chrisvoncsefalvay/vaers-outcomes huggingface dataset:
when she touches her skin it hurts really bad, mostly on the leg and back; felt nauseous; bad, kind of tired bad; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (when she touches her skin it hurts really bad, mostly on the leg and back), NAUSEA (felt nauseous) and FATIGUE (bad, kind of tired bad) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer and Thyroid disorder NOS. Concomitant products included TAMOXIFEN, LEVOTHYROXINE SODIUM (SYNTHYROID), VITAMINS NOS and CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced TENDERNESS (when she touches her skin it hurts really bad, mostly on the leg and back), NAUSEA (felt nauseous) and FATIGUE (bad, kind of tired bad). At the time of the report, TENDERNESS (when she touches her skin it hurts really bad, mostly on the leg and back), NAUSEA (felt nauseous) and FATIGUE (bad, kind of tired bad) outcome was unknown.            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-396314, MOD-2021-396316 (Patient Link).
About 20 minutes after receiving injection, client felt dizzy and shortness of breath, pressure in chest. Called 911 and was taken to ER; treated with epinephrine and Benadryl.
Immediately c/o being dizzy, light headed, red face, sweating, nausea, c/o back pain-muscle tightness. Lasted less than 5 minutes.
received the 1st Moderna vaccine and is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine and is pregnant) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Amoxicillin). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Sep-2020 and the estimated date of delivery was 05-Jun-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine and is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine and is pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient's previous pregnancies included one live birth with the pregnancy end date 20-Nov-2019.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
PRETTY SERIOUS REACTION TO THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced pretty serious reaction to the vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of pretty serious reaction to the vaccine was not reported. This report was non-serious.
pt recvd flu vax & approx 1 hr later c/o feeling lightheaded & had a prickly feeling; felt faint, hot in the chest, flushed; BP 138/78; 2 hrs later felt better;
Initial and follow-up information has been received from the Merck Pregnancy Registry via physician concerning a 26 year old female with a history of Epstein-Barr virus infection, who on 09-MAR-2007 was vaccinated with a first dose of GARDASIL. On 10-MAY-2007 the patient was vaccinated with the second dose of GARDASIL. Subsequently the patient became pregnant. The patient's last menstrual period was on 22-JUN-2007. The estimated date of delivery is on 28-MAR-2008. Unspecified medical attention was sought. Ultrasounds were performed on 14-AUG-2007, 17-SEP-2007, and 13-NOV-2007 and were all within normal limits. At the time of the report patient's outcome was unknown. Follow-up information indicated that 37 1/7 weeks from her last menstrual period on 09-MAR-2008 the patient gave birth to a female infant. The infant weighed 7 pounds 3 ounces, and her apgar score was 9/9. The infant was normal with no congenital anomalies. The patient had no previous pregnancies and one full term delivery. Complications were possible mild pre-eclampsia and mild shoulder dystocia during labor and delivery. During pregnancy the patient experienced pregnancy induced hypertension (PIH). Diagnostic tests performed during pregnancy were a 24 hour urine every 6 weeks and NST's every week at starting at 32 weeks. Additional information is not expected.
bad muscle spasms/chills and soreness; bad muscle spasms/chills and soreness; bad muscle spasms/chills and soreness; Shortly after felt nauseous and had episodes of vomiting; Shortly after felt nauseous and had episodes of vomiting; Took temperature and had a mild fever at 100.4f.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3247, Expiration date was not reported), via an unspecified route of administration, administered in right arm on 04Feb2021 16:00 (age at the vaccination 34-year-old) as second dose single for covid-19 immunisation. Medical history included intestinal disorder (unknown gastric intestinal illness that is still be diagnosed). Concomitant medications included dexlansoprazole (DEXILANT) and vitamin d2. Historical vaccine included first dose of BNT162B2 (Lot number: EL3247), via an unspecified route of administration, administered in right arm on 14Jan2021 04:00 PM for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient felt fine after the injection and had no issues when patient went to sleep at 0600hrs. Woke up at the indicated time below to bad muscle spasms/chills and soreness. Shortly after felt nauseous and had episodes of vomiting. Took temperature and had a mild fever at 100.4 f on 05Feb2021 09:30. Patient Took a Goody's powder for fever and soreness. Symptoms have improved but nausea still persist. The outcome of the event nauseous was not recovered while for other events was recovering.
The same day I was feeling tired and it continued for 3-4 days.  I felt better for about 3-4 days again,  I relapsed with the muscle pain in chest and sometimes my extremities, sore throat, runny nose and extreme fatigue, more labored breathing upon exertion.  I am still very weak and right now, walk with weakness (I cannot walk down my basement stairs at this point -- hoping to improve).  As mentioned before, I don't know if this is a covid relapse or an adverse reaction.
Patient received the COVID 19 vaccine for age 5 to 11, yet patient is not age 5. Patient was registered as the wrong DOB which indicated he was already 5.  Family reports no adverse effects related to having received the vaccine.
Excessive dizziness vomiting sleeping in weeks months after receiving vaccine   Mental capability reduced to a child Rather distant and lost always exhausted  Always sleep
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 4 (booster), single (Lot number: GH9697) at the age of 57 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 08Apr2022 as dose 3 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. The patient had rebound beginning with runny nose and mild sore throat on evening of Saturday, 30Sep2023 (was symptom-free the previous two days). Positive Binax antigen test on morning of Sunday, 01Oct2023 (this morning). Today, sore throat was gone, but runny nose persists, as does mild fatigue (a lot like a mild head cold). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 23Sep2023 to 27Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314846 Same reporter/patient, different drug/event;
After the normal 24-48 hr symptom time period passed I continued to feel achy, foggy in the head, tired, difficulty with breathing.  Went to the gym 2weeks after for a workout and had to leave and eventually cancelled membership since it was painful to my joints when using the equipment.  If I exercised I was extremely tired and body aches kept coming back as if I had the shot symptoms again.  I had difficulty going up the stairs at work and after the first 7 steps had to stop at the landing and catch my breath to continue.  I am now having blood pressure issues that my heart doctor wants to start me on medication for.
Felt tongue tingle; Felt tongue going numb; Feel foggy; Having trouble sleeping; Having bad dreams; Have diarrhea; Have constipation; Burp has been smelling bad; Arm is still hurting; nauseous; Having chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Felt tongue tingle), HYPOAESTHESIA ORAL (Felt tongue going numb), FEELING ABNORMAL (Feel foggy), INSOMNIA (Having trouble sleeping) and NIGHTMARE (Having bad dreams) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PARAESTHESIA ORAL (Felt tongue tingle), HYPOAESTHESIA ORAL (Felt tongue going numb), FEELING ABNORMAL (Feel foggy), INSOMNIA (Having trouble sleeping), NIGHTMARE (Having bad dreams), DIARRHOEA (Have diarrhea), CONSTIPATION (Have constipation), ERUCTATION (Burp has been smelling bad), PAIN IN EXTREMITY (Arm is still hurting), NAUSEA (nauseous), CHILLS (Having chills) and HEADACHE (headache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date at an unspecified dose and frequency; SALINE [SODIUM CHLORIDE] ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (Felt tongue tingle), HYPOAESTHESIA ORAL (Felt tongue going numb), FEELING ABNORMAL (Feel foggy), INSOMNIA (Having trouble sleeping), NIGHTMARE (Having bad dreams), DIARRHOEA (Have diarrhea), NAUSEA (nauseous), CHILLS (Having chills) and HEADACHE (headache) had not resolved and CONSTIPATION (Have constipation), ERUCTATION (Burp has been smelling bad) and PAIN IN EXTREMITY (Arm is still hurting) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
patient has not received the second dose yet and more than 2 months has passed since first dose; A spontaneous report was received from a consumer concerning a female patient who experienced patient has not received the second dose yet and more than 2 months has passed since first dose.    The patient's medical history was not provided. No concomitant products were provided.   On 15-JAN-2021, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient was supposed to get the second dose on 12-FEB-2021, but the facility only had the Pfizer vaccine. The patient tried going to another distribution center but the patient could not get a dose. The patient had an appointment for the second dose on 25-MAR-2021, but that will be more than two months after the first dose. The patient was trying to get a different date for the second dose.     Action taken with mRNA-1273 in response to the event was reported as unknown.  The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of patient has not received the second dose yet and more than 2 months has passed since first dose for mRNA-1273 (lot# unknown), with no associated adverse events.
10 - 15 seconds of bleeding.  Patient later reported a bruise and nickel - sized knot
Red, itchy rash from neck to thighs. Not on arms, face or lower legs.
Patient is fully vacciated.  COVID+ on 11/25/2021.  Hospitalized from 11/25/2021-12/5/2021.  Dx on admission: hypoxia, new onset afib with rapid ventricular response, elevated troponin, COVID virus infection.Positive for fatigue. He presents to the ED due to a 2 day history of fatigue, cough, shortness of breath, fever, body aches, nausea, vomiting and diarrhea. Positive for dizziness.  Denies chest pain. Upon arrival, patient was found to be in A. fib with RVR, which he does not have a history of. Patient started on a heparin drip and Cardizem drip due to A. fib with heart rate ranging from 100 up to 130-140s. He is followed by cardiology infectious disease and palliative care.  He is followed by social work.  He is treated for covid 19 pneumonia.  DVT prophylaxis with heparin.  Remdesivir and decatron given. Despite medical treatment he continued to decline and he subsequent passed away.
throat was getting somewhat tight, some swelling; throat was getting somewhat tight, some swelling; slightly lightheaded; mild headache; This is a spontaneous report from a contactable other health professional (patient).  A 52-year-old female patient received first dose of BNT162B2 (lot no. and expiry date were not reported), via an unspecified route of administration into left arm on 20Jan2021 13:30 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history included allergies to shrimp and lobster, mild asthma and high blood pressure. Concomitant medication included diltiazem, benzoyl peroxide (BP), cetirizine hydrochloride (ZYRTEC), loratadine, paracetamol (TYLENOL) and vitamins. The patient had allergies to past blood pressure medications which included amlodipine besilate (NORVASC), irbesartan (AVAPRO) and lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. After taking first dose about 20 minutes on 20Jan2021 at 13:50 the patient felt slightly lightheaded and had mild headache, no real concern. Left observation area to go home after 45 minutes. No other symptoms at that point. Light headedness went away. While driving and running errands a few hours later the patient noticed her throat was getting somewhat tight, some swelling on 20Jan2021 at 16:30; this is similar to when she used to have shrimp/lobster allergic reactions. The patient took 1 tab of Benadryl before it got too bad and it subsided after about 30 min. No shortness of breath or any more symptoms so she went home and went to sleep after a few hours. She woke up and her throat had still some swelling. She called her doctor and she was recommended to take more allergy meds throught out the day and to report event to facility and to monitor. The swelling has not gone but much better. She was concerned about 2nd shot if it can be given where she was observed and monitored for a day. The patient recovered from slightly lightheaded on unspecified date. The outcome of headache was unknown and the remaining events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events throat tightness and throat swelling are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Received Pfizer COVID 19 vaccine on 1/3/21.  While waiting 15 minutes in observation patient report tightness  to her throat.  Was taken to ER
Chills (6hrs) , body aches (24hrs), headache (24hrs), Low grade fever (6hrs)
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 23-JUL-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (strength, dose, route of administration were not reported; lot# L007227, expiry date 03-MAR-2017), which had been improperly stored. There were no concomitant therapies reported. No adverse experience was reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Headache, Myalgia, Fever, Swollen under the armpit and breast Narrative:
p/vax pt seen for facial rash & itching;no other s/s reported;child sent home w/instructions to take DPH over the week;
no additional adverse event; Caller is a vaccine coordinator calling to report a temperautre excursion for VARIVAX. Caller reports that the VARIVAX was stored in the refrigerator since 15NOV2021. Caller reports that the refrigerator had an excursion with maximum temperautre of 5; This spontaneous report was received from a vaccine coordinator concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 01-JAN-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U015678, expiration date: 18-MAY-2023, administered as prophylaxis (strength, and route of administration were not provided) after experiencing a temperature excursion at a temperature of 51 Fahrenheit degrees (product storage error).   The reporter stated that the vaccine was accidentally placed and stored since 15-NOV-2021, in a refrigerator that had a temperature excursion. No previous temperature excursions and no additional adverse events were reported.   This is one of several report received form the same source.; Sender's Comments:  US-009507513-2209USA006115:
Several symptoms: Extreme fatigue after light exercise for a few minutes General aches and pains body-wide Night Chills and sweats
Initially had difficulty swallowing and facial droop within 45 minutes.  No has developed functional movement disorder and pseudoseizure.
Symptoms started a few hours after vaccine was given. Patient experienced fever up to 102 degrees F, joint pain, shivers, chills, fatigue, loss of appetite. Symptoms lasted about 24 hours.
A non-serious spontaneous report of fever, cough and nasal congestion has been received from a consumer concerning herself, an adult patient, subsequent to FLUMIST. The medical history included: patient did not have any concurrent illness nor did she receive any other vaccines within 30 days of receiving FLUMIST. No concomitant medications have been reported for this patient. On an unknown date, the patient received FLUMIST. On an unknown date, the patient experienced fever, cough and nasal congestion. The events fever, cough and nasal congestion resolved without treatment. Additional information was received on 25-Apr-2011 and incorporated into the narrative: outcome of adverse events as resolved and medical history.
Information has been received from a certified medial assistant concerning a 67 year old female, with unknown medical history and unknown drug reaction/allergies, who on 03-MAR-2006 was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#651330/1048P).  Later that same day, on 03-MAR-2006, the patient developed reddened area of 10 centimeters by 14.5 centimeters, swelling, and local heat at the injection site.  Unspecified medical attention was sought.  The patient's present statue was reported as recovering.  no product quality complaint was involved.  Additional information has been requested.
The child's attorney alleged that his mother received two injections of Rho {D} immune globulin, which contained thimersol, while she was pregnant. However, medical records indicate that the second injection was administered on 03-FEB-1994 and that the child was born on 02-FEB-1994. The child's immunization records indicated that he received injections of Engerix-B on 30-MAR-1994 and 09-JUN-1994. He received a third injection of heaptitis B vaccine on 27-APR-1995. He received Orimune on 30-MAR-1994, 09-JUN-1994, 27-AUG-1994 and 30-AUG-1995. He received Hib-Titer on 30-MAR-1994, 09-JUN-1994, 27-AUG-1994 and 30-AUG-1995. He received diphtheria and tetanus toxoids on 27-AUG-1994. he received a 4th injection of diphtheria and tetanus toxoids on 30-AUG-1995. He received a tuberculin skin test on 01-FEB-1995. He received injections of MMR vaccine and varicella vaccine on 30-AUG-1995. The child's attorney alleged that the child experienced autism and mercury poisoning. the reported sources of the mercury were the immunolobins his mother received, the childhood vaccines he received and the "highly toxic emissions of certain power production facilities in the environmental zone of his residence". The attorney alleged that "in the fall of 1999, test results revealed that (the child's) hair contained evidence of highly elevated levels of mercury deposits." The child reportedly "displays an array of symptoms typical of mercury poisoning" including "regression from normal neurological development into a severely impaired state of development." The attorney further alleged that the child "suffers neurological and other injuries as a result of having toxic heavy metals introduced into his developing body...The primary heavy metal contaminant is mercury. the mercury contamination combines with and compounds other exposures to cause permanent and disabling injury".