chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm  flet sore and  heavy; light headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm  flet sore and  heavy) and HEADACHE (light headaches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Headache. Concomitant products included PARACETAMOL (TYLENOL) for Headache, BLACK COHOSH [CIMICIFUGA RACEMOSA] for Hot flushes, ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine, VITAMIN D [VITAMIN D NOS] and PANTOPRAZOLE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm  flet sore and  heavy) and HEADACHE (light headaches). At the time of the report, PAIN IN EXTREMITY (left arm  flet sore and  heavy) and HEADACHE (light headaches) outcome was unknown.            Treatment medications include Tylenol and Consulted Gynecologist for hot flushes, prescribed with: Black Cohosh 540mg capsule once a day. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 7-jun-2021 had- No New Information.
16 year old female patient was administered a dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a 16-year-old female patient. The patient's concurrent conditions, pertinent medical history and drug reactions/allergies were not provided. Concomitant medication included sterile diluent (MK- 9395).  On 01-APR-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (PROQUAD)(rHA) (strength, and dose were not provided), lot #S027459, expiration date 02-MAR-2021, route of administration was defaulted to subcutaneous for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) information was provided.
Doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  On 18-Oct-2021, the vial was removed from freezer at 8 AM.   This case was linked to MOD-2021-364617 (Patient Link).
Abdominal pain and nausea  lingering side effect of vaccine.  4/15: Prescribed Zofran For nausea (caused headaches, discontinued taking)  4/28:  Prescribed promethazine for nausea & Tylenol w/codeine for pain   The abdominal pain and nausea have been going on since Getting vaccine, no doctor has an answer as to when it might stop.
19 days between first and second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (19 days between first and second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (19 days between first and second dose). On 02-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (19 days between first and second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Approximately 3 hours after vaccination patient was urinating - arose from the toilet and passed out (was in her daughter's hospital room - elective admission for IVIG).  Had felt well before - no prodromal symptoms.  Found pulseless - required CPR and intubation.  Extubated and well 2 hours later.  Patient had history of multiple ICU admissions for severe asthma, opiate withdrawl and prior syncope attributed to SVT.  NO rash, wheezing, angioedema seen during event.
Initial report received from a healthcare professional on 07 OCTOBER 2013. A 28-year old female patient had received intramuscularly first dose of TDap (lot number: C4426AA, expiry date 10 SEPTEMBER 2015 and site of administration was not reported) on 07 OCTOBER 2013. The patient's last menstrual period date was 18 JANUARY 2013 and the expected date of delivery was 25 OCTOBER 2013. The patient health problem during pregnancy, specific risk factors and concomitant medications were not reported. At the time of this report, the patient  did not experience any adverse event. List of documents held by the sender: None
Seizures X 4 = eyes rolled back, lasted 1 min x4. episodes at 1 am, 3 am 5 am and on arrival feverish during night (Temperature on arrival to ER -100.8 F) and took Tylenol (Family hx of seizures-sister). Tx-Fosphenytoin, Vancomycin, Acyclovir, Tobramycin, Tylenol, D5W 1/2 NS,NS. Transferred to another facility.
vaccinated, still got them/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient was vaccinated, and still got shingles. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset for event and laboratory confirmation of shingles were not provided.
Booster 10/30 11/8 whole body became itchy 11/9 red raised hive like lesions appeared on hips and armpits. Bilateral  11/10 rash connected from hips to armpits. Was seen at urgent care and given oral steroids  11/11 swelling went down at initial areas of rash but continue to spread all over my body. Arms. Neck. Head. Toes.  Continue to take Benadryl,  Zyrtec and apply hydrocortisone with no relief.
hives on arms & shoulders approx 5hr p/vax;pt called MD & instructed to take DPH but did not because had A.C.T. test next day;hives were gone by end of Saturday;pt is to call MD a/3rd dose is due;
Fever of 99.9, chills, muscle pain and weakness, joint pain, upset stomach, and the standard soreness at the injection site. Onset was about five or six hours after injection, starting with upset stomach, progressing to chills, fever and pain. Pain in legs and back was really uncomfortable. Took ALEVE to ease the pain, 440 mg over the counter. Pain in muscles and joints remains, but is lessening. I would say this is was a pretty unexpected and painful reaction and I still have to get the second dose.
COVID-19 Breakthrough disease which possibly resulted in death. Patient was fully vaccinated and was COVID-19 positive at time of death. Patient had symptom of cough that began 7/17/2021; the patient died on 07/20/2021. Patient tested positive for COVID-19 on 7/20/2021 at the long-term care facility at which they were a resident. I do not have death certificate details available at this time.
Patient feels painful and numbing in her both legs ,and her  back  .  She even has a difficult of walking.  Patient seeks help at  ER and they prescribed pain medication.  It didnt go away  even after 3 weeks.  Patient came today and seek for 2nd dose of vaccine, I recommend her to seek for medical help again.
Patient was given Moderna vaccine by mistake when they should have received a pfizer booster dose. Patient was notified. Patient is aware to report any adverse effects to us or primary care doctor.  Patient was told not to reschedule for a "third" dose.
patient was given vaccine and within 2 min of administration pt. started to have chest tightness and unable able to talk or breath and grabbing her throat. Orders to give 1 dose of epi pen 0.3mg given to her left thigh and oxygen given @ 2 liters. EMS was activated. Patient was taken by EMS.
Systemic: RIGHT FACIAL PARALYSIS-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
No additional AEs; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 05-OCT-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot # W017574, expiration date: 29-NOV-2023, administered for prophylaxis (dose, anatomical location, and route of administration were not provided). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) was stored at 10.8 degrees Fahrenheit for 1 hour and 39 minutes, no previous temperature excursion were reported (product storage error).  There were no adverse events reported (no adverse event).; Sender's Comments:  US-009507513-2210USA002259: US-009507513-2210USA002344:
Started running a fever 100.1 around 7:00 pm that night. Also had muscle aches. Took ibuprofen around 4 am that morning and fever broke only to return about 4 hours later.  Temp was 99.1 around 3:00pm Saturday afternoon.  Continued taking ibuprofen. Fever again broke over night and this time remained gone. Muscle aches subsided Sunday morning. Sunday evening noticed a rash on left arm. Rash became more pronounced on Monday and began itching Monday night into Tuesday.  Monday and Tuesday also had issues focusing and mind seemed foggy.
AT 12:30AM MIDNIGHT I BEGAN WITH A LIGHT HEADACHE AND STARTED MY BODY FEELING ACHY. I TRIED TO GO TO SLEEP, BUT I COULD'NT, IN FACT IT TOOK ME A LONG TIME TO BE ABLE TO FALL ASLEEP. I DID NOT HAVR TACHYCARDIA, BUT I DID FEEL ANXIOUS-LIKE. I WOKE UP AT AROUNF 5 AM WITH A FEVER OF 101.1 F, CHILLS, LIGHT BODY ACHES AND MY INJECTION SITE FELT AS IF I HAD BEEN PUNCHED OR HIT REALLY BADLY. I THEN TOOK TWO TYLENOL, EACH 250MG, AND I BEGAN FEELING NORMAL AGAIN.
dizzy, itching, pain at inj site, headache, chills, nausea, rash swollen lymph nodes  still have rash and swollen lymph nodes went to PC and derm and neither know what to do
cough; stuffy nose; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included: MUCINEX. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COUGH (non-serious) with onset 17Nov2022, outcome "recovering"; HEADACHE (non-serious) with onset 17Nov2022, outcome "recovering"; NASAL CONGESTION (non-serious) with onset 17Nov2022, outcome "recovering", described as "stuffy nose". Therapeutic measures were not taken as a result of cough, nasal congestion, headache.  Additional information: The patient had no known allergies other medical history. The patient did not received any other vaccine within the four weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
t104, unconsolable crying for 1 hr, eyes glassy; had a 2nd crying spell & 6 soft stools; neurological & PE nl;
Swollen lymph node- right armpit. No treatment   Cold/flu like symptoms(headache, joint pain/tightness, malaise, sinus congestion, cough). Treat at home/rest.
On 09/29/2021 I had really bad brain fog. I can't remember things as well. When forget things when walking into a room. Happened about 5 times a day. Also had fatigue and back pain. I was stiff when I first got vaccinated.  Also I had Covid-19 January 2021.
fever; persistent cough; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 22Jan2021 15:00 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies and was not pregnant. She had not been diagnosed with COVID prior to vaccination. Concomitant medications included metformin 500 mg and hydrochlorothiazide 12.5 mg. The patient experienced fever a persistent cough and fever on 22Jan2021 19:00. No treatment was received for the events. The outcome of the events was recovering. The patient was not tested for COVID post vaccination.    Information on the lot/batch number has been requested.
pt recvd vax & exp high fever (not reported how high), & vomiting; pt seen in ER dx acute lt arm local immun-react vs cellulitis; arm still red & sore;
Hair on legs & arms fell off.; This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number and expiration date was unknown) via unspecified route of administration in the right arm, on 04Mar2021 at 19:00 (at the age of 39-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 since the vaccination. No allergies to medications, food, or other products. On 11Mar2021, the patient's hair on legs & arms fell off. The reported seriousness was non-serious. Patient didn't receive treatment for the adverse event. The outcome of the event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Relevant medical history none was deleted since not reported on source, final sentence updated as 'No follow-up attempts are needed; information about lot/batch number cannot be obtained' and the whole narrative corrected.
pt recvd vax & approx 6 hrs later exp a 5 min episode of hypotonia accompanied by paleness, episode followed a nap; brought to MD office exam nl, t97.6, recovered; p/1st immun, pt was unusually quiet, no ther sx;
9 x 7cm rash and swelling at the DTaP injection area, one day after the injection. Advised cool compress and Bendryl 4ml every 6-8 hours as needed.
Case number PHEH2013US026651 is an initial spontaneous report from a pharmacist received on 20 Dec 2013. This report refers to a 28-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with 0.5ml of FLUVIRIN (batch number: 1345P, expiry date: May 2014) intramuscularly on 26 Dec 2013. He pharmacist reported that the FLUVIRIN which had undergone excursion at 51 F for 9 hours has been administered to the patient. No adverse event was reported following this medication error. No additional information was available.
Muscle spasms, back pain, neck pain, daily migraines, diarrhea
Fever; Migraine; This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE (Migraine) and PYREXIA (Fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced MIGRAINE (Migraine). On 28-Mar-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine) and PYREXIA (Fever) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MODERNATX, INC.-MOD-2021-030312 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-030312:Cross Linked case
This spontaneous report as received from a Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored VAQTA (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
No AEs were reported; A total of 13 doses were administered after the excursion happened; Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minute; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minute), POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened) and NO ADVERSE EVENT (No AEs were reported) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     Patient  relevant medical history/conditions, allergy, concomitant diseases and risk factor was unknown.     On 09-May-2023, 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 04-May-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minute). On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened). On an unknown date, the patient experienced NO ADVERSE EVENT (No AEs were reported). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minute), POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened) and NO ADVERSE EVENT (No AEs were reported) 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 AEs were reported) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minute) and POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened).    No concomitant medication was reported.  HCP stated 10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minutes. Maximum temperature reached was 10.5°F. A second excursion happened a couple hours later during 15 minutes and maximum temperature reached was 9.3°F. A total of 13 doses were administered after the excursion happened. No treatment information was reported.      This case was linked to US-MODERNATX, INC.-MOD-2023-728417 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728417:
After vaccination, she reported to the ER. She stayed in observation for about 4 hours.  States about 20 minutes afterward developed some sensation of tightness in her throat, upper chest pain, and some dizziness.  Patient has a history of allergic reactions and in the past has had anaphylaxis she does carry a EpiPen.  Patient took Benadryl prior to vaccine this morning and then again afterwards a total of 50 mg, did not notice any swelling of her face tongue or lip, there is no wheezing or difficulty breathing not noticed any rash or hives.  Received Famotidine, methylprednisolone and IV fluids when in the ER. The next morning she was found be Covid Positive and they did not know it previous.
This spontaneous report was received from a nurse and refers to a multiple unknown patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On approximately 27-FEB-2017, reported also as unknown dates since 27-FEB-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# reported as M031553 with an expiration date 19-MAR-2018 for prophylaxis (dose was not reported). There was no adverse effect reported. Administered doses of ROTATEQ experienced temperature excursion from 0 to 2 degrees Celsius for 1 hour and 26 minutes. A digital data logger was involved. There was no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005123: US-009507513-1703USA005121: US-009507513-1703USA005122:
Patient states that a couple of hours after receiving the injection she experienced severe nausea and a fever. She states she felt better the morning after the injection.