chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FAINT; NAUSEA; RIGHT SHOULDER BACK PAIN; LEFT CHEST PAIN; DIZZINESS; RIGHT HAND NUMBNESS; COULD NOT MOVE; WEAKNESS; FEVER 102-103 F; BODY ACHES; SLIGHT HEADACHE; FELT LIKE HAVING AN ALLERGIC REACTION/FELT LIKE HIT BY TRUCK; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included pneumonia. 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: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient had a slight headache. On 10-APR-2021, the patient got off at midnight and felt body aches and upon waking up she could not move. On the same day, she felt like hit by a truck and experienced dizziness, right hand numbness, fever of 102-103 Fahrenheit and weakness. The patient took Bayer aspirin (acetylsalicylic acid) and Tylenol (paracetamol). The patient's headaches were excruciating and came and went and some she had all day. The patient also felt like having an allergic reaction. On 12-APR-2021, the patient had left chest pain and right side of her up shoulder back pain upon taking a breath. On 15-APR-2021, the patient had nausea and visited emergency room and had blood test, chest X-ray and electrocardiogram and everything was normal. The patient was treated with unspecified anti-inflammatory medications, Toradol (ketorolac tromethamine) as intravenous, and they advised to visit a heart doctor. On 17-APR-2021, the patient was faint.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left chest pain, fever 102-103 F, faint, right shoulder back pain, and right hand numbness, had not recovered from slight headache, weakness, nausea, and dizziness, and the outcome of body aches, could not move and felt like having an allergic reaction/felt like hit by truck was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: :20210436128 -covid-19 vaccine ad26.cov2.s -faint, bodyaches, left chest pain, dizziness, right hand numbness, could not move, right shoulder back pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210436128 -covid-19 vaccine ad26.cov2.s -weakness, fever 102- 103 F,  nausea, slight headache, allergic reaction. This event(s) is labeled per Agency and is therefore considered potentially related.
This spontaneous report was received from a pharmacist regarding two unspecified infants of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 15-JUN-2015, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Nothing other than a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Batch/Lot number: unknown) as dose 1, single and administration date 23Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Nothing other than a sore arm".  Additional information: Patients first 2 Covid shots did not react like third dose, and she was on the same medications and had the same medical problems. Prior Vaccinations (within 4 weeks) was none. she did not want to go to the ER and possibly expose herself to Covid unless it is necessary.  No follow-up attempts are possible. No further information is expected.
"Swelling/Urticaria of injection site that lasted >10days.  Pt given triamcinolone 0.1% cream, cetirizine 10mp PO Daily and Clindamycin 150mg cap 1 cap PO TID x4 days for reaction.  Pt received second dose on 3/5/21.  To date, pt has not reported a reaction to the second dose.  Allergies: Codeine (N/V  PMH:  Sleep Apnea  Obesity Low Back Pain HTN Hyperlipidemia Heartburn Headache Gallstone Eosinophillia Diverticulosis Diverticulitis depression Chronic  Constipation Arthritis Anal Fissure Uterine Fibroid Surgery (1996) Cholecystectomy (1997)  Medications at the time of vaccination: Bupropion SR 150mg 1 tab PO BID Amlodipine 2.5mg 1 tab PO Daily Metoprolol XL 50mg PO Daily Chlorthalidone 25mg tab 0.5tab PO Daily Diclofenac 1% Gel apply to affected areas BID bisacodyl 5mg EC tab 2tabs PO QHS PRN Constipation"
High heartrate in 140-160 beats per minute range for about 36 hours (2 hours after shot).
This spontaneous report as received from a consumer (also reported as mother of the patient) refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot number and expiry date not reported) (dosing regimen and frequency unknown) for an unknown indications. No concomitant medications were reported. On an unknown date the patient received first two shots of GARDASIL but never received the 3rd shot of GARDASIL. The patient experienced no adverse event. No product quality issue was reported. Additional information has been requested.
FIRST DAY OF VAC......CHILLS AT NIGHT.........DAY AFTER VAC  SOME DIARRHEA
Eight days after receiving the COVID vaccine I developed  a red itchy rash to my left arm. I also was itching all over my body. That resolved  in 3 days. I now have a burning and prickly sensation in my arm. This has not resolved and is very irritating at times. I am due for my second vaccine on 3/26/2021 and am reluctant to receive it.
itching and rash to torso area.  Started 3 days after Moderna Vaccine and 6 days after Shingrix vaccine.  Patient did not disclose at clinic that she had a Shingrix vaccine in the time frame before Modernal.
Eye swelling right under my eyebrow on both sides, more pronounced on the right side.; inflamed lymph node left armpit area; I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my  psoriasis flare was barely noticeable; I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my  psoriasis flare was barely noticeable; Sore arm; body aches; headache; 100.3 temperature; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in arm left on 23Mar2021 13:00 as dose 2, single for COVID-19 immunization (at the age of 38-year-old). Medical history included psoriasis and underactive thyroid. Concomitant medications included vitamin d3 and vitamin b12 nos (other medications in two weeks). No known allergies. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in arm left on 02Mar2021 13:15 as dose 1, single for COVID-19 immunization (at the age of 38-year-old). The patient did not took any other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. On 23Mar2021 23:00, the patient experienced sore arm, body aches, headache and 100.3 temperature. On 24Mar2021, the patient experienced inflamed lymph node left armpit area, have mild psoriasis on his forehead. He noticed that a day after the vaccination and the redness of his psoriasis flare was barely noticeable. On 27Mar2021 07:00, the patient experienced eye swelling right under his eyebrow on both sides, more pronounced on the right side. The patient did not received any treatment for adverse events. On 23Mar2021, the patient underwent lab tests and procedures which included body temperature: 100.3. The outcome of the event eye swelling right under his eyebrow on both sides, more pronounced on the right side was not recovered and for all other events was recovering.   No follow-up attempts are needed. No further information is expected.
Bottle of Pfizer Pediatric 5-11 years was not diluted and 0.2ML was administered to the patient undiluted. The patients parents were called in multiple times to see if the patient presented any symptoms and to explain the events but have not yet been able to contact them.
Use of COVID-19 vaccines from more than one manufacturer in the 2-dose primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Use of COVID-19 vaccines from more than one manufacturer in the 2-dose primary series) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (first dose). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Use of COVID-19 vaccines from more than one manufacturer in the 2-dose primary series). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Use of COVID-19 vaccines from more than one manufacturer in the 2-dose primary series) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No medical history information was reported.  Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Live follow-up information included no new information.
tching; arm sore to touch; extreme fatigue; lung muscles tight, hard to breathe; knees, arms and legs numb and heavy; shortness of breath; squizzing chest pain; chills; headache; dizzy; diarrhea; cough; could not move left arm at all; could feel the warm liquid coming up her shoulder and into the upper chest, like burning; really really red; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (squizzing chest pain), DIZZINESS (dizzy), DIARRHOEA (diarrhea), COUGH (cough) and VACCINATION SITE MOVEMENT IMPAIRMENT (could not move left arm at all) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Mar-2021, the patient experienced FEELING HOT (could feel the warm liquid coming up her shoulder and into the upper chest, like burning) and VACCINATION SITE ERYTHEMA (really really red). On 13-Mar-2021, the patient experienced DIZZINESS (dizzy), DIARRHOEA (diarrhea), COUGH (cough), VACCINATION SITE MOVEMENT IMPAIRMENT (could not move left arm at all) and HEADACHE (headache). On 14-Mar-2021, the patient experienced CHEST PAIN (squizzing chest pain), HYPOAESTHESIA (knees, arms and legs numb and heavy), DYSPNOEA (shortness of breath) and CHILLS (chills). On 18-Mar-2021, the patient experienced MUSCLE TIGHTNESS (lung muscles tight, hard to breathe) and FATIGUE (extreme fatigue). On an unknown date, the patient experienced PRURITUS (tching) and VACCINATION SITE PAIN (arm sore to touch). At the time of the report, CHEST PAIN (squizzing chest pain), DIZZINESS (dizzy), DIARRHOEA (diarrhea), COUGH (cough), VACCINATION SITE MOVEMENT IMPAIRMENT (could not move left arm at all), HYPOAESTHESIA (knees, arms and legs numb and heavy), DYSPNOEA (shortness of breath), MUSCLE TIGHTNESS (lung muscles tight, hard to breathe), FEELING HOT (could feel the warm liquid coming up her shoulder and into the upper chest, like burning), PRURITUS (tching), VACCINATION SITE ERYTHEMA (really really red), HEADACHE (headache), CHILLS (chills), FATIGUE (extreme fatigue) and VACCINATION SITE PAIN (arm sore to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   reatment Advil for the pain, antihistamine for burning, swelling and itching
Initial misuse report received from a healthcare professional on 18 October 2013. The cases were received on 21 March 2014. A baby patient received 0.5ml dose of FLUZONE (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
9-7-05 Slight fever- Rx Tylenol. 9-9-05 Pustular rash
PATIENT DESCRIBED AS ITCHY, SPLOTCHY RED AREAS COVERING BOTH ARMS DOWN TO ELBOWS, BACK AND NECK WITHIN 1 DAY OF INJECTION.  PATIENT SELF TREATED WITH BENADRYL AND HYDROCORTISONE CREAM...IT WOULD WORK AND HE WOULD STOP, THEN RASH WOULD REAPPEAR WITHIN A FEW DAYS. PATIENT JUST REACHED OUT TO THE PHARMACIST YESTERDAY (BEING A LITTLE OVER A MONTH POST INJECTION). CONTACTED PATIENT THIS MORNING FOR ADDITIONAL DETAILS AND TOLD HIM TO CONTACT HIS MD TODAY AND TO CALL US BACK.  PT HAD NOT CONTACTED MD PRIOR TO HIS CALL TO US.
Information has been received from a physician concerning a 62 year old female with several autoimmune diseases, who about a month ago approximately January 2009 was vaccinated SC with a 0.65ml dose of ZOSTAVAX (Oka/Merck) approximately in January 2009, the patient "had an outbreak of herpes" on her buttocks. The physician said it was not shingles. According to the physician, the herpes "seems to be recurrent" and it "crosses over and then it comes back". The outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a physician concerning a 62 year old female with several autoimmune diseases, who about a month ago approximately January 2009 was vaccinated SC with a 0.65mL dose of ZOSTAVAX.  The physician reported that within 48 hours of getting ZOSTAVAX (Merck) approximately in January 2009, the patient "had an outbreak of herpes" on her buttocks.  The physician said that it was not shingles.  According to the physician, the herpes "seems to be recurrent" and it "crosses over and then it comes back".  The outcome of the patient was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
Red butterfly shaped rash below the injection site (3 inches across and 2 inches tall); Itchiness below the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Red butterfly shaped rash below the injection site (3 inches across and 2 inches tall) ) and INJECTION SITE PRURITUS (Itchiness below the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No past medical history was reported by reporter.  Concomitant products included LISINOPRIL, ATENOLOL and LEVOTHYROXINE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced RASH (Red butterfly shaped rash below the injection site (3 inches across and 2 inches tall) ) and INJECTION SITE PRURITUS (Itchiness below the injection site). At the time of the report, RASH (Red butterfly shaped rash below the injection site (3 inches across and 2 inches tall) ) and INJECTION SITE PRURITUS (Itchiness below the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Patient presented with CP and concern for repeat STEMI. PCI showed clean coronaries and pain resolved. Echo showed low normal systolic function with akinetic and aneurysmal apex. No thrombus. ECG changes thought to be due to apical aneurysm. Per cardiology okay to dc on 2/4/22. She was sent on ASA & Plavix (instead of Brilinta), warfarin, and colchicine (total 3 months as per previous) along with previous BB & statin. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Syncopal episode SpO2 98%@RA BP 66/32 P 54 before discharge BP = 121/71
26Jan96 Pt recv 1st dose vax. 18Jan98 Pt devel 6-8 lesions on face,abdomen,chest & back. 19Jan89 Pt to MD for evaluation.
No adverse event; Administered vaccine after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis. No Medical History information was reported. On 12-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date).    This case contains information for the 4th of 4 child patients described by the reporter. No concomitant information was reported. No symptoms reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704265 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704265:Master case - 1st child
Client put an incorrect birthdate on her client record so it appeared she was 18. When the record was sent to the state they recognized the patient record had a different date of birth (age 16). Parent confirmed she was 16 and client appointment for 2nd dose was cancelled as she is not eligible for Moderna vaccine at this time.
Vaccine and then 20 minutes after -Tingling tongue and roof of mouth and lip metallic taste mouth Slight swelling of upper lip
Narrative COVID infection after completion of COVID vaccine series: 02/09/2021 COVID vaccine dose #1 03/02/2021 COVID vaccine dose #2 07/04/2021 Pt reported onset of decrease appetite and nausea, right-sided myalgia, and burning with urination. 07/10/2021 Pt presented to ED c/o decreased appetite, right-sided myalgia, burning with urination, and smelling cigarette smoke. Minimal non-productive cough present. Stated that has not needed to increase O2 use at home (hx of COPD). CTA showed LUL consolidation. 07/10/2021 Pt admitted to inpatient service. Decadron and Zithromax administered. 07/12/2021 MD attending reported pt no longer smelling cigarette smoke. Pt continued coughing and having right-sided myalgia. Continuation of Decadron therapy. Stated that remdesivir therapy would be initiated if pt's O2 needs increased above baseline (2L at home). 07/13/2021 MD attending reported pt experienced SOB and labored breathing above baseline (put on 3L O2). Remdesivir initiated. Continuation of Decadron therapy. Pt experienced "acute on chronic right shoulder pain" that has worsened. Ketorolac ordered. 07/13/2021 Azithromycin d/c (pt received 4 days of tx) 07/14/2021 Continuation of remdesivir therapy
non-immunocompromised patients received their 2nd shingrix dose at 1 month, rather than 2 months; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: non-immunocompromised patients received their 2nd shingrix dose at 1 month, rather than 2 months).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 25-SEP-2023 The health care professional reported that some of our non-immunocompromised patients received their 2nd shingrix dose at 1 month, rather than 2 months.  He/she understand the shortest interval could be 4 weeks for certain populations. For the ones not in that population. The reporter wanted to know do we need to repeat a second dose and should we check a titer at some point. Are there any considerations that we have to tell the patient. The patient received 2nd dose of Shingrix shorter than the recommended interval, which led to shortening of vaccinations schedule. The reporter consented to follow up.
Tinnitus, headache, joint pain. Initially.  On 05/10/14 cough, parotid area swelling and pain, headache, tooth pain, myalgias.
This female consumer was vax with Hepatitis B vax and subsequently noted that she had had a reaction in 1992 which she described as numbness, tingling, and muscle pain. The pt noted that she has been 'disabled since that time frame.' Additional information has been requested.
Syncope (12/14/2021 11pm passed out) Racing heart (12/15/2021 morning - still unresolved as of 1/27/2022) Chest pain (12/15/2021 morning - still unresolved as of 1/27/2022) Stabbing chest pain at left side (12/15/2021 morning - still unresolved as of 1/27/2022) Burning in chest (12/15/2021 morning - still unresolved as of 1/27/2022) Fatigue (12/15/2021 morning - still unresolved as of 1/27/2022) Armpit discomfort on injection side (12/15/2021 - still unresolved as of 1/27/2022) Rash on torso/arms/legs (12/16/2021 - 12/18/2021) Swollen lymph nodes and glands in and around neck/head (12/31/2021 - still unresolved as of 1/27/2022)