chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diffuse generalized pain aching. Worse (R) arm & shoulder. (R) hand feels numb started 3 - 4 days after receiving the flu shot. Seen on 11/15 & again on 11/17.
Ever since I had the vaccine. I have grass and other things coming out of my skin. All I do is itch morning to night. Very itchy, it comes in my eyes, out my feet everywhere. My son and husband had it too.
According to MD infant was cranky. Red macular rash began morning after shot. Rash more on upper extremities, no fever, swollen glands or difficulty breathing. Spoke with mom who states rash lasted about 3 days. Vomited 3 time evening after immunization. Rash started on stomach, spread around neck and arms. Blotches worse if overheated.
This case was reported by a physician and described the occurrence of injection site pain in a 12-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  The subject had no adverse events following receipt of prior immunizations and no relevant medical history.  There were no concurrent medications.  On 19 August 2003 the subject received unspecified dose of Engerix B (.5 ml, unknown) in the right arm.  On 19 August 2003, the subject also received a booster dose of Td adsorbed (Aventis Pasteur) in the left arm.  On 19 August 2003, less than one day after vaccination with Engerix B, the subject experienced injection site pain and arm weakness of the right arm.  The physician reported that the subject, "had to use her left arm to raise her right arm."  The physician reported that the "symptoms occurred intermittently and resolved after one year without treatment."  The vaccination course with Engerix B was discontinued.  The physician considered the events were probably related to vaccination with Engerix B.  Follow up information was received on 09 May 2007 via the physician, who reported that the subject had not previously received Engerix-B prior to the first administration on 19 August 2003.  The immunization series was discontinued, and the events resolved.  Upon follow-up, the physician indicated that the events were possibly related to vaccination with Engerix B.
Ringing in the ears lasting a few hours , swollen lymph nodes in armpit, still swollen and painful.
4 weeks of extreme fatigue, joint swelling and pain in hands, feet, muscles. skin around joints hurts to touch at night.
Died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: DEATH (death, medically significant), outcome "fatal", described as "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The reporter stated that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020087 as same reporter/drug/event, different patient;; Reported Cause(s) of Death: Died since taking your COVID vaccine
I had experienced soreness in my left arm right after getting my vaccine that lasted for about a couple of days. I have also noticed in June; I was experiencing hair loss. I had gone to a Dermatologist, and I had to start taking steroid medication called Betamethasone and Rogaine to help with the hair loss.
Bone pain; Muscle pain into the soles of her feet; burning sensation in arm which radiated into finger tips and joints; burning sensation in arm which radiated into finger tips and joints; headache; inability to concentrate; a quickly rising fever reaching 102.5, for 18 hours; Nausea; teeth sensitivity, all the nerves in patient's teeth hurt; teeth sensitivity, all the nerves in patient's teeth hurt; Swelling under arm of second dose injection site; Swelling under arm of second dose injection site, painful to put at side; It felt like there was a scorching hot balloon in there and other heat radiates into patient's chest; Feeling of heaviness in head still three days later; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiration date not provided), via an unspecified route of administration, in right arm, on 03Feb2021 (at the age of 56-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history was not reported. Patient had no known allergies. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medications included colecalciferol (VITAMIN D), estradiol (VIVELLE) patch .05 estrogen only, and famotidine (PEPCID). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiration date not provided), via an unspecified route of administration, in left arm, on 14Jan2021 20:30 (at the age of 56-year-old), at single dose, for COVID-19 immunization, and had headache, tired and arm soreness. On 04Feb2021 12:00, 16 hours post injection, patient had sudden onset of severe bone pain, muscle pain into the soles of her feet, burning sensation in arm which radiated into finger tips and joints, headache, inability to concentrate, a quickly rising fever reaching 102.5, for 18 hours, the above symptoms had left. Patient also had following persist events included nausea for 3 days day, teeth sensitivity, all the nerves in patient's teeth hurt, for 3 days; swelling under arm of second dose injection site, painful to put at side for three days; It felt like there was a scorching hot balloon in there and other heat radiates into patient's chest. Patient had feeling of heaviness in head still three days later. Lab test included COVID test (Nasal Swab, PCR) on 03Feb2021 was negative. No treatment received for events. The outcome of events "bone pain/muscle pain into the soles of her feet/burning sensation in arm which radiated into finger tips and joints, headache, inability to concentrate, a quickly rising fever" was recovered; of other events was not recovered.
Had first seizure in April 2007. Currently diagnosed with juvenile myoclonic epilepsy. Have had between 10-15 seizures from 2007-present. Currently on KEPPRA to control seizures.
Tdap (Boostrix) .5 cc given to patient. (Given to patient outside approved age range).
Extreme menstral cramping and bleeding (not time and very out of ordinary), bad headache, fever, chills, nausea and vomiting
One day after Tdap, Meningococcal, Flu and HPV vaccine were given, patient had itching and appearance of multiple small bumps on both deltoid area.
A nurse reported that a 57 year old male received Pnu-Imune 23 on 12/7/99. That evening, he developed a "severe" injection site reaction characterized by swelling and redness "which wrapped clear around to axillary area" and low-grade fevers. He recovered. This is 1 of 4 pts, out of 6 vaccinees, from this facility who experienced this event following receipt of Pnu-Imune 23.
Covid vaccine given one day past 72 days use by date.  No ill effects.  Physician notified and physician notified parent.  Pfizer notified as well.
pt recvd vax & became lethargic for 4 days following immun; occurred 2 years ago;
Red blotch on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red blotch on the injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red blotch on the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red blotch on the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment.   Reportedly, the patient denied any allergies and PMH.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Email address is updated On 04-Jun-2021: Event outcome updated.
shortness of breath followed by syncope lasting several minutes, when patient awoke she has chest pressure and soight shortness of breath. She went to sleep and it resolved
My daughter starting losing large amounts of hair a couple weeks after her second Gardasil shot. It is still falling out in large amounts. The doctor checked her thyroid which tested normal. A perfectly healthy girl that does not take any medication. Never sick. Hasn't changed her lifestyle.  Hair loss began shortly after second shot.
This is a spontaneous report from a contactable consumer (medical assistant) received via a Pfizer sales representative. This consumer reported similar events for four patients. This is the first of four reports. An infant patient of an unspecified gender received PREVNAR 13, (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling and a little hardened area at the injection site. The reporter spoke to the doctor that said the swelling and a little hardened area at the injection site was okay and nothing serious. The outcome of the event was recovered within a few days on their own. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018482514 Same reporter, same drug, same events; different patient; US-PFIZER INC-2018482515 Same reporter, same drug, same events; different patient; US-PFIZER INC-2018482516 Same reporter, same drug, same events; different patient.
Same-day reactions  -within 5 minutes: hives in face and neck - a few more minutes later: swollen lips (had to take Benadryl and 20 mg of prednisone that I was carrying because the hospital only had the epipen) - within 24 hours: shortness of breath, palpitations - couple of days later: admitted to the ER with pneumonia and PVC arrhythmia
BURSITIS IMPROVED; UNEXPECTED  THERAPEUTIC EFFECT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included bursitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced bursitis improved, and unexpected therapeutic effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bursitis improved and unexpected therapeutic effect was not reported. This report was non-serious.
No additional AEs; missed dose/ patient received the 4 valent Human Papillomavims Vaccine ( 4 valent) when she was 13 years old, on an unknown date, but did not receive any additional doses until the now 22 year old patient received GARDASIL 9; patient received the 4 valent Human Papillomavims Vaccine ( 4 valent) when she was 13 years old, on an unknown date, but did not receive any additional doses until the now 22 year old patient received GARDASIL 9; This spontaneous report was received from a registered nurse via a company representative and refers to a 22-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported.    On an unknown date, at the age of 13 years, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (dose, route of administration, vaccination site, lot # and expiry date were not provided) for prophylaxis.  The patient did not receive any additional doses until 19-APR-2021, when she was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 mL (route of administration, vaccination site, lot # and expiry date were not specified) for prophylaxis (inappropriate schedule of product administration and interchange of vaccine products). No additional adverse events were reported. Product quality complaint was not involved.
First dose 3/23/21; second dose 4/24/21.  First dose I had face numbness within an hour of injection, symptoms subsided by next day however would return intermittently for the next 2-3 weeks.  After second dose once again returned and have been on going ever since, I advised  PHCP and he advised it was a side affect and there was nothing that he could do.   Overall feeling is a numbness from cheek bones down to mouth, lower lip tingles at times, face feels swollen but not visually noticeable, feels restrictive when I smile,
Vertigo started on the 13th of Feb. and then the morning of the 14th I had Vertigo and extremely high Blood Pressure (202  over 96).  I went to the ER.  I had bilateral hernia surgery April 2nd and since then I have not been myself.  Severe lower back pain, some lower abdominal pain, loss of weight(20 lbs). Chest X-ray showed possible "air trapping disease" and Nuclear Bone Scan (head to toe) showed only arthritic aging.  A blood test on Aug. 4th showed Sed Rate 25 mm/Hr,  SGOT/AST 45 IU/L, Alk Phos 275 IU/L, SGPT/ALT 126 IU/L.  A:G Ratio .9
About 15-20 minutes after injection, complained of wheezy, scratchy throat with metallic taste. Also complained of headache.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 08-MAR-2013 at 12:00 pm, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 62.50 hours (also reported 17 hours -1, then 179, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Fever for 5 days, starting 7 days, post vax. Had red blanching plaques and macules from hairline. Symptoms persist.
Mild arm soreness; fatigue; mild body aches; chills; received 1st dose of BNT162B2 on 29Dec2020, second dose received 12Jan2021; This is a spontaneous report from a contactable consumer. An adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiration date not reported) via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 on 29Dec2020 for COVID-19 immunization. The patient experienced mild arm soreness starting about 4 hours after the shot on 12Jan2021 and able to do subsequent work out. About 12 hours after vaccine, developed fatigue and mild body aches followed by about an hour of chills, which resolved. Took some ibuprofen and melatonin and slept well until 6 am. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Severe Itching; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 25Aug2021 at 09:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 31Aug2021 at 19:00, the patient experienced severe itching. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event severe itching was not recovered at the time of report.
beginning about 5 hrs p/vax pt began to devel a fever, body shakes, vomiting, muscle spasms, & mild deleriums; fever rose to 104 oral; by next afternoon;
Per mother patient started with a rash to bilateral inner thighs, then broke out in a pinkish rash from her elbows to her wrists, after rash spread to her flank area. Mom gave patient Benadryl which stopped the itching but did not improve the rash. Advised mom on 01/29/20 if rash does not improve visit pcp.
This spontaneous report was received from a pharmacist (who is also the patient) of unknown age regarding herself. On an unknown date, the pharmacist administered herself with a dose of ZOSTAVAX (lot #, expiry not reported), intramuscularly. On an unknown date, the patient developed a knot at the site where ZOSTAVAX was injected. The outcome of knot developed at the site where ZOSTAVAX was injected was unknown. No Varicella Zoster Virus Identification Program (VZVIP) packet faxed at this time. Additional information has been requested.
Patient experienced severe nausea and vomiting that started about 1 hour post second Moderna vaccine. Patient became severely dehydrated due to the vomiting and went to Emergency Room that evening. The physician decided to admit the patient to administer fluids and monitor patient. The patient stated she recovered after about 48 hours post-vaccination and has not had any symptoms since.
lt facial swelling x 1 qd;s/p MMR/DTP/HIB 2d prev;no fever no skin rxn noted;good appetite;tx rest, APAP PRN pain & >t101;
15 minutes post immunization the patient experienced dizziness & nausea that was not relieved. He was sent to the ER for further evaluation.
Clogged ears; Severe vertigo; This is a spontaneous report from a contactable other healthcare professional.  This 51-year-old male other healthcare professional (patient) reported for himself that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3248) intramuscularly into the left arm on 11Jan2021 (at the age of 51-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EK5730) intramuscularly into the left arm on 21Dec2020 (at the age of 51-year-old) as dose 1, single for COVID-19 immunisation. The patient also received dose 3 of BNT162B2 (Lot number: 30135BA) intramuscularly into the left arm on 29Sep2021. On an unspecified date in Jan2021, the patient experienced clogged ears and severe vertigo. After the second dose, the patient developed clogged ears and severe vertigo that would occur every week or so for several months, gradually getting better and less severe. It finally resolved and then he received the third shot and in less than a week had severely clogged ears and now tinnitus which had lasted for a full week now; adverse event start date was 26Sep2021; patient had not recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Device date was reported to be 04Oct2021. Treatment received included MRI, CT scan, hearing test. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome was resolved on an unspecified date in 2021 for both the events.  Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Extreme dizziness that began with sweating. Went to the bathroom as if felt nauseous. Blacked out. (Hit head, which is still bruised and had urinated.) When woke up still very dizzy with vomitting, stomach cramps, dhiaria, continued sweating. This lasted two--three hours. I could not leave the bathroom. Made it to my bed with help. Finally slept  for a few hours. Awoke with continued stomach cramps and moderate dizziness. Stomach cramps on and off for the next 24 hours. Unable to get out of bed.
received the second dose / subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) for prophylaxis.   On 20th June 2021, the patient received the 2nd dose of Shingrix (subcutaneous). On 20th June 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received the second dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose); 42 years old non-immunocompromised patient received 2nd booster.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose)) and EXTRA DOSE ADMINISTERED (42 years old non-immunocompromised patient received 2nd booster.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 939903, 01451A and 040121A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Diabetes type 1).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Apr-2022, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose)) and EXTRA DOSE ADMINISTERED (42 years old non-immunocompromised patient received 2nd booster.). At the time of the report, ACCIDENTAL OVERDOSE (Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose)) and EXTRA DOSE ADMINISTERED (42 years old non-immunocompromised patient received 2nd booster.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  The Reporter stated that a 0.5mL dose from a red cap and a label with a light border was administered as patient 2nd booster dose (4th dose) instead of 0.25mL.The patient was not immunocompromised.  Treatment information was not provided.   This case was linked to MOD-2022-537620 (Patient Link).