chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse (R.N.) referring to a 6 month old patient of unknown gender. The patient had no pertinent medical history or drug allergies. On an unknown date the patient was vaccinated with the third dose of ROTATEQ (oral: dose, lot# and expiration date not reported) in the series. There was no concomitant medication. The patient immediately vomited after receiving the ROTATEQ on an unknown date. The patient did not seek medical attention and no treatment was given for the event. The outcome of the event was fully recovered on an unknown date. Causality assessment was not reported. Additional information has been requested.
chest pain; difficulty of breathing; heart pounding; stiffness; muscle ache; BP of 70/40/Blood pressure continues to lower down; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), DYSPNOEA (difficulty of breathing), BLOOD PRESSURE DECREASED (BP of 70/40/Blood pressure continues to lower down), PALPITATIONS (heart pounding) and MUSCULOSKELETAL STIFFNESS (stiffness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 011A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, AMLODIPINE and FUROSEMIDE for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLOOD PRESSURE DECREASED (BP of 70/40/Blood pressure continues to lower down). On an unknown date, the patient experienced CHEST PAIN (chest pain), DYSPNOEA (difficulty of breathing), PALPITATIONS (heart pounding), MUSCULOSKELETAL STIFFNESS (stiffness) and MYALGIA (muscle ache). At the time of the report, CHEST PAIN (chest pain), DYSPNOEA (difficulty of breathing), BLOOD PRESSURE DECREASED (BP of 70/40/Blood pressure continues to lower down), PALPITATIONS (heart pounding), MUSCULOSKELETAL STIFFNESS (stiffness) and MYALGIA (muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2021, Blood pressure measurement: 70/40 (Low) Low.         No medical history was provided by reporter.  No treatment medication was reported.
1 month post vax had myalgia, chest pain, radiating to back left calf cramping left leg and arm edema. Treated with nsaids and HCT.
swelling; nodule; wrist pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), NODULE (nodule) and ARTHRALGIA (wrist pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling), NODULE (nodule) and ARTHRALGIA (wrist pain). At the time of the report, SWELLING (swelling), NODULE (nodule) and ARTHRALGIA (wrist pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Initial headache then sharp/shooting pains in ears/neck. Dizziness and vision changes.   possible trigeminal neuralgia
Contracted shingles, required anti-viral drugs. Symptoms included very painful puss-filled rash across head, face, neck, shoulder. Lasted 3 weeks.
Hives, itching all over body. Have not resolved with treatment of Benadryl and prednisone, and famotadine.
A little warm; Dizzy; Off balance; Swollen and raised; It was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (A little warm), DIZZINESS (Dizzy), BALANCE DISORDER (Off balance), VACCINATION SITE SWELLING (Swollen and raised) and VACCINATION SITE ERYTHEMA (It was red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012LZCA) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), METOPROLOL, LOVASTATIN, MONTELUKAST SODIUM (SINGULAIR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LINACLOTIDE (LINZESS), VITAMIN D NOS, AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE (DYMISTA) and TIMOLOL MALEATE (TIMOPTIC) for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen and raised) and VACCINATION SITE ERYTHEMA (It was red). On 24-Jan-2021, the patient experienced DIZZINESS (Dizzy) and BALANCE DISORDER (Off balance). On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (A little warm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (A little warm) and VACCINATION SITE SWELLING (Swollen and raised) had not resolved and DIZZINESS (Dizzy), BALANCE DISORDER (Off balance) and VACCINATION SITE ERYTHEMA (It was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Approximately 2-3 minutes after receiving shot I noticed my chest began to hurt & I felt a little light-headed. I assessed how I was feeling and decided to go sit down. At that time I began feeling very short of breath & light-headed. I alerted staff I couldn't breathe &  they assisted me to sit. A nurse took my pulse and found my heart rate 200. It had been about 5-6 minutes. EMS was called. My blood pressure was noted to be 158/74.  I was asked to cough, which I did. When EMS arrived my heart rate was noted to be 100-110 and my blood pressure 132/72. I was taken to the ER where I was evaluated further for the next 6 hours. No further episodes were noted and all medical tests were normal.
Fever,  Chills, muscle ache tired in AM then extreme chills and muscle ache for 12 hours then fever for  24 hours
Vaccine was given to patient after expiry; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry).    Concomitant drugs were not reported.  It was reported that the 6 doses monovalent vial of 5. size was initially stored in refrigerator on 16-Feb-2023 and was administered to patients on 24-Feb-2023, 28-Feb-2023, 01-Mar-2023 and 06-Mar-2023. The vial was not exposed to temperature excursion.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715785, US-MODERNATX, INC.-MOD-2023-715792, US-MODERNATX, INC.-MOD-2023-715804, US-MODERNATX, INC.-MOD-2023-715806, US-MODERNATX, INC.-MOD-2023-715780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715785:same reporter US-MODERNATX, INC.-MOD-2023-715792:same reporter US-MODERNATX, INC.-MOD-2023-715804:same reporter US-MODERNATX, INC.-MOD-2023-715806:same reporter US-MODERNATX, INC.-MOD-2023-715780:same reporter
approx 1705 pt recieved vaccine. 1735 pt reported throat closing, has had hx of anaphylaxis in past and requested that we give her benadryl b/c it has helped in past. epinepherine available but pt declined. 1737: gave benadryl 50 mg PO to pt. 1745: pt reported throat feeling better, VS stable, HR a bit elevated according to pt. A&O x 4, no other signs of anaphylaxis. 1800: snack and water given to pt. throat "ok", almost back to normal, reported feeling slightly dizzy or "spinny" 1812 Pt states that she "feels better and OK to leave" with husband, VSS vital signs: 1737 HR 114, BP 134/86, RR 18, O2 98% 1743 HR 111 BP 119/74, RR 16, O2 97% 1748 HR 112, bp 131/86, RR 20, O2 97% 1753 HR 107, BP 134/74, O2 97% 1806 HR 103, BP 139/87, RR 16, O2 97% 1810 HR 99, BP 138/86, RR16, O2 97%
Left eye isn't right; Didn't get second dose of Covid-19 vaccine as scheduled; Everything on the left side of body was going numb/Left nostril went numb/Left cheekbone really tight and numb/Left back side of neck went numb/Left shoulder and arm were numb; Tingling in fingers; Lymph nodes on left side of neck were swollen; Left shoulder and arm were numb; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: was not reported; Expiration Date: Jul2021) via an unspecified route of administration on 16Mar2021 18:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 16Mar2021 the patient experienced everything on the left side of body was going numb, left nostril went numb, left cheekbone really tight and numb, left back side of neck went numb, left shoulder and arm were numb on 16Mar2021, tingling in fingers, lymph nodes on left side of neck were swollen. The patient experienced left eye isn't right and didn't get second dose of covid-19 vaccine as scheduled on an unspecified date. Caller reported that she was supposed to get her second dose of the Covid-19 vaccine on 06Apr2021 but she is waiting to get the second dose. Caller reported that her physician is going to run tests because her symptoms have been kind of bizarre. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial unsolicited report received from a physician via Pfizer (under the reference number: 2016499114) on 09 Nov 2016. This case involves a 61-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, route, dose not reported) on an unspecified date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and concomitant medications were not provided. On an unspecified date, following the vaccination, the patient experienced allergy to influenza virus vaccine inactivated. Lab data and corrective treatment was not reported. The patient's event outcome was not reported. List of documents held by sender: none.
Received BNT162B2 and it was longer than 7 days after their 2nd dose that they contracted COVID-19/Patient was vaccinated and contracted COVID-19; Received BNT162B2 and it was longer than 7 days after their 2nd dose that they contracted COVID-19/Patient was vaccinated and contracted COVID-19; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), on an unspecified date (lot number was not reported) as dose 1, single; then on an unspecified date (lot number was not reported) as dose 2, single - both via an unspecified route of administration for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received BNT162B2 and it was longer than 7 days after their 2nd dose that they contracted COVID-19 on an unspecified date. The patient was vaccinated and contracted COVID-19 who died with it and they were young. The patient underwent COVID-19 RT-PCR test: contracted COVID, positive on an unspecified date. The patient died due to COVID-19 and drug ineffective. It was unknown if an autopsy was performed or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Drug ineffective; COVID-19
(DOB 08/10/1985) received the 1st dose COVID vaccine (Pfizer, lot # EW0187 and use by date 06/28/2021 @ 0945) at 11:00am. Patient reported having mild shallow breathing to (EMT) who immediately reported to Lead RN. Lean RN assessed the patient while (EMT) took a full set of vitals. Patient was apprehensive to receive vitals including BP and O2 saturation monitor but consented after further education from RN and EMT. Vital signs at 11:06 were BP of 132/82, HR of 94, RR of 16, and O2 Saturation Level of 97%. RN observed patient was A&O x4 with no wheezing, hives, or angioedema present. Patient denied chest pain, difficulty breathing, changes in vision, difficulty swallowing, and nausea. Patient denied benadryl, EMS, food, and transfer to a zero-gravity chair. Patient denied vitals every 5 minutes and explained that she has a history of SVT induced by anxiety. Patient reported that having vitals taken increases her anxiety and refused q5 minute vitals. Patient agreed to have vitals taken once more after 30 minutes of observation. At 1115 patient was drinking water and stated "I delivered my baby 3 weeks ago, so I am always tired." Patient explained that she has been quarantining over the last year due to her pregnancy and had increased anxiety being around so many people at the vaccine site. At 11:16 patient stated "my breathing is good now." Patient has NKDA, no chronic conditions, and a pertinent history of panic attacks and SVT induced by anxiety. At 1125, patient consented to one additional set of vitals. Vitals were BP of 144/88, HR 92, RR of 16, and O2 Saturation Level of 98%. At 11:30, Lead RN and (Co-lead) educated about Vaccination program, ER precautions, and f/u with PCP. At 11:33 patient stated that "water is making me feel much better." Patient denied SOB, dizziness, lightheadedness, and changes in vision. At 11:38 patient stated that her brother is driving her home and left the site. Co lead RN observed a steady and symmetrical gait as patient walked away.
Nose bleeding, that continues for 10 min several times a day.  it started 4 days ago and still continues. She never had a nose bleed before.
tired; burned when injected; redness; heat; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th February 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site burning. On 21st February 2020, the patient experienced tiredness. On an unknown date, the outcome of the injection site erythema, injection site warmth and tiredness were recovering/resolving and the outcome of the injection site burning was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, tiredness and injection site burning to be related to Shingrix.  Additional details were provided as follows: The pateint received Shingrix and experienced  burned when injected, pain, redness and heat at the injection site. The patient very tired at the time of reporting and did not want to get out of bed. The follow up consent was granted.
Chest pressure; Shortness of breath; Tiredness/ tired; Headache; Muscle pain; Chills; Joint pain; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 27Aug2021 at 09:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 06Aug2021 at 09:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 27Aug2021, first two days after second dose, the patient experienced chest pressure, shortness of breath, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell and tired. On 03Sep2021 at 01:00, the patient experienced all of the same symptoms on day 7,8 and 9 after the second dose and this was the problem. The events resulted in doctor or other healthcare professional office/clinic visit. 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 events chest pressure, shortness of breath, tiredness/tired, headache, muscle pain, chills, joint pain, nausea and feeling unwell were not resolved at the time of this report.
This case was reported by a healthcare professional and described the occurrence of hives in a 11-year-old female subject who was vaccinated with Boostrix, GlaxoSmithKline for prophylaxis. On 6 June 2007 the subject received unspecified dose of Boostrix in the left arm. On 8 June 2007, following vaccination with Boostrix, the subject experienced hives. At the time of reporting the event was unresolved.
Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022; No Adverse event; 5th Patient received expired booster doses after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5th Patient received expired booster doses after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5th Patient received expired booster doses after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5th Patient received expired booster doses after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (5th Patient received expired booster doses after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022).    No concomitant medications were reported. Vial initially was thawed on 29-JUL-2022 and kept in the refrigerator. Patient received booster dose. The patient was not pregnant. Vial did not undergo any temperature excursions. This case contains information for the 5th of 8 adult patients described by the reporter. No treatment information was provided.
Moderna on 1/25 and 2/18. Positive on 9/1 admitted on 8/31 to current
Site right deltoid - app. 10/26/05 area from elbow to shoulder red, swollen, over outer aspect. Normal ADL, afebrile, normal activity with good I & O.
No adverse event; Vaccine administered after beyond use date; This spontaneous case was reported by a non-health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 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 (Vaccine administered after beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication information was reported. The vaccine was received at the clinic on 07-Jun-2022. The vaccine beyond use date was reported as 07-Jul-2022. No treatment information was provided.
SWEATING; VOMITING; CAN NOT SLEEP ON LEFT SIDE; DON'T FEEL GOOD RIGHT NOW; LEFT ARM PAIN; MILD HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. 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 was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, treatment medications included: paracetamol. On 13-MAY-2021, the subject experienced sweating. On 13-MAY-2021, the subject experienced vomiting. On 13-MAY-2021, the subject experienced can not sleep on left side. On 13-MAY-2021, the subject experienced don't feel good right now. On 13-MAY-2021, the subject experienced left arm pain. On 13-MAY-2021, the subject experienced mild headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, vomiting, and mild headaches, had not recovered from don't feel good right now, and left arm pain, and the outcome of can not sleep on left side was not reported. This report was non-serious.