chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ (dose, frequency and lot# were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Mother called today 2-6-12 states son had shots flu & hep A on 1-25-12. Next day had nausea/vomiting diarrhea over last week has rash on neck, chest & back bruises on shins, knees top of feet elbows & hands appt made with clinic to see dr today.
On 1/15/2021 patient presented at emergency department for evaluation of nausea, abdominal cramping, lightheadedness, diarrhea. Patient stated that two days after vaccination, she had myalgia, nausea, malaise. She started to feel better, but then developed nausea, abdominal cramping, and loose stool. It is nonbloody. She has not had a fever. She is able to tolerate fluid intake, but this triggers abdominal cramping and diarrhea. She has started to feel lightheaded. Patient was given supportive treatment and discharged home. On 1/16/2021, patient reported to emergency department again with significant abdominal pain, nausea, and diarrhea. Patient was diagnosed with pancolitis and given outpatient prescriptions for ciprofloxacin and metronidazole.
I noticed my daughter was scratching her arm near the bandaid covering her injection site.  Upon closer inspection I realized that my daughter's arm was red nearly from shoulder to elbow, with the area closest to the injection point being very hot, hard, and swollen.
I noticed on 4/13/22 that I was unable to hear out of my left ear and I decided to go to my doctor. I noticed that my ear hurt and was in pain, and it felt like it was full. My doctor sent to a specialist and they determined that I had profound hearing loss in left ear. I am still dealing with this at this time.
This spontaneous report as received from a 60 years old retired female nurse refers to herself. The patient was vaccinated with a dose of ZOSTAVAX "4 years ago", in JUL-2008, and the physician who gave it to her at that time might have stored the ZOSTAVAX at room temperature. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. No adverse reactions were reported. Additional information has been requested.
patient reported to pharmacist left chest pain, shortness of breath, ball in throat (sticky saliva), tingling in left arm down to fingertips  and feelings of anxiety
That same night had severe body aches. I felt really sick. I had joint pain, painful burning urination and a bad headache. I went to sleep and when I woke could not get out bed. Did not go to the doctor. In bed for two days.
Product temperature exersion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided. It was reported that 6 patients were administered a dose of the Moderna covid-19 vaccine after a temperature excursion at the frozen range reaching a temperature 50°C.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Added patient demographic details.
Had injection on 9/24/07 in AM. Began with small areas of erythema and hives that would last minutes to hours over various areas of body. Not specifically at injection sites. Given Benadryl by parents. Lasted 3 days.
Student complaint of feeling hot inside. Red patches noted to forhead, cheeks, chest and back approximately 15 minutes after vaccination. Vital signs as follows; T 96.9, P 106, R 18  B/P  120/100. Benadryl 50 mg/ml injected IM to her Lt. deltoid. Tolerated well. Rash was cleared one minute after Benadryl injection. Mother was notifed and student pick ed up from school.  Instructions given to parent.
My mother came home after receiving the Moderna vaccine shot and did not feel well. She had confusion, pain in her left arm near the injection site. She attempted to relax for a while and then became very nauseous, faint, and vomited. She claimed she tried to lay down in her bed and then attempted to get up to vomit and could not physically move.   On Tuesday, I found her at 2:30 PM unconscious in her bed. Vomit/blood all over the floor by the bed side, her face was very warm, her breathing was very short. I could not get her to respond to me through feel or communication so I called 911. She was taken to the ER by ambulance at this time.   She was taken the hospital where she was placed on IVs (I think one for antibiotic and the other was a steroid). Hospital performed blood work, CT scan, chest x-ray, and lumbar tap. They did not find any issues with my mother other than she had an "elevated white blood counter". Lumbar tap did not yield any signs of infection or foreign bacteria. She was discharged on Wednesday (02/10/2021) evening and went home to rest. She has been very fatigue since her return home and reported to me today (02/19/2021) that she had symptoms of being faint, cold sweats, and overall weakness. I checked her blood pressure and temperature and did not see a concern.
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 97-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter stated that the patient was his/her mother, the patient had Shingrix vaccines in 2019, then got shingles in 2022. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
PT CALLED AND STATED SHE HAS REDNESS/SWELLING/WARMTH AT INJECTION SITE- SOUNDS LIKE INJECTION SITE REACTION, PT TOLD TO MONITOR AND LET PHARMACY KNOW IF IT DOESNT GET BETTER/IF SYMPTOMS WORSEN
took my 2nd dose 2 months apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took my 2nd dose 2 months apart) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took my 2nd dose 2 months apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took my 2nd dose 2 months apart) had resolved.            No concomitant medications were reported .  No Treatment was reported by reporter.   Reporter did not allow further contact
Moderna - Dose Number: 2 ... Pfizer / BioNTech - Dose Number: 3; COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 28Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETAMINOFEN, start date: 20Oct2022, stop date: 24Oct2022; BENZONATATE, start date: 20Oct2022, stop date: 02Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Aug2022, outcome "unknown", described as "Moderna - Dose Number: 2 ... Pfizer / BioNTech - Dose Number: 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The excursion expiration date of 7 days thawed in the refrigerator  was followed because of the Pfizer email approving the 7 days. Pharmacy policy was to follow the expiration of 5 days.
I was diagnosed with Frontal Fibrosting Alopecia 12MAY2023, I first noted in the summer of 2021 looking back in pictures it actally started in 2020.  I did not seek medical attention until April 2023. Symtoms started before I was ever vaccinated and I have had confirmed  COVID-19 January 2022 and unconfirmed in January 2020.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note: "No notes on file, patient is a 66yr old female with a history of HTN, COPD, Astham, Hypothyroidism who presetned with cough, fever and was found to have acute covid. She has had covid previously in Nov 2021 and feels symptoms are about the same as prior. She was placed on dexamethasone and completed remdesivir. Today she says she feels much better though she still complains of some cough and congestion. She quit smoking a few years ago. She really wants to go home to get a good nights sleep. She is being discharged on 3L NC oxygen as nebulizers proved insufficient. She would also need portable tank for ambulation insider and outside her home."
he has cold like symptoms; Stuffed up nose; doesn't feel really good; pain in the site area; slept a lot and was tired; slept a lot and was tired; his stomach is nauseous and queasy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration in Jan2021 (also reported as "around 19Jan2021" or "19Jan2021 or 20Jan2021", pending clarification) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his first COVID dose around 19Jan2021 (also reported as "19Jan2021 or 20Jan2021") and now he has cold like symptoms. Stuffed up nose, doesn't feel really good and wanted to know if this part of the COVID vaccine. On the first day, he had pain in the site area, slept a lot and was tired. It has been 10 days since the shot and he had symptoms of a cold and his stomach was nauseous and queasy (also reported as squeezy). The reporter wanted to know if this was a part of the side effects or does she need to call his primary care. She was told about symptoms to watch for within the first seven days and this was well beyond the seven days. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Approximately 3 months after receiving my fourth dose of the Pfizer vaccine, my husband and I tested positive for COVID-19. My symptoms were a fever for two days, a little nausea and mild fatigue. It felt like allergies with nausea. I don't feel that it was a bad case at all. When we contacted our doctor she prescribed Paxlovid and it helped both of us.
Severe muscle pain; 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 MYALGIA (Severe muscle pain) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Severe muscle pain). At the time of the report, MYALGIA (Severe muscle pain) outcome was unknown.            The patient had severe muscle pain after receiving the second dose.  No Concomitant product use was reported.  No treatment information was provided.
p/vax pt devel tinnitus in rt ear; lasted 1 wk; lt large 1inch lump on arm for 1 wk; lethargy & mild depression
Pt received PREVNAR-13 on 6/26 and in the pm, she had chills, hot flashes and threw up. Arm was very painful and warm.
This spontaneous report as received from a Registered Nurse and pharmacist refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. From an unknown date in September 2015 to 15-NOV-2015, an unspecified number of patients have been administered doses of RECOMBIVAX HB lot# reported as L022261 exp. 01-APR-2015 (route and site of administration, dose were not reported), which were improperly stored. There was no adverse effects reported. Additional information has been requested.
lump, the size of a marble on neck (left side) right under ear; tenderness in arm where injection was received; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (lump, the size of a marble on neck (left side) right under ear) and VACCINATION SITE PAIN (tenderness in arm where injection was received) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002C21A) for COVID-19 vaccination.     The patient's past medical history included Fracture (Fracture in back) and COVID-19 (she had COVID-19 last August 2020.). Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/APAP) for Back pain, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for Vitamin B12 deficiency, PROMETHAZINE (PHENERGAN [PROMETHAZINE]) for Vomiting, SERTRALINE HYDROCHLORIDE (ZOLOFT), VITAMIN C [ASCORBIC ACID] and BIOTIN for an unknown indication.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK MASS (lump, the size of a marble on neck (left side) right under ear) and VACCINATION SITE PAIN (tenderness in arm where injection was received). At the time of the report, NECK MASS (lump, the size of a marble on neck (left side) right under ear) and VACCINATION SITE PAIN (tenderness in arm where injection was received) had resolved.            Treatment information include Phenergan, Hydrocodone apap, hot pack Reporter reported that patient took concomitant medication biotin for hair skin and nails Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-231691 (Patient Link).
1 month of bad arthritis flare up   3 does of prednisone before flare up receded
Son became very ill few days after receiving vaccination on 12-18-09. High fevers to 106.2, vomiting, diarrhea, coughing, aching body and confusion. Took to ER. Could not diagnose him with anything.
This spontaneous report was received from a certified nursing assistant referring to an unspecified patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 21-AUG-2015, the patient was administered a dose of improperly stored GARDASIL 9 (dose and route of vaccination were not reported, lot # L004741 exp. date: 04-MAR-2017). No adverse events have been reported. This is one of several reports from the same reporter. Additional information has been requested.
I woke up the morning following  the covid shot with lower back ache.  I thought it may be dehydration, so I have drunk plenty of water and tried acetaminophen.  The pain has been getting a little worse each day.  Now it feels like some sort of internal organ more so than my lower back.  Not sure what else to try to alleviate the pain
Woke up around 8am the next morning after receiving  Moderna Vaccine. Lips were swollen. Purple in color. Not painful. Not tender. No changes to breathing, tongue, and airway. No rash or hives. Lip swelling and discoloration went to normal around 12pm. There were no medications or variety of foods that were new. No Tylenol, ibuprofen or Benadryl was taken.
On Eliquis and on and off had bloody urine; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-020443), license party for apixaban (ELIQUIS).  This spontaneous case was reported by a patient family member or friend and describes the occurrence of haematuria (On Eliquis and on and off had bloody urine) in 78-year-old male patient who received apixaban (Eliquis) for Cerebrovascular accident prophylaxis. Co-Suspect Products included Covid-19 Vaccine for COVID-19 immunization. The patient's past medical history included Prostate cancer (about 10 years ago), Radiation therapy and Capillary fragility. On an unknown date, the patient started Eliquis (unknown route). On 24-Feb-2021, the patient started Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced haematuria (On Eliquis and on and off had bloody urine). The action taken with Eliquis (Unknown) was unknown. At the time of the report, haematuria resolved. Event reoccurred on 24-Feb-2021 For Eliquis (Unknown), the reporter did not provide any causality assessments. The reporter stated that the patient got the Covid vaccine the previous day, he had a history of prostate cancer from about 10 years ago and was treated by radiation, the radiation had caused capillaries in the penis to be fragile and so sometimes when he urinate, he urinate blood or little blood clots, neurologist was aware of it, cardiologist was aware of it but they did not treat it, they just waited for it to resolve itself. He was also on Eliquis for a Atrial fib so the previous day when we came home after he got the vaccine, he was bleeding with the clots and with the bloody urine which he had done in the past. He had a blood urine one hour post vaccination. She was shocked. It would take at least a few hours for the medication to get in the system before having any kind of reaction. It resolved on it's own he did not have a blood urine anymore. The second dose of the vaccine was due on 16-Mar-2021.
The patient states that he had a bilateral hand /forearm dermatitis that was getting better when he received his first dose of Pfizer vaccine.  Thereafter in about 24 hours the dermatitis erupted again and he developed hand swelling, redness and itching.  he consulted his physician and was given oral prednisone at 50mg /d for 7 days which calmed the dermatitis.  We reviewed the possibility of his rash erupting again after he receives dose 32--for which he is here today--and the possibility that the previous corticosteroids that he was given might inhibit a full immune response from the vaccine.  He opts to receive the second dose today anyway and it is administered.  This is to report the worsening of the dermatitis after the first dose was given.  He still had remnants of a dermatitis (wrinkled skin, etc)
You saw APRN-CNP on Tuesday June 1, 2021. The following issues were addressed: Benign essential hypertension; Dizziness; Acute nonintractable headache, unspecified headache type; and Abnormal EKG. PR ELECTROCARDIOGRAM, Blood pressure 150/100  O@ sat 95 %     6/2/2021 Chief complaint narrative was entered by triage nurse, not by physician.   12:34 PM patient, a 50 year old female with a past medical history that includes--migraine--presents to the ER c/o a HA. Pt had a HA for 2 days. Pt states it feels different than her normal migraine. She was seen at her PCP and reported she had an abnormal EKG and was found to be hypertensive. She also had nausea. Today, she developed chest pressure in the middle of her chest that radiated to her L arm. No hx of CAD. No other complaints or modifying factors at this time. Review of Systems Constitutional: Negative for chills, fever and weight loss. Respiratory: Negative for cough, shortness of breath and wheezing.   Cardiovascular: Positive for chest pain. Gastrointestinal: Positive for nausea. Negative for diarrhea and vomiting. Neurological: Positive for headaches.  All other systems reviewed and are negative.   BP (!) 140/101  | Pulse 80  | Temp 98.4 °F (36.9 °C) (Oral)  | Resp 18  | Ht 1.651 m (5' 5")  | Wt 98.9 kg (218 lb)  | LMP  (LMP Unknown)  | SpO2 100%  | BMI 36.28 kg/m²
Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was feeling very weird/ felt awful; my arm hurt; This is a spontaneous report from a contactable nurse reporting for herself.  A 70-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899 (as reported: "don't know if it E or and F, looks like EH9899") & Expiry Mar2021, via an unspecified route of administration on 22Dec2020 as a single dose (age at vaccination 70 years old), for COVID-19 immunization. Medical history included pulmonary hypertension.  The patient's concomitant medications were not reported. The patient had a persistent headache that doesn't go away, and had body ache (onset 23Dec2020). She reported feeling "like I had COVID." She went and got tested because she was a healthcare worker; her first test was negative (Dec2020) and her second test today (29Dec2020) was negative. She thought because it all started the day after vaccine (23Dec2020), that day she felt very sick with headache on and off, nausea, and was dizzy. She was feeling very weird and her arm hurt and she knew that she was going to have some side effect, so she went to work and took some ibuprofen (MOTRIN) for the pain and that was it. She took the vaccine on Tuesday, Wednesday she felt awful, Thursday, the only thing she had was pain in arm that's it but Friday started again with headache and all these symptoms that haven't gone away. The clinical outcome of the event persistent headache, body ache, nausea, dizzy, feeling very weird/ awful was not recovered.