chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient slumped down in chair, was non-responsive. 911 called immediately, was moved carefully to horizontal position on floor. Patient was able to nod head in response to questions, and swallowed 2 Benadryl and some water at around 04:12 PM. Patient's breathing became more labored, and lips started to become a blue color, and she was increasingly non-responsive. A dose of Epi-pen 0.3mg was administered at 04:15 PM. EMS arrived shortly thereafter and took patient to hospital.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond 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 (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    Concomitant product use was not provided by the reporter.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 days beyond use date.  The lot number for the monovalent vaccines with their corresponding BUD dates were 027C21A (BUD - 21-May-2021), 053C21A (BUD - 01-Jul-2021), 939902 (BUD - 02-Sep-2021), 011F21A (BUD - 04-Nov-2021), 012H21B (BUD - 23-Dec-2021), 056M21A (BUD - 12-May-2022), 082B22A (BUD - 08-Sep-2022).   The lot numbers for the bivalent vaccines with their corresponding BUD dates and the interval period of administration. 052D22A (BUD - 17-Nov-2022), dates of administration 18-Nov-2022 to 28-Nov-2022, 023H22A, (BUD - 15-Dec-2022), dates of administration 16-Dec-2022 to 20-Dec-2022.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live ollow-up information received contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master Case
I tested positive for COVID-19 on January 10, 2022. Just a running nose and a scratchy throat. It was very mild cold like symptoms.
Reporter states approx 19MAY90 pt devel morbilliform rash while playing w/cousin who was vaxed w/MMR on 07MAY90 WAES 90080335; Pt was on Cefaclor; Reporter felt pt's rash was related to Cefaclor;
I got my booster shot on 3/3/22. Since my booster shot I've had body aches, fatigue, chills, slight headache, occasional periods of hot flashes, and occo. waves of nausea  almost every evening  starting  around 4-5p for the last 2.5 weeks and lasting most of the night.  Every morning  I get up I feel better, but then it starts all over again the next evening. I previously was vaccinated on 8/12/21 and  9/8/21 with only 2 days of symptoms post each initial shots.  I left the medical professional section blank because I have not seek any medical care regarding my symptoms yet.
This case was reported by a consumer via out of hour services and described the occurrence of pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ankylosing spondylitis (all her life). On 24th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, several hours after receiving SHINGRIX, the patient experienced pain, neck pain, sickness, numbness of upper extremities, headache, shoulder pain and knee pain. On 24th September 2018, the patient experienced burning sensation, tingling, feeling bad and injection site pain. On an unknown date, the outcome of the pain, neck pain, burning sensation, tingling, sickness, numbness of upper extremities and injection site pain were not recovered/not resolved and the outcome of the headache, feeling bad, shoulder pain and knee pain were unknown. It was unknown if the reporter considered the pain, neck pain, burning sensation, tingling, sickness, numbness of upper extremities, headache, feeling bad, shoulder pain, knee pain and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient reported that she had the SHINGRIX vaccine on Monday afternoon and she had been so sick with aches. The patient claimed that she had Ankylosing spondylitis so she was not sure if it was making it worse. She also reported pain in her neck, shoulder and knees and her arm goes numb. She claimed that her side effects were just horrible. She felt a stinging when the vaccine was administered in her arm and later there was a numbness down her arm with burning and tingling. She awoke in the middle of the night and felt so bad. She claimed that her knees were killing her and her head hurt so bad. The patient claimed that she was not getting the 2nd shot because of her experience with the 1st shot.
Fatigue the day after. More concerning, the continual "butterflies" he felt in his chest the day following the second vaccine does.
Mild headache around sinuses and back of head; cold symptoms (very mild congestion, mild eyes burning); cold symptoms (very mild congestion, mild eyes burning); cold symptoms (very mild congestion, mild eyes burning); mild chest discomfort (similar to acid reflux/GERD which I have a history of).; chest pain (thought was related to my GERD condition); This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 25Feb2021 13:45 (Lot number was not reported) (at the age of 54-years-old) as dose 1, single for covid-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), mild mitral valve prolapse. There were no concomitant medications received within two weeks of vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient did not have covid-19 prior to vaccination and was tested for covid-19 post vaccination. On 04Mar2021, the patient experienced mild headache around sinuses and back of head and cold symptoms, very mild congestion, mild eyes burning and mild chest discomfort similar to acid reflux/GERD which she had a history of. The symptoms began about a week after first vaccine dose and were present 1.5 weeks later. The patient was preoccupied with possibly having caught COVID during that time and the chest pain in Mar2021, she thought was related to her GERD condition. The patient had polymerase chain reaction (PCR) test by nasal swab on 10Mar2021 and the result was negative. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The outcome of chest pain was unknown and outcome of all other events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Had vaccinations @ clinic 8-3-09. Mom reports today that both thighs swelled up, but L went down, right one still swollen. R thigh mid-thigh to knee very swollen, diffusely red and very warm to touch. Referred to private MD as soon as possible.
diabetes; weight loss; stomach cramping; trouble sleeping; high cholesterol; fast heart beat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 02186127 (Agency).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "weight loss"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach cramping"; SLEEP DISORDER (non-serious), outcome "unknown", described as "trouble sleeping"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "high cholesterol"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart beat". The patient underwent the following laboratory tests and procedures: Blood cholesterol: high; Heart rate increased: Increased.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no additioanl AE reported; a five year old patient received a dose of RECOMBIVAX HB on 05-OCT-2020 and 23-OCT-2020; This spontaneous report was received from a physician and refers to a 5-year-old female patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On 05-OCT-2020 and 23-OCT-2020, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB)(dose, strength, route of administration, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). There was no additional adverse events reported.
I felt shot going into corroded artery into head, it numbed left side of face and I developed migraine on right arm. I had 2 episodes since this started. Last event I had to be care flighted from the local hospital to the stroke ward of a different.  Blood clot found in aorta at hospital. Classified as TIA which triggers strokes currently.
Approximately 4 days after receiving my second dose, I started to experience stomach issues, including pain/cramps, loose stools/diarrhea.  The symptoms finally started to ease on 3/29/21 but I visited my doctor on March 30, 2021 who gave me a Zpack in case it was stomach virus but also told me to report my experience.  At first, I did not think anything of it because I have had stomach issues from time to time, especially after eating certain foods.  This, however, lasted much longer than any other times and I was only able to really eat crackers.
This spontaneous report was received from a physician regarding a 16 year old female patient. Her medical history, concurrent conditions and concomitant medications were unknown. On 19-AUG-2010 and 04-MAY-2012, the patient was vaccinated with first and second doses of human papillomavirus (HPV) vaccination series with GARDASIL (doses, routes, lot #s, and expiration dates unknown) for prophylaxis (inappropriate schedule of drug administration). On 15-AUG-2017, the patient returned to the physician's office for third dose of HPV series with GARDASIL 9 (dose, route, lot#, and expiration date unknown) for prophylaxis (circumstance or information capable of leading to medication error and interchange of vaccine products). No adverse effects were reported. This is one of two reports from the same reporter (1708USA009484 involving the patient's brother).
REDNESS, SWELLING TO INJECTION SITE STARTED ON 12/23/20. 8x12 AREA OF BLANCHABLE REDNESS, CALORIC, INDURATION NOTED UPON EXAM WITH EOH ON 12/31/20.
BARELY WALK; LOST A LOT OF WEIGHT; SEVERE PHYSICAL PAIN; BARELY STAND; THROWING UP; This spontaneous report received from a parent 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, start therapy date were not reported 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 barely walk, lost a lot of weight, severe physical pain, barely stand, and throwing up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the barely walk, throwing up, lost a lot of weight, severe physical pain and barely stand was not reported. This report was non-serious.
patient was administered 0.2ml of the Pfizer pediatric dose.  However, the vaccine given had expired 5 days prior.  the lot number expired 09/30/2022 and the vaccine was given 10/05/2022.
Information has been received from a pharmacist via company representative referring to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 10-MAR-2016 (reported as "one week ago"), the patient was vaccinated with a shot of ZOSTAVAX (dose and lot#, unknown) subcutaneously. The patient's concomitant medication was not reported. On 10-MAR-2016 (reported as "one week ago"), after the shot, the patient had developed spots and had to be hospitalized. Unspecified treatment was given. The patient had subsequently been discharged. The outcome of the event was reported as recovering/resolving. The causality between the event and ZOSTAVAX was not reported. Additional information has been requested.
Emp complains of continuing left arm pain, loss of strength and reduced range of motion.  Pain wakes her up at night.
Pervasive myalgia on 11 February lasting into 12 February; on 12 February a large moveable and painful lump found in the left axillary, abdominal cramping, diarrhea, and a syncopal episode. (ER visit, all labs and diagnostics normal, 1000mL NS via IV and discharged); 13 February general weakness and continued myalgia across the chest and back into 14 February.
I started having a fever and headache around 7pm. At 10 pm my back was hurting badly, head hurting badly, and lots of chill shaking my body
PMH: Breast cancer with metastasis and polypharmacy. History of reflux, on pepcid and has not taken it today.ALL: deniesVS: 98%, HR 95, BP 127/91  Symptoms: This is Dose#1Heartburn and mild stomach upset Assessment: chest is clear, Heart rate mildly elevated on auscultation. No distress. Treatment: None Patient observed for 15 minutes with no further symptoms and driven home by companion.
The patient was given a 3rd shot when only 2 shots are required in the series. Patient said he had not experienced any negative effects after 5 days.
This spontaneous report was received from a pharmacist and refers to a 76-year-old female patient. The patient drug reactions/allergies included statin drugs. The patient had no medical history. On 18-SEP-2017, the patient was vaccinated in the arm with PNEUMOVAX23 (dose and route of administration were not provided, lot # N010105, expiration date on 15-NOV-2018) as routine vaccination. On the same day, in the same arm the patient was vaccinated with an influenza virus vaccine (dose and route of administration were not provided, manufacturer Sanofi, lot# UI832AD, expiration date on 20-MAR-2018). Concomitant therapies included irbesartan, liothyronine sodium, amlodipine and ranitidine. On unspecified day in September 2017 (reported as either on the 18th or the 19th), the patient experienced swelling, redness and warmth in the upper arm, radiating from the injection site. The patient sought medical attention therefore he spoke to physician and pharmacist. No laboratory diagnostics/studies were performed. It was unknown if the patient received treatment for the adverse events. At the reporting time, the patient was recovering form the events. The causality between the events and PNEUMOVAX23 was not reported.
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No Concomitant medications were provided. Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not report any adverse event. No treatment medications were provided.
Pain in shoulder---Dr. said it was too high in muscle of shoulder and hit the nerve pain got more severe and went to Dr. 6 weeks later.
Information has been received from a physician concerning an approximately 48 year old male pt, who on 8/26/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (641532/1353L) in the arm. Concomitant vaccination included a dose of influenza virus vaccine in the other arm. On approximately 8/27/02 the pt experienced an injection site reaction with swelling, warmth and redness "the size of a hand." The injection site was painful for 3 to 4 days. The pt was treated with Tylenol and cold compresses. The reporter expressed a concern with the lot. Five other patients (WAES0209USA00016, 0209USA00030, 0209USA01591, 0209USA01593 and 0209USA01594) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
having a really bad swelling under the right armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 31Oct2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunisation. The following information was reported: SWELLING (non-serious) with onset 31Oct2021, outcome "recovering", described as "having a really bad swelling under the right armpit".  Additional information: Caller wanted to know if anyone else has reported having a really bad swelling under the armpit. Caller stated she has gotten this after receiving the 2nd dose of Comirnaty. Area under arm pit swelled up, like a third breast, after second vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Turner Parsonage Syndrome = vaccination associated acute left brachial plexopathy. Treatment: inflammatories, Physical therapy.
Raised; Knot; Redness on upper arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number D7797, expiry date 9th July 2021) for prophylaxis.   On 21st May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site nodule. On an unknown date, the outcome of the injection site erythema and injection site nodule were recovered/resolved and the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site nodule to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that the patient received Shingrix and experienced redness on upper arm covering area of 6 to 8 inches in size. She also experienced a raised knot in size of inch to inch and a half. It took about two weeks for the redness and knot to be resolved. No further details were provided.
High Blood Pressure, Fast Heartbeat, Tingling in arms and legs, pain in chest
Arm pain; Immobility of the right arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received Shingrix, Boostrix and PNEUMONIA VACCINE. On an unknown date, unknown after receiving Shingrix and Boostrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix and Boostrix.  Additional detaails were provided as follows: The age at vaccination was not reported. The patient received  Boostrix, Shingrix, and a pneumonia vaccine on the same day. The reporter stated that, after vaccination with Boostrix, Shingrix, and a pneumonia vaccine, the patient had pain in right arm and immobility of right arm. The reporter did not sure which vaccine caused the adverse events. The reporter did not consent to follow up.
I received the Moderna BOOSTER on 11/2/21 at 7pm.  The next morning I was experiencing severe dizziness... then about a week later I started also experiencing vertigo.  It is ongoing.