chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2015, the patient was inoculated with ZOSTAVAX, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine was administered by a physician. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician (the same physician who administered the vaccine) for the onset of a vesicular rash which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.  Additional information has been requested.
Pt c/o lightheadedness, slightly nauseous. Denies LOC. Pt offered water, declined snack. Ambulatory independently from w/c to stretcher. No s/s of distress noted. Orthostatic VS obtained. VSS. Pt spouse at bedside. VS are as follows: 0855: BP 143/69, HR 75, RR 20, O2 sat 94% on RA 0911: lying VS: BP 127/62, HR 71, RR 18, O2 sat 97% on RA 0912: sitting VS: BP 138/62, HR 69, RR 20, O2 sat 98% on RA 0913: standing VS: BP 148/79, HR 75, RR 18, O2 sat 97% on RA
hospitalization; 2nd dose given beyond 36 days; allergic reaction; inflamed; itching a lot; Swollen arm; Really red; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (hospitalization) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 037AZ1B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Patient's medical history included No Adverse event.  Concomitant products included ROSUVASTATINE [ROSUVASTATIN] for Cholesterol, METFORMIN for Diabetes, METHIMAZOLE for Thyroid disorder NOS, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), HYDROCHLOROTHIAZID, ALPRAZOLAM, TEMAZEPAM and DOXAZOSIN for an unknown indication.  On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given beyond 36 days), ALLERGY TO VACCINE (allergic reaction), INFLAMMATION (inflamed), VACCINATION SITE PRURITUS (itching a lot), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Really red). On an unknown date, the patient experienced HOSPITALISATION (hospitalization) (seriousness criterion hospitalization). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 24-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given beyond 36 days) had resolved. At the time of the report, HOSPITALISATION (hospitalization), ALLERGY TO VACCINE (allergic reaction), INFLAMMATION (inflamed), VACCINATION SITE PRURITUS (itching a lot), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Really red) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Concomitant medications and details about second dose were  added. Adverse events for second dose were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
"Hives"-Started with few small red raised itchy bumps around shot site ((L) arm where VARIVAX and TDAP given" with swelling of site. Next day (6/24) started with red bump itchy under both underarms. Then 2-3d later large red raised patches on back. No other constitutional symptoms. Pt clinically stable otherwise. Seen 6/30/10 at office. Given ATARAX and steroid cream topically.
Vertigo; Felt a little off/Felt a little tinge; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and MALAISE (Felt a little off/Felt a little tinge) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Bug bite (took an anti-itch medication for it). Previously administered products included for Psoriasis: Tremfya (not taken since 5 months and as per patient it was anti-immunosuppressant) in 2021. Past adverse reactions to the above products included No adverse reaction with Tremfya. Concurrent medical conditions included Itching and Psoriasis. Concomitant products included HYDRALAZINE for Itching.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VERTIGO (Vertigo) and MALAISE (Felt a little off/Felt a little tinge). At the time of the report, VERTIGO (Vertigo) had not resolved and MALAISE (Felt a little off/Felt a little tinge) outcome was unknown.            No treatment information was provided.  The patient came back from traveling and had a bug bite and took an anti-itch medication for it, called Hydralazine because their foot was itchy, and woke up this morning and had vertigo. After the booster dose, the patient felt a little off, not much else, and just felt a little tinge from it. The patient has taken this medication in the past and does not recall having vertigo at that time. Consumer thinks there may be a correlation between the Moderna COVID-10 vaccine, the hydralazine medication, and vertigo.   The patient also reported that they were taking a medication called Tremfaya for psoriasis but had not taken it for 5 months. It was an anti-immunosuppressant, according to the patient and reported that they were considered immunocompromised but did not receive the 3rd full dose for immunocompromised individuals as the patient was traveling to  and did not want to feel a lot of side effects, so they got the booster dose instead. The patient was still experiencing the effects of the vertigo and reported no reaction to the first dose of the vaccine.   This case was linked to MOD-2021-391143 (Patient Link).
Patient developed moderately severe erythema surrounding L Deltoid injection site.  This was associated with mild pain and pruritis and occured 3-5 days after the injection.  Patient self treated with naproxen and diphenhydramine and was feeling improved when I examined her on 31 Dec 2002.  She missed no work from these events.
Fever 101.4. Severe arm pain, redness 4 cm swelling, restricted motion shoulder.
BUMP ON LEFT DELTOID AREA WHERE RECEIVED THE VACCINE; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 270 pounds, and height was 64.8 inches. The patient's past medical history included anemia, and concurrent conditions included non smoker, alcohol user, and penicillin allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced bump on left deltoid area where received the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bump on left deltoid area where received the vaccine. This report was non-serious.
Swollen left leg, extremely irritable, hysterical crying. Temp 103.8 at 1/31/08 visit.
12yo patient received adult Pfizer COVID vaccine (30mcg) on 10/16/21 as appropriate, but ended up receiving the pediatric Pfizer COVID vaccine (10mcg) as a 2nd dose on 11/11/21.
WORSENED TINNITUS IN BOTH EARS (RINGING WORSENED IN BOTH EARS BUT LEFT EAR MORE AFFECTED); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: low level tinnitus, and allergies, and other pre-existing medical conditions included: The patient was not taking any other medications at the time the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk.) dose was not reported, administered on MAY-2021 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. On an unspecified date, the patient experienced worsened tinnitus in both ears (ringing worsened in both ears but left ear more affected). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worsened tinnitus in both ears (ringing worsened in both ears but left ear more affected) was not reported. This report was non-serious.
-dizziness happened about 15 minutes after the shot. pt had flu shot every year before and never experience any fainting/dizziness before  -dizziness/ fainting comes and go for at least 8 hours after the shot.
Right arm at site of injection it has a huge knot, very red and hot and hurts to touch.
sore arm; some chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and CHILLS (some chills) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Full blood count decreased (history of lowblood cell count and wanted to be protected). Concurrent medical conditions included Muscle weakness (Since 20 years( issue with muscles in the lower back, and was had trouble walking and moving)).    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and CHILLS (some chills). At the time of the report, PAIN IN EXTREMITY (sore arm) and CHILLS (some chills) outcome was unknown.            No concomitant medications were reported. After receiving the previous Moderna vaccines the patient had a sore arm and some chills. When the patient took newbivalent booster vaccine on 07-Sep-2022 and states the vaccine was great and it was the first dose that did not cause patient any reaction. After receiving new bivalent booster the next day patient visited the doctor because of issues with the muscles in his lower back, he was having trouble walking and moving. The patient mentioned that these were not related to the vaccine, as patient had historical weak muscle problems (for 20 years). On 09-Sep-2022 the doctor gave the patient a 7 day treatment of prednisone and a shot of Toradol. The patient was wondering if these medications interfere with the vaccine and he was very concerned, he mentioned that he had history of low blood cell count and wanted to be protected. No treatment medication were provided for the events pain in extremity and chills.   This case was linked to US-MODERNATX, INC.-MOD-2022-644268 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644268:(Case for Friends)
Arm is sore; I got the booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (009679). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 82 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "I got the booster shot"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is sore".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Feel achy; Mucle aches; Chills; Headache; Diarrhea; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2022 08:30, the patient received Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced pain, muscle pain, chills, headache and diarrhea. On an unknown date, the outcome of the pain, muscle pain, chills, headache and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the pain, muscle pain, chills, headache and diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUL-2022 Reporter's comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix yesterday (day before reporting) at 8:30 and felt achy, muscle aches, chills, headache and diarrhea.  The patient asked that how long this would take to go away. Additional supportive information: The follow-up would not possible as no contact details were available.
C/O leg weakness hours after vac was administered patient was advised to go to the ER and was admitted in a CVA dx.
Sore throat; Vomiting; Diarrhea; Anemia; This is a spontaneous report from non-contactable consumer (patient) via COVAES. This non-pregnant 16-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 25May2021 at 10:45 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphocytic colitis from an unknown date and unknown if ongoing. The patient had no known allergies, had not been diagnosed with COVID-19 prior to vaccination and had not received any other vaccines in four weeks. Concomitant medications included calcium supplements, macrogol 3350 (MIRALAX), and nutrition shakes, all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number unknown) on 04May2021 at 10:00 (at the age of 16-years-old) for COVID-19 immunisation. On 26May2021 the patient experienced sore throat, vomiting, diarrhea, and anemia, which the patient reported was confirmed with labs. The events resulted in an emergency room visit; no treatment was received for the events. The clinical outcomes of sore throat, vomiting, diarrhea, and anemia were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot number cannot be obtained.
Pain in the left armpit and left chest that has persisted, and pain in the rectum for 18 hours now.
BLOOD CLOT ISSUES; This spontaneous report received from a consumer via a company representative through media concerned a patient of unspecified age, sex, race and ethnicity. 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, 1 total, start therapy date was not reported for covid-19 prophylaxis. 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 blood clot issues. It was reported as "One friend had blood clot issues and is still in bad shape from it". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot issues. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221222696, 20221222717 and 20221222719.; Sender's Comments: V0: 20221222695- blood clot issues. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
s/s L arm was red & swollen, hot to touch.  Advised to apply cool moist towel to area
Thursday-shot area swollen egg shaped, hot to the touch, rest of arm and shoulder cold. Couldn't lift arm up or straighten it, tendon in elbow felt odd and more than half way down arm would feel numb. *Friday-sick to stomach, arm still swollen and hot to touch rest of arm and shoulder cool. Arm ached and still weird feeling in elbow tendon. Patient was very cold it was 81 in the house and she was bundled in winter clothes and comfortor, bad chills and sweaty. *Saturday-felt like she was going to faint during teaching a class. The nursed helped me off the floor. She could not balance. she felt like she was going to drop. She dosen't remember her whole conversation. Nurse said she was cold. The shot area was warm, and she was sweaty and hot. *Sunday-Pt's body hurt from head to toe. She felt like she fell off a horse. She couldn't walk without pain, she stated that it hurt to move. Gradually feeling better, still ache in right shoulder, it hurts to lay on.
Itching all over her body; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itching all over her body) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (Itching all over her body). At the time of the report, VACCINATION SITE PRURITUS (Itching all over her body) had not resolved.        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.   Company comment: This case concerns a 52-year-old female who experienced a nonserious unexpected event of pruritus without associated rash.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 52-year-old female who experienced a nonserious unexpected event of pruritus without associated rash.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Medium
Pt developed a 10 x 10 cm reddened, mottled area, slightly indurated  warm to touch.
I started having chest pains that would go down my right arm on 12/30/2021 that would come and go so I went to the ER on 1/7/2022 and had a complete workup and they couldn't find anything wrong. I went to my cardiologist on 1/10/2022 and she said that the Covid-19 I had last year has caused a cardiovascular disease. I have been diagnosed with heart failure. She ordered nitroglycerin and told me to take it if the chest pains get bad. I am still having chest pain, arm pain, and neck pain. My cardiologist thinks it's the microvascular congestion that is causing the chest pain.
Local injection site redness, induration, warmth, itch and 2 vesicular papules inside redness.  Redness measures about 5 x 5 cm along right tricep area.
13 year old patient received pediatric dose (0.2 mL/10 mcg)  of Pfizer Covid vaccine on Monday, November 15, 2021. On Wednesday, November 17, 2021 patient received  and completed  first dose with the remaining (0.4 mL/20 mcg) of Pfizer Covid vaccine.
11:50 am on August 26, 2017 headache behind the eyes developed with a sudden onset. Other symptoms included chills, feet falling asleep. Pain was described by my son as the worst pain he as ever felt. Gave 400mg Ibuprofen to relieve the pain and no relief happened. Threw up at 4:15 and 4:45. Lots of watery throw up. Went to the ER at 5:00pm and headache was a level 10. Patient was given an IV, PHENERGAN, TORADOL, and BENADRYL and still couldn't relieve the pain. The ER preformed a CT and it came back ok, no mass or sinus infection. We went home at 11:20pm and he threw up 3 more times at home. Fell asleep and when he woke up on August 27, 2017 the pain behind his eyes was a lot less. During the entire ordeal his headache was localized behind his eyes.
This spontaneous report was received from a physician referring to 18-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 30-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012768:
R arm swelling, redness, pain, tactile fever on 10/22.  Took Ibuprofen, Dayquil, and Nyquil.   Pt seen on 10/25 for follow up visit regarding test results from visit on 10/17 for evaluation of urticaria/facial edema and mentioned having received the PPSV23 vaccine on 10/20 with reaction beginning 10/22, slowly improving with Ibuprofen, Dayquil, Nyquil.   Exam of RUE on 10/25: large area of erythema, mild warmth, mild ttp, no edema, no abcess, no cellulitis, able to raise RUE above her head, normal ROM R elbow
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. On 02-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot# reported as L028286, expired date: 28-OCT-2016) which was improperly stored (Incorrect product storage). No adverse effects reported. Additional information has been requested.
pt (1 of 8 events) out of 20 pts immunized, w/lederject syringe devel inject site pain & sterile abscess which had to be surgically drained; pain & swelling persists; reporter states needle is too short for IM inject;