chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up at early Sunday morning with low grade fever (100.7) chills, headache. Took Tylenol. Symptoms continued until Monday around 8:00 am the low grade fever was continual throughout the entire time, chills would come and go, headache was also persistent.
No adverse event; patient was given the Moderna bivalent vaccine as the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was given the Moderna bivalent vaccine as the first dose) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (patient was given the Moderna bivalent vaccine as the first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient was given the Moderna bivalent vaccine as the first dose) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (patient was given the Moderna bivalent vaccine as the first dose).    No concomitant medications were reported.  It was reported unknown patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported no reported adverse event from the patient as per HCP.  No treatment medications were reported.
A non-serious spontaneous report of half the total dose of FLUMIST was received from a physician concerning a female child subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician reported that his office received a report of 30 children ages ranging form five to seven years-old who received half the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Pain at injection site,  right deltoid, for 3 days and as this started to dissipate...on day 5 a very warm red/pink pruritic rash developed and increased in size.  Pt came into office on Day 7 after injection. No shortness of breath or chest pain.  No coughing.  No fever, nausea, vomiting.  No diarrhea or constipation.  Since on qd Claritin for good control of allergies and edges of rash becoming more faint, I added ranitidine as adjuvant to Claritin to stop pruritis. To return if no better in 3 days.  BP was elevated but pt had a lot of stressors which were discussed.  Follow up visit planned in 4 days.
First shot was fine no itching Or redness very mild side affects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (First shot was fine no itching Or redness very mild side affects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Encephalitis (Brain infection), Bilateral pneumonia (was hospitalized for 6 days and was pumped with so many steroids, antibiotics and Heparin injections) and Neurosurgery (3 brain surgeries). Concurrent medical conditions included Epilepsy (Epilepsy due to brain infection) and Drug allergy (Multiple allergic reactions to drugs).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (First shot was fine no itching Or redness very mild side affects). At the time of the report, VACCINATION COMPLICATION (First shot was fine no itching Or redness very mild side affects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-286573 (Patient Link).
Vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Obesity, Triglyceride increased and Depression. Concomitant products included HYDROXYZINE for an unknown indication.   On 07-Sep-2021 at 2:31 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Polymerase chain reaction: positive (Positive) Positive for COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no known drug allergies. The patient had no acute illnesses at the time of vaccination and up to one month before. Treatment medications were not reported.
Information has been received from a physician concerning a 17 year old female who on 19-OCT-2007 was vaccinated with the first dose of GARDASIL (655322/1211U). Per the reporter the patient developed a rash on her injection site arm "2 weeks after receiving the first dose of GARDASIL." Subsequently, the rash resolved on its own. On 27-DEC-2007 the patient was vaccinated with the second dose of GARDASIL . Per the reporter, again after a couple of weeks the rash reappeared. On 18-JAN-2008 the patient went to Urgicare and was given 60mg of PROMIFEN (prednisone) (unknown manufacturer). The prednisone therapy lasted until 22-JAN-2008 and the rash was resolved temporarily but returned again on 27-JAN-2008. No further information was provided. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-MAR-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 1644, unknown and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested
Pfizer Booster shot was given outside of CDC guideline on 8/19/21 at around 10:30 am.     His second Pfizer shot was given  on 3/10/21 and technically he was not eligible for a booster until  11/21.   My Distric Manager,   discussed this matter with the patient in person and the patient seemed to be ok'ed  with it.   At the time of the vaccination, the  patient physically  appeared fine and he was seen shopping in the store later.
felt bad, feels like something strange in body; felt bad, feels like something strange in body; lymph node growing near his rectum and it is uncomfortable and painful when he is sitting or when he is pushing on it with his fingers; lymph node growing near his rectum and it is uncomfortable and painful when he is sitting or when he is pushing on it with his fingers; lymph node growing near his rectum and it is uncomfortable and painful when he is sitting or when he is pushing on it with his fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2 (BNT162B2), administration date 05Jun2021 (Batch/Lot number: unknown) at the age of 53 years 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: FEELING ABNORMAL (non-serious), FEELING ABNORMAL (non-serious), outcome "not recovered" and all described as "felt bad, feels like something strange in body"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), DISCOMFORT (non-serious), outcome "not recovered" and all described as "lymph node growing near his rectum and it is uncomfortable and painful when he is sitting or when he is pushing on it with his fingers".  Additional information: Reporter states that he was calling about the Pfizer COVID 19 vaccine and provided a number of E100187. Reporter was not sure what this number was for.  No follow-up attempts are possible. No further information is expected.
she experienced a slight rash a couple days after the administration of PNEUMOVAX 23.; This spontaneous report was received from a retired pharmacist referring to herself, a female patient of unspecified age. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, vaccine scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.   On an unspecified date (reported as "many years ago"), a couple of days after the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient experienced a slight (mild) rash.   The outcome of rash (mild) was unknown. The reporter stated that she was not sure if the event was a result of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Immediate muscle contraction  and  injection site pain, not improved, and then increase in remaining injection site pain plus left arm weakness and reduced range of motion following 2nd injection  in series. ? SIRVA
Allergic reaction.  Itchy eye lids, swollen eyes, itchy scalp.  Rash on opposite arm, inside right elbow lasting at least a week.  Hive-like rash on same side (left) hip lasting two weeks.
This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. A male patient of an unspecified age and ethnicity received PREVNAR 13, (batch/lot number and expiry date unknown) at a single dose, rotavirus vaccine at an unspecified dose, and  TDAP at an unspecified dose; all vaccines administered on 29Jan2018 for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever on an unspecified date. The outcome of the event was unknown. Event took place after use of product. No follow up attempts are possible. No further information is expected.
Flu-like symptoms, headache, low-grade fever, very sore muscles/joints, loss of appetite, vomiting, diarrhea, dizzy, temporary loss of taste, continued random sharp/stabbing pains in various locations all over body with greater intensity.
Fully vaccinated patient developed Covid-19 breakthrough infection approximately 2 months after second dose and 1.5 months after 2 week waiting period. First dose of Pfizer vaccine administered on 8/10/ 2021. Patient reported severe headache, nerve pain, shooting pains in neck, brain fog, severe pain in injection site and fatigue beginning 20 min after first dose. Second  dose  administered per FDA guidance 21 days after first injection on 8/31.  No symptoms reported after second dose. COVID-19 test was administered on 10/29 and results were positive. Developed severe headache, cough, upper respiratory illness and sinus infection. Fever occurred 2 days after infection, 99.8 degrees, on 11/2 and was relieved by Tylenol. Severe fatigue, chest pain, cough and difficulty breathing reported 2 days after first symptoms on 10/31 to 11/2. Pulse oximeter showed oxygen level at 98% on 11/6. Gastrointestinal issues began approximately 5 days after first symptoms. Persistent fatigue, chest pain,  and GI symptoms have not yet resolved as of the date of this report, 11/9.
Unevaluable event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) 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 UNEVALUABLE EVENT (Unevaluable event). At the time of the report, UNEVALUABLE EVENT (Unevaluable event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter.  Treatment medication use information was not provided by reporter.
Client received flu vaccine 12/2/2017, her 4 yo child got the flu and her OB/Gyn prescribed TAMIFLU 2/15/2018 and she took 5 days of the TAMIFLU, at her next OB appointment on 3/6/2018 US showed the fetus had died. Client is not sure if the TAMIFLU had something to do with the miscarriage.
Initial medication error report received from a healthcare professional on 14 October 2013. The patient had received unstable dose of PENTACEL (Lot# unknown) on an unspecified date. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
First dose of Moderna was administered on 03/24/2021. Second dose was due on 04/21/2021, but was administered on 04/12/2021. Patient experienced swelling and tenderness in the arm where vaccine was administered, headache, body ache and fatigue. Patient experienced no adverse reactions post vaccination.
Fever of 101, muscle aches, nausea began 03/07/2020, lasting approx. 12 hours.  Woke on 03/08/2020 with red, swollen lips.  Took 50 mg Benadryl, swelling began going down within a few hours.  When swelling was gone, small vesicles began to appear across upper and lower lips, lasting approx. 2 weeks.  Swelling of lips and vesicles continue to appear every few days-few weeks.  Each subsequent episode is slightly less than previous episode and symptoms disappear more quickly, usually within 2-4 days at present.  In April 2020, vesicles began to form above upper lip, which continues to become red from time to time, and again each episode is more minor than previous. At present, vesicles seem to only appear in corners of mouth.  Saw health care provider in April and given antiviral, which cleared symptoms within 1-2 days, although they have continued to appear as noted above.
Exposed to COVID-19 around noon on September 1, 2022.  September 2, 08:00PM began having itchy scratchy throat, followed by headache, no cough but experienced pain in my chest. Went to bed very early. Woke up early with horrible sore throat. Took shower and got no relief. Developed wet cough. Slept for nearly a week. Lost 16 pounds.  The agency should instruct the public to perform a PCR test when you feel you have been exposed and the antibodies test to know when you are no longer contagious.
Woke up 8/20/21, 1 day after immunization, pain, redness to her elbow, warm to touch.  Went to the pharmacy where she was told to put on cortisone cream.  Called our office 8/25/21 to report incident.  Arm fine at that time.
Fever of 101.1 Nausea Excessive pain in right arm  Symptoms started about 11 hours after receiving the shot, and lasted for about 6 hours. Right arm is still sore a day later.
On the 10th, I had a sore throat. On the 11th, I woke up with a stuffy runny nose, coughing, mucus in my throat, and headache. I went to my Primary Care doctor on the 12th. I received a steroid shot and an antibiotic. I am still coughing and very congested.
Aug 29-Fever 103 deg, diarrhea, severe headache and lethargic. Symptoms 8/29-8/30. Sept 1 had hives on body. Improved on Sept 2. Returned to school on Sept 4.
Got a call from ER today 12/21/05 pt brought by paramedic seizing, fever 104.6. Did blood work, urine, CSF analysis all appear benign, fever persisted 8 days. ER doc was to admit pt. Physical was normal. Admitted hospital.
Shots given and instructed to use cold packs to site if soreness, redness, or inflammation occur. Pt. stopped by health dept. on 8/26 c/o pain in neck, left shoulder down to elbow. No signs of redness, swelling or infection noted. Cool to touch.
Left side chest pain (weighted chest, pressure pain,  piercing pain),  loss of movement\numb left arm,  right arm and both legs tingly and numb,  headache,  left side of neck numb.  Persistent for 12hrs.
Information has been received from a pharmacist concerning a geriatric or patient less than 60 years of age who on 12-OCT-2006 was vaccinated IM with a dose of Pneumovax 23. On approximately 12-OCT-2006, the patient experienced intense pain and soreness in the arm. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No product quality was involved. Additional information is not expected.
I got triple Moderna for vaccines. About 2 weeks after getting my booster shot, I started breaking-out in full body hives. I was extremely sensitive to all touch/abrasion. February 2022, I saw a dermatologist, and she diagnosed me with dermatographia. Now I have to take Claritin daily to prevent the hives. It has been over 2 months now and symptoms still persist (if I do not take Claritin daily).
I tested positive in rapid Antigen test; I tested positive in rapid Antigen test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 at 13:30 as dose 3 (booster), single (Lot number: FF2589) at the age of 53 years, 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's relevant medical history included: "High BP" (unspecified if ongoing), notes: High BP; "High triglycerides" (unspecified if ongoing), notes: High triglycerides; "Moya moya disease (middle cerebral artery" (unspecified if ongoing), notes: Moyamoya disease (middle cerebral artery block). Concomitant medication(s) included: AMLODIPINE oral; METOPROLOL oral; ATORVASTATIN oral; BABY ASPIRIN oral. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "I tested positive in rapid Antigen test". Clinical course: Other medication details: other medication in 2weeks product: amlodipine, other medication in 2weeks brand: generic, other medication in 2weeks administrator route: oral, other medication in 2weeks product: metoprolol, other medication in 2weeks brand: generic, other medication in 2weeks administrator route: oral, other medication in 2weeks product: atorvastatin, other medication in 2weeks brand: generic, other medication in 2weeks administrator route: oral, other medication in 2weeks product: baby aspirin, other medication in 2weeks brand: (name Withheld), other medication in 2weeks administrator route: oral. Adverse event: Pt suddenly felt sick (cough, chills, congested nose and throar). Pt tested positive in rapid Antigen test. Pt had finished full 5 day course of Paxlovid last Sunday (today was day 7) and tested negative last Tuesday. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive in rapid Antigen test; negative, notes: tested negative last Tuesday. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: The patient had received other medications within 2 weeks. Antiviral details, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 31May2022, Treatment stop date: 05Jun2022, Indication Treatment of COVID-19, Administrator route: Oral. Other medical history: High BP, High triglycerides, Moya moya disease (middle cerebral artery block).  Follow-Up (15Jun2022): Follow-up attempts are completed. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Patient received 0.1cc Td injection intradermally instead of a PPD test on 4/12/07.  On 4/13/07 the patient contacted Dr's office with a complaint of a local adverse reaction of erythema, induration and pain at the injection site.  On 5/24/07, the doctor's office confirmed that the patient recovered.
Left upper arm reddened on 9/16/00. Child was not complaining. On 9/17/00 at 07:30. left arm from shoulder to elbow was red, hard with a small blister. By 12:00, she was taken to ER. Arm from shoulder to elbow was red, hard, blistering and oozing. She was given a prescription for prednisolone and hydroxyzine. On 9/18/00, arm is improving.
blood clot in his pulmonary artery and several others in his legs; blood clot pulmonary artery; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot in his pulmonary artery and several others in his legs) and PULMONARY EMBOLISM (blood clot pulmonary artery) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Factor V deficiency, Factor II deficiency and MTHFR deficiency.    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 THROMBOSIS (blood clot in his pulmonary artery and several others in his legs) (seriousness criteria hospitalization prolonged and medically significant), PULMONARY EMBOLISM (blood clot pulmonary artery) (seriousness criterion medically significant) and DYSPNOEA (shortness of breath). At the time of the report, THROMBOSIS (blood clot in his pulmonary artery and several others in his legs), PULMONARY EMBOLISM (blood clot pulmonary artery) and DYSPNOEA (shortness of breath) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.  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.; 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.
Patient with febrile illness starting 6 days after vaccination. Nightly fever with myalgias for 6 nights, then improved. Patient did have blood work and urine studies done which were normal.
Vaccine given 2/7/12 on 2/9/12 client called office and stated "got hives all over" took BENADRYL with relief. Advised no more GARDASIL.