chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented to the ED with shortness of breath, body aches, cough, congestion, fever, hypertertensive, and hypoxic 56% Chest X ray showed bilateral multifocal pneumonia Started on decadron and remdesivir, BiPAP, combivent, pulmicort, albuterol, zinc, vitamin D, melatonin,  Discharged home with decadron, amoxicillin, and azithromycin
Woke up with swollen red arm, large area, not painful, slightly tender, no other symptoms
Bell's Palsy; Anaphylactic reaction; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program. (Patient reported for self). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that she had several medication allergies (possibly to thiosulfate) and trying to determine if those anaphylactic reaction to those medication; predispose her to have a reaction with the Pfizer COVID-19 vaccine. The patient experienced anaphylactic reaction and Bell's palsy on unspecified dates. The patient stated, her pharmacist told her to call Pfizer and give medications she was allergic to and to check on any cross reaction. The patient stated he had a side effect after the first dose of the vaccine. Should she get the second dose?, the patient queried stating, what if she had an anaphylactic reaction after the first does? Response given from (LAB-1457-10.0 Revised: 25Jun2021) under section 4 CONTRAINDICATIONS. Patient was referred to speak to her healthcare provider about the risks of the vaccine. Patient stated, the overlapping ingredient that was found in the mediations she was allergic to and Pfizer COVID-19 vaccine was polyethylene glycol; would that predispose the patient to having an anaphylactic reaction? the patient queried. For further queries, the patient was guided to PI on pfizer.com (FACT sheet for HCPs, Recipients and the PI). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100954802 same reporter/ drug, different AE/ patient;US-PFIZER INC-202100954801 same reporter/ drug, different AE/ patient
unusual continuous crying beginning approx 4 hrs p/vax given; lasted for 1/2 of day; whined all noc; the next day cried when touched or moved leg; states lt leg red & felt hot to touch;
felt nausea after the first dose; sore arms; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program: 159558. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot# unknown), on 11Mar2021 and second dose on 06Apr2021, both via an unspecified route of administration as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced nausea and sore arms after the first dose. The patient was treated with Tylenol for sore arms. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Patient symptoms began on 08-23-21with a positive test result on 08-27-21. He was tested when he went in for dialysis. He hasn't been in the ICU during this hospital stay. He had heart surgery 2 years ago and has a kidney condition requiring him to receive dialysis twice a week. He is also on antibiotics for infection in his system.
The patient states she has redness, swelling, itching, soreness, and tenderness from her shoulder down to her elbow. She says she feels like it is an allergic reaction. I called Merck and asked if this was a normal reaction. Merck said that it is rare but some people do get more than localized swelling near the injection site. I explained this to the patient and advised her to call her MD to get in to see him so that he can take a look at it. I also told her to ice the area while she was waiting for the MD to call her back. She said she would call her MD immediately.
Redness at injection site after 1st dose; Tender at injection site after 1st dose; Hard at injection site after 1st dose; Hot at injection site after 1st dose; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site after 1st dose), VACCINATION SITE PAIN (Tender at injection site after 1st dose), VACCINATION SITE REACTION (Hard at injection site after 1st dose), VACCINATION SITE WARMTH (Hot at injection site after 1st dose) and FATIGUE (Fatigue) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site after 1st dose), VACCINATION SITE PAIN (Tender at injection site after 1st dose), VACCINATION SITE REACTION (Hard at injection site after 1st dose), VACCINATION SITE WARMTH (Hot at injection site after 1st dose), FATIGUE (Fatigue) and NAUSEA (Nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site after 1st dose), VACCINATION SITE PAIN (Tender at injection site after 1st dose), VACCINATION SITE REACTION (Hard at injection site after 1st dose), VACCINATION SITE WARMTH (Hot at injection site after 1st dose), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has been advised to use ibuprofen and ice for now.   Patient is going to see her doctor.
The morning of 1/20/21, I awoke with a very itchy, moderately reddened upper left arm.  Reddened, itchy area 3 inches X 5 inches, on outer aspect of L arm in Deltoid area.  I was given the vaccination injection within this same area.  The symptoms were worse Th. 1/21.  Called Dr.  He believes it is an allergic reaction.  Discomfort continues.  Only relieved by cold compress, ice pack.
soreness in arm at injection site/ tenderness in the arm at the injection site; little bit of a headache/ little mild headache; a little of the fatigue; forehead feels a little warm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received bnt162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Lot number: EW0169, Expiration Date: 31Aug2021) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "gastro issues" (unspecified if ongoing), notes: not affected by the vaccinations; "migraines" (unspecified if ongoing), notes: not affected by the vaccinations; "fibromyalgia" (unspecified if ongoing), notes: not affected by the vaccinations; "dry eyes" (unspecified if ongoing), notes: not affected by the vaccinations; "tonsil" (ongoing); "appendix" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot number: EW0150, Expiration date: 31Jul2021, Anatomical Location: Arm Left), administration date: 05Apr2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "a little of the fatigue", "soreness in arm at injection site/ tenderness in the arm at the injection site", "little bit of a headache/ little mild headache", "forehead feels a little warm". The following information was reported: FATIGUE (non-serious) with onset 26Apr2021, outcome "unknown", described as "a little of the fatigue"; HEADACHE (non-serious) with onset 26Apr2021, outcome "unknown", described as "little bit of a headache/ little mild headache"; VACCINATION SITE PAIN (non-serious) with onset 26Apr2021, outcome "unknown", described as "soreness in arm at injection site/ tenderness in the arm at the injection site"; FEELING HOT (non-serious) with onset 2021, outcome "unknown", described as "forehead feels a little warm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had soreness on her arm at the injection site, had a little bit of a headache, and her forehead felt a little warm, however the rest of her body did not feel warm. She remembered when she got each of her Covid vaccinations, she would get them in the morning. She would fly to place (Withheld) and the driver would take her to clinic and then he would take her back to airport. If she got vaccinated at 8:30 AM or 9 AM by 2 PM when she got back to airport, she would get tenderness in the arm at the injection site. With all her vaccination a little over 5 hours after vaccination the soreness and fatigue and little mild headache started.
The pt experienced erythema, pain, heat and a nodule at the site of injection. This was 7cm in diameter circle.
Eyes started to itch and swell up and cloud over with a film and throat started to feel closed off and dry. 9pm became very cold-put on a heating pad and blankets-could not get warm. Had to use washcloth next morning to remove "gunk" from eyes. Had a headache but did not take any medication for it until the next day.
Flu-like symptoms; Sneezing; Cough; Tiredness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, 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: COUGH (non-serious) with onset 03Oct2023, outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03Oct2023, outcome "unknown", described as "Flu-like symptoms"; SNEEZING (non-serious) with onset 03Oct2023, outcome "unknown"; FATIGUE (non-serious) with onset 03Oct2023, outcome "unknown", described as "Tiredness". Therapeutic measures were taken as a result of influenza like illness, sneezing, cough, fatigue. Additional information: The patient reported on she got the Pfizer COVID-19 vaccine, 2023-2024 on a Friday prior to the time of the report (29Sep2023). On Tuesday (03Oct2023), she started to experience sneezing, cough, and tiredness. She had been taking Tylenol and cold medicine. The patient asked if it was normal to have flu-like symptoms after getting the vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist refers to a 59 year old female patient. On an unknown date in October 2013, the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported). On an unknown date in October 2013, the patient experienced rash at the injection site. The patient sought the medical attention and called the pharmacist. The outcome of rash at the injection site was reported as recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
ON 1/20/21, DEVELOPED FEVER, NAUSEA, AND VOMITING. FOLLOWED UP WITH HIS PCP.
3/29/2021 patient received one dose of Moderna vaccine.  Patient had actually already received his full series of Pfizer vaccine through the group home he lives in.  2/6 and 3/17 respectively.  Patient group home confirmed this.  Patient reports no adverse reactions to Moderna vaccine.  PCP made aware.
Incorrect dosage fro Age Group 12 y.o and up - Booster  sx: Fever(mild) soreness from injection site
Rash started 24 hrs after flu shot. Areas affected with bilateral forearms, sides of abdomen, center of back and lower back at beltline. Chills but no fever. Patient still had hive rash 9 days later. Not painful, itchy.
Mother called with rash on trunk from pubic area to nipple area, mouth, no itching, 12 hrs after shot. Went to family Dr, ? from shot, encourage to have next set of imm at Dr's office.
Reddened raised rash noted on bilateral legs, diaper area. Rash then spread to hands, lips and chin, feet, arms. Rash noting to get better slowly today (12/11).
Patient contracted COVID after being fully vaccinated, no booster Cough and Shortness of breath
I developed a viral exanthum rash the following day and as that was fading (about 2 days after that) I developed 3 clear fluid-filled medium-sized blisters in a line on my left side front midsection at the base of my sternum.   The fluid turned cloudy over the next few days and eventually the blisters dried up and went away.
When woke up felt real nausea. She had fever and chills more like flu symptoms. She had body aches and tiredness.
UrticariaPruritus Narrative: Approx. 6 hours after receiving my 2nd dose on 1/9/2021, I developed hives on my face and neck. Symptoms resolved after taking Benadryl.
Patient experiencing all side affects on sheet, with the exception of injection site swelling and redness. Arm sore yesterday 1/20/2021, came on over night. Did not experience anything after first dose.
I noticed a metallic taste in my mouth around April 12 and I still have it. It seems to have improved but I?m nervous now that it has lasted so long and I?m due for my second vaccine on April 27.
She was diagnosed with a "UTI" this morning; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (She was diagnosed with a "UTI" this morning) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URINARY TRACT INFECTION (She was diagnosed with a "UTI" this morning). At the time of the report, URINARY TRACT INFECTION (She was diagnosed with a "UTI" this morning) had not resolved.            No concomitant medication information was provided. Treatment medication include antibiotics for UTI. The patient took booster dose on 04Nov2021and had no side effects.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow-up includes booster dose information was added.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Apr2021 (Lot number: EL9264, Expiration Date: 21May2021) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Spleen removed", start date: 2007, stop date: 2007. Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for systemic lupus erythematosus; TRIAMCINOLONE. Past drug history included: Methotrexate for arthritis, notes: diagnosed prior to receiving the Pfizer COVID Vaccine; Methotrexate for Lupus, notes: Stopped four weeks before the 1st dose of Pfizer COVID vaccine and stayed off Methotrexate for four weeks afterward; began Methotrexate 10 years ago. Vaccination history included: Bnt162b2 (Dose 1, single; Lot no: EL9263, Anatomical Site of injection: Arms), administration date: 01Apr2021, when the patient was 66 years old, for COVID-19 immunization; Shingles, for immunization. The following information was reported: CONTUSION (non-serious) with onset 2021, outcome "not recovered", described as "broke out completely all over her face and fingers / is still breaking out in the corners of her mouth and the side of her nose"; BLISTER (non-serious) with onset 2021, outcome "not recovered", described as "blisters"; ORAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "soreness of mouth"; ERYTHEMA (non-serious) with onset 2021, outcome "not recovered", described as "redness"; OCULAR HYPERAEMIA (non-serious) with onset 2021, outcome "not recovered", described as "eye turned real red". The event "broke out completely all over her face and fingers / is still breaking out in the corners of her mouth and the side of her nose" was evaluated at the physician office visit. Additional information: Patient stated her husband died on 29Apr2021 and it upset her, and she thinks she did start a sleeping medication about 5-6 days after his death. But has no name of that sleeping medication or lot, expiry date or NDC to provide as it has been discarded; stated she took one pill of the sleeping medication and her eye turned really red and she never took it again and threw them all away. Patient stated the breakout began about 2-3 weeks and she was not certain about the dates, but the breakout began about 2-3 weeks after the 2nd dose of the Pfizer COVID Vaccine. Patient stated she was still breaking out in the corners of her mouth and the side of her nose, but it was a lot better than what it was. In morning vaccination was given. Not any additional vaccines administered on same date of the Pfizer suspect. Not any family medical history relevant to AE(s). No follow-up attempts are possible. No further information is expected.
January 4-6th I had severe headaches with no relief from Tylenol.  24 hrs after my first dose, I started my menstrual cycle which lasted till the 8th. Formally I was experiencing no menstrual cycle since being on the Nexplanon. Now I've had 4 menstrual cycles since being given the vaccine.  From the 6-8th, I had diarrhea. Symptoms seemed to resolve on their own by January 9th
Information has been received from a physician concerning a 26 year old female with penicillin allergy and no relevant medical history who on 25-AUG-2008 was vaccinated intramuscularly with a first dose of GARDASIL in the left arm (lot number not reported).  At time of administration, the patient experienced pain.  The pain became severe and impaired lifting the arm.  The patient self-treated with unspecified non-steroidal anti-inflammatory medications and the pain resolved in 3 weeks.  On 27-OCT-2008, the patient was vaccinated intramuscularly with a second dose of GARDASIL in the gluteus muscle (lot number not reported).  Concomitant therapy included YASMIN.  Within a few hours, the patient developed a red, raised, itchy rash on her torso and both arms.  The patient self-treated with BENADRYL.  The patient contacted the physician's office by phone the next day to inform them of the reaction and at that time, the rash was improved.  According to the physician, the patient's events were considered to be disabling.  Additional information has been requested.
patient was administered expired Tenivac with no reported adverse event; Initial information received on 08-Feb-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 75 years old female patient who was administered expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Feb-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Suspension for injection) (frequency: once) (Strength: standard)  [lot C5779AA and expiry date: 02-Oct-2022) via intramuscular route in the left deltoid for Immunization.  On 08-Feb-2023 the patient was administered expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
experienced significant reaction; fever; nausea; muscle aches; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (experienced significant reaction), PYREXIA (fever), NAUSEA (nausea), MYALGIA (muscle aches) and PAIN IN EXTREMITY (sore right arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive and Asthma. Concurrent medical conditions included Adhesive tape allergy. Concomitant products included OMALIZUMAB (XOLAIR) for Asthma.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ADVERSE EVENT (experienced significant reaction), PYREXIA (fever), NAUSEA (nausea), MYALGIA (muscle aches) and PAIN IN EXTREMITY (sore right arm). At the time of the report, ADVERSE EVENT (experienced significant reaction), PYREXIA (fever), NAUSEA (nausea), MYALGIA (muscle aches) and PAIN IN EXTREMITY (sore right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatments were reported.   Reporter did not allow further contact
01-09-14 developed increasing erythema, edema and pain to (L) deltoid - went to ER that PM for eval. Ibuprofen, ice and BENADRYL recommended and taken. On 1-10-14 f/u in clinic erythema, edema and discomfort increased - 1-11-14 f/u clinic visit edema and redness extended to (L) elbow. KEFLEX TID started PO. Client played a basketball game on 1-11-14. today on 1-13-14 mom reports it's "much better".
Information has been received from a male physician who in approximately August 2001 was vaccinated with one dose of Hepatitis B. The physician reported that he was notified that his EMG indicated that he almost certainly had chronic idiopathic or(innumologic-auto immune) demyelinating polyradculneuropathy (CIDP). The physician noted the he will need blood and spinal fluid tests. His EMG indicated little axonol damage and lots of demyelination. He felt it may be early in its course. A repeat test was interpreted the same way by two neurologists.  The physician's wife WAES01092572 also received hepatitis b vaccine and developed bilateral optic nerve swelling, calf tenderness, frontoparietal headache, transient visual loss in right eye, sensory fifth left nerve loss and lightheadness. The physician indicated that it is extremely improbable that anything other than the hepatitis b was the inciting factor for both he and his wife. Both had been extremely healthy and infection free. Upon internal review, chronic idiopathic demyelinating polyradiculoneuropathy was determined to be an other important medical event. No further information is available.