chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she usually have body and muscle ache after getting the vaccine / For the boosters she had body aches; she usually have body and muscle ache after getting the vaccine / For the boosters she had body aches; 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 female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "For the first two she felt a little tired", "she usually have body and muscle ache after getting the vaccine", "she usually have body and muscle ache after getting the vaccine"; Bnt162b2 (Dose 2, Single), for COVID-19 immunization, reaction(s): "For the first two she felt a little tired", "she usually have body and muscle ache after getting the vaccine", "she usually have body and muscle ache after getting the vaccine". The following information was reported: PAIN (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "she usually have body and muscle ache after getting the vaccine / For the boosters she had body aches". Therapeutic measures were taken as a result of pain, myalgia.  Additional information: Caller was a consumer stating that she received her Pfizer COVID vaccine "last Saturday" where she felt "little sore, nothing terrible" and "felt no pain the next day, Sunday". Caller added that she actually felt a little sore yesterday, but she was experiencing muscle soreness at the injection site area this time. Caller stated that her arm hurt a lot today and expressed "I can't barely lift my arm and I never had that muscle ache before." Caller also mentioned that she usually has body and muscle ache after getting the vaccine, but this time is different. Caller wanted to know if it was normal for the arm to hurt a lot after skipping a day. Caller also mentioned that she took Tylenol but the pain was still there. She was also asking for recommendations whether to put heat or cold compress to the area of muscle pain. After providing response, caller wants to know information for bivalent about how long muscle pain was experienced by the subjects during clinical trial.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Bilateral lower arm urticaria-(below elbow to and including writs.)red, welts, severe itching, required 10mg prednisone for 3 days to stop itching. Lasted 4 days. Also Left arm pain, 4 days. Fatigue and subjective fever.
pregnant patient /received 2 doses of Fluarix; pregnant patient /received 2 doses of Fluarix; one on sept2020 and the other one on 27Jan2021; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th January 2021, the patient received the 2nd dose of Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In September 2020, the patient received the 1st dose of Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Tetra 2020-2021 season at week 28 of the pregnancy. On 27th January 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device and not applicable after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the patient experienced vaccine exposure during pregnancy and vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown. The pregnancy was lost to follow up.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: The pregnant patient with 28 weeks, received 2 doses of Fluarix vaccine. The patient received 2nd dose of Fluarix vaccine in same season, which lead to Extra dose administration. The reporter consented to follow up.   Follow-up information received on 03-JUN-2022: This follow-up was considered significant. Reporters comment: After completion of all the follow up attempts, the pregnancy case was considered as lost to follow up. Summary of Changes: Pregnancy outcome was updated.
Low grade fever; Minor pain on the injection site; Minor fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), VACCINATION SITE PAIN (Minor pain on the injection site), FATIGUE (Minor fatigue) and HEADACHE (Headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Allergic to penicillin). Concomitant products included VALSARTAN, ATORVASTATIN, HYDROCHLOROTHIAZIDE, SILODOSIN, CALCIUM, COLECALCIFEROL (CALCIUM + VITAMIN D3), VITAMIN C [ASCORBIC ACID], CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN and OMEPRAZOLE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PYREXIA (Low grade fever), VACCINATION SITE PAIN (Minor pain on the injection site), FATIGUE (Minor fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL 8 HR ARTHRITIS PAIN) for Pain, at a dose of 650 mg. On 24-Feb-2021, PYREXIA (Low grade fever), VACCINATION SITE PAIN (Minor pain on the injection site), FATIGUE (Minor fatigue) and HEADACHE (Headache) had resolved.            This case was linked to MOD-2021-308129, MOD-2021-308181 (Patient Link).
paralysis went to my ring figure; Uncontrollable twitch in my thumb, in my hand; Could not control my pinky; My pinky kind of curls and it was like a cramp in it; I could not grab anything with my pinky and my ring figure; This is a spontaneous report from a contactable consumer reporting for him self.  A 52-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose  for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced paralysis went to my ring figure , uncontrollable twitch in my thumb, in my hand , could not control my pinky; my pinky kind of curls and it was like a cramp in it , I could not grab anything with my pinky and my ring figure all the events on an unspecified date with outcome of unknown.  All the reported events were considered Important Medical Events.  Course of the event: "I got my Pfizer shot on Saturday. On Sunday I had uncontrollable twitch in my thumb, in my hand. It was subtle when it started and then it gets worst. So it was subtle, it wasn't lot to begin and then over the course of next 24 hours it got worse and then it stopped. I mean that's not the end of the story. Once the twitching stopped then I could not control my pinky, so my twitching in my thumb stopped then my pinky finger is kind of just wanted to curl over like I have a permanent cramp in my pinky. My pinky kind of curls and it was like a cramp in it, so it was like I have no control over the pinky, either I could straight my pinky or I could make a fist out of my pinky that is it. I could not like close it half way or grip anything like that. 24 hours later that paralysis went to my ring figure, so up until it seems to get little better since this morning. I can control them a little bit but last night I could not hold anything with my finger, I could not control them. I could not grab anything with my pinky and my ring figure."   Information on the lot/batch number has been requested.
Patient had a fever following the vaccination.  A red, hot bump was at the spot of the immunization (right arm).  Redness, soreness and bump lasted for about 2 weeks.  Cold ice pack applied to area per doctor's instructions.  Patient was very fussy, still.
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a adolescent male patient who received BEXSERO (batch number 15E301A, expiry date 31st May 2018) for prophylaxis. On 4th February 2018, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema, bruising and joint range of motion decreased. On an unknown date, the outcome of the injection site erythema, bruising and joint range of motion decreased were recovered/resolved. It was unknown if the reporter considered the injection site erythema, bruising and joint range of motion decreased to be related to BEXSERO. Additional details were provided as follows: Following 1st dose of BEXSERO, the patient experienced redness at and around injection site, bruising and limited range of motion. The events remained for over a week before fully resolving. This case has been linked to the case US2019GSK055816, reported by the same reporter.
rash (trunk, extremities)devel 3 days post vax; no fever, cough, rhinorrhea;tx w/DPH no better;atarax, Pred, aveeno lotion;
dizziness, h/a, nausea, weakness, itching (no rash), anorexia, no fever;sx began w/in 12-24 hr-still persisting @ 48hr-slowly improving
Injection site itching, went away but developed again on 22Jan2021; injection site redness, went away but developed again on 22Jan2021; This spontaneous case was reported by a dentist and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching, went away but developed again on 22Jan2021) and VACCINATION SITE ERYTHEMA (injection site redness, went away but developed again on 22Jan2021) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itching, went away but developed again on 22Jan2021) and VACCINATION SITE ERYTHEMA (injection site redness, went away but developed again on 22Jan2021). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching, went away but developed again on 22Jan2021) and VACCINATION SITE ERYTHEMA (injection site redness, went away but developed again on 22Jan2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medications were reported.
Round, red lesion about 3 inches in diameter at injection site.  Warm to the touch, tender, itchy. Treated with ice, Clobetasol propionate cream.  Doctor just prescribed Cephalexin 500 mg Capsule but have not taken first one yet.
The dosage was not correct they received the adult dose whether than 5-11 yr. olds.
immunocompromised patient given 0.25 ml for the 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25 ml for the 3rd dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 045A21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 18-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25 ml for the 3rd dose). On 18-Nov-2021, ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25 ml for the 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.
tiredness; flu like symptoms; sore arm; This case was reported by a consumer via sales rep and described the occurrence of tiredness in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness, influenza-like symptoms and pain in arm. On an unknown date, the outcome of the tiredness, influenza-like symptoms and pain in arm were unknown.   It was unknown if the reporter considered the tiredness, influenza-like symptoms and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not The case was reported by a GSK field employee overheard a staff member, who was patient's daughter. The patient experienced flu like symptoms consisting of tiredness and a sore arm. The reporter did not consent to follow-up.  The reporter declined to provide their own information.
Swelling of face and hands beginning about 3-4 hours after vaccine shot and lasting about 24-48 hours
EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced expired product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product administered was not reported. This report was non-serious.
Woke up with a swollen lymph node in my left armpit on 12/22 (6 days after injection).
Patient reported edema started 3 days post-vaccination. Patient sought medical care 12 days after vaccination.  Mild edema noted in hands, feet, and face, no other symptoms.   No treatment was given and patient was not on any OTC medication. Upon recheck 24 hours later, patient was normal in all respects and had lost 6 verified pounds of weight.
Pt received Varicella vaccine 3 days ago; now having sudden onset of involuntary fasciculations to (R) side with muscle weakness. Sx are worsening; getting stronger. Urgent referral to neurology has been sent for further eval.
Allergic to pneumonia inj: swelling; This spontaneous report was received from a physician via Pfizer and refers to a patient of anonymized age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown): swelling. The outcome of the event was not reported.  The reporter considered drug hypersensitivity to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).
Breakthrough case admission after 2 vaccines Pfizer 9/18/21 lot# Ew0162;  Pfizer 10/13/21 lot# EW0186
pt devel rash on arms, legs, face 6 days p/vax;consisted of target type macular lesions, resembling erythema multiforme;no mucosal involvement;rash resolved w/o tx;p/48hr question whether r/t new formula introduced 2 days prior to rash
Feeling of a heavy weight in my arm at injection site for three days which then went away.  About a week later a rash appeared and  I felt as if I were coming down with a cold or upper respiratory bug.  This went off but the rash is getting bigger and  is swollen, hot and itchy.   I can feel pressure up the side of my head , ear and face  and in my lower arm.  This doesn?t stop me from doing my usual activities?just uncomfortable.
Have a large red area 6" x 3"  where I got the shot  just noticed it last night when I took a shower.  Arms was a little sore previously and still is sore.
Rash Around Vaccine Site approx. 3-4 cm in size, Warm to touch, Itchy, Resolving on its own. Feeling better today
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 20-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022). No concomitant medications were reported. The patient received full dose. The vial was initially stored in the refrigerator on 04-Jun-2022. Reportedly, the vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Patient received the 1st dose on 5/10/18 and experienced aches, pains, and a low grade fever. Patient returned for the 2nd dose on 7/6/18 and developed aches, pains, sore throat, headache, fever of 100.5 F, and an all over body rash within 3 hours of administration. Patient saw his physician on 7/11/18 and later called our pharmacy to explain what happened.
This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 at single dose in right arm for COVID-19 immunisation at the age of 81-year-old. Medical history included hypertension, atrial fibrillation. Concomitant medications included losartan, amlodipine, metoprolol, apixaban (ELIQUIS). Historical vaccine included first administration of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at single dose for COVID-19 immunization. On unknown date, blood cholesterol resulted a little bit high. On unknown date, the patient experienced little spot on arm got bigger and started to swell, It got worse, patient had red splotches down my arm, down my wrist, underarm, and then even on side of body; on the other arm a few spots, he had soreness in that arm, the patient might have shingles, doctor gave the patient medication (Unspecified Medication); it did not do anything, the splotches actually got a little bit worse, right arm has 3 splotches on it, one in muscle area on upper arm, down elbow is another red spot, right down the elbow another one; other one has a lot of them; It was getting a little bit itchy. The outcome of the events was unknown.
very little information sent in medical records; pt in respiratory failure; admitted to hospital; COVID pneumonia; positive COVID test on 12/20/21; pt transitioned to hospice( in hospital) and passed away
There was no adverse event experienced by patient. She was underage (16 years old) to receive the Moderna vaccine. She was vaccinated at a COVID vaccination clinic for over 120 people conducted at Facility on Sunday, March 14, 2021. She was turned away at least two times but was persistent. She went through again and the person administering the vaccine did not catch that she was too young. She went through with her brother who was of age to receive the vaccine. Her parents were informed. Her father is a physician in the community. She had no adverse reaction to the vaccine.
pt recv vax 9Am crying started 10Am;fever 103 ax;started 11AM noted swelling around leg but not actual inj site;cried 36hr off & on cried 3 1/4 straight hr;
She got her vaccine around noon and she had no reaction, the arm did not hurt, the site at all.  She went and had a light lunch . She came home and felt like she wanted to take a nap.  She went into her bedroom and felt sick to her stomach, and then started throwing up.  She had huge amounts of vomiting coming out very watery, and three different times and each time she threw up 3 times.  In addition to that she had diarrhea, and it too was extremely forceful and very watery, no form to it at all.   Finally around 7:00 PM she was no longer throwing up or having diarrhea.  She did not have anything to eat during that time, but did drink some ginger ale around midnight, which did not come back up, it stayed down.  On Monday, she was just tired, she did not feel like anything, but she did not feel sick.  She was afraid to put anything in her stomach.  Around noon on Monday she was able to eat, but ate light food.  On Monday night she did not get much sleep, but woke up Tuesday morning and felt fairly good.
I developed a fever, total body muscle aches, and a headache within a few hours.  By the end of the next day I was in so much pain that I could not move.
Pt recv vax & exp pain & soreness @ the inj site that cont 1 mo p/administration; No further specific info was available from the reporter;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium