chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse concerning an unspecified number of patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients received an improperly stored dose of GARDASIL 9 (Lot # L016429; expiration date: 09-AUG-2017) (dose and route not provided). Concomitant therapies were not provided. No adverse effect was reported. It was reported the following temperature excursion for the administered vaccines: 50 F for 4 hours and 6 minutes. No previous temperature excursion was reported. This is one of two reports received from the same source. Additional information has been requested.
EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.
C/O soreness at injection site within one hour after injection. Next afternoon at 1:30 pm, mom noticed dark red, blotchy rash L arm starting at site of injection and going up the arm and halfway down his back. Pt described area as painful and itchy. Site not warm to touch rash slightly raised. No fever. "Cold feels good." Pt's sister noticed redness arm and back yesterday-worse today. Rash is "blotchy." 6/27/03-rash the same-no better-no worse. Still itchy and painful. Benadryl q 4 has not helped. Cold compress helped with discomfort but did not decrease rash. Rash gone by 7/3/03. 6/28 developed "bumps down over his back," "looks like pimples." 7/1/03 rash improving. Continues to receive Benadryl. Also developed headaches (dad thinks headaches were ? head and doctor not worried about headaches.
itching rash on chest 5 hrs p/drug given contin to get worse-involving entire body 22 hrs p/inject;
Diarrhea; stomach was upset; did not feel good; She and her husband both got their booster; Coughing; Extreme Fatigue; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 77 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 16:00 (Lot number: FF2588) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot En6201, expiration unknown; Route, Anatomical Location: Right arm in the muscle., Verbatim: They were fine with them), administration date: 28Jan2021, when the patient was 76 years old, for COVID-19 Immunisation, reaction(s): "They were fine with them"; Bnt162b2 (Dose: 2, Lot EL1284, expiration unknown; Route, Anatomical Location: Right arm in the muscle., Verbatim: They were fine with them), administration date: 19Feb2021, when the patient was 76 years old, for COVID-19 Immunisation, reaction(s): "They were fine with them". The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "She and her husband both got their booster"; COUGH (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Coughing"; FATIGUE (non-serious) with onset 15Nov2021, outcome "recovering", described as "Extreme Fatigue"; HEADACHE (non-serious) with onset 15Nov2021, outcome "recovering", described as "Headache"; DIARRHOEA (non-serious) with onset 16Nov2021, outcome "recovering", described as "Diarrhea"; ABDOMINAL DISCOMFORT (non-serious) with onset 15Nov2021, outcome "unknown", described as "stomach was upset"; MALAISE (non-serious) with onset 15Nov2021, outcome "unknown", described as "did not feel good".  Additional information: Vaccination Facility Name was PRIVACY. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient had no AE(s) following prior vaccinations. Patient's Medical History was none. Patient was not diagnosed with allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Family Medical History Relevant was none. She did not have an address, phone or email for his primary care provider. Her husband has the same primary care provider. It was reported that patient and her wife both got their booster on 15 Nov2021. This was 6 months after first one and they decided to get the booster. Most of their symptoms started within 2 hours of getting it. After receiving the booster, they stopped and got dinner and took care of their animals.  By 7pm, neither one felt like eating and their stomach was upset and did not feel good. Coughing started in Evening, Headache started Late in the evening and Diarrhea in the middle of the night. AE(s) did not require a visit to Emergency Room.   No follow-up attempts are possible. No further information is expected.
Narrative:  Shortly after vaccination reported substernal chest pressure and dizziness as well as a new mild itchy rash on the upper extremities and lower extremities. No dyspnea, swelling, or difficulty with swallowing. Reports he has needed to go the ED in the past after influenza vaccines when "he swelled up a lot". Did ok with the prior COVID vaccines but notes those were all Moderna rather than Pfizer. Triaged from clinic to the ED where he received IM epinephrine, IV diphenhydramine, and oral famotidine.
A report has been received from a Physician concerning a male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 20-JAN-2015. Patient had been administered expired FLUMIST Quadrivalent on 20-JAN-2015. The outcome of the event of patient has been administered expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
Vaccination related malaise; Very Sick After Covid-19 Vaccine; Osteoporosis; This is a Spontaneous report based on information received by Pfizer from AbbVie (Manufacturer Control Number#: 21K-163-4102232-00).   A 62-years-old female patient received BNT162B2 (Pfizer/BioNTech solution for injection), dose 3 intramuscular on 24Sep2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunization(Age at vaccination 62 years); adalimumab (HUMIRA), subcutaneous from Feb2021 (Batch/Lot number was not reported) to Feb2021, at DOSE NUMBER UNKNOWN, SINGLE for colitis ulcerative. The patient past medical history included Non-smoker user, Alcohol Use/Socially from an unknown date and unknown if ongoing and Colitis ulcerative from an unknown date and unknown if ongoing. Concomitant medication(s) included mesalamine (MESALAMINE) taken for colitis ulcerative, start and stop date were not reported; vitamin D (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported and calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported. On 03Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 03Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. on an unspecified date in Sep2021, the patient experienced Possible Osteoporosis. On 24Sep2021, the patient experienced Very Sick After Covid-19 Vaccine and Vaccination related malaise. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures which included bone scan: 2.6 no unit on Sep2021 Normal value: >2.5. The event outcome was not recovered for Osteoporosis and recovered for Vaccination related malaise and Very Sick on 26Sep2021.  Causality for HUMIRA 40MG/0.4ML (ADALIMUMAB) The reporter's causality for the event(s) of Possible Osteoporosis and Very Sick After Covid-19 Vaccine with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A pt received an injection of Pnu-Imune 23 and subsequently, developed an injection site reaction characterized by swelling and bruising which extended to the entire arm. This is 1 of 3 pts from this facility since 10/8/99 who developed this adverse event following receipt of this vaccine. The reporter stated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Fever x 7 day. Started day of vaccine. T. max 103. TYLENOL/MOTRIN.
On April 3rd, 2022, I had bruising and swelling in my lower left arm. I went to have an ultrasound done of my arm because the doctor didn't think it was an infection and it turned out to be a blood clot. The blood clot was from the length of my elbow to my wrist. I've had history of blood clots before but never in this location of the arm, which is very unusual. Symptoms were swelling and pain. Ultrasound indicated the blood clot. Physician took me of Eliquis because it failed and changed my medication to heparin injections. On April 10th, 2022. I started having migraine headaches which I've not had in decades. I had migraines when I was in my teens and 20s and I have had 7 migraines between April 10 and today, May, 13. They are ocular and again it's been decades. Don't know if it's in relation to the vaccine but its very unusual that they're suddenly back. Another note here: I've had a bump at the location site of my 2nd injection since I've gotten that vaccine (01/12/2021). There's still a bump there and it's sore. It's not always sore, sometimes it is, sometimes it isn't. About the size of a pea. Sometimes itches. Blood clot - unknown recovery. Migraines - no to recovery
Patient was observed for the full 15 minutes, was released to her car. Started feeling nauseas, returned to clinic to vomit several times, became faint, hyperventilated. Cool compress applied, EMS called. Laid of floor to prevent falling. No head injury.
Patient was given a dose of Proquad and Varicella at the same time resulting in over vaccination.
redness in her shoulder blade and a under arm areas; Slightly raised rash on the left arm; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness in her shoulder blade and a under arm areas) and RASH (Slightly raised rash on the left arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced RASH (Slightly raised rash on the left arm). On an unknown date, the patient experienced ERYTHEMA (redness in her shoulder blade and a under arm areas). At the time of the report, ERYTHEMA (redness in her shoulder blade and a under arm areas) and RASH (Slightly raised rash on the left arm) outcome was unknown.            Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.
Information has been received from a nurse concerning an unknown number of unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates starting on or after 29-NOV-2016, improperly stored doses of PROQUAD (dose, strength, frequency and route were unknown, lot # M032496, expiration date 02-JAN-2018) were each administered to the unspecified patients for prophylaxis. The PROQUAD was exposed between -15 Celsius and -10 Celsius for a time frame of 30 minutes. There were no previous excursions, and a data logger was in use. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1701USA001052.
red swollen area at top of forehead/swelling at top of nose between the eyes; red swollen area at top of forehead; This is a spontaneous report from a contactable consumer (Patient). A 83-Year-old (non-pregnant) female patient who received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number, Expiry date UNKNOWN), via an unspecified route of administration at left arm on 24Feb2021 10:00 (at the age of 83-years-old) as a single dose for COVID 19 immunisation. Medical history included cancer survivor, 4.5 years thyroid and part of parathyroid removed. The patient received other vaccines prior to the COVID vaccine within 4 weeks date 03Feb2021. Patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and Expiry date: Unknown) via an unspecified route of administration on 03Feb2021 as a single dose for COVID-19 immunisation. Facility type vaccine was Hospital. On 05Mar2021 12:00 patient on day 9 after second dose developed red swollen area at top of forehead and by day 10 swelling at top of nose between the eyes which has continued to day 11 patient tried to call # today and after almost 2 hours on hold operator picked up and hung up on me when I was 4 in que. Patient was not received treatment. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    No concomitant medications were reported. Patient was over 18 years of age. Staff gave patients vaccines past the use date of 18 Jun 2023. On 23-Jun-2023, 3 doses were administered at administration site 2. Treatment medications were not reported.  This case is for 29th patient out of 47 patients reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live significant follow up received: Vaccine administration date was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case (Patient 01)
maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 12-Dec-2020 and the estimated date of delivery was 18-Sep-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided. Treatment history was not reported.
This spontaneous report was received from an office manager and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies or concomitant therapies was provided. On unknown dates reported as "over the past 3 months", the patients were vaccinated with improperly stored doses of vaccine, VAQTA lot # M032492, expiration date: 02-MAR-2018 (dose, route and site of administration were not reported). No adverse experience was reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 21 hours cumulatively over "3 months," on unspecified dates. Data logger was not involved. There were no previous excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA014473: US-009507513-1703USA014471: US-009507513-1703USA014472: US-009507513-1703USA014469: US-009507513-1703USA007914.
Dizzyness, worse next day, lessened day after but continued at same level for 2-3 months. Eventually disappeared.
The 2nd one listed is actually supposed to be for Meningococcal ACWY but I didn't see that as an option. Patient had a reaction involving an intense headache, uncontrollable shaking, stomach cramps, spiked a fever to 101, had chills, and was hyperventilating (panic attack). The panic attack involved loss of feeling in her hands and arms.
EYES HURT; SEVERE MIGRAINE LIKE HEADACHES; VERY NAUSEATED; FEVER OF 102F; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug or non-drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 04-AUG-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the subject experienced eyes hurt. On 04-AUG-2021, the subject experienced severe migraine like headaches. On 04-AUG-2021, the subject experienced very nauseated. On 04-AUG-2021, the subject experienced fever of 102f. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe migraine like headaches, eyes hurt, very nauseated, and fever of 102f. This report was non-serious.
Screaming for 4 hrs continuously; 745PM mom stated pt was having trouble breathing, lips turned blue, then white, pt was shaking; transported to hosp via EMS; MD met their; pt adm to hosp for observation;
Patient had her 2nd shot on the 24 of march, on the 25th of march she couldnt walk terrible pain in her left leg, pain between hip and knee about halfway down the leg.  Friday the 25 she went to the emergency room, they did xrays and foundnothing   monday the 29th she went to see her primary care physican.  He gave her tramadol.  she had been to the urgent care , the doctors office several time, 2 different physical therapsits, had a sonogram of her leg, and wednesday the 4th of august, she had a ct scan with dye.  ordered by yet another doctor, who is an orthopedic doctor,  they have found nothing wrong with her leg, but yet she seems to have such pain, walking, sleeping, anything is difficult.   and dr and the orthopedic docotr, dont feel its covid related,,  i find it hard to believe that she is still in pain for over 5 months and i feel like she is being passed from one doctor to another.
Heart failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CARDIAC FAILURE (medically significant), outcome "not recovered", described as "Heart failure". The event "heart failure" required physician office visit. The patient underwent the following laboratory tests and procedures: Lab: unknown results. Therapeutic measures were taken as a result of cardiac failure. Clinical course: Patient received treatment of Beta blockers and Propranolol. Reporter stated adverse events do require physician visit but not emergency room and outcome of the event Persisting. Reporter did not had Immunization card handy and stated it was early 2021 and do not know the month. Patient had no other vaccine administered within 4 weeks prior to the first administration date of Pfizer vaccine.  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-202300221719 Same patient, different drug/ AE;
Second day after the second dose, I started feeling chill and muscale pain for two days, and it went away.  The following week, I started feeling loss of taste on sweetness mostly.  The loss is sudden and signficant.  Few days after and now I am pretty much lost the taste to sweetness.  Other tastes are not as bad, but less sensitive.