chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tiredness; not feeling well; diarrhea; arm sorbess; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 43-year-old non pregnant female patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 24Jun2021 17:45 (Batch/Lot number was not reported) as DOSE 1, SINGLE (at the age of 43-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Seasonal asthma from an unknown date and unknown if ongoing and no known allergies. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient not diagnosed with COVID-19. The patient experienced Tiredness, not feeling well, diarrhea and arm sorbess on 24Jun2021 at 19:00. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events reported as recovering.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
pt reported by phone to MD office on 27FEB97 @ 830AM rxn @ site of inj;pt came to office @ 1:00 today nurse checked site measured 60mm diameter, red, raised area;applied spray DPH instructed;
Chills; Fever; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: negative (Negative) Negative. On 02-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Red, itchy rash with specific outline covering upper arm.  Sore lymph nodes under left arm.
Information has been received from a physician concerning a 16 year old female patient who on 28-JUN-2007 was vaccinated with a dose of Gardasil. There was no concomitant medication. As the injection was being administered, the patient had a syncopal episode and appeared to be shaking. It was also reported that she had a vasovagal reaction immediately upon removal of needle following administration of Gardasil. She recovered immediately with no treatment of medication. The patient was reported to be fine, totally asymptomatic. The reporter believed the patient had a vasovagal reaction to the actual injection, not to product, and had no suspicions other than a young, nervous adolescent. No further information is available.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. In October 2014 (exact date unspecified, reported as between 08-OCT-2014 and 22-OCT-2014) those patients were vaccinated with an improperly stored at 31F for 10 hours PEDVAXHIB (dose, units, route of administration, anatomical location, lot number was not reported). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient developed hives on face, arms, swelling around eyes. Benadryl given in office; patient sent to ER for EPI. Symptoms onset at minutes after shot.
weakness; nausea; a couple of people at my clinic  have gotten really ill from the vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weakness), NAUSEA (nausea) and ILLNESS (a couple of people at my clinic have gotten really ill from the vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), NAUSEA (nausea) and ILLNESS (a couple of people at my clinic have gotten really ill from the vaccine). At the time of the report, ASTHENIA (weakness), NAUSEA (nausea) and ILLNESS (a couple of people at my clinic have gotten really ill from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment details included Not provided.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 52 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
I experienced a body aches  and extreme fatigue from Sunday, 10/23 through Tuesday 10/25. On 10/25 I felt congested, tight in the chest and coughing up green phlegm so I decided to go to Urgent Care. I had been traveling on 10/21 maskless so I figured I caught something while traveling. I was prescribed Z-Pac antibiotic, Methyprednisolone tablets and Albuterol inhaler which I am currently still taking and improving slightly.
Per mom, pt complained of pain in left arm where shots were given. Redness noted today and swelling. No fever noted, no streaking noted. MD looked at it and was told to keep an eye on it over the weekend. If it gets any bigger or any streaks presents itself, then call the after hrs. clinic or go to the ER.
Pregnant; Initial Report Received on 31-May-2022  A pregnant patient (age, race, ethnicity, and gestation period not provided) spontaneously reported to the HEPLISAV-B pregnancy registry that she, received one dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.  No relevant medical history was reported.    The last menstrual period date, estimated date of delivery, pregnancy history, and pregnancy risk factors were not reported.  No relevant concomitant medications were reported.  On an unspecified date (# weeks of gestation or # trimester not reported), the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported). The patient was referred to the pregnancy registry by a pharmacist. She wanted to know if it was safe to take the second dose of ~HEPLISAV-B.  No additional information was reported. The patient declined follow up from the pregnancy registry.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
1 day post vaccination- Soreness to injection site, cough, congestion, red eyes, irritability, sleeplessness, forgetfulness. 7 days post vaccination- sleeplessness, difficulties recalling short term information
patient reported 2 hours after vaccine was administered he noticed an increase of his tinnitus in bilateral ears. Tinnitus did improve 2 days after but then worsened again 3 days after and has since remained. Patient will be seeing audiology in the coming week for evaluation.
Had high blood pressure; Didn't feel well; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (Had high blood pressure) and MALAISE (Didn't feel well) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Controlled by medication) and Drug allergy (Toradol).    On 29-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced HYPERTENSION (Had high blood pressure) and MALAISE (Didn't feel well). At the time of the report, HYPERTENSION (Had high blood pressure) had not resolved and MALAISE (Didn't feel well) outcome was unknown.            Concomitant medications included unspecified medication for high blood pressure. Patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. On 09-Feb-2021, patient administered 1st dose of Moderna (Lot number: 039K20A). On 09-Mar-2021, patient administered 2nd dose of Moderna (Lot number: 030A21A). On 29-Oct-2021, patient administered 1st booster dose of Moderna (Lot number: 011F21A). On 07-Apr-2022, patient administered 2nd booster dose of Moderna (Lot number: 084J21A). On 29-Sep-2022, patient took the fifth booster, but patient didn't have fever or chills. Patient didn't feel well though. Then patient had high blood pressure, which made her go to her doctor's office, but theydidn't know anything. Patient had office visit on 03-Oct-2022. The patient did not experienced a similar event in the past. The doctor just upped patient's medication on 03-Oct-2022.   This case was linked to MOD-2022-654748 (Patient Link).
Patient received 1st dose covid MODERNA 2/2021. I informed them we did not have Moderna here,  they wanted Pfizer. This was given, then I realized it was her 2nd dose.
itchy on upper buttocks and lower back; redness began and now I have red blotches and a rash from upper buttocks, up my back and on the sides (flanks.); redness began and now I have red blotches and a rash from upper buttocks, up my back and on the sides (flanks.); itchy red rash spots on stomach; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 06:30 AM at left arm at single dose for COVID-19 immunization. Medical history included known allergies to milk products and seasonal allergies. Patient is not pregnant. Other medications in two weeks included fexofenadine hydrochloride (ALLEGRA). No other vaccine in four weeks. 8 hours after the first dose of vaccine (15Jan2021 02:30 PM) patient became itchy on upper buttocks and lower back. Then, redness began and now patient have red blotches and a rash from upper buttocks, up her back and on the sides (flanks.) Also, itchy red rash spots on stomach. No covid prior vaccination. No covid tested post vaccination. No treatment received for the events. Outcome of the events was unknown.   Information about lot/batch number has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 07-SEP-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported) that was improperly stored. The vaccine was exposed to 37 F from 27-AUG-2012 to 07-SEP-2012. No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date, the patient almost fainted immediately after receiving Gardasil. The nurse at the physician's office stated that the girl seemed "afraid of needles." The outcome of the event was not reported. Additional information has been requested.
She noticed swelling and increased warmth to the touch. She notes the swelling is decreasing. She is concerned about how warm it feels and the spreading of the skin redness. She notes her temperature right now is 98.8 F. She notes her normal is 96.4 F. She feels the pain is getting better. Denies changes in shortness of breath. Denies any other significant symptoms. She also recalls the day after the shot she felt fatigued and had body aches. That has resolved as well.   Discussed she does appear to be experiencing an adverse effect from vaccine administration. Discussed this doesn't appear to be an infection. Symptoms will self resolve with time. Advised of RTC vs ED recommendations. Will make sure it is reported on VAERS. Conservative treatment measures for relief reviewed.
Bumps and lumps are spread all over the body; Patient started with bumps and lumps that started itching; When she goes out in Sun, they get aggravated; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient started with bumps and lumps that started itching), PRURITUS (When she goes out in Sun, they get aggravated) and SWELLING (Bumps and lumps are spread all over the body) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa allergy). Concomitant products included CALCIUM and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Mar-2021, the patient experienced PRURITUS (Patient started with bumps and lumps that started itching) and PRURITUS (When she goes out in Sun, they get aggravated). On 15-Mar-2021, the patient experienced SWELLING (Bumps and lumps are spread all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Patient started with bumps and lumps that started itching), PRURITUS (When she goes out in Sun, they get aggravated) and SWELLING (Bumps and lumps are spread all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included acidophillus. Treatment medication also included steroid cream.
After the shot I got the worse headache of my life, throat started swelling. I hot really hot, clampy and almost passed out. treated with Benadryl. Throat opened a little, but head really hurt. completely exhausted, woke up throwing up several nights. dizziness nausea, lump in throat as if having an allergic reaction, felt like an allergic reaction to shellfish. Also was unable to swallow or eat anything. For days just started breaking out in sweat. I was forced to stay in bed for 6 days. The shot was in the right arm and every since the arm gets very painful. Painful down to the joint. and the injection site is still swelling and itching.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bilateral Duane Syndrome" (unspecified if ongoing); "Penicillan" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 Included Paxlovid from 21Jul2022 to 26Jul2022.
reported feeling a "hot flush" over her head, face & neck immediately post vaccination & on arrival to observation lot, husband noted redden area on anterio neck & chest.  Requested medical evaluation. Seen as requested.  Denied any other adverse symptoms what so ever.  Redden area resolved without treatment in the 15 mins. advised wait period.
Quadracel being administered to a patient under 4 years of age with no reported adverse event; Initial information received  on 18-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 months old male patient, quadracel being administered to a patient under 4 years of age with no reported adverse event while receiving vaccine diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  Concomitant medications included Hepatitis A vaccine (Hepatitis A) for Immunisation.  On 17-Jan-2023, the patient received 0.5ml dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (lot: C5970AA) via intramuscular route in unknown administration site.  On 17-Jan-2023 the patient had a non-serious event of quadracel being administered to a patient under 4 years of age with no reported adverse event (product administered to patient of inappropriate age) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine.  Action taken with diphtheria, tetanus, AC pertussis and IPV vaccine (Quadracel) was 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.
Started on inside of left arm - spread out and around to bicep - about 1/3 of upper arm affected. 8 small hives. 3 medium hives. 1 large hive. None are itchy. Skin is warm and blotchy. Arm is throbbing. No open skin. Pain in arm has spread. Now neck hurts. Advised pt to get immediate medical care.
Patient received Moderna first dose 7/22, but was accidentally scheduled for Pfizer 2nd dose, Vaccinator gave Pfizer without looking at the card or patient record first.  Patient was informed of error and what to expect as far as side effects.
Pain, swelling, very hot to touch at injection site. Started 24 hours after inj. today is day 2 of symptoms. 4-29-08 recheck arm improving.
No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 23-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815: