chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient indicated that approximately 2 hours after receiving the TD shot he felt achiness, headache, fever, SOB, itchiness of throat area. These symptoms intensified into the next day. The patient did not seek medical attention but reported this on Monday and was feeling fine by then.
brain fog; vicious chills; Really Hot; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6100 and expiration date not provided), via an unspecified route of administration, in arm right, on 19Feb2021 (at the age of 68-year-old), at single dose, for COVID-19 immunization. Medical history included ongoing asthma, brain injury, concussions (patient stated he had three. The most severe was three years ago. Patient stated he was knocked completely unconscious and was unconscious for a while), pneumonia from 1980 to 1983. Patient got pneumonia back in the 1980s, around 1983; and after that he had asthma. Patient was having issues seeing things as he went to the eye doctor today and they dilated his pupils. Concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318 and expiration date not provided), via an unspecified route of administration, in arm right, on 29Jan2021 16:00 (at the age of 68-year-old), at single dose, for COVID-19 immunization; and experienced brain fog and tired. The patient experienced brain fog, vicious chills, and really hot. Patient stated that he also had 1-2 instances of vicious chills and 1-2 instances of being hot. Patient said the hot and chills definitely happened after the second vaccine. Patient stated it happened somewhere in the 7-10 days after the vaccine and then was gone. Patient had brain fog after first dose vaccine. It never went away completely. After the second injection the brain fog returned stronger again. Patient stated that if he was to rank his brain fog on a scale of 1-10 with 10 being not able to function; at it's worst he would rate it as a 6. Patient said he could function but would be working and be in the middle of an email and typing and would get lost in the middle of a sentence. Patient said it had improved; as of now he would rate it as a 3-4 on the same scale. No additional vaccines administered on same date of the Pfizer suspect. The outcome of the event "brain fog" was recovering; of events "vicious chills", "really hot", was recovered on unknown date.    No follow-up attempts are possible. No further information is expected.
Patient reported a sore arm directly after receiving the vaccine. She called the pharmacy to report the sore arm and concerns that she didn't think her arm should be that sore. The pharmacist went over the vaccine technique used by the technician who remembered the patient. Technique seemed appropriate, so we recommended patient follow-up with her PCP  if the discomfort continued. Pharmacy let the patient know that discomfort in the arm for up to 7 days can occur and is not unusual.  On 4/19/21, patient reported that she  followed up with PCP, tried taking a Medrol Dose Pak and was then referred to doctor with sports medicine. The pharmacy called doctor for more information for the VERS reporting. Doctor had determined patient had injury of left shoulder with bursitis relating to vaccine administration and is a "well known phenomenon" per doctor. Patient continues to follow-up with doctor and will begin PT to help with the condition.
pt recvd vax 4MAY94 AM states vomiting off & on; also short sz 8MAY94; states not self; has microcephaly, history of sz & gastroesophageal reflux;
Intense right armpit nose pain- shooting electrical pulses at times down side of torso Chest pain that moves Most often under left upper chest plate  but often in spleen location and sometimes more centered Extreme thirst and dry nose throat tho drinking so much water and no alcohol. Drinking soups.  Extreme fatigue- can?t stay awake- headache worse today.
mom states pt had elevated temp & does not know what temp was but temp was accommanied by shaking arms & legs & pupils would not dilate @ approx 1AM 23FEB95; saw MD aprpox 9AM 23FEB95;
Joint pain, swelling day after vaccine (10/23/09) physician ordered Medrol Dose Pak. No missed time.
Reports dizziness immediately following vaccine inject. She reports same symptom with first vaccine, and was transported to Rush ER. VS 130/78, 68, O2 sat 99 %
Patient was given .2ml of Covid Vaccine 5-11 year old Orange Cap without being reconstituted with 1.3 ml of saline
Itching of skin at site with erythema, induration, warmth.  Erythema spreading from site to elbow - cellulitis reaction.
This spontaneous report as received from a consumer refers to her son: a male patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (dose and route was not reported, lot # M014929). Concomitant therapies included MENACTRA. On an unknown date, the patient experienced a sore tender arm following the vaccination. The primary reporter stated that her son's physician stated that the dose of GARDASIL 9 that was administered was improperly stored. The outcome of the events was not reported. Causality assessment was not reported. Additional information is not expected as no follow up can be obtained from the physician.
tenderness at injection sight, rash at and below injection site, fatigue, headache, chills, nausea, fever - intense for 24 hours, less intense next day, no fever next day, symptoms gone by next day.
Took vaccine on 8/11 had a reaction 3 days later 8/14, while she was out of town. Upper GI stomach pain, esophagus pain, horrible re-flux after a couple of days moved to throat and now has mouth and gum sores headache consistent over last week and half. Returned on 8/21 from vacation, She scheduled an appt. to see a PCP about the symptoms
Drug ineffective; getting Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for influenza immunisation, on 02Oct2023 as dose number unknown, single; RSV VACCINE PROT.SUBUNIT PREF 2V taken for immunisation, on 23Oct2023 as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown"; SUSPECTED COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "getting Covid". Clinical course: patient had a hard time with shots at (withheld). The first 2 shots he got were Covid and Flu on 02Oct. Then he had RSV vaccines 23Oct and felt ill and wound up getting Covid.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300178373 same reporter/patient,different drug/AE;
Rash around injection site immediately after injection. Pt was instructed by physician to take Benadryl. Rash resolving before pt left the office.
Information has been received from a nurse concerning her 20 year old daughter with a history of sulfonamide allergy who on 15-MAY-2007 was vaccinated with the second dose of GARDASIL (lot number not provided). Concomitant therapy included hormonal contraceptive (unspecified). On 24-MAY-2007 the patient fainted under the hair dryer at a beauty salon. The patient reported feeling hot then slumped forward unconscious. She was  sweaty, her lips were white, and her right side was jerking. The paramedics were called and they could not find a pulse but her blood pressure was low and her blood sugar was 65. She came to before being transported to the emergency clinic and had blurred vision. At the hospital her left side began jerking, her left arm was rigid, and she had a severe headache and nausea. She had many lab tests in the clinic including an electrocardiogram which was normal, a CT scan that was normal except for sinusitis. She had no fever her pulse ox was 99, pulse 80 on arrival then 64 later, her blood pressure was 78/50 on arrival then 90/60 later, and her blood sugar was 85. She was not admitted. Subsequently, the patient recovered from fainted, sinusitis, left arm rigid, left side jerking, blurred vision, right side jerking, right side jerking, loss of consciousness, severe headache and nausea. Additional information has been requested.
Patient gets a lot of mosquito bites, but since she received the vaccine mosquito bites do not itch; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Patient gets a lot of mosquito bites, but since she received the vaccine mosquito bites do not itch) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (codeine allergy.). Concomitant products included CHONDROITIN SULFATE, GLUCOSAMINE SULFATE (1120 GLUCOSAMINE & CHONDROITINE) for Bone density abnormal, ESTRADIOL for Hormone level abnormal, ALENDRONATE SODIUM.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Patient gets a lot of mosquito bites, but since she received the vaccine mosquito bites do not itch). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Patient gets a lot of mosquito bites, but since she received the vaccine mosquito bites do not itch) had resolved.            No information on treatment medication was provided. CALCIUM MAG POTASSIUM for bone density and D3 & K2 for healthy heart ,ALENDRONATE SODIUM  for pre- osteo are concomitant medication taken by patient.   Patient claims has not had any itching from mosquito bites and thinks the vaccine may have some long term effects and company should act on it.  Residual effects: PATIENT  WALK HER DOG AT DUSK AND CAN FEEL THE MOSQUITOS STING HER , BUT THE RESULTING ITCH IS STILL NOT AS BAD AS BEFORE SHE RECIEVED THE VACCINES.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: TCR Received-AE Outcome and Email Address provided On 28-Jul-2021: significant Follow Up received concomitant medication and allergy added, address updated, vaccine facility info and event updated.
Pt. reported having HIV/HepC and was told to get hepA and hepB vaccine. HepB was given as a 3rd dose because of pt. reported disease state. We learned later from the HIV clinic provider he does not have HIV.
Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication. On unknown dates the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot # L004740 with expiration date of 16-NOV-2017; strength, dosage, frequency and route unspecified) (incorrect product storage). No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills; another arm headache; another arm headache; neck ache; body aches; upset stomach; teeth aching; leg aching; foot aching; stomach hurting; wrist pain; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Nov2021 09:45 (Lot number: F63527) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose:1, Left upper arm, Intramuscular, time:09:00, Batch/Lot Number: EN6204), administration date: 06Mar2021, when the patient was 67 years old, for Covid-19 Immunization; Bnt162b2 (dose:2, Left upper arm, Intramuscular, time:09:15, Batch/Lot Number: ER8737), administration date: 06Apr2021, when the patient was 67 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 11Nov2021, outcome "unknown" and all described as "another arm headache"; NECK PAIN (non-serious) with onset 11Nov2021, outcome "unknown", described as "neck ache"; PAIN (non-serious) with onset 11Nov2021, outcome "unknown", described as "body aches"; ABDOMINAL DISCOMFORT (non-serious) with onset 11Nov2021, outcome "unknown", described as "upset stomach"; TOOTHACHE (non-serious) with onset 11Nov2021, outcome "unknown", described as "teeth aching"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "unknown", described as "leg aching"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "unknown", described as "foot aching"; ABDOMINAL PAIN UPPER (non-serious) with onset 11Nov2021, outcome "unknown", described as "stomach hurting"; ARTHRALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "wrist pain"; CHILLS (non-serious) with onset 12Nov2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "body ache". Additional information: User reported the Adverse Event as well another arm headache, neck ache, body aches, wrist pain, upset stomach, teeth aching, leg aching, foot aching, stomach hurting, Chills, headache and Body Ache. Relevant Tests were None.   No follow-up attempts are possible. No further information is expected.
Sore; Sore throat; Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Sore), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Sore), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever). At the time of the report, PAIN (Sore), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.
no adverse effects reported; incorrect product storage; This spontaneous report was received from a licensed practical nurse referring to unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported.  Since 01-OCT-2019, the patients were vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose number, route and anatomical location were not provided) lot # R002510, expiration date on 25-JAN-2020 and a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose number, route and anatomical location were not provided) lot # R020672, expiration date on 18-JUL-2020 for prophylaxis.  The vaccines were stored in temperature of 6°F (Fahrenheit degrees) to 14°; 6.4°F for 11 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
temp of 100.7;rash-pruritic maculopapular rash p/vax;no other causes of rash could be established by MD;
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2009, a physician at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2014, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported   This case was linked to MOD-2021-364288 (Patient Link).
Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced TENDERNESS. At the time of the report, TENDERNESS had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.    Reporter did not allow further contact.
Patient recieved pfizer-BioNtech COVID-19 doses 1 and 2 with no reactions.   Patient received Pfizer-BioNtech booster dose 3 today. Two hours after the dose, patient began to see floaters and light strobes in her left eye. Patient came down to clinic, and was told to rest in the observation area. Patient felt heart palpitations and "felt worse" and was subsequently taken to the ER.
soreness of the arm of the injection; felt really bad; rash on the left forearm that was really itchy / Saturday the rash had spread from head to toe.; they had not slept since Friday; felt really ill; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness of the arm of the injection), FEELING ABNORMAL (felt really bad), RASH PRURITIC (rash on the left forearm that was really itchy / Saturday the rash had spread from head to toe.), INSOMNIA (they had not slept since Friday) and MALAISE (felt really ill) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness of the arm of the injection), FEELING ABNORMAL (felt really bad), RASH PRURITIC (rash on the left forearm that was really itchy / Saturday the rash had spread from head to toe.), INSOMNIA (they had not slept since Friday) and MALAISE (felt really ill). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MYALGIA (soreness of the arm of the injection), FEELING ABNORMAL (felt really bad), RASH PRURITIC (rash on the left forearm that was really itchy / Saturday the rash had spread from head to toe.), INSOMNIA (they had not slept since Friday) and MALAISE (felt really ill) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       List of concomitant medication were not given.   This case was linked to US-MODERNATX, INC.-MOD-2021-073854 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073854:Spouse's case
Vaccine was given in upper left deltoid. Upon withdrawal of the needle the patient started bleeding heavily. We cleaned him up and band aid was applied and he left. Patient seemed coherent and lucid when he left from the clinic. He is concerned that the vaccine came out when he was bleeding. He wants to get another Flu vaccination.
Patient received PNEUMOVAX 23 in office and approximately 4hrs later had significant pain with chills overnight. Patient presented to urgent care and endorsed right arm swelling and pain, as well as fatigue. Patient took ibuprofen with some relief. MD instructed patient to use ibuprofen for pain, cetirizine for itching, ice packs, and elevate arm when resting. Patient followed up with PCP on 11/21 with decreased redness noted although right arm was still tender. Patient prescribed prednisone 20mg tablets take 2 tablets PO daily x 3 days.
reactivation of herpes zoster; Rash; This case was reported by a other health professional via call center representative and described the occurrence of herpes zoster reactivation in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster and rash.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced herpes zoster reactivation and rash. On an unknown date, the outcome of the herpes zoster reactivation and rash were unknown.   It was unknown if the reporter considered the herpes zoster reactivation and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient's herpes zoster was reactivated after getting the first dose of Shingrix. The patient experienced a rash. The reporter consented to follow up. The reporter thinks this has already been reported to GlaxoSmithKline. Product details (lot number, expiration date) and other details are not available at the time of reporting.