chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; BODYACHES; CHILLS; TIREDNESS; LOW GRADE FEVER 99-100 DEGREE F; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker. The patient had no known allergies and no drug abuse/illicit drug usage. The patient was not pregnant at the time of report. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total, administered on 09-APR-2021 to right arm as prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021,six hours after vaccination, patient experienced chills, body aches, low grade fever (99-100 degrees F) and tiredness. The patient took paracetamol (Tylenol) to manage her symptoms and went to sleep. On 10-APR-2021, the patient woke up at 05:30 and all symptoms was resolved, except for the tiredness.  On 04-MAY-2021, the patient took her first antibody tests (blood) and the result was negative. On 27-MAY-2021, the patient took her second antibody tests (blood) and the result came as negative(confirmed immunological vaccine failure). The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches, chills, and low grade fever 99-100 degree f on 10-APR-2021, had not recovered from tiredness, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210612856-Covid-19 vaccine - Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
6/14/21 Janssen Covid vaccine 8/5/21 ill 8/13/21 + Covid PCR 8/19/21 RTW
body aches for 2 days.  Extreme depression for 2 weeks, joint pain still going on as of today 9/23/21
Drug ineffective; Suspected COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown".Clinical course: It was reported that her HCP said, he and his wife both took two shots and ended out with the virus. Clarified she doesn't know what the name of the two shots her HCP and his wife took. Clarified she has no product information to provide. Clarified her HCP and his wife had it two times after getting the shots. Further clarified she does not know what product her HCP or the HCP's wife took.  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-202300146105 Different patient/same product, different dose/event;US-PFIZER INC-202300147048 Different patient/same product, different dose/event;US-PFIZER INC-202300147135 Different patient/same product, different dose/event;
Miscarriage at 25 weeks. No hx of pregnancy related issues. No hx of miscarriage. Reason for miscarriage not established/no clear reason for miscarriage.
Allergic to the pneumonia vaccine; This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for Immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was Allergic to the pneumonia vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected
Information has been received from a medical assistant concerning a 13 year old female with no pertinent medical history, drug reactions or allergies who on 08-AUG-2008 was vaccinated intramuscularly in the right deltoid with a first 0.5 mL dose of GARDASIL (Lot #659962/1740U). Secondary suspect vaccination was VARIVAX. On 08-AUG-2008, "about an hour after receiving GARADSIL," the patient developed an unspecified fever and then experienced facial itching that resolved within an hour after onset. The patient sought medical attention by phone call and did not seek treatment for the symptoms. On 09-AUG-2008 the patient recovered from the events. Additional information has been requested.
8" x 5" area of slight erythema and purple discoloration at site of injections. Not warm to touch. Not raised when seen in our office.
The evening of the vaccine (I guessed around 6:00 p.m.), my ears felt like they became stopped up, especially the left.  I still feel pressure.  I feel like I can?t hear quite as well as before.  I hear a high pitch sound when everything is quiet.
Swelling around where the Moderna vaccine was given; Red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling around where the Moderna vaccine was given) and VACCINATION SITE ERYTHEMA (Red) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     there is no historical conditions reported by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling around where the Moderna vaccine was given) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE SWELLING (Swelling around where the Moderna vaccine was given) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
A few days after my second dose 02/02/2021, I started to smell cigarettes smell. I constantly had to keep my face cover because it was all I smelled. I went to the doctor in March because I ended up getting an infection and I had a sore on the tip of my nose from constantly trying to mask the smell. He prescribed some Mupirocin for the sore, but it didn't treat the smell. He was going to have me go to an ENT specialist after a couple of months because I kept smelling the same cigarettes smell. It took a while for an appointment due to COVID and by the time the appointment was made, it had improved. I do have the occasional smell of cigarettes within last 6 months, but it was much lighter and it would only last a couple of hours. I have recovered but not sure if it will return because it has a couple of times. I am not sure if my sense of smell just got sensitive.
This spontaneous report was received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown dates, the patients were vaccinated with an improperly store dose of M-M-R II (rHA) lot number L035674 and expiration date of 17-SEP-2017 for prophylaxis (dose and route of administration were not reported). The sterile diluent used to reconstitute the M-M-R II was properly stored. No symptoms were reported. The vaccine was exposed to a temperature excursion of 47.5°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. Sender's Comments: US-009507513-1709USA004384.
Information has been received from a physician concerning a 16-week-old patient who was vaccinated with the first dose of Rotateq. It was unknown if medical attention was sought. No symptoms were reported. Additional information has been requested.
Patient called the pharmacy on January 28th, 2020 to inform the pharmacist that she believed that when she received the flu shot on October 18th, 2019, the needle hit a nerve, causing some long-term pain. She thinks that the pharmacist that gave her the shot was forceful and instead of pinching the area of the deltoid muscle, the vaccine was administered too low. She stated that after she received the vaccine, her arm was severely sore and that the pain never subsided. She went to her physician and other healthcare professionals, who concluded that it may have been from the flu shot after some time. The pain wakes her up at night and she cannot really lift her arm nor pick up bags in the left arm/hand.
Information has been received from a physician concerning a 12 month old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The child appeared to have shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Muscular pain along spine from bottom of shoulder to the neck. On going.  Severe, spreading rash along back, moving to left side and up along the right shoulder
Per patient's husband, approximately five days after receiving the Flublok vaccine, patient began running a fever the night of 9/23. Patient then passed away in her sleep.
right arm pain; liquid dripping out of the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Feb2021 (Lot number: EL3428) at the age of 62 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (at right arm, as dose 1, single), administration date: 27Jan2021, when the patient was 62 years old, for COVID-19 immunisation, reaction(s): "arm pain in his right arm, at the injection site". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "right arm pain"; VACCINATION SITE EXTRAVASATION (non-serious) with onset 17Feb2021, outcome "unknown", described as "liquid dripping out of the injection site".  Additional information: It was reported that right arm pain was not as severe as her first dose. During the second administration, the person administering the shot was using an auto retractable syringe (which she never used), and he noticed that after the administration there was liquid dripping out of the injection site.  No follow-up attempts are possible. No further information is expected.
No additional AE; HCP called to report a TE with PROQUAD.  Improperly stored. TE case reference 02490108.  No adverse effects reported.  Consent to contact is no. No additional AE/No PQC. AE cross reference cases 02490153, 02490133, 02490163, 02490160, 02490148, 02490; This spontaneous report was received from medical assistant and refers to a 3-years-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHa) (PROQUAD) injection, 0.5 milliliter, lot #W029555, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration (Product storage error).No additional adverse event was reported.
At 8:30pm several hours after injection, pt had raised/swollen site of injection pt reported minimal pain, but swelling that was going down.
staring,headache (whcih became worse as time went on)- dizzy, unable to stand or ambulater on her own
Syncope immediately following injection. Pt. had pallor, was diaphoretic. BP remained stable. No significant medical Hx.
On the next day he began to get right eye pain in eye and around the eye socket.  Went to eye doctor on 2-24-21 and checked eye nothing in the eye irritation gave drops for irritation. Follow up with Dr. eye doctor still having issues. Went to Emergency Room in March still having pain and irritation in right eye-doctor said there was nothing that they could do for him. Made an appointment with MD ophthalmology corneal and external disease on 5-24-21 and nerve damage and there was nothing that they could do.
Received the Phizer Vax at pharmacy and a few days later I broke out with shingles on my forhead. Went to Drs office he confirmed shingles prescribes meds. Last week my arm started to hurt today he gave me a anti-0inflamitorty shot.
Admission Date: 1/23/2023 Discharge Date: 1/27/23  PRESENTING PROBLEM: Acute renal failure (ARF) (HCC) [N17.9]  Patient reported to hospital for nausea and vomiting. PCP suspected this was due to Ozemptic. Patient was a direct admit due to ongoing nausea/vomiting concerns as well as recent history of Covid and lung transplant (2017).
Chicken pox vaccine notice yesterday on reaction - on 7/29/08 measures 30mmx30mm.  Red, swelling L deltoid SQ area.
Systemic: Exhaustion / Lethargy-Medium, Systemic: Eye floaters, 24 hours after shot received-Medium
Pain at site, muscle cramps; proceeded to swelling size of 50 cent piece with tenderness at site, continued muscle cramps, pain/redness/itching at site; on 11/18/2011 slight elevation of temp to 99, continued pain/itchy/red/elevated hard at site, muscle cramps and pain, fatigue; seen in Employee Health at Hospital.
6/29/2022   I started feeling like I was getting a cold that night. The next day, I started having a cough, runny nose and sneezing. On 7/1/2022 I was not feeling much better. That night I had a low grade fever. The next morning, I still had a cough and was sneezing, but did not have a fever. I took a home COVID test and it was positive. I went to a doctor associated with my doctor in their clinic. He prescribed Paxlovid at my request. I started taking it on 07/02/2022. The next day I started to feel better. On 7/4/2022 I felt a little tired. The coughing, sneezing and runny nose had gone away.  Today, I feel really good. I do not feel tired and have no lingering symptoms. I feel I have recovered.
Muscle Aches; Headache; This is a spontaneous report from a contactable consumer. This 56-year-old (age at vaccination) female consumer reported in response to Non-HCP follow-up letter sent that included that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number; ER8735) via an intramuscular route of administration on 19Apr2021 at 10:00 in left arm for covid-19 immunisation. Vaccine facility type was reported as Pharmacy or drug store. Patient's medical history and relevant tests was reported as none. Concomitant medications was reported as none. Prior vaccination within 4 weeks was none. Patient took second dose of BNT162B2, Batch/Lot number: EW0167 via an intramuscular route of administration on 10May2021 at 10 am in left arm for covid-19 immunisation. Patient experienced muscle aches, headache on 20Apr2021 at 03:00 am. Treatment was given for the AE (Aleve). Patient experienced rash on 20May2021 at 08:00 pm. Seriousness criteria for the events was provided as non serious. Treatment given for the AE was Benadryl for seven days. Autopsy information was not provided. The outcome of event myalgia and headache was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Moderna Covid-19 Vaccine EUA Full body aches, temperature of 101 degrees, dizzinesss and weakness, chills.   I slept for almost 24 hours. Waking periodically for the restroom, checking my temp and relieving my thirst.
Patient stated she felt "hot" post vaccination and her face was remarkedly flushed. Improved with rest and hydration
couldn't walk upstairs; continuing muscle and joint pain in lower back; hurting in arm; severe muscle pain to the point it hurt to lay down; the joint and muscle pain lasted for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (couldn't walk upstairs), BACK PAIN (continuing muscle and joint pain in lower back), PAIN IN EXTREMITY (hurting in arm), MYALGIA (severe muscle pain to the point it hurt to lay down) and ARTHRALGIA (the joint and muscle pain lasted for 2 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2020, the patient experienced MYALGIA (severe muscle pain to the point it hurt to lay down) and ARTHRALGIA (the joint and muscle pain lasted for 2 days). On 29-Dec-2020, the patient experienced GAIT DISTURBANCE (couldn't walk upstairs), BACK PAIN (continuing muscle and joint pain in lower back) and PAIN IN EXTREMITY (hurting in arm). At the time of the report, GAIT DISTURBANCE (couldn't walk upstairs), BACK PAIN (continuing muscle and joint pain in lower back), PAIN IN EXTREMITY (hurting in arm), MYALGIA (severe muscle pain to the point it hurt to lay down) and ARTHRALGIA (the joint and muscle pain lasted for 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-343058 (Patient Link).
Hives Heart problems. Palpitation  irregular heart beat. Low blood pressure. Rapid heart beat Vocal chord dysfunction  Tremors. All limbs and head
Swelling and itching at injection site. 08/03/2016 12:00 PM continues heat and swelling at injection site and a few red splotches on face, 7:00 PM red hives on face and both arms 8:00 AM hives down both arms and legs stomach and back swollen arms and hands and toes starting to turn blue. Went to Asthma specialist who administered Zyrtec, Benadryl, and Prednisone with followup in hour and followup with MD on 08/05/2016 and specialist on 08/09/2016.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 08-SEP-2011 the patient was vaccinated with the first dose of GARDASIL (strength, dose, route and lot number was not reported). The patient received the second, the third and the fourth dose of GARDASIL on 10-JUL-2012, 17-AUG-2012, 24-MAY-2013 respectively (strength, doses, routes and lot numbers were not reported). No adverse effects was reported. Additional information has been requested.
Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown. Not Provided          No concomitant medication were reported. No treatment information was reported.
Mixed series.  Patient given Pfizer vaccine in error; his first vaccine in the series was Moderna.
Redness and swelling to L deltoid area; tender to touch upon palpation; patient also c/o discomfort radiating across posterior shoulder area up to neck.
Ongoing throbbing headache since 20 minutes after vaccine was administered. No previous history of headaches like this. Went to ER and ruled out clot via MRI/MRV and was given cocktail injection with Benadryl, Gadoteridol, Ketorolac, with improvement of headache for 5 hours.
Dime-sized swelling at injection site immediately after administering vaccine. Treated with diphenhydramine 50 mg within 5 minutes of reaction, and watched patient for half hour in store. Swelling decreased and patient felt no other symptoms.
Possible deviation from the recommended interval between the first and second moderna covid-19; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possible deviation from the recommended interval between the first and second moderna covid-19) 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 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possible deviation from the recommended interval between the first and second moderna covid-19). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possible deviation from the recommended interval between the first and second moderna covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-106417 (Patient Link).   Reporter did not allow further contact
4 hrs after vaccines administered (PENTACEL, PREVNAR 13, Hep B, Rotavirus) infants became pale "gray", less active for about an hour. No vomiting no loss of consciousness. Nursed well. No fever no cyanosis no abnl movements. Sounds like hypotonic hyporesonsive episode.
there had been administrations of the vaccines to patients since the first excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 20-JUL-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019463, expiration date: 24-JUN-2021) 0.5 milliliter (dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperatures to which the vaccine was exposed were: -13.5 degrees of Celsius (C), -11.4 C, -1.8 C  and the time frame was reported as 24 minutes, 27 minutes, 2 hours and 8 minutes. There was previous temperature excursion reported. A digital data logger was involved.
Nov at 9am, fever, chills and body aches and went off 24hrs then chest left side pains 5 Nov at 4.30PM tightness in chest and radiated to my back left on Thursday and went to Urgent Care , chest x-ray and EKG and directed to primary care. Did physical exam and bloodwork 11/15/2021 - normal. started dosage of steroid. Chest pains are intermitted and still these. Halter monitor at 17 years - had periodic chest pains with tightness and did Echo and everything was clear.
Dose 1 1/26/2021 EL1283 Pfizer Patient died of heart failure in the emergency room
Pt. received several vaccines during doctor's visit. No reaction noted during vaccine administration. Medical Assistant noticed she had given an Adult dose of HepA instead of pediatric dose. Medical Assistant informed LVN. LVN called vaccine manufacturer and informed medical provider. As per Glaxo Smith Kline, no adverse reaction to pt.