chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore shot arm; Tired and achy; Tired and achy; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Sore shot arm), PAIN (Tired and achy), DIARRHOEA (Diarrhea) and FATIGUE (Tired and achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diverticulitis (Severe diverticulitis and had three one feet sections of his intestines removed and wore an ostomy bag for one and one-half years) in 2014, Heart attack (and got two stents in his arteries in the heart) in 2015 and Hartmann's pouch procedure (was reversed in 2016) in 2014. Concurrent medical conditions included Type 2 diabetes mellitus and Gastric disorder (has a sensitive stomach and gets diarrhea from eating too much beef, fish, dairy products, etc.).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIMB DISCOMFORT (Sore shot arm), PAIN (Tired and achy), DIARRHOEA (Diarrhea) and FATIGUE (Tired and achy). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Sore shot arm), PAIN (Tired and achy) and FATIGUE (Tired and achy) outcome was unknown and DIARRHOEA (Diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter.  It was reported that the diarrhea has been yellow and smelly and severe.   This case was linked to MOD-2021-028292 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Additional Information received. Patient's medical history and event information updated.
Severe swelling in right jaw bone and cheek.   Numbness throughout right side of face.
Patient is having difficulty breathing, mom called to inform us, patient looked up signs/symptoms of reaction and mom thinks she might be have slight problems breathing, instructed mom to tell daughter to go to ER or MD asap to be seen as this is a severe reaction and possible allergic reaction
Pt came in to the pharmacy not feeling very well, looking pale and shivering. Pt wanted flu shot, despise the suggestion of waiting until feeling completely well to get the shot. Pt and her daughter insisted on getting the flu shot anyway. The flu shot was administered around 3 pm of the 26th.  About 10 minutes later, she was shivering more and turned more pale and finally fainted, faced down to the floor. We called 911, had pt lie still, faced up and legs up on the chair until the paramedic arrived. Pt was responsive the whole time of the incident.
Headache, nausea, vomiting, pain, redness and swelling to injection left arm.
Subjective dyspnea, flushing. No hives, vitals stable, no desats. Sxs resolved after self-administered Benadryl.
Tiredness, muscle pain, fever (101.8), elevated heart rate (110bpm)
Site: Redness at Injection Site-Mild, Additional Details: RPh received fax from VAERS , but is unaware of the reaction patient had to the vaccine. RPh tried to call patient but the phone number is invalid. RPh only filled out the information required, but cannot verify if that is the reaction that the patient had. can only verify lot number , exp date, date of administartion. do not have any further information to verify reaction
tired all day, can't wake up from bed; chills; Body hurts really bad, bone pain; terrible headache; think she has fever; has been feeling really bad, ¨i have never felt this bad before¨; arm is really sore and hurts; Legs hurt a lot not able to walk due to the pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (has been feeling really bad, ¨i have never felt this bad before¨), PAIN IN EXTREMITY (arm is really sore and hurts), PAIN IN EXTREMITY (Legs hurt a lot not able to walk due to the pain), FATIGUE (tired all day, can't wake up from bed) and CHILLS (chills) in a 66-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.     No Medical History information was reported.   On 31-Mar-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 01-Apr-2021, the patient experienced FEELING ABNORMAL (has been feeling really bad, ¨i have never felt this bad before¨), PAIN IN EXTREMITY (arm is really sore and hurts), PAIN IN EXTREMITY (Legs hurt a lot not able to walk due to the pain), CHILLS (chills), MYALGIA (Body hurts really bad, bone pain), HEADACHE (terrible headache) and PYREXIA (think she has fever). On an unknown date, the patient experienced FATIGUE (tired all day, can't wake up from bed). The patient was treated with PARACETAMOL (TYLENOL) on 01-Apr-2021 at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (has been feeling really bad, ¨i have never felt this bad before¨), PAIN IN EXTREMITY (arm is really sore and hurts), PAIN IN EXTREMITY (Legs hurt a lot not able to walk due to the pain), FATIGUE (tired all day, can't wake up from bed), CHILLS (chills), MYALGIA (Body hurts really bad, bone pain), HEADACHE (terrible headache) and PYREXIA (think she has fever) outcome was unknown.            Blood pressure medication is the concomitant medication reported by reporter.
Redness, swelling and intense itching below injection site. Developed golf ball sized lump for two weeks. Redness is still there today.
A report has been received from a Health Professional concerning a 9 year old, male subject who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient experienced multiple patients received a half a dose of FLUMIST QUADRIVALENT which started on 28-Oct-2014. The outcome of the event of multiple patients received a half a dose of FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Severe Headache; Muscle Aches; unable to sleep due to severity; Sore Arm; Fever; injection site still hot to touch and sore; injection site still hot to touch and sore; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration, administered in arm left on 19Feb2021 12:45 (at the age of 50-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via unspecified route of administration, administered in arm left on 29Jan2021 14:00 as dose 1, single for covid-19 immunisation. On 20Feb2021 19:00, the patient fever spiked to 101 degrees. Severe/moderate headache, muscle aches continued in which patient was unable to sleep due severity, and sore arm. It was also reported that the injection site was still hot to touch and sore, but temperature normal and all other symptoms improving. The outcome of the events was recovering without treatment.   No follow-up attempts are possible. No further information is expected.
Hives - generalized on trunk. BENADRYL has helped the itch and rash and has lessened the next morning but not completely cleared.
pins and needles through the body; bump on arm; hard to the touch; swollen; red; chills; muscles in body aches and feel funny, feels like pins and needles through the body; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (pins and needles through the body), VACCINATION SITE MASS (bump on arm), VACCINATION SITE INDURATION (hard to the touch), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) in an 82-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 (No medical history reported.).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (pins and needles through the body), VACCINATION SITE MASS (bump on arm), VACCINATION SITE INDURATION (hard to the touch), VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red), CHILLS (chills) and MYALGIA (muscles in body aches and feel funny, feels like pins and needles through the body). At the time of the report, PARAESTHESIA (pins and needles through the body), VACCINATION SITE MASS (bump on arm), VACCINATION SITE INDURATION (hard to the touch), VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red), CHILLS (chills) and MYALGIA (muscles in body aches and feel funny, feels like pins and needles through the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant product and treatment information were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Myalgia, chills, vaccination site induration, vaccination site swelling and vaccination site erythema are consistent with the product safety profile
Pt vaccinated with DTP/OPV developed tachycardia -220 on apnea monitor - fever admitted to hosp for monitoring due to tachycardia.
pt recvd vax; 18jun95 began to exp aches in both knees; pain caused insomnia;no swelling or limitation walking; the knee pain was relieved by asa;
The patient then reported injection site soreness, redness, warmness, and a bump on 03/10/2021 and weakness/redness around the injection site on 03/12/2021.; The patient then reported injection site soreness, redness, warmness, and a bump on 03/10/2021 and weakness/redness around the injection site on 03/12/2021.; The patient then reported injection site soreness, redness, warmness, and a bump on 03/10/2021 and weakness/redness around the injection site on 03/12/2021.; The patient then reported injection site soreness, redness, warmness, and a bump on 03/10/2021 and weakness/redness around the injection site on 03/12/2021.; The patient then reported injection site soreness, redness, warmness, and a bump on 03/10/2021 and weakness/redness around the injection site on 03/12/2021.; The patient then reported injection site soreness, redness, warmness, and a bump on 03/10/2021 and weakness/redness around the injection site on 03/12/2021.; A dose of PROQUAD was inadvertently administered following its expiration. The dose expired on 01/31/2021, and the dose was administered on 03/08/2021.; This spontaneous report was received from a licensed practical nurse and refers to a 32 year old female patient with metabolic syndrome, migraines and contact dermatitis from animals, who had as concomitant therapy an unspecified birth control.   On 08-MAR-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml injected, once, for prophylaxis, lot # S021325 reported expiration date of 31-JAN-2021 but upon internal review it was stablished as 05-JAN-2021.  The product had never experienced a temperature excursion.        The patient then reported injection site soreness (vaccination site pain), redness (vaccination site erythema), warmness (vaccination site warmth), and a bump (vaccination site mass) on 10-MAR-2021 and weakness/redness (injection site muscle weakness and vaccination site erythema) around the injection site on 12-MAR-2021. The patient did not seek medical attention, did not received treatment for the events, did not have disability, or need of hospitalization.   The outcome of vaccination site mass, expired product administered, vaccination site warmth, vaccination site erythema, vaccination site pain and injection site muscle weakness was unknown.     The causal relationship between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)and the events was not provided.
received only the diluent of Menveo; received only the diluent of Menveo; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA431A, expiry date 30th October 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Menveo .5 ml. On an unknown date, unknown after receiving Menveo, 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 details were provided as follows: The age at vaccination was not reported. The patient received only the diluent of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The diluent was not used to reconstitute the lyophylized powder to administer a complete dose of vaccine. The patient did not experience any adverse effects following administration of the diluent alone. The reporter consented to follow up.
Right arm pain, swelling, redness and night sweats. No treatment required. Given instructions to return to clinic or ER if symptoms worsen.
Shingles. Tingling sensational around core felt approximately 4 or 5 days after shot and rash noticed after 6 days. Went to urgent care clinic and diagnosed with shingles. Received valacyclovir prescription with enough for 1 week.  As of today, about 9 days following taking valacyclovir, shingles is improving but not gone.  Note: the Department of Public Health and the Environment has shut down the clinic I received the shot and deemed the shots we did receive invalid because of inability to determine proper handling of the vaccine occurred.
Information has been received from a physician concerning a 14 month old premature (WAES #0707USA01443) male with a history of diarrhoea, dermatitis diaper, circumcision (all reported in 0908USA00770), respiratory distress, bronchiolitis, constipation, very gassy, rectal bleeding/haematochezia, runny nose (all reported in 0908USA00771) who on 17-SEP-2008 was vaccinated SC with a first dose of MMR II (Lot #659704/0667X). Secondary suspect therapy included a first dose of VARIVAX (Lot # 659953/0329X) SC, a fourth dose of HEP B (Lot #659259/1612U) IM administered on 17-SEP-2008. concomitant therapy included PREVNAR (Lot #C27701), and TRIHIBIT (Lot #U18987C). On 21-NOV-2008 the patient was taken to the emergency room by ambulatory with complaint of fall and hitting head. The event happened "one hour ago", patient fell from a standing position. He had a laceration on the right forehead area. The grandparents had a bandaid on and the bandaid had some blood on it. Patient did not have any loss of consciousness. The patient cried initially. Physical examination showed 1 cm superficial laceration on the right temporal. He was diagnosed with laceration face. The patient was discharged with with dermabound wound care. There was no recorded prescription. The patient was discharged home home after instructions were given with follow up with his primary care physician. On 17-MAY-2009 the patient presented to the emergency room with complaint of matted eyes, fussy. It was reported that the events occurred 2 days ago on 15-MAY-2008. The mother reported the child had been fussy in the past two days, had had matted eyes since this morning. The mother also reported that he had standing water in eyes. The patient presented for the evaluation of upper respiratory infection symptoms, rhinorrhea and nasal congestion associated with eye pain. Nasal discharge was clear. The symptoms were mild. Physical examination showed tympanic membrane was injected and bulging, bilateral eye reddening noted, bilateral eye drainage noted. Breath sounds were clear and equal bilaterally, no respiratory distress, no accessory muscle use. The patient was diagnosed with left otitis media and pink eye. The treatments included amoxicillin power for reconstitution 250 mg/5ml oral three times a day, antipyrine-benzocaine solution solution 54 mg-14 mg/ml otic flood ear as need, TYLENOL or ADVIL for pain. If symptoms worsened, the patient would return. He was to be followed up with his primary care physician in 3-4 days. On 07-JUL-2009 the patient had an office visit. There was no abnormality detected. During the visit, the patient was vaccinated with a first dose of VAQTA. Additional information is not expected.
Moderna vaccine, lot # 048C21A) was received on 7/16/2021 and placed under refrigerated temperature.  3 vials were transferred to another store where 20 doses were administered beyond use date.
Erythema and puffiness of site surrounding injection on left shoulder, mild itching at lower arm.
Case number PHEH2013US017323 is initial report received from a health care professional on 13 AUG 2013. This report refers to an 18-year-old male patient. He was given only the Men A component of MENVEO (batch number: M12123) intramuscularly on 09 AUG 2013. MenA was reconstituted with diluent instead of MenCYW-135. No adverse event was reported following the administration error (wrong solution used in drug reconstitution). Doctor planned to re-vaccinate the patient with properly reconstituted MENVEO.
Pain upon lifting arm/resistance, decreased range of motion of shoulder in arm administer. Tried OTC pain relievers.
AFTER 2 DAYS PATIENT EXPERIENCED SEVERE SHARP INTERMITTENT MYALGIAS OF LEFT DELTOID, THEN L-SHOULDER SUPRSPINATUS, THEN INFRASPINATUS, THEN TERES MINOR AND SUBSCAPULARIS.  PAIN ELICITED WITH  ABDUCTION AND INTERNAL ROTATION L-ARM.  SYMPTOMS ARE NOT CONTINUAL, AND MOVE AMONG THESE MUSCLE GROUPS SOMETIMES AS SHORT SHARP PAINS AND OTHER TIMES AS BURNING ACHING, MAKES USE OF L-UPPER EXTREMITY DIFFICULT
chills; fever; This case was reported by a physician and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were recovered/resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. In 2020, the patient received 2nd dose of Shingrix and experienced chills and fever for 2 and a half days. The patient completed the series of vaccine last year. The reporter did not consent to follow up.
had a stroke; instantly had a pounding headache; blood pressure was elevated; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported.  On 25Mar2021, she received the first COVID-19 vaccine and instantly had a pounding headache.  She went to her doctor who said her blood pressure was elevated and was going to do more testing. She and her sister went away thinking she just needed to relax but then had a stroke in the hotel that same day and was in the hospital for 3 days (until 28Mar2021). She has never had high blood pressure and no history of headaches.  The doctor in the hospital thought that this could be related to the vaccine since she had no high blood pressure or headaches before.  She asked the doctors if she should get the second one and they all said they don't know enough about the vaccine to give her guidance. Outcome of the events were unknown.   Information about the Lot/batch number has been requested.
Pt developed swelling in right thigh that evening, by time of doctor visit 09/29/2001 there was 5cm induration and 13cm erythema. Able to walk, not painful; non-toxic.
HYPOTENSION 3/20/2022 -- RECURRENCE OF SAME SYMPTOMS
experienced sudden bleeding in lower leg like artery is broken; open skin 1mmx 1mm, small opening needle-stick like; This spontaneous case was reported by a physical therapist and describes the occurrence of HAEMORRHAGE (experienced sudden bleeding in lower leg like artery is broken) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Environmental allergy. Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D2, VITAMIN B12 NOS, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.   On 29-Dec-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced HAEMORRHAGE (experienced sudden bleeding in lower leg like artery is broken) (seriousness criterion medically significant) and SKIN INJURY (open skin 1mmx 1mm, small opening needle-stick like). The patient was treated with NAPROXEN SODIUM (ALEVE) on 10-Aug-2021 for Headache, at a dose of 220 mg. At the time of the report, HAEMORRHAGE (experienced sudden bleeding in lower leg like artery is broken) and SKIN INJURY (open skin 1mmx 1mm, small opening needle-stick like) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication reported, as centrum.  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. Further information has been requested; 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. Further information has been requested
Expired vaccine. No temperature excursion occurred. Moderna determined the vial "maintained the activity necessary to protect against the SARS Co-V 2 virus at the time of administration." No adverse reactions reported.
Reported cyanotic spell that happened 12 hours after administration. Lasted less than one minute. Taken to ED, and was told she had a postictal state and febrile seizure. Temperate was 100.5 reportedly at ED.
Large local reaction 7 days after injection--pain, redness, swelling around injection site  12 cm diameter.   Pain radiating to left ear and left hand.