chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost her twin nephews due to a severe side effect; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient 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), outcome "fatal", described as "lost her twin nephews due to a severe side effect". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The reporter specified that she lost her twin nephews due to a severe side effect and a heart attack after getting the vaccine and her niece got a severe illness from taking bad shots of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300039512 same reporter, drug and different patient, event;US-PFIZER INC-PV202300017123 same reporter, drug and different patient, event;; Reported Cause(s) of Death: lost her twin nephews due to a severe side effect
I have swollen under my left armpit and very painful to touch, it makes it hard to do lay on left side or do anything with my left arm; I have swollen under my left armpit and very painful to touch, it makes it hard to do lay on left side or do anything with my left arm; This is a spontaneous report from a contactable nurse (patient). A 36-year-old non-pregnant female patient had received second dose bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: 30155BA) via an unspecified route of administration into arm left (at age of 36 year) on unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history had included allergies for Penicillin, gluten, egg and latex. The patient concomitant medication had included Cetrizine hydrochloride (Zyrtec) for unknown indication and Diphenhydramine (Benadryl ) for unknown indication. It was reported that patient was not pregnant at the time of vaccination. Patient did not received any vaccination within 4 weeks prior to vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination and Since the vaccination, the patient had not been tested for COVID-19. The patient previously took first dose bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: FD0809) via an unspecified route of administration into arm left on unspecified date as DOSE 1, SINGLE for covid-19 immunization.On 03Oct2021;03:00 the patient had experienced swollen under the left armpit and very painful to touch, it makes it hard to do lay on left side or do anything with the left arm. The clinical outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 27-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter. No treatment given to patients.
Skin rashes over arms around elbow/hands, legs mostly over knees and low thighs, buttocks, flanks. Started since July 2022 and still appearing, each lasting weeks. Very itch. It looks like Pityriasis Rosea as reported in an article
BODY ACHES; CHILLS; LACK OF ENERGY; HEADACHE; FELT TIRED ALL THE DAY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced felt tired all the day. On 07-MAR-2021, the subject experienced body aches. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced lack of energy. On 07-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt tired all the day, body aches, chills, lack of energy and headache was not reported. This report was non-serious.
Pain/discomfort started 11/14/15 in back/rib cage. Rash started to appear on back/front 11/18/15. Patient was started on valacyclovir 1 gm on 11/19/15 Q 8 hours x 7 days.
nausea; vomited; headache; achiness; tingling like pins and needles in his thumb; felt dehydrated; Took Ambien to go to sleep; fatigued; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achiness), PARAESTHESIA (tingling like pins and needles in his thumb), DEHYDRATION (felt dehydrated), SLEEP DISORDER (Took Ambien to go to sleep) and FATIGUE (fatigued) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Johnson COVID-19 vaccine, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine (2 doses of Pfizer vaccine). Past adverse reactions to the above products included No adverse event with Johnson COVID-19 vaccine, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.  On 03-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Oct-2022, the patient experienced PAIN (achiness), PARAESTHESIA (tingling like pins and needles in his thumb), DEHYDRATION (felt dehydrated), SLEEP DISORDER (Took Ambien to go to sleep) and FATIGUE (fatigued). On 04-Oct-2022, the patient experienced NAUSEA (nausea), VOMITING (vomited) and HEADACHE (headache). The patient was treated with ZOLPIDEM TARTRATE (AMBIEN) at an unspecified dose and frequency. At the time of the report, PAIN (achiness) had not resolved and PARAESTHESIA (tingling like pins and needles in his thumb), DEHYDRATION (felt dehydrated), SLEEP DISORDER (Took Ambien to go to sleep), FATIGUE (fatigued), NAUSEA (nausea), VOMITING (vomited) and HEADACHE (headache) outcome was unknown. No concomitant medications was reported.  After receiving the bivalent vaccine patient came home at 2:00 and felt fine. Patient ate a late lunch or an early dinner, laid down, and went to bed. Slight achiness when he woke up with light fatigue, and Felt a little tingling like pins and needles in his thumb. Woke up at 10:00 PM. Patient took Ambien to go to sleep. Patient felt dehydrated. Drank dehydrated soda. Around 1-2 AM he went to the bathroom with nausea, and vomited. Went back to sleep. Got up next day morning. Had a small protein cookie for breakfast. The more patient moved around felt achy. Had a headache. Laid down from 11-12:00 to 3:00. Woke up with continued achiness. No sore throat. No additional medications or treatments.
PATIENT LEFT THE IMMUNIZATION ROOM, WALKED LESS THAN HALFWAY DOWN AN AISLE, GOT DIZZY, LOST CONSCIOUSNESSAND FELL ONTO THE FLOOR ON HER BACK, HITTING HER HEAD. THIS WAS UNWITNESSED, BUT REPORTED BY ANOTHER CUSTOMER UPON DISCOVERING HER MOMENTS LATER. WITHIN 2 MINS I HAD CALLED 911, THE PATIENT HAD REGAINED CONSCIOUSNESS, REPORTED ONLY HEAD PAIN, UPON ASSESSMENT I DISCOVERED SHE WAS BLEEDING FROM THE BACK OF HER HEAD. I CONTINUED TO MONITER HER FOR CHANGES UNTIL PARAMEDICS ARRIVED, 10 MINS AFTER THE INCIDENT OCCUREED, AND TRANSPORTED HER TO THE LOCAL HOSPITAL.
Patient experienced an itchy throat during observation after vaccination.  Patient observed and had no other notable issues.
Guillain Barre Syndrome.  3/1/07 Received medical records from PCP which reveals patient experienced Lymes disease in 7/05 after receiving multiple mosquito bites at summer camp in NY.  Fever of 102, blotchy rash & fatigue.  Treated w/antibiotics.  In 10/06, felt Lymes worsening & eval by ortho included MRI of shoulder & cspine. which were reported as WNL.  Saw neuro also & EMG of UE & LE reported as WNL.  PCP note of 11/06 states neuro now thinks GBS & weakness had improved.  By 2/07 was symptom free w/resolved muscle weakness. 3/30/07 Received medical records from neurologist which reveal patient was initially evaluated on 10/23/06 after experienced weakness of bilat UEs.  Weakness had started approx 2-3 wks prior when he noted having difficulty raising his arm & had pain in sides of his neck radiating to shoulders bilat when turned head to that particular side.  Neuro exam revealed gen weakness of shoulder abductors & hip flexors.  DTRs were absent in UEs & right knee and decreased in left knee & both ankles.  EMG/NCS done that day revealed decreased recruitment suggesting central process.  MRI of brain & c-spine was to be reviewed.  Returned to office on 11/2/06.  MRI was read as WNL.  Strength had improved but right remained weaker than left arm.  It was felt that his constellation of s/s was suggestive of GBS, resolving spontaneously.  Returned to office on 11/13/06 & continued to improve & regain strength.  He was d/c from neuro f/u at that point & permitted to return to sports.  No EMG/NCS report was included with records. FINAL DX: acute inflammatory polyradicular neuropathy (GBS). 4/5/07 Per direction of CDC: Please change the lot # that was entered for VAERS # 272473. It was reported incorrectly. The correct lot # for the Menactra given was U2108AA.  Please correct this is the VAERS database.
This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN, CHEST PAIN, FACIAL PAIN, INFLUENZA LIKE ILLNESS and PAIN OF SKIN in a 42-year-old male patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) (batch nos. 036A21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 30-Jul-2021, the patient received first dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced BONE PAIN (when he touches his bone there is physical pain), CHEST PAIN, FACIAL PAIN, INFLUENZA LIKE ILLNESS, PAIN OF SKIN, PARAESTHESIA, SKIN TIGHTNESS and ARTHRALGIA. 23-Aug-2021, the patient experienced SLEEP DISORDER (sleeping only 30 minutes intervals, he cannot get sleep. The sleep is a cycle.). 23-Aug-2021, the patient experienced PYREXIA (he states that immediately he had a fever within 5 minutes/the fever rotated from 97F-102F/he had a 102 Fever for the past 24 hours). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency and Bed rest (He took Advil and has been laying in bed.) for Pyrexia. At the time of the report, BONE PAIN (when he touches his bone there is physical pain), CHEST PAIN (He also mentions that the bones in his chest hurt), FACIAL PAIN (the bones in his face hurts), INFLUENZA LIKE ILLNESS (It is similar to how he reacts from the flu), PAIN OF SKIN (his skins hurts as if there is charcoal), SLEEP DISORDER (sleeping only 30 minutes intervals, he cannot get sleep. The sleep is a cycle.), PARAESTHESIA (When he wets his hair, it feels like pins and needles), SKIN TIGHTNESS (He feels like he has a mask on his face/tightness on his face), ARTHRALGIA (If he moves, there is pain in his shoulder and joints) and PYREXIA (he states that immediately he had a fever within 5 minutes/the fever rotated from 97F-102F/he had a 102 Fever for the past 24 hours) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 102 (High) he had a 102 Fever for the past 24 hours. On 23-Aug-2021, Body temperature: 97f-102f (High) 97F-102F. This case was linked to MOD-2021-294777 (Patient Link).
This initial spontaneous case was received from other health professional on 04-Oct-2017, concerning a female patient. The patient's medical history and concomitant medications were not reported. On 04-Oct-2017, the patient was administered expired vaccine that expired in April of this year FLUVIRIN Thiomersal (dose: 0.5 ml, batch number: 1618621, expiry date: Apr-2017, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded to expired vaccine used). It was reported that, no adverse effect was noted. It was reported that the patient had revaccination with the current season. The reporter assessed the report as non-serious. Significant case correction received with IRD 04-Oct-2017: The LLT coding for the event "no adverse effect note" from no adverse event to no adverse effect was corrected. Follow-up received from the reporter on 08-Nov-2017: Updated patient's gender, age, route of administration and anatomical location. It was reported that, no adverse effect was noted. The narrative was amended accordingly.
Fever and chills that started approximately 24 hours after injection lasting for approximately 8 hours.
Severe headache in back of right side of head started two days after shot. Sensitivity of noise shortly after that and a few days later I woke up with a numb tongue. Throughout that same day I noticed the facial drooping and went to the ER to get checked for possible stroke. Stroke was ruled out by CT scan and I was diagnosed with Bells Palsy
Lt arm celluliits seen by MD 24JAN92 given Diclox-Rocephin;
Pt was seated during administration.  Within 5 minutes patient became pale and light headed.  Pt was reclined on table with feet elevated.  After 20 minutes, patient felt better to leave.
Patient received the Moderna Vaccine within 5 minutes complained of throat tightness and not feeling well.   The patient was noted to be pale and hypertensive.  She was placed on a stretcher, placed on oxygen and a Rapid Response was called.  MD responded and initiated IV fluids and administration of Pepcid 20 mg IVP.   Patient was transported to the Emergency Department (ED) for further evaluation.  In the ED,  patient received Methylprednisolone succinate 125 mg IV x 1 dose and Diphenhydramine 25 mg IV x 1 dose.  Patient reported relieve of throat tightness and upper chest pressure.  Patient was discharged with prescriptions for oral Prednisone x 3 days, Pepcid 20 mg oral twice daily and Benadryl 25 to 50 mg every 6 hours as needed for and recurrent symptoms.
DT given outside of recommended age.  Patient should have received TD.  Per nurse, no need to revaccinate with TD.
I did have an episode of collapsing after the first vaccination due to a nauseous, lightheaded feeling however no hospitalization required. Second vaccination, I had the typical flu achy feeling, low grade fever, body aches, headache for a few days and it just never went away. Before the booster had time to take effect, I was exposed to a new variant of COVID-19, and I was sick continuously until now. I have tested positive and negative for COVID-19. Most recent was Feb. 25th 2022, home test was positive, PCR test was negative. My husband was tested and he was positive. I have had continuous feeling of flu like feeling for about 3 months. I started steroids and antibiotics on 26th of February. I did get on antibiotics towards the end of January prior. I was able to maintain my condition at home and stay out of the hospital, however I am still not improving fully. I am still having a post vaccine feeling of being sick, and then I seem to develop a secondary infection after like a sinus infection and pneumonia. I have also still had a continuing cough if I speak for long periods. I keep track of my O2 and it stays at 94-96 since COVID 1 year ago, and they do not drop.
instance of off-label use we wanted to flag.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   In JUL-2023, the patient received Bexsero. In JUL-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: instance of off-label use we wanted to flag.). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 20 Jul 2023 This case was reported by a consumer via interactive digital media. The reporter patient's parent. The reporter stated that his/her son got bexsero at his well visit last week. The practice was pro any preventative care and it was brought up as a  recommended one for him and we did it. When  the reporter was in college there was an out break and it was pretty scary and many of us got  vaccinated on campus right away. The reporter believed this was a mistake on the commentor's side and they were talking about the ACWY vaccine, but in case it was an instance of off-label use. The patient received bexsero instead of ACWY vaccine which led to wrong vaccine administered
Achy flu like symptoms and general malaise, sweats, weakness, convulsions, joint pain, leg pain, muscle pain, lethargy, trouble sleeping, head pressure, headache, itchy, inability to function, foggy.
lymph nodes in my armpit were swollen; inflammation extended to my left breast.; Following day after I got the vaccine I had arm pain that became stronger at night.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 at 16:45 as dose 4 (booster), single (Lot number: FM0173) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INDERAL; LANSOPRAZOL; ROSUVASTATIN. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: EW0151, Location of injection: Arm Left), administration date: 03Sep2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "little discomfort"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EL1284, Location of injection: Arm Left), administration date: 08Jan2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "little discomfort"; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EH9899, Location of injection: Arm Left), administration date: 16Dec2020, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "little discomfort".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21May2022 at 10:00, outcome "recovered" (May2022), described as "Following day after I got the vaccine I had arm pain that became stronger at night."; BREAST INFLAMMATION (non-serious) with onset 22May2022 at 10:00, outcome "recovered" (May2022), described as "inflammation extended to my left breast."; LYMPHADENOPATHY (non-serious) with onset 22May2022 at 10:00, outcome "recovered" (May2022), described as "lymph nodes in my armpit were swollen". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy, breast inflammation.  Additional information: The patient had not received other vaccine in 4 weeks. Reporter stated, following day after I got the vaccine, I had arm pain that became stronger at night. By morning noticed the lymph nodes in my armpit were swollen. Following day, the inflammation extended to my left breast. This was the first time that I got this side effects, the first three were great, just a little discomfort. The patient had not covid prior vaccination and covid tested post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200765075 Same patient and drug, different event separated in time
This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
joint pain; throat hurts; has moved to his chest & back pain; has moved to his chest & back pain; This is a spontaneous report received from a contactable consumer (patient himself). This male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration on 05Apr2021 as single dose for COVID-19 immunization. Patient medical history included arthritis and concomitant medications were not reported. On an unspecified date, the patient experienced joint pain, that has moved to his chest, back pain and throat hurts. Caller stated that "it feels like I been working out, kind of like I've been in a fight". Caller also voiced that his throat hurts as well. Caller was seen in his local ER and told he had arthritis and needed to take Tylenol. He seen his PCP who ran test and diagnosed him with increased inflammation that may have been from the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Complained of severe pain (without movement and unable to raise arm due to pain) upper left arm following Tdap injection. Denied redness, swelling or warmth at site. After 48 hours, pain improved some, then has persisted to present. Pain is slowly resolving. Client described as "frozen shoulder" with feeling of joint pain. Client called to report event 12 days afterwards, and advised to seek medical evaluation. Seen per Dr the next week. No diagnosis given. Only treatment Ibuprofen as needed.
Mom called about 30 minutes following administration of vaccines to report rash and complaint of itchy throat. Patient came back to office had an urticarial rash around ears, neck, upper chest. C/O itchy feet - no rash seen. POX 97%, Lungs CTA, throat without ant erythema - patient stable - sent to ER for observation.
I have had genital herpes for decades with almost no outbreaks. I take 500 mg of l-lycine per day that  has (again, for decades) prevented outbreaks. Rarely over the years, only in times of stress wil Il get a mild outbreak. Since getting the first shot of Moderna I have had my herpes flare up and at a point where I'm tripling my l-lycine dose to no avail. I am hoping that once the second dose kicks in it will abate. Hey, it's still better than getting Covid!