chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever that held at 101.4 but did increase to 102.4 around 8hrs post shot. Chills and body aches were also noted. Nausea throughout. Injection shot is still red and swollen 48hrs post shot.
Mother of patient called on 2/23/07 and reported that child had developed a circular area less than 1" in diameter around the injection site. Described as "white" bumps that "itched." Child had removed the bandaid shortly after receiving the vaccination. Mother described that child has dry skin and alcohol used to cleanse area may have caused increased dryness. Follow up call on 2/26 and area improving/clearing.
Cellulitis of right upper arm below injection  and injection sites and inclusive of lower injection site on 2nd day of reaction.
Report received from patient who is receiving care from his primary care provider and local hospital.  Patient called Clinic to report the onset of sore throat, cough, headache, fever, body aches, chest tightness and difficulty sleeping on 10/22 late in the evening after receiving his 1st dose of Moderna earlier that day.
Chills, fatigue, fainting.   Cut head during fainting episode on 3/26  which required urgent care to close the wound with stapes.
skin problems for 2 months.  Red spots and itches on both arms and legs..; itches on both arms and legs.   I am taking Bernadryl everyday to ease the itches but i still have itches and reddish skins; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 14Feb2021 at 00:00(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to apple(fruit allergy) and other fruits. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and unknown if ongoing. On 27Feb2021, the patient experienced red spots and itches on both arms and legs and the patient reported that he has skin problems for two months, she was taking benadryl everyday to ease the itches but still had itches and reddish skins. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with benadryl(MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red spots and itches on both arms and legs was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Oct, Nov 1990 pt vax 2 doses;  n/v devel 10 hrs after 2nd dose.  lasted for 24 hrs.
Lump appeared on arm the size of a golf ball. (red and warm to touch). Chills, achy feeling.
Swollen lymph nodes; fatigue; headache; chills; burning sensation of eyes; joint pain; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262), via intramuscular, administered in right arm on 30Jan2021 at 15:00, (at the age of 70 -years) as 1st dose, for COVID-19 immunization. Patient's medical history included fibromyalgia, rheumatoid arthritis, ulcers, vertigo, osteoporosis, and hepatitis C. Patient's concomitant medications were not reported. Patient had allergy to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not tested for COVID-19, since the vaccination. On 31Jan2021 at 18:00, the patient experienced swollen lymph nodes, fatigue, headache, chills, burning sensation of eyes, and joint pain. Patient did not receive any treatment for the events. The outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.
TC from MD 14MAR95 430PM; around 3PM pt devel welts on trunk arms & legs; MD administered adrenlin even though no breathing difficulties occurred; also given DPH;
Pt became nauseated and began dry-heaving within 5 minutes of vaccination. Did not vomit, but did become pale. Pt was seated when symptoms began and remained seated throughout. Applied cool, wet, paper towel to back of neck. Dry-heaves resolved after approx 1 min, and provided pt with water to sip. Pt denied any other symptoms. Recovered completely after about 10 minutes.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CHF" (unspecified if ongoing); "GERD" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive test (Binax NOW) before starting Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Jul2023 to 15Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded. ,Linked Report(s) : US-PFIZER INC-202300254720 Same patient, different drug, different event;
9vHPV "allergy"; nausea; vomiting; injection site pain, swelling, and pruritus; injection site pain, swelling, and pruritus; injection site pain, swelling, and pruritus; the second dose 2 years prior; 9vHPV 0.05 mL intramuscular was then administered followed 15 minutes later with the remaining 0.45 mL; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 22-year-old female patient. The patient's medical history, concurrent condition and concomitant medication were not provided.  On unknown dates, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (also reported as 9vHPV) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis.  On an unknown date, after the second dose vaccination, the patient self-referred for allergy to vaccine after experiencing nausea and vomiting associated with injection site pain, swelling, and pruritus (vaccination site pruritus, vaccination site swelling, vaccination site pain). She had been advised by the gynecology nursing staff not to receive the third dose due to her reaction. The outcome of all events were recovered.  2 years after the second dose in the office of her gynecologist, during her allergy consultation, she had negative prick test with full-strength 9vHPV followed by a negative 1:100 dilution 9vHPV intradermal test. Then the patient was administered the third dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.05 mL followed 15 minutes later with the remaining 0.45 mL via intramuscular route (strength, route, lot# and expiration date were not provided) for prophylaxis (product administration error and inappropriate schedule of product administration) without adverse reaction during a 2-hour observation.  The reporter considered allergy to vaccine, vaccination site pruritus, vaccination site swelling, vaccination site pain, vomiting and nausea to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  A copy of the published article is attached as further documentation of the patient's experience.
Got TDAP at 10:30 (A), called at 2:45 p, had vomited x 2, arm with only quarter sized erythema, no swelling.  "Worse headache ever", difficulty/sensitivity to light.  Advised to ED.  9/24 - I called patient back - she went to ED.  On 9/23 diagnosed with a headache.  Treated and released.  Patient states she feels "a lot better" today, no headache or stiffness in neck.
COVID 19 Treatment; COVID 19 Treatment; 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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 2 (booster), single (Lot number: FD0809) at the age of 69 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 17Mar2021 as dose 1, single (Lot number: 1805025), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penecillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (unspecified date) Negative; (18May2022) positive; (18May2022) positive. Therapeutic measures were taken as a result of covid-19.  Additional information: If vaccine received: Yes; Other medication in 2 weeks: No. Adverse event: 18May2022, 12 days after positive test and 6 days after stopping paxlovid, symptoms returned (drippy eyes and nose, aches, tired) so I home tested and got a positive antigen test. Other medical history: None
Very ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Very ill".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
one nearly killed him; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: one nearly killed him) (serious criteria GSK medically significant).The outcome of the near death experience was not reported.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine.   It was unknown if the company considered the near death experience to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a consumer via interactive digital media. The reporter said that not to get the shingles vaccine. The reporter stated that two must be taken. The reporter stated that first one nearly killed him. The reporter further stated that it was nice to have an honest man.
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/28/2023 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
The pt experienced a swollen, erythematous and tender injection site occurring 12 hours post vax.
Patient has not reported any adverse events but third vaccine was given early. Patient received first dose 5/30/18, second dose 7/11/18, and third dose 9/26/18 (last dose was 2 months early). I spoke with GSK this morning and they recommended the patient get one dose of HAVRIX adult for full protection against Hepatitis A.
Hot swollen hard muscle at injection site Headache Muscle aches Joint and tendon aches  Continuing  Headaches and muscle aches periodic
Baby was given a dose of baby flu (0.25) in our pediatric office instead of a Hep B. Dr spoke with mother and baby is doing well, eating and a febrile.
Supraclavicular lymphadenopathy noticed; Generalized blanching rash covering thighs abdomen chest and arms,around 24 hours after the second dose resolved within a day; This is a spontaneous report from a contactable Physician (patient) A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: unknown, expiration date: unknown) via an unspecified route of administration anatomical location Left arm on 13-FEB-2021 12:45 at single dose for COVID-19 immunization. Patient historic vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: unknown, expiration date: unknown) via an unspecified route of administration anatomical location Left arm on 23Jan2021,10:30 at single dose for COVID-19 immunization. medical history included Autoimmune urticaria. concomitant medication include Antihistamine. On 14Feb2021 13:00 patient experienced Generalized blanching rash coveringthighs abdomen chest and arms, around 24 hours after the second dose resolved within a day.Supraclavicular lymohadenopathy noticed 72 hours after. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior and post to the vaccination, the patient was not diagnosed with COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior and post to the vaccination, the patient was not diagnosed with COVID-19.The outcome of event was Recovering/Resolving.  Information on the lot/batch number has been requested
Patient said she got extremely sick 5 days after the vaccine, whish the patient is insisting the vaccine causes.   She had fever, chills and headache.
PATIENT WAS WAITING IN WAITING ROOM AFTER RECEIVING VACCINE. GIRLFRIEND KNOCKED ON HEALTH SCREENING ROOM WHILE ANOTHER PATIENT WAS GETTING READY FOR VACCINE. PATIENT HAD PASSED OUT IN CHAIR. PHARMACIST CAME INTO ROOM, TRIED TO ROUSE PATIENT AND DID STERNUM RUB. PATIENT SCARED AWAKE. TOOK A COUPLE MINUTES TO REGAIN COMPLETE CONSCIOUSNESS. PATIENT WAS SWEATING, SOON BECAME VERY COLD AND VERY SHAKY. EMS WAS CALLED AND ON SCENE WITH PATIENT. EMS WANTED PATIENT TRANSPLANTED TO HOSPITAL BUT PATIENT DENIED MEDICAL ATTENTION AND TRANSPORT. ACCORDING TO EMS, PATIENT DID HAVE LOW PULSE BUT BLOOD SUGAR WAS NORMAL. EMS HAD ME HAVE PATIENT SIT FOR ANOTHER HALF HOUR WHILE PATIENT ATE A PROTEIN BAR AND HAD A GATORADE. AFTER THE HALF HOUR PATIENT STATED THAT HE WAS FEELING FINE AND LEFT THE BUILDING.
Pain at injection site. Tightening in injection shoulder. Mild onset of nausea 7 hours after injection. Severe nausea after 12 hours of injection. Profuse sweating 12 hours after injection. Headache.
hair fall; little body aches; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair fall) and MYALGIA (little body aches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 042B212A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced ALOPECIA (hair fall) and MYALGIA (little body aches). At the time of the report, ALOPECIA (hair fall) and MYALGIA (little body aches) outcome was unknown.            The concomitants include blood pressure medication, cholesterol medication and nature's brown hair, skin, nail vitamins. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27-may-2021 contains no new information.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. On unknown dates over an unspecified period of time,  the patients were vaccinated with an improperly stored dose of GARDASIL 9 with either lot number M024261 and expiration date of 30-JUL-2018 or M034780 and expiration date of 15-APR-2019(strength, route of administration and dose were not reported) for prophylaxis, which was stored between 32 Fahrenheit degrees (°F) to 35°F for 15 hours and 30 minutes. There was  previous temperature excursion. However, the temperature excursions were not detected by a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA010440: US-009507513-1705USA006606:
headache, sweating and shaking 15 minutes after vaccine During the night woke up  with chest tightness and shortness of breath and went to the ED-xray,ekg, IV fluids and Zofran
This case was reported by a pharmacist and described the occurrence of swelling injection site in an adult female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 16 October 2007 the subject received 1st dose of Flulaval (.5 ml, unknown).  On 16 October 2007, less than one day after vaccination with Flulaval, the subject experienced swelling injection site and injection site warmth.  The subject questioned the possibility of a wrong route of administration.  She believed that she was vaccinated subcutaneously due to the swelling and heat at the injection site.  At the time of reporting the outcome of the events were unspecified.
FEVER, SITE WARM TO TOUCH, PAIN NOTED WITH MOVEMENT OF EXTREMITY.
achiness; chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), CHILLS (chills) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achiness), CHILLS (chills) and FATIGUE (Fatigue). At the time of the report, PAIN (achiness), CHILLS (chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.    This case was linked to MOD-2021-076873, MOD-2021-042580, US-MODERNATX, INC.-MOD-2021-042580, US-MODERNATX, INC.-MOD-2021-076873 (Linked Report).; Sender's Comments:  MOD-2021-076873:Same reporter/different patient (wife 1st dose case) MOD-2021-042580:Same reporter/different patient (wife 2nd dose case) US-MODERNATX, INC.-MOD-2021-042580:Same reported/different patient (Husband case) US-MODERNATX, INC.-MOD-2021-076873:Same reporter/different patient (husband)
Initial case was received on 31 March 2010 from a healthcare professional. The reporter stated she had a patient in the practice, who was inquiring if she was at an increased risk of GBS (GUILLAIN-BARRE Syndrome) following a H1N1 vaccination. The concern was because her mother, a female patient (age not specified), received an injection (route and site not reported) of INFLUENZA VACCINE (manufacturer and lot number not reported) on an unspecified date last year and experienced GBS (onset date not reported). The mother was not a patient in that practice. Outcome was not reported. The reporter had no further information and did not want to be contacted. Documents held by sender: None.
she did not have any symptoms or concerns; patient received her first dose of GARDASIL 9 at age 66; This spontaneous report was received from a female nurse practitioner reporting on herself.  The patient's medical history was not reported. The patient's concurrent conditions included  penicillin allergy (rash). Concomitant therapies were not reported.  On 26-AUG-2022, at age 66 (product use issue), the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot #U008316, expiration date: 15-AUG-2023, administered intramuscularly, in the left arm, for prevention of HPV infection due to new sexual partners.  The patient stated that she was expecting to feel some discomfort or pain from the injection or in the next few days after the injection, but she did not. She stated that the lack of soreness in her arm made her wonder whether she actually got the correct vaccine. Otherwise, she didn't have any symptoms or concerns (no adverse event).  The patient did not seek medical attention. No lab diagnostic tests were performed.  Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not discontinued.
This case was reported by a consumer via call center representative and described the occurrence of epistaxis in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 23 hrs after receiving SHINGRIX, the patient experienced epistaxis, injection site pain, vomiting, fever, neck pain, ear pain and headache. On an unknown date, the outcome of the epistaxis, injection site pain, vomiting, fever, neck pain, ear pain and headache were unknown. It was unknown if the reporter considered the epistaxis, injection site pain, vomiting, fever, neck pain, ear pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Thursday, at 2:00 pm, the patient received the first shot of SHINGRIX. On Thursday, at 8:00 pm, 6 hours after receiving  SHINGRIX the patient experienced extreme pain where shot was given that traveled up neck and into the left side of head. On Thursday night, at 11:00 pm, 9 hours after receiving SHINGRIX the patient experienced threw up and ran a fever of 101. On Friday, at 1:00 pm, 23 hours after receiving, SHINGRIX the patient experienced nose bleed in left nostril. On Friday, at 9:00 pm, 1 days 7 hours after receiving SHINGRIX the patient experienced extreme throbbing pain on left side of brain with stabbing pain in left ear. It seems that patient might had really reacted badly to this vaccine. The patient was asked whether to continued to got the second vaccine if yes, would this happen again. Lab Comments: Lab test was done on an unknown date.