chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feel sick; Felt really bad; Neck Pain; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Feel sick) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MALAISE (Feel sick) (seriousness criterion hospitalization), FEELING ABNORMAL (Felt really bad), NECK PAIN (Neck Pain) and NAUSEA (Nausea). At the time of the report, MALAISE (Feel sick), FEELING ABNORMAL (Felt really bad), NECK PAIN (Neck Pain) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Laboratory test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 13-Mar-2021, the patient felt very sick that she ended up going to Emergency. The patient stated that she stayed in hospital for a whole da.  Company Comment: 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.; Sender'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.
influenza, hep a, and hep b vaccines were exposed to a low temperature; possible vaccines were administered after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis and Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine, Hepatitis A vaccine and Influenza vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, Hepatitis A vaccine and Influenza vaccine, the patient experienced incorrect storage of drug (Verbatim: influenza, hep a, and hep b vaccines were exposed to a low temperature) and circumstance or information capable of leading to medication error (Verbatim: possible vaccines were administered after temperature excursion).  The outcome of the incorrect storage of drug and circumstance or information capable of leading to medication error were unknown.   Additional Information: GSK receipt date: 2-Oct-2023 The pharmacist reported that the vaccines were exposed to a low temperature of minus 0.7 C on the day of reporting at 10:40 am.  The reporter stated that these were GlaxoSmithKline vaccines but was not able to confirm brand name at time of call.  The reporter stated that it was possible these vaccines were administered after the temperature excursion in an employee health setting, but she did not know this for certain.  She did not have any patient information or further details available at time of call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. Influenza, Hepatitis A and Hepatitis B vaccines were possibly administered after temperature excursion, which led to incorrect storage of drug and circumstance or information capable of leading to medication error.
Gave Hep A in left deltoid.  Child stated no pain.  Gave VZV sub-q in left arm.  Child complained of pain.  Gave meningococcal in right deltoid.  Child immediately lay back on examination table, clenched hands and jerked about 2 times, then sat back up - pale and clammy.  Child vomited.  Drank sierra mist.  Stated he felt fine.  BP 100/64.  Sat in office for 10 minutes then went home.  Mom stated she'd call if concerns.
Within approximately 56  hours from 1st injection, I got an intense left eye pain.  Went to the ER where they flushed it, numbed it, and prescribed drops for conjunctivitis.  I had no symptoms prior.  Completed treatment and seemed fine.    Within 13 hours of second dose (3/3/21 @ 2:00 pm), I woke up with eye pain in the left eye and used part of the remaining drops; thankfully did not get as bad as the first one, so far.
About 10 minutes after getting the Modena vaccine my face started getting numb.  The most predominant area is my forehead and right side of my face, and the corner of my mouth.  At the dr office a rash was also noticed.
post menopausal bleeding. Had vaccination May 29th. Had spotting on June 13 and June 20th. Had prior complete workup for post menopausal bleeding and workup demonstrated no pathology.
experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn; experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn; fever; nausea; aches; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn), RASH MACULAR (experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn), PYREXIA (fever), NAUSEA (nausea) and MYALGIA (aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Medical history was not provided by the reporter.    On 17-Apr-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) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced PYREXIA (fever), NAUSEA (nausea) and MYALGIA (aches). On 19-Apr-2021, the patient experienced RASH ERYTHEMATOUS (experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn) and RASH MACULAR (experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn), RASH MACULAR (experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn), PYREXIA (fever), NAUSEA (nausea) and MYALGIA (aches) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. Treatment information was not provided.
I have weakness of the left arm where the shot was given. I have minimal range and pain if I try to move my arm. I cannot grasp any items nor can I hold any other position besides my side.
FEVER; MUSCLE ACHES; HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced muscle aches. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, muscle aches, headache, and nausea. This report was non-serious.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (COVID vaccine issue/Sore arm) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.          No concomitant and treatment medications were reported.  It was reported that female patient with events of non-serious COVID vaccine issue/Sore arm, and maternal exposure during pregnancy with Adalimumab solution for injection, single dose pen.   No medical history was reported. The fetus was exposed to maternal use of Humira in utero. It was unknown if patient was enrolled in COVID-19-Vaccine trial.  It was reported that Humira 40MG/0.4ml was citrate free. Moderna COVID-19 vaccine was also considered as suspect.
swelling in my arm pit; It is look like a lump; It is soft and sore; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling in my arm pit), MASS (It is look like a lump) and PAIN (It is soft and sore) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D27C21A and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced SWELLING (swelling in my arm pit), MASS (It is look like a lump) and PAIN (It is soft and sore). At the time of the report, SWELLING (swelling in my arm pit), MASS (It is look like a lump) and PAIN (It is soft and sore) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included Thyroid medications, Estrogen medication and Antidepressant for unknown indication. No treatment was received by the patient.
Information has been received from a physician concerning a 7 yr old female who on 12Jul00 was vaccinated with a 0.5mL dose of varicella virus vaccine live (lot632726/0088K). The physician reported that on 08Dec05, the pt presented to his office with a breakthrough case of chickenpox characterized by six lesions. At the time of this report, the pt was recovering. Additional information has been requested.
NOT FEELING WELL; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not 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-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not feeling well. This report was non-serious.
Flu-like symptoms including: fever, myalgia, cough, and fatigue. Local reaction: 2-3 in area of edema, erythema, and warmth on left lateral mid-upper arm (below injection site), ecchymosis at injection site.
approx 10 mins p/MMR given; parents return w/pt; had had hives & was still aggitated form receiving shot;
Fever up to 102, bone and muscle aches, malaise, enlarged axillary lymph node under right arm.  Alternated Ibuprofen with Tylenol lol
pt recvd vax; uncontrollable screaming, fever 99; was seen by PMD;
6/7/2021 DAY 12 POST VACCINE, BOTH ARMS FELT TINGLY AND NUMB ON AND OFF.   6/12/2021  WENT TO URGENT CARE IN THE MORNING WITH VERY SORE BACK.  SENT TO ER.  TREATED WITH MUSCLE RELAXER FOR PINCH NERVE IN NECK.    A FEW HOURS LATER, HE SUDDENLY COLLAPSED AT HOME UNABLE TO MOVE.  TRANSFERED TO ER VIA AMBULANCE.   IN ER ALL NIGHT.  TRANSFERED 6/13 WHEN AMBULANCE  WAS AVAILABLE.  NOW HE IS COMPLETELY PARALYZED FROM  HIS NECK TO HIS TOES.  AFTER MANY TESTS AND EXAMS, HE WAS DIAGNOSED WITH TRANSVERSE MYELITIS.  HE REMAINED AT MEDICAL CENTER FOR 3 WEEKS.  THEN TRANSFERED TO  WHERE IS REMAINS.
Left arm began itching late on Saturday night (2/13/21 - one week after receiving the vaccine).  When I woke up on Sunday morning, my left arm was itchy, swollen, sore, and red with the skin on my upper arm being warm to the touch.   It remained that way throughout Sunday.  On Monday morning (2/15/21) the swollen area has increased down to my elbow.  I have not had a fever, no chills,  or other symptoms.  Just local site itching, soreness, swelling as described above.  I have taken Benadryl and Ibuprofen for symptom relief.
Received flu shot 10-17, stated throat and tongue swelling 10/17. 10/18 lips swelling. 10/19 few hives on legs. 10/20 total body hives. 10/20/16 evaluation and treatment: SOLUMEDROL 125 mg IM/BENADRYL 25 mg IM/ZOFRAN 4 mg.
PRESSURE; ARM WAS A LITTLE NUMB; SORE AROUND ARM PIT; SORE ON LEFT ARM; FEEL LIKE BLOOD PRESSURE CUFF IN LEFT ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced pressure. On 01-MAY-2021, the subject experienced arm was a little numb. On 01-MAY-2021, the subject experienced sore around arm pit. On 01-MAY-2021, the subject experienced sore on left arm. On 01-MAY-2021, the subject experienced feel like blood pressure cuff in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel like blood pressure cuff in left arm, pressure, sore on left arm, arm was a little numb, and sore around arm pit. This report was non-serious.
Client received Pfizer COVID vaccine at approximately 8:42am and reported that he immediately felt tingling in upper left leg/ hip area. The tingling continued and moved down  his leg to his foot. First Aid and EMS assessed client. V/S WNL. Client given aspirin and leg massage. Client declined transport to ED for further evaluation. The tingling remained only in foot at time client left.
RECEIVING 2.5ML OF THE  JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 22 year old female. 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: 211A21A expiry: 14-DEC-2021) 2.5 ml, administered on 13-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-NOV-2021, the patient experienced receiving 2.5ml of the janssen covid-19 vaccine. On 13-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the receiving 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
they told him they gave 6 does (1 full vial) instead of 1 dose; fever; lethargy; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 12:30 (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: OVERDOSE (non-serious) with onset 11Jan2022 12:30, outcome "unknown", described as "they told him they gave 6 does (1 full vial) instead of 1 dose"; PYREXIA (non-serious) with onset 11Jan2022, outcome "recovering", described as "fever"; LETHARGY (non-serious) with onset 11Jan2022, outcome "recovering", described as "lethargy"; PAIN (non-serious) with onset 11Jan2022, outcome "recovering", described as "body aches". It was unknown if therapeutic measures were taken as a result of pyrexia, lethargy, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The device date  was 12Jan2022.   The lot number for bnt162b2 was not provided and will be requested during follow up.
12/23/2020 1st Covid vaccine 025J20-2A left arm 6pm 1/20/2021 2nd Covid vaccine 030L20-A right arm 6pm 5/11 tested for covid for travel - asymptomatic, positive covid PCR test 5/22 potential to return to work
Within 5 hrs of receiving shot, lower inside lip broke out in cold sores, and upper lip outside, beneath nose, broke out. Have also had an intestinal virus since 12/4/14.
Varivax given 11/23/01 subcutaneous at arm. Seen in office 12/5/01 per local reactive at injection site.
12-24 hr. after vax pt devel neck pain, stiffness & "hot rashes" at the inject site. This is 1 of 6 pts at this site which had similar rxn.
Vaccines were given at about 1030am 8/5/09. Patient was without symptoms when she left the office. Family stopped at a fast food restaurant after leaving the office and patient drank a "slushie" at about 1130am mom called office to report that patient was covered in hives and starting to swell. Instructed to give benadryl and return to office. On arrival patient was covered in fine erythematous macular rash from scalp to mid thigh with several small urticarial lesions, no respiratory distress, bp 110/64, pulse 105, pulse ox ~95%, no complaints of dizziness or weakness. She was given additional beanadryl (25mg total for weight 76#) and observed for about 30min. During abservation her symptoms decreased and she was discharged to home on oral benadryl.
I had fatigue that evening; the start of flu like symptoms that evening of the vaccine and through the night. The following day, (10th) flu-like symptoms. Those resolved the day after that (11th) - I was still tired but didn't have the aches and pains of the flu. Then on starting on the day after all of that (12), I had mild and intermittent pain in my right hamstring. That persisted for a couple of days - it would come and go throughout the day and even throughout the night. It resolved after about 2 1/2 days . The pain  made it uncomfortable to sit. (I had scheduled a dr appt  at noon on the 14th, but I felt fine by then - in the morning of that day when I woke up it had gone away - I'd fallen asleep on the 13th.)  I cancelled my doctor appt since it had resolved.
My temperature went to 103 and I drank lots of fluids. When I got up during the night I was peeing and felt like I was going to black out and I grabbed the towel rack and pulled it out of the wall and blacked out in between the toilet and counter. I was like a pretzel. It was rough to get out and now I have a bathroom with 3 handicap bars. After, my temperature went back to normal. I'm not sure how long I blacked out for but I woke up to my dogs licking and barking at me. I have since put in a smaller cabinet so I can't get wedged in. After that everything was good. Next day there was no temperature and a little bump where vaccination was but it wasn't red or sore and unfortunately we are going to get boosters forever so I guess that's how life is going to be. I know now to drink lots of water the day of the vaccine and life will be fine. When I went to see Dr. I told him about it and he checked my oxygen and it was fine but I did buy a concentrator and my heart surgeon neighbor left a 2 liter bottle if I ever need it. I do exercise more than I did with my other doses. I weighed 275 with the first shot and in August, just after flu vaccine, I couldn't fit in any of my dress up clothes and I now weigh 228. I walk every day and it's currently 28 degrees out and I walk for 3 miles. I do that every day now and I think I'm healthier now when I got my first two shots.
fever to 105 <24 hrs p/flu shot; adm to hosp, no abn test noted to explain fever;
Child became incredibly cranky followed by a significant loss of engagement and attention. He also became orally fixated and began licking and mouthing everything completely out of nowhere. Child was already delayed and received therapies, all therapists agree that he has lost a year of hard work.
Visual aura 3 hours later, headache for 2 days, then at 3 days sudden onset nausea, vomiting, emotional upset then sleepiness, pupils to me seemed very constricted on that day, stiffness of neck for several days and right sided head/ face pain  for 5 days difficulty concentrating/ reading.I took ibuprofen for 5 days which helped  symptoms
Patient described onset shoulder pain approximately 1 week after 2nd covid vaccine injection. Patient presented to PCP office on 4/5/21 for initial evaluation following pain with no resolve after trying exercises etc. At this time during evaluation PCP discussed possibility of vaccine related injury. Since this time, patient has undergone oral pain medications, PT exercises, and steroid injection, TENS treatment. Seen today 6/24/21 for continued evaluation. Major ongoing symptom is near constant pain. Bothers even at night, making it hard to sleep.   Does not use arm because of the pain.  Painful if tries to reach behind herself. Does not feel she is improving.  PCP diagnosed as SIRVA, and next plan is MRI of shoulder.
Pfizer-BioNTech COVID-19 Vaccine EUA, Itching that started about 3 minutes
Stuffy, runny nose, headache, significant fatigue and malaise - lasted 72 hours onset about 48 hrs after vaccination - no treatment.
After receiving the full vaccine the patient experienced increased pain, swelling and numbness to right arm. Pt was seen through the ER-given IM-Benadryl and PO-Vicodin. Pt did have a fever at the time of ER visit.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (10Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 from 31Jan2023 to 03Feb2023.  Clinical information: Other medication in 2 weeks was Yes Lisinopril. There is no known allergies.  No follow-up attempts are possible. No further information is expected.
Error found in reports review. Mom reports no adverse effects with phone follow-up. Aware that patient still needs 2 MMRs.
Pt developed itching of R hand, later of the L hand, then of both feet. developed mild rash of both hands and feet, pruritic, lasting about 48h, responded to self administered certrizine. Possible allergic reaction?