chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient. This refers 23rd out of 84 patients. It was reported that, the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported) between 25-Oct-2017 to 27-Oct-2017 (as reported). The vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C) and was administered to the patient. The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain). Vaccine has since been discarded. Follow up received on 09-Nov-2017: It was reported that, the vaccine was administered between 25-Oct-2017 to 27-Oct-2017 (as reported). The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-17 (could have been between 2-8C, but not certain). Vaccine has since been discarded. Amended narrative accordingly.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; 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 62-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 at 13:00 as dose 3 (booster), single (Lot number: Fk9893) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 30Mar2021 at 13:00 as dose 1, single (Lot number: 1808980), in left arm and on 26Nov2021 at 10:00 as dose 2 (booster), single (Lot number: 1822811), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Apr2022 at 13:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 19Aug2022 to 23Aug2022 for Treatment of COVID-19. Clinical Course: There were no other medication in 2weeks. After paxlovid therapy, rebounded with flu like symptoms. Congestion, sniffles, low grade fever and chills.
Two days after my first dose, I lost all taste.  It was evening time when I tried to eat and realized I could not taste any of it.  I could smell it but no taste.  I have not seen my doctor yet but have made dental appointment to make sure it is not dental related as well as contacting the ENT to rule out any issues related to that.  I did a nasal wash through both nostrils but that did not help me regain my taste.  I never regained my taste when the second dose was administered on 9/2/2021. As of today 9/13/2021 I still have no taste.
Soreness in arm from shoulder to elbow for at least a week. Arm is still bothering him after at least 6 weeks. He describes it as he has worked out too hard (sore muscle ache) when not in use and when he uses his arm it hurts and feels like a pinched muscle. I encourage him to see dr and advised him to apply warm and cold compresses alternating them.
Drug Ineffective; suspected COVID-19; Unusually heavy periods following injection that still persists today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: EP7533) at the age of 20 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug Ineffective"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "suspected COVID-19"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 01Jun2021, outcome "not recovered", described as "Unusually heavy periods following injection that still persists today". The patient underwent the following laboratory tests and procedures: covid-19: (unspecified date) positive; sars-cov-2 test: (2021) negative. Therapeutic measures were not taken as a result of heavy menstrual bleeding. Clinical course: Unusually heavy periods following injection that still persists today. With no other contributing factor. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Covid test post vaccination: Covid test result: positive. Device date was reported as 23Aug2021.  No follow-up attempts are possible. No further information is expected.
The morning after the shot, I noticed vaginal bleeding/light spotting. I thought maybe it was just a slight reaction. By the evening, it had become heavier. By the following day, it was heavy and clotting was starting to develop. The Tuesday and Wednesday following the vaccine I had extremely heavy vaginal bleeding and clotting - going through a super plus tampon every hour and a half to two hours. By Thursday it had subsided a bit. By Friday it had lightened tremendously and by the following Saturday it was gone. But then Saturday evening the spotting picked up again. Sunday (3/14) the flow picked up again and by Monday (3/15) it was heavier with small clotting. Today (3/16) it is heavier with clotting again. My gynecologist did an exam and advised that I double my birth control for a few days to see if that will control it. She also took blood work (results not in yet).
This spontaneous report was received from a patient's mother and refers to a 3-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-FEB-2019, the patient was vaccinated for the first time with VAQTA, (reported as "Hep A manufactured by Merck"), (dose, frequency, lot # and expiration date were not reported) for prophylaxis. On the same date, the patient was vaccinated with an unspecified influenza virus vaccine. On 14-FEB-2019, shortly after receiving the vaccines, the patient experienced a reaction to vaccines and developed redness and swelling at the injection site, trouble breathing and tremors. The patient sought medical attention. He was taken to an unspecified urgent care, and at the time of the report, was under medical care for the symptoms. The outcome of tremors, trouble breathing, redness and swelling at the injection site was reported as not recovered. The reporter considered the events to be related to VAQTA and influenza virus vaccine.
Information has been received from a nurse referring to a patient of unknown age and gender. No current or historical conditions were reported. On 02-APR-2015, the patient was vaccinated with VARIVAX (Merck), 0.5 ml, subcutaneous (lot # K003420 and expiration date 06-MAR-2015). The vaccine of VARIVAX (Merck) was post temperature excursion, which excursion was supported. No adverse effects noted. This is one of two reports from the same reporter. Additional information has been requested.
Low grade fever, heart palpations, heavy feeling in chest, fatigue 8/02/2106 low grade fever muscle pain in legs and feet, fatigue causing me to miss work. This continued and 13 days later a severe, painful herpes outbreak. My Dr. treated me with anti viral meds on 8/13/16. As of today I still have nerve pain in bottom of feet and fatigue.
Case number PHEH2016US027471, is an initial spontaneous report received from a health care professional on 20 Oct 2016. This report refers to a female patient of an unknown age. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX Quadrivalent (batch number 185325A) at a dose of 0.5 ml subcutaneously instead of intramuscularly on 19 Oct 2016. No adverse event was reported following this maladministration. This case was considered lost to follow up at initial
excruciating stomach pains for several hours, fatigue, body aches, headache.
Injection arm became sore about an hour after receiving the shot. The following morning when I woke up I had mild body aches, on the third I feel like a mild case of the flu and very tired.
itching similar to when I've eaten shellfish when I break out in hives; woke up from my sleep; itching; scratching; red spots; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), SCRATCH (scratching), RASH MACULAR (red spots), URTICARIA (itching similar to when I've eaten shellfish when I break out in hives) and SLEEP DEFICIT (woke up from my sleep) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Shellfish allergy and Allergy to chemicals (Allergic to polyethylene glycol ingredient).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PRURITUS (itching), SCRATCH (scratching), RASH MACULAR (red spots) and SLEEP DEFICIT (woke up from my sleep). On an unknown date, the patient experienced URTICARIA (itching similar to when I've eaten shellfish when I break out in hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Itching, at a dose of 1 dosage form once a day. At the time of the report, PRURITUS (itching), SCRATCH (scratching), RASH MACULAR (red spots), URTICARIA (itching similar to when I've eaten shellfish when I break out in hives) and SLEEP DEFICIT (woke up from my sleep) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported.
Sore arm; He did have a temperature; first vaccine to underage patient on 16/Aug/2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (He did have a temperature) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first vaccine to underage patient on 16/Aug/2021) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C219) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (He did have a temperature) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first vaccine to underage patient on 16/Aug/2021). On 16-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first vaccine to underage patient on 16/Aug/2021) had resolved. On 18-Aug-2021, PAIN IN EXTREMITY (Sore arm) and PYREXIA (He did have a temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Body temperature: increased (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment  medications were provided.  It was reported that patient went to get the second dose on 17-SEP-2021 but did not get the second dose because  as he was under age. The clinic did not have any vaccines made by other manufacturers. His mother was concerned because he could not get another vaccine until he would be 16. He had a letter from the vaccine provider for his school as the vaccine was required.
I was going in to have a surgical procedure on May 5th, they prepped me, did a transesophageal echocardiography and discovered I had blood clots in my heart in the aortic appendage. They woke me up and told me I needed to go home, make an appointment with my cardiologist to see where I should proceed from here. I am currently waiting to see my cardiologist.
Unsure of advents. Patient returned to pharmacy in a wheelchair on 1-27-13 at 2:30pm requesting a copy of the VAR consent form. She said 3 weeks after getting flu shot she ended up in the hospital with a diagnosis of ADEM.
This is a spontaneous report by a contactable medical assistant. This female medical assistant reported on behalf of a male patient who was administered with the second dose of PREVNAR 13 in thigh on 29Nov2012 at 10:15 am. Vaccines taken within the last four weeks were none. He had previously received the first dose of PREVNAR 13 in thigh, a dose of PENTACEL, and a dose of hepatitis A vaccine, on 27Aug2012. Relevant medical history included ongoing heart murmur. Relevant concomitant medications were none. On 29Nov2012, after vaccination, the patient experienced seizures. Relevant lab data was none. At the time of the report the clinical outcome of above mentioned event was unknown. Follow-up (28Jan2013): Follow-up attempts completed. No further information expected.
rash on arm; itchy arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH (rash on arm) and PRURITUS (itchy arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced RASH (rash on arm) and PRURITUS (itchy arm). On 04-Mar-2021, RASH (rash on arm) and PRURITUS (itchy arm) had resolved.        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.
Shortness of breath. Elevated Blood pressure. Chest tightness. Diaphoretic. Took BAYER Crystals at home - did not seek medical attention.
Mom reports to PHN 12/18/07 that first 9/17/07 IMM given and returning home baby had redness, swelling from thigh to knee, knot at injection sites.  Duration about 36 hrs.
Developed L-sided facial pain c/w trigeminal neuralgia on 3/20/23, developed L-sided facial weakness c/w Bell's Palsy on 3/21/23. Pain resolved within 1 week, continues to have mild Bell's Palsy.
Did not witness-mother said same symptoms as sister just not near as severe-redness, swelling on left arm.
Partial dose injection; Syringe leaked; A spontaneous report was received from a pharmacist concerning a 44 year old patient who received Moderna's COVID-19 Vaccine (mRNA-1273)and experienced a partial dose injection.   The patient's medical history and relevant concomitant medications were not reported.   On 29 Dec 2020 the patient received their first of two planned doses of mRNA-1273 intramuscularly  for prophylaxis of COVID-19 infection.   While the dose was being administered, some of the vaccine leaked out and caused a partial dose injection  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event partial dose injection was recovered/resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered and syringe issue for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of Incorrect dose administered and syringe issue.
pt ran a fever of 102 or 2 days; persistant crying for 5 hrs; hooping cough like sx; pt also ran a low grade fever for a wk; pt did not want to eat; crying during sleep & hard to wake up;
2 days after having vaccine she fell and scratched knee. 3 days later dad noticed a ring of hives around scratch, also hives on back of thighs, lower back -  did not have BENADRYL. Within next 12-24 hours had developed fever 101-102 - had TYLENOL. Lethargic, vomited 2-3 x was better after 36 hrs. Has had reaction to amoxicillin.
Pt reported mild itchiness on both hands and face , no SOB , reported by mother, supervisor was advised and EMT assesed pt, was advised to go to hospital if symptoms get  worse, advised to drink benadryl as needed , BP 127/85 , P - 98 , O2- 97 .  Pt. stable, no SOB, not in distress.
No adverse affect reported from patient. Moderna vaccine held at lower temp than recommended by Moderna (-90 to -60 degrees Celsius). Moderna deemed vaccine viable for use.
Vomitting and chills; Vomitting and chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in leg right, administration date 10Nov2021 16:30 (Lot number: FK5127) at the age of 7 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]. The following information was reported: CHILLS (non-serious), VOMITING (non-serious) all with onset 11Nov2021 16:45, outcome "not recovered" and all described as "Vomitting and chills". Therapeutic measures were not taken as a result of chills, vomiting.  Additional information: Facility type vaccine was given as hospital. There was no other vaccine administration in four weeks. Other medications in two weeks reported as focalin. Patient had no covid prior vaccination or tested covid post vaccination. No known allergies were reported.   No follow-up attempts are possible. No further information is expected.
Starting about 4 hours after injections, had alternating one hour of unconsolable crying and 4 hours of sleep. About 14 hours after injections, developed fevers of 103 degrees rectally. About 24 hours after injections, developed pale episodes with mildly limp.
2 days p/DTP #2 given lt arm pt devel 9.5cm x 7.5cm indurated red macule, painful, hot, whole upper arm swollen;
Initial unsolicited report received from a non healthcare professional on 28-Oct-2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of YF-VAX (manufacturer: Sanofi Pasteur, batch number, expiry date, dose details, route and site of administration were not reported) on an unspecified date (reported as 3 weeks ago). The patient illness at time of vaccination and pre-existing physician diagnosed allergies, medical conditions, birth defects were not reported. It was unknown if the patient was previously vaccinated. On unspecified date, post vaccination, the patient experienced a sore arm. There was no erythema, warmth or tenderness to actual site and there was no fever. It was reported that patient had multiple vaccines administered on the same day (details were not provided). Laboratory investigations and corrective treatment was not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
softball size lump reported at injection site (deltoid), armpit tender and hard; side of L breast tender; itching  Narrative:
Hurt on all of her body; Headache; Calf hurting really bad/ Shooting pain into foot; Both feet extreme cold; Nose was running; All the stuff going down her throat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN, HEADACHE, PAIN IN EXTREMITY, PERIPHERAL COLDNESS, and RHINORRHOEA in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included TEMAZEPAM and DOXEPIN for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN, HEADACHE, PAIN IN EXTREMITY, PERIPHERAL COLDNESS, RHINORRHOEA, and OROPHARYNGEAL DISCOMFORT. The patient was treated with ASPIRIN at an unspecified dose and frequency. At the time of the report, PAIN, HEADACHE, PAIN IN EXTREMITY, PERIPHERAL COLDNESS, RHINORRHOEA, and OROPHARYNGEAL DISCOMFORT outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Additional information received. Added new events and their outcome. Updated concomitant medications and Treatment medications.
temperature excursion that occurred several days ago in the Freezer; No adverse event; Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, 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 18-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer) 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 POOR QUALITY PRODUCT ADMINISTERED (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer).    No Concomitant medications were provided.  It was reported that vaccine that underwent a temperature excursion in the freezer was just found out about the excursion today in an audit.  Patient did not reported any adverse event.  No treatment medications were provided.
After 30 minutes had tingling in lips, swelling n cheeks, slight rash on her chest and some chest tightness.  Within an hour felt abdominal gassiness and burping
Arm slightly sore about 2 hours after injection. Only upper arm near injection site was sore for a little over 48 hours. Headache and fatigue started about 9hours after injection. Continued symptoms lasted about 48 hours.
Severe neck and throat pain, throat hurt when breathing.  No chest pain, no shortness of breath.  Lasted until about 2am.  Anxious because concern about being cardiac.  Next day very tired and headache.