chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administrated with a 3rd dose of an expired Twinrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received HAB (Twinrix) (batch number 75c72, expiry date 13th June 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th June 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 15th June 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:  15-JUN-2022 Reporter's Comments: The patient was administrated with a 3rd dose of an expired Twinrix No adverse event was reported .  The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. No patient's identifiers provided. Additional supportive information: The patient received Twinrix which was already expired which led to expired vaccine used.
So I started feeling numbness and tingling in my pinkie finger. It stayed pretty consistent and then I started having weakness in that hand it lasted about a month and it started getting better for about a week or so. It came back it started to tingle again and numbness in my hand and then I developed weakness in my legs and lost the ability to run and then it started to affect my ability to walk. I seen a physician and was diagnosed after several test with multiple focal demyelinating neuropathy. I had to walk with cane and I finally got approved for the IV therapy IG therapy and last week my doctor started me on steroid therapy which helped till I could start the IG therapy yesterday.
FELT FLUSED FEELING, LEFT ARM /LEFT HAND TINGLING - LEFT FACILITY AFTER VITAL SIGNS TAKEN BY EMS ON SCENE
Initial unsolicited report received from a pharmacist (director of pharmacy) on 12 Oct 2016. This case was linked to 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. (Same lot number). This case involves a patient (age, gender unknown) who was vaccinated with a dose of Fluzone Quadrivalent (batch number- UI669AA, expiry date: 30 Jun 2017) by intramuscular route on 04 Oct 2016. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. On 06-Oct-2016, 2 days following the vaccination the patient had terrible muscle pain in neck in that morning and was progressively getting worse. On 08-Oct-2016, 4 days following vaccination patient and 09-Oct-2016, 5 days following vaccination, patient had nerve and joint pain and was not able to lift (may) arms past a certain height. On 10-Oct-2016, 6 days post vaccination, the patient had pain in both shoulder blades up into neck. The patient's lab tests were not reported. Patient did not sought out any treatment. The outcome of the event was reported as unknown. List of documents held by sender: none.
Patient was given I.M. flu shot at 12:45pmon 12/12/16. He passed out/fainted briefly after administration. We observed him and talked with him for 30 min post fainting.
I got flu like symptoms. Not really a fever, but I was warmer. Aside from that I felt like I had tachycardia. I already have issues with that but the vaccine made it worse. It went away on Monday, but I still had irregular heartbeat until around Wednesday. The 3 worst days were Saturday, Sunday and Monday.  The symptoms slowly went away, but yesterday seemed to be better.
Significant swelling at injection site (approximately 2 in diameter/size of a silver dollar). Included large raised bump and redness. No previous site reactions to vaccines. Also elevated temperature and nausea, but not atypical vaccine response for me
Severe pain all over Headache  especially at night pain keeps me awake never had this type of pain before
administered only the adjuvant; administered only the adjuvant; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number PA77M, expiry date 24th September 2023) for prophylaxis.   On 13th September 2022, the patient received the 1st dose of Shingrix. On 13th September 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-Sept-2022 Reporter's comment: The reporter consented to follow-up. This case is for 1 of 2 linked patients. Additional supportive information: The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022133247:Same reporter
Fever; Chills; Body Aches; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EN6207) for 1 day, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PREMPRO LOW DOSE oral. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6205; Anatomical location: Left arm), for COVID-19 Immunization, reaction(s): "Chills", "Fatigue", "Body Aches", "Fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body Aches"; FATIGUE (non-serious), outcome "unknown".  Additional information: It was also reported that the patient received unknown (Influenza Vac quadrivalent Prsv free 3 years IM within 4 weeks on 16Nov202 in the left arm. Fever, Chills, Body Aches, Fatigue began approximately 12 hrs. Post dose and continued for 12-16 hrs. This has happened after each of the vaccination doses. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201358718 same patient/AE, different vaccine dose;US-PFIZER INC-202201359444 same patient/AE, different vaccine dose;US-PFIZER INC-202201359446 same patient/AE, different vaccine dose;
Large (about 4 cm round) red, firm to area developed over injection site 2 weeks after injection (right thigh).
HEPATITIS B #2 (accelerated schedule) given 4/15/09 - later on 4/14/09 pt called with "arm burning".  No other symptoms advised ADVIL/cold compress.  On 4/28/09 pt.  notified me that on 4/15/09 he came down with severe H/A.  Fever, aches & extreme fatigue.  PCP diagnosed "para-flu" & he was to stay home & Tx symptoms. 4/28/09 Gave HB #3 (accelerated schedule). 4/29/09 Pt. called feeling very tired, achy. "Not as sick as before". Denies H/A, fever, N/V/D. Taking OTC ADVIL to Tx symptoms.
Expired vaccine administered to two patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to two patients.) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to two patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to two patients.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. The reporter stated that the vaccine vial was left out for 12 hours and then the prefilled syringes expired by 8-10 hours after. She does not know whether the patients are experienced  any symptoms No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Papular vasicular rash on trunk, legs, arms,and feet (including soles) and hands (including palms). Began on 05/20, 2 days post vax.
3 DAYS AFTER THE 2ND INJECTION, I DEVELOPED 2 BLOOD CLOTS AT THE BASE OF MY LUNGS - 1 ON EACH LUNG. IN CONNECTION WITH THAT, I DEVELOPED SEVER PAIN IN MY LOWER RIGHT FLANK AREA THAT RADIATED TO MY SHOULDER AS WELL AS HIGH BLOOD PRESSURE. THERE IS NO HISTORY IN MY FAMILY OF ANY CLOTTING ISSUES AND I MYSELF HAD NEVER HAD SUCH A THING OCCUR.  THE PAIN BECAME SO BAD IT FORCED ME TO GO TO A HOSPITAL EMERGENCY DEPT.  AFTER CT SCANS CONFIRMED THE PRESENCE OF THE CLOTS, I WAS SUBSEQUENTLY ADMITTED FOR OBSERVATION ON A REGIMEN OF DRUGS, BLOOD THINNER, PAIN MED, AND A CLOT BUSTER (NOT SURE WHICH MANUFACTURER.)  I AM STILL EXPERIENCING PAIN IN MY RIGHT FLANK AREA - SOMEWHAT RADIATING TO MY RIGHT SHOULDER DAY 1 POST DISCHARGE AND AM HAVING TO RELY ON OPIOID PAIN MED AS WELL AS THE CLOT BUSTING MED AND A HIGH BLOOD PRESSURE MED. TO ME, IT SEEMS THAT THIS MAY NOT BE JUST COINCIDENTAL.  I WAS FEELING FINE PRIOR TO THE S 2ND DOSE OF THE MODERNA VAC AND THIS SEEMS TO ME THAT IT MIGHT BE RELATED TO THE 2 DOSE.
Felt like she was choking after 1st dose; Felt like couldn't swallow after 1st dose; Felt like throat was swollen after 1st dose; Couldn't drink after 1st dose; Face swelling after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Felt like she was choking after 1st dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history. ). Concomitant products included THYROID (ARMOUR THYROID) and CELECOXIB (CELEBREX) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHOKING (Felt like she was choking after 1st dose) (seriousness criterion medically significant), DYSPHAGIA (Felt like couldn't swallow after 1st dose), PHARYNGEAL SWELLING (Felt like throat was swollen after 1st dose), OROPHARYNGEAL DISCOMFORT (Couldn't drink after 1st dose) and SWELLING FACE (Face swelling after 1st dose). At the time of the report, CHOKING (Felt like she was choking after 1st dose), DYSPHAGIA (Felt like couldn't swallow after 1st dose), PHARYNGEAL SWELLING (Felt like throat was swollen after 1st dose), OROPHARYNGEAL DISCOMFORT (Couldn't drink after 1st dose) and SWELLING FACE (Face swelling after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included-Benadryl and Antihistamine.   Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded   Reporter did not allow further contact; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Patient called pharmacy 9/14/21@9:30 am and stated that he just cooked eggs around 9:00 and about 20 minutes later he was having SOB. He could only take about 1/4 breath, vision was not normal, couldn't move, went to ER. ER did not think this was related to shot though. However, Patient believes it is related to shot. The ER diagnosed him with dehydration and sent him home. Followed up with patient on 9/15/21 @7pm  and he said that overnight has had fever from 101-102, hot and cold, sweats, joint pain, back pain, diarrhea, dizzy, tired, muscle aches, no appetite, throwing up, headache, ear pain, very foggy brain, lightheaded, his primary doctor made an appointment for him for 5 days, they require a negative covid test to be seen. I called Moderna also to report and was given a case # MOD21-143961, patient was not interested in calling the company to update them on his symptoms. Patient was ok with Moderna dose #1, just happened with #2.
A regulatory report was received from a other healthcare professional concerning a 65 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot/thrombosis, black and blue mark on her shoulder/contusion, brain fog/feeling abnormal, stomach cramps/abdominal pain, diarrhea,  left arm was hot/vaccination site wamth, fatigue, headache, vaccination site pain/Soreness at the injection site,Left arm was red /vaccination site erythema,Left arm had a rash /vaccination site rash and left arm had swollen mark /vaccination site swelling. The patient's current history includes multiple sclerosis. The relevant concomitant medications se were reported include natalizumab, levothyroxine, calcium time release and vitamin B. On 09Feb2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 010M20A) through Intramuscular on Left arm for prophylaxis of COVID-19 infection. On 12 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number:048A21A) through unknown for prophylaxis of COVID-19 infection. On 12 Mar 2021 patient experienced Soreness at the injection site, Stomach cramps. On 13 Mar 2021, black and blue mark on her shoulder, brain fog. On 14 Mar 2021, Fatigue, headache. On 15 Mar 2021, left arm was hot, left arm was red,  left arm had a rash and left arm had swollen mark . On unspecified date , diarrhea, blood Clot. Treatment information was provided include acetaminophen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, left arm was hot, stomach cramps, left arm was red, left arm had a rash and Left arm had swollen mark were considered recovered.  The outcome of the events, black and blue mark on her shoulder, fatigue, brain fog, headache, soreness at the injection site, diarrhea  and blood clot  were considered unknown.; Reporter'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.
weakness; her symptoms were getting progressively worse; second episode being worse then what it was the first time; shortness of breath; heart palpitations; pain; extreme fatigue, fatigue, fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), PALPITATIONS (heart palpitations), PAIN (pain ), FATIGUE (extreme fatigue, fatigue, fatigue) and ASTHENIA (weakness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DYSPNOEA (shortness of breath), PALPITATIONS (heart palpitations), PAIN (pain ), FATIGUE (extreme fatigue, fatigue, fatigue), ASTHENIA (weakness), PAIN (her symptoms were getting progressively worse) and SYMPTOM RECURRENCE (second episode being worse then what it was the first time). At the time of the report, DYSPNOEA (shortness of breath), PALPITATIONS (heart palpitations), PAIN (pain ), FATIGUE (extreme fatigue, fatigue, fatigue), ASTHENIA (weakness), PAIN (her symptoms were getting progressively worse) and SYMPTOM RECURRENCE (second episode being worse then what it was the last time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated IM with the first dose of GARDASIL (lot number not provided). The physician reported that immediately after vaccination the patient experienced 24 hours of extreme dizziness, headache and weakness. It was reported that therapy with GARDASIL was discontinued. On an unspecified date, the patient recovered from extreme dizziness, headache and weakness. The patient did not seek medical attention. Additional information has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of chest pain in a female patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX. On 7th June 2018, 3 days after receiving SHINGRIX, the patient experienced chest pain and chest discomfort. On an unknown date, the outcome of the chest pain and chest discomfort were unknown. It was unknown if the reporter considered the chest pain and chest discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the initial dose of SHINGRIX on in her left arm and was reported as fine. However, the patient reported pain and discomfort in her left chest cavity. Both PA-C (reporter) and the physician were not sure if what the patient was experiencing was a result of SHINGRIX, but want to report the event.
Breakthrough COVID infection. Patient reports onset fatigue and cough roughly 3 weeks prior to 6/6/2022. Unsure of exact onset.
NAUSEA; DIARRHEA; VOMITING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAY-2021, the subject experienced diarrhea. On 11-MAY-2021, the subject experienced vomiting. On an unspecified date, the subject experienced nausea. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) Does not have the results back, and COVID-19 rapid POC test (NR: not provided) negative. The action taken with covid-19 vaccine was not applicable. The outcome of the vomiting, diarrhea and nausea was not reported. This report was non-serious.
Initial report was received on 01 March 2012 from a health care professional. A two-month-old female with no reported past medical history and no illness at the time of vaccination had received on 17 March 2012 the following vaccines: an intramuscular left thigh injection of ACTHIB, lot number UH622AA (sanofi pasteur SA lot number G1371-1); an intramuscular left thigh injection of DAPTACEL, lot number C4022AA; an intramuscular right thigh injection of IPOL, lot number G1500-1; an intramuscular right thigh injection of PREVNAR 13, Pfizer lot number F611177; an intramuscular right thigh injection of HEPATITIS B VACCINE, lot number B1455AA and ROTATEQ, lot number 1036AA (route and site of administration not reported). On 18 February 2012, the patent experienced a rash and urticaria that started on the face, moved to the extremities, arms and more on the legs. The rash was also noted on the chest and trunk. The urticaria was a red, raised rash however the patient did not "seem to be itchy". The patient was evaluated by a physician. Treatments were not reported. Concomitant medications and adverse events following prior vaccinations were reported as none. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
No additional AE reported; A patient was administered PROQUAD after a temperature excursion.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 25-MAY-2022, the patient was vaccinated an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number U024508 with expiration date: 02-FEB-2023, as prophylaxis (dose, vaccination scheme frequency, anatomical location, and route of administration were not reported). The vaccine suffered a temperature excursion at 8.3 fahrenheit (F) degrees for 15 minutes (product storage error). There were no previous temperature excursions. No adverse event was reported.  ; Sender's Comments:  US-009507513-2206USA000886: US-009507513-2206USA000990:
Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS. At the time of the report, INFLUENZA LIKE ILLNESS outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Concomitant product includes Blood pressure medication and Cancer medication. No treatment medication was provided.
dizziness and lightheadedness; arm is little sore; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (dizziness and lightheadedness) and PAIN IN EXTREMITY (arm is little sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PRAVASTATIN, TROMETHAMINE, HCTZ, FISH OIL, CLOMIPHENE CITRATE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIZZINESS (dizziness and lightheadedness) and PAIN IN EXTREMITY (arm is little sore). On 08-Feb-2021, PAIN IN EXTREMITY (arm is little sore) had resolved. At the time of the report, DIZZINESS (dizziness and lightheadedness) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Local reaction - Rt thigh redness upp 6 cm in diameter, area blanches, sm.  purplish lump mid area or redness. no fever. red area appeared thur day of shot, redness cont. at outer edge of pint now pinkened area.