sx persisted for approx 3 1/2 wks before resolving;
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA 1. 3/2/2021 - Within 4 hours had a dull head ache the same say vaccine given.  It lasted for 4 hours. (Recovered) 2. 3/2 - 3/4/2021 - Left arm where injection was given was sore for two days. (Recovered) 3. 3/5/2021 - Had rash in bends of both arms, on chest, and on stomach. (Still have rash)