chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report was received from a consumer concerning a 79-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, body aches/ pain and slight fever/ pyrexia. The patient's medical history was not provided. No relevant concomitant medications were reported. On 24 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection. On 31 Jan 2021, the patient experienced chills, body aches and slight fever. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 1 Feb 2021, the outcome of event, slight fever was resolved. The outcome of the events, chills and body aches was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Janssen eua Very slight dizziness afterwards, and then very heavy feeling in chest, hard to breathe about 45 minutes later, and then hives about an hour later.  Next day very slight feeling in the injection area, muscle aches, still have heavy chest and breathing issues, but not as bad as yesterday.  I took a Zyrtec tablet around 6:00 p.m. on 3/9/21.  Also used CPAP during the night. Oops, forgot to add CPAP and Zyrtec to medication list, I use CPAP nightly and Zyrtec 1xd at night time.  I also had a resting pulse of 111 with fast heartbeat.  My blood pressure was 136/84, my oxygen was down to 93.
This is a spontaneous report from a contactable consumer (patient/herself). A 75-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6203; expiration date: unknown), at the age of 75, via an unspecified route of administration, on Feb 20, 2021, single dose, for COVID-19 immunization. No medical history or  concomitant medications reported. The patient called to tell about her headaches. On Feb 21, 2021, she had headaches on right-side of her head and she never has them. She does not even take aspirin. She had a mammogram on Saturday as well and everything went wonderful. Then on Sunday, Feb 21, 2021, she noticed she had a headache and she did not understand because she did not have headaches. She has had one every day since then. She even had one today on the right-side. They have stayed about the same. She can still do everything but since they are so rare for her, she notices them right away. They do not linger; they do not keep her from doing things; they were not blinding. They were just there. The only thing that concerned her was she had a mammogram Saturday (the appointment was at 9:00) and as soon as she finished the appointment, she hopped in the car and got the vaccine. She has been doing some reading and it does not seem like that was necessarily the smartest thing she did that day, but she did not know. She said the mammogram results came back good. The outcome of event not recovered. Follow-up (May 12, 2021): Follow-up attempts completed. No further information expected.
rash; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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. The patient experienced rash after first vaccine on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
After vaccine, Pt stated feeling dizziness, weakness. Patient reported feeling "passed out"  for a few seconds. Pt remained sitting. Pt had foggy memory after, stated experiencing neck pain, headache.
approximately 24 hours after vaccine administration, employee called the office to report a rash to her torso and back with itching. no fever or other reported symptoms. Instructed to isolate, wear a mask and go to ER for treatment and evaluation by an advanced practitioner. Pt. did not have a ride on 9/20/2023 so went to the ER on 9/21/2023
PEDIARIX was given instead of PREVNAR 13. Patient had no adverse reaction or side effects from immunizations.
Severe shaking chills lasting 5 hours and sweats and low fever of 99.2F. Starting about 12 hours after the injection.
12/31/2020 very dizzy 1/1/2021 not as dizzy but still dizzy 1/2/2021 still dizzy
patient stated when she went home she started to notice swelling in face + numbness in her left side. Took benadryl + completely resolved in 48 hours
flu-like symptoms for five days after shot, then developed severe vertigo on or around 3/24/21, including nausea, lack of balance, mental fog, feelings of dissociation, severe anxiety, feeling like floating, feeling like floor tilting, inability to stand without feeling I would fall, headache on and off, tired, woozy, irritable, rapid heartbeat. Mental confusion still exists as does dizziness. Dizziness not as severe, save when I move my head rapidly, or stand up, but mental confusion (brain fog) still a problem.
I am not sure exactly when it happened (immediately after or days after the 2nd dose) but i developed chronic (never stops) tinnitus.    I am using holistic methods to alleviate.  I have never had any issues with tinnitus and didn't even know what it was until i developed it AFTER the second shot.    the vaccine mfg was Moderna.    My card says Moderna 001A21A for first vaccine and Moderna 046A21A for the second shot.
her tongue and mouth stayed numb for 3 days; her tongue and mouth stayed numb for 3 days; having difficulty speaking; 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 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "her tongue and mouth stayed numb for 3 days"; SPEECH DISORDER (non-serious) with onset 2021, outcome "unknown", described as "having difficulty speaking".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Have has 3 severe allergic reactions; Hives; Lip swelling; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 04Apr2021 13:00 (Batch/Lot Number: E97533) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Hypertension and "Hashimotos". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included metoprolol, potassium, furosemide (LASIX), famotidine and levothyroxine sodium (LEVOTHYROX); all from unspecified dates and unknown if ongoing, for unspecified indications. Patient's known allergies includes, strawberries, aspirin, zyban, eggs. On 23Apr2021 08:00, the patient had 3 severe allergic reactions; these reactions include hives and lip swelling requiring treatment via injection of epinephrine, decadron, albuterol and pepcid. Due to pandemic isolation, any other possible triggers for reaction have been tested and excluded. the events resulted in Emergency Room/ Physician's Visit.  The outcome of event was reported as recovering.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
On 10/27/08 a 70 y/o female was vaccinated with influenza and pneumococcal vaccine at a senior citizen community walk-in vaccination clinic.  The vaccines were provided by the agency and administered by the nursing staff. Pneumo and Flu vaccine were administered at the same time in different sites.  Patient notified the Health Department Vaccine Safety Officer to report the following event:  Aprox. 24 hours post vaccination the pt. c/o Lt. deltoid redness, extending to under armpit, with accompanying pain lasting 7 days.  Pneumo  vaccine documented was administered Lt. deltoid.   Pt saw Pvt. MD on 10/29/08 was evaluated no Tx or therapies given.
Pt looked like he was having a seizure right after the flu shot was administered. His eyes rolled back and his body stiffened. He lost consciouness for a minute. I administered a Epipen 0.3 mg into the anterolateral part of right thigh and call was placed to 911. The fire department arrived 5 minutes after and checked heartrate, respiratory rate and pulse which was found normal but the patient was tired from the Epipen withdrawal and pt was send home with advice to contact MD.
Patient developed cellulitis in the injection arm. Swelling, redness & pain that required an office visit to see MD. Patient diagnosed with cellulitis & prescribed cephalexin 500mg twice daily for 20 days.
No additional AEs; patient received PROQUAD by intramuscular route, instead of subcutaneously; This spontaneous report was received from a nurse referring to a 4 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported.  On 15-FEB-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (0.5 ml, strength was not reported, lot #T027116 has been verified as valid, expiration date was 07-FEB-2022) intramuscularly instead of subcutaneously for prophylaxis (subcutaneous injection formulation administered by other route) with 5/8 inch needle. No additional adverse events were reported. The outcome of the events was unknown.
Information has been received from a registered nurse concerning a 74 year old female with no medical history and allergies to acetaminophen (+) propoxyphene napsylate (DARVOCET-N) and codeine who on 21-SEP-2006 was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot#651399/0486F).  Concomitant therapy included aspirin, loratadine (CLARITIN), Lovastatin (manufacturer unknown), risedronate sodium (ACTONEL), vitamins (unspecified), folic acid and mometasone furoate (NASONEX).  On approximately 21-SEP-2006 within 12 hours after vaccination, the patient experienced hot and cold chills, felt shaky, with pain and swelling in the injection site arm from the axilla.  The patient did not have a fever.  She took aspirin for pain (timeframe undetermined).  The next morning 24 hours after vaccination, the arm was still swollen and painful and the patient still did not feel good.  The patient was not as shaky.  Unspecified medical attention was sought.  No diagnostic studies were performed.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Hot and cold chills, felt shaky, pain and swelling in the injection site arm from the axilla were considered to be disabling and other important medical events.  Additional information has been requested. (OMIC)
Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Additional Details: Patient was administered first dose of Pfizer vaccine approximately 9:40am (MSD). Upon reviewing intake sheet there were no discrepancies to continue with the vaccination. Upon successful administration, patient was instructed to sit near Pharmacy in waiting area.  Patient was standing next to wellness room where patient had fainted. Dr. and N.P. rushed to the scene to take control of the situation. Patient was assessed and asked a series of questions. He hadn't eaten in the morning.
This spontaneous report as received from a consumer and refers to herself of unknown age. The patient started her period 13 years ago (from 2002). On an unknown date, the patient was vaccinated with first dose of GARDASIL in the arm (lot number, dose, frequency and route of administration not reported). On an unknown date, the patient missed her period for the first time. From 19-MAY-2015 (reported as last 3 weeks), the patient was experiencing injection site pain every time when she lifts her arm to pick something up. The patient likened the pain to a muscular "Charlie horse pain". The patient did not sought for the medical attention. The outcome of missed period and injection site pain was reported as not recovered/not resolved. The causality was not reported. No product quality complaint (PQC) was filed. Additional information is not expected as no reporter details were provided.
3/24: 8:15am headache, chills, 99.8/100.1 temp, sweating, arm super sore could hardly move and soreness in whole body especially injection site and shoulder and neck   Shortness of breath. - took Tylenol  3/25: temp at 99.8, spiked to 101.0 at 10pm- took Tylenol and liquids 3/26: temperature lowered but still higher than normal, woke up with headache took Tylenol   I had a headache following every morning for about a week and a half. I tried not to take Tylenol unless needed. I also limited it to  Tylenol twice a day
OB pt given 2 H1N1 vaccines instead of 1 seasonal & 1 H1N1 vaccine pt had no adverse reaction.
Very heavy/longer menstrual cycle; Very heavy/longer menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. Since the vaccination, the patient had been tested for COVID-19. On 26Apr2021, the patient underwent lab tests and procedures which included quest (via nasal swab) and tested negative. On 27Apr2021, the patient experienced very heavy/longer menstrual cycle. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcome of the events very heavy/longer menstrual cycle was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
First dose on Jan 7yh 2020 but he never received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th January 2020, Batch no-3EC24, Expiry date-10th May2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
FOUR HOUR LATER INHALED A BUCKET OF CHICKEN, THEN IT HIT HIM AND FOR 8 HOURS KICKED HIS BUTT, AND HE WOKE UP LIKE SUPERMAN; This spontaneous report received from a patient concerned a 53 year old white male of unspecified ethnic origin. The patient's height, and weight were not reported. The patient was moderately healthy with no real co-morbidities. The patient was previously treated with covid-19 vaccine (dose number in series 1) (form of admin, route of admin, batch number, and expiry were not reported) dose, start therapy date were not reported for prophylactic vaccination.  On an unspecified date, by the other vaccines the patient felt super terrible for days (dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: unknown) dose was not reported, 1 total administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included L-arginine (arginine hydrochloride) for drug used for unknown indication.  On 26-MAR-2021, 4 hours after vaccination patient inhaled a bucket of chicken, then it hit him and for 8 hours kicked his butt (dose number in series 2). Patient woke up like superman. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of four hour later inhaled a bucket of chicken, then it hit him and for 8 hours kicked his butt, and he woke up like superman was not reported (dose number in series 2). This report was non-serious.
This is a spontaneous report received from a contactable consumer. An 18-year-old female patient received TRUMENBA (lot number: S26962, expiry date 31Jan2019), intramuscular at left deltoid on 07Aug2017 at 0.5 ml, single to prevent meningitis. There were no reported medical history. The patient's concomitant medications were not reported. On 08Aug2017, the patient woke up with redness, swelling and itching at the site of injection. The patient further reported that it was worsening. At the time of the report, the patient was seen by a physician and was prescribed BENADRYL and ALLEGRA to treat them. The outcome of the events was not recovered.
Vaccine was moved from the freezer to the refrigerator on 21-Apr-2023/Vaccine administered on 22-May-2023; No adverse event; patient was given a dose of the Moderna Bivalent vaccine after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was given a dose of the Moderna Bivalent vaccine after the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was moved from the freezer to the refrigerator on 21-Apr-2023/Vaccine administered on 22-May-2023) and NO ADVERSE EVENT (No adverse event) in a 25-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was given a dose of the Moderna Bivalent vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was moved from the freezer to the refrigerator on 21-Apr-2023/Vaccine administered on 22-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was given a dose of the Moderna Bivalent vaccine after the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was moved from the freezer to the refrigerator on 21-Apr-2023/Vaccine administered on 22-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient was given a dose of the Moderna Bivalent vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was moved from the freezer to the refrigerator on 21-Apr-2023/Vaccine administered on 22-May-2023).    No concomitant medications were reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Vaccine was moved from the freezer to the refrigerator on 21-Apr-2023.  No reported symptoms.  No treatment medications were reported.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route were not reported, lot # K024035, expiration date 26-NOV-2016) and with an improperly stored dose of VAQTA (dose and route were not reported, lot # L009445, expiration date 01-JUN-2017). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included biotin, Cetirizine, Levothyroxine, Omega 3 Fish Oil, RESTASIS, Vitamin B12, vitamin D, melatonin, PREMARIN Vaginal Cream and XOPENEX. On 30th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 31st May 2018, the patient experienced shivering, influenza-like symptoms, fever, blood pressure decreased and lightheadedness. On an unknown date, the outcome of the pain in arm, shivering, influenza-like symptoms, fever, blood pressure decreased and lightheadedness were recovered/resolved. The reporter considered the pain in arm, shivering, influenza-like symptoms, fever and blood pressure decreased to be related to SHINGRIX. It was unknown if the reporter considered the lightheadedness to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX on left arm and reported that day of injection, the patient experienced sore arm and that the following day she experienced a fever of 101 degrees F, drop in blood pressure to 90/60 which resulted in feeling lightheaded. The reporter noted that her blood pressure normally was around 112/72. The patient reported also experiencing flu like symptoms and shivering. The patient was seen by physician on 31st May 2018 due to low blood pressure and it was 106/61 in the office on that visit. The patient reported that all events were resolved by the 3rd or 4th day post dose of SHINGRIX.
some of the vaccine leaked out during administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 71-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7594A, expiry date 23-JAN-2025) for prophylaxis.   On 15-SEP-2023, the patient received Arexvy. On 15-SEP-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: some of the vaccine leaked out during administration). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 19-SEP-2023 The pharmacy Intern reported that a patient was being administered a dose of Arexvy and some of the vaccine leaked out during administration.  The immunizer believed the patient received most of the dose.  At the time of reporting, no further dosing had been administered. The Vaccine Administration Facility was the same as Primary Reporter. Reporter did not want contact information stored in our database but agreed to follow-up by safety.  Email with contact information will be sent to Safety Team. The reporter consented to follow up. The patient received a dose of Arexvy and some leaked out during administration, which led to incomplete dose administered.