chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant medications were not reported. On 04-MAY-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection, lot # K005402, expiration date 07-NOV-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to the following temperature excursions (dates unspecified): the first lasting for 72 hours, with the highest recorded temperature of 46.3 degrees Fahrenheit (7.944444444 Degrees Celsius), the second lasting for 24 hours, with the highest recorded temperature of 64.8 degrees Fahrenheit (18.222222222 degree Celsius), the third lasting for 372 hours, with the highest recorded temperature of 59.9 degrees Fahrenheit (15.5 degrees Celsius), the fourth lasting for 48 hours, with the highest recorded temperature of 48.2 degrees Fahrenheit (9 degrees Celsius), the fifth lasting for 24 hours, with the highest recorded temperature of 48.1 degrees Fahrenheit (8.944444444 degrees Celsius), the sixth lasting for 24 hours with the highest recorded temperature of 47.5 degrees Fahrenheit (8.611111111 degrees Celsius), the seventh lasting for 96 hours, with the highest recorded temperature of 47.2 degrees Fahrenheit (8.444444444 degrees Celsius), the eighth lasting for 48 hours, with the highest recorded temperature of 46.8 degrees Fahrenheit (8.222222222 degrees Celsius), the ninth lasting for 48 hours, with the highest recorded temperature of 46.4 degrees Fahrenheit (8 degrees Celsius), the tenth lasting for 24 hours, with the highest recorded temperature of 46.2 degrees Fahrenheit (7.888888889 degrees Celsius) and the eleventh lasting for 24 hours, with the highest recorded temperature of 46.6 degrees Fahrenheit (8.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Was in ER yesterday for her COPD; A little sinus problem; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Was in ER yesterday for her COPD) and SINUS DISORDER (A little sinus problem) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Heart disease, unspecified.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced SINUS DISORDER (A little sinus problem). On 25-Mar-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Was in ER yesterday for her COPD). At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Was in ER yesterday for her COPD) and SINUS DISORDER (A little sinus problem) outcome was unknown.            Laboratory details were not provided.  No concurrent medication was reported. No treatment information was provided by the reporter. .   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Allergy reported; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events of sinus disorder and COPD, a causal relationship cannot be excluded. Patient's underlying COPD may have been contributory.
This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste/she can taste some things that have a "sharper" taste, but feels like it's more a memory of how those foods taste/Most of the things she eats taste like "blah") in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 001B21A) for COVID-19 vaccination. Concurrent medical conditions included Headache and Tremor of hands (Patient mentioned that had the hand tremors for a long time.). Concomitant products included CAFFEINE, PARACETAMOL (ACETAMINOPHEN AND CAFFEINE) for Headache, METOPROLOL, DILTIAZEM HYDROCHLORIDE (CARTIA XT), LOSARTAN, DIGOXIN, POTASSIUM CHLORIDE, WARFARIN, LEFLUNOMIDE, ATORVASTATIN and CALCIUM, COLECALCIFEROL (CALCIUM + D3 [CALCIUM; COLECALCIFEROL]) for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced AGEUSIA (loss of taste/she can taste some things that have a "sharper" taste, but feels like it's more a memory of how those foods taste/Most of the things she eats taste like "blah".). At the time of the report, AGEUSIA (loss of taste/she can taste some things that have a "sharper" taste, but feels like it's more a memory of how those foods taste/Most of the things she eats taste like "blah") outcome was unknown. No treatment medications were reported. Patient stated that since receiving the Moderna vaccine had been experiencing a loss of taste and also stated that did not remember exactly when the loss of taste started, it had started sometime in Feb-2021 or Mar-2021, and had lingered on. Company Comment: This case concerns a 77-year old female patient with no medical history, who experienced the unexpected non serious AESI event of Ageusia (of taste/she can taste some things that have a "sharper" taste, but feels like it's more a memory of how those foods taste/Most of the things she eats taste like "blah") unspecified days after receiving mRNA-1273 Vaccine. The patient received the 1st dose of on 13FEB2021, her 2nd dose on 14MAR2021. Loss of taste started sometime in FEB2021 or MAR2021, and has lingered on. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a 77-year old female patient with no medical history, who experienced the unexpected non serious AESI event of Ageusia (of taste/she can taste some things that have a "sharper" taste, but feels like it's more a memory of how those foods taste/Most of the things she eats taste like "blah") unspecified days after receiving mRNA-1273 Vaccine. The patient received the 1st dose of on 13FEB2021, her 2nd dose on 14MAR2021. Loss of taste started sometime in FEB2021 or MAR2021, and has lingered on. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Narrative: Patient received 1st and 2nd doses of Moderna Covid Vaccines on March 16 and April 13, 2021. Patients Covid Vaccine booster wasn't due until October 13, 2021 IF his first doses of the vaccine had been the Pfizer Covid Vaccine. However, patient came to clinic on 9/27/2021 and was administered a Pfizer booster dose of the vaccine. Patient is not immunocompromised. No adverse event was noted to have occurred as the result of this error.
In the 24 hours after the shot I had a sore arm, chills and sweats. A week and a day after the shot, my arm began to itch.  I examined the area and found a quarter size rough patch, slightly red. Within 24 hours I had a large(3x3) red, itchy, hot welt in that area. It went away after 2 days, leaving an itchy dry patch on my arm.  2 weeks after the shot, I got a migraine that lasted 3 days and was untouched by tylenol or ibuprofen, along with body aches, nausea, cramps, and diarrhea.
Itchy in the injection site; Swelling around injection site; Redness around the injection site; Pain around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy in the injection site), VACCINATION SITE SWELLING (Swelling around injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Pain around injection site) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FLUTICASONE FUROATE (ARNUITY ELLIPTA) and ETONOGESTREL (NEXPLANON) for an unknown indication.    On 27-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced VACCINATION SITE SWELLING (Swelling around injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Pain around injection site). On 03-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy in the injection site). On 30-Dec-2020, VACCINATION SITE SWELLING (Swelling around injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) had resolved. On 04-Jan-2021, VACCINATION SITE PRURITUS (Itchy in the injection site) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; Reporter'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.
I have RA and take medication to suppress my immune system. The booster shot, boosted up my immune system and so I had a flare-up of my joints, feet,knees,hands and shoulders. I stopped my Xeralto and instead t have been taken 3 Aspirens every morning to control the inflammation of my RA. It is now for the first time today, that I woke up with out pain. so I am ok again, but did want you to know of my reaction to the booster shot.
fever devel approx 9PM;mom reports just under 101;pt went to bed;devel hives on cheeks @ 12MN;c/o itching;mom gave APAP et DPH;sx resolved;
Initial unsolicited report received from a consumer (patient parent) on 23 August 2016. This case involves a 18 -year-old female patient who was vaccinated with a third dose of MENACTRA (batch number, expiry date was not reported) by intramuscularly in right deltoid on 12 August 2016. The patient had previously received Claritin 10mg, olanzapine 10mg and medical history of Type 1 diabetes, LANTUS and humulin Insulin and Hx of head/brain injury March 18 2016. Concomitant medications were not reported. On 18 August 2016, six day following the vaccination, the patient blood sugars went out of control 800-900 with elevated ketones. It was reported that, on an unspecified date the patient has been taken to emergency departments multiple times. The patient required ER. Laboratory investigations included urine culture showed trace of bacteria. Corrective treatment was not reported. On an unspecified date, the patient was recovered from the event and released from the emergency department. Upon internal review the case was considered as serious because of important medical event blood sugars went out of control 800-900 with elevated ketones. List of documents held by sender: none. Sender's Comments: This case concerns a 18 years old female with known history of type 1 diabetes, who experienced blood sugars went out of control 800-900 with elevated ketones 5 days after vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Time to onset is compatible with role of vaccine. However increase of sugar level can be due to many reason as patient is known case of diabetes type 1. Details regarding patients relevant medical history, about life style, patient diets, past vaccination history and tolerance are needed for complete assessment of the case. Based on the available information, no conclusion on the role of the vaccine can be drawn.
Hepatitis a shot given in left deltoid-noted pain in left neck 1 hr post shot given. Felt ok rest of the day. At 10:30 pm returning from work, had fuzzy vision, headache, took 2 Tylenol, went to bed, woke up at 2 am with severe headache, ringing in ears, fever checked at 102 degrees F,  joint hurt-esp left neck, took 2 Tylenol at 9am.  Ok by 4 pm.
7 moths too late for 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient asked if 7 months was too late for 2nd dose of Shingrix Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Felt wiped out; Fever; Chills; Aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt wiped out), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches and pains) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2020 and Convalescent plasma transfusion (Convalescent plasma therapy).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, 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 experienced FEELING ABNORMAL (Felt wiped out), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches and pains). At the time of the report, FEELING ABNORMAL (Felt wiped out), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches and pains) outcome was unknown.            Concomitant medications were not reported.  No treatment information was specified.   This case was linked to MOD-2021-071109 (Patient Link).
Patient received all vaccines.  Patient asked for an alcohol swab to snif because he stated he felt "dizzy".  Patient felt clammy and had a syncopal episode.  Patient remained in chair while the nurse and friend accompanying him supporting him.  Nurse called for assistance and three other nurses came to room.  Patient BP 80/40, HR palpable 50s, pale, pt arousable but not alert and oriented.  Applied cool compresses and monitored patient until more alert and oriented x 3, pt given small sips of water and a snack.  Pt explained he has a history of fainting with blood draws but not vaccines.  He also does not like watching tv or movies that show blood.  Patient monitored for another 15 minutes and left clinic with friend.
Skin rash on my right arm (I was injected on my left arm). Also hives from the rash in my ear canal. Itchy and swollen but not painful.
pt exp 4 hrs of screaming uncontrollably; APAP given twice a/any relief noted;
within an hour pt experienced body aches, head ache, fatigue, wheezing, lump in throat and eventually a red, tender arm at the injection site
This is in follow-up report(s) previously submitted on 7/15/2008. Initial and follow up information has bee received from a physician, a medical assistant and from a female patient through the Merck pregnancy registry, concerning the 26 year old patient with no known allergies, one previously pregnancy with one full term delivery, and no pertinent medical history, who on 21-May 2007 was vaccinated with her first dose of GARDASIL (lot #0210U), and on 22-JUL-207 was vaccinated with her second dose of GARDASIL (lot #0469U). There was no concomitant medication. The patient reported that in September 2007 she was currently 2 months pregnant. Follow up information received from the physician indicated the date of the patient's LMP was 26-JUL-2007, and the estimated date of delivery was 01-MAY-2008. The patient took prenatal vitamins (unspecified) during the pregnancy. On 28-DEC-2007, the patient had a routine ultrasound which was within normal limits. No further details were provided. Follow up information has been received from a medical assistant who reported that on 08-APR-2008 the patient had a normal vaginal delivery of a healthy and normal female infant born at 36 5/7 weeks estimated gestational age, pre-term with birth weight of 5 lbs 7 ozs. There were no complications for the mother or baby. Additional information is not expected.
At the time of filing this report, it has been over six months since my second dose of the Pfizer vaccine. There is a painful lump (not visible to the eye) in my arm where the vaccine was administered. It feels like an injury and stings every time I massage it. I feel the need to cut off that spot with a knife. It is very irritating. I have not yet seen a doctor, will be seeing one soon.
shortness of breath; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), HEADACHE (headache) and PYREXIA (fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Blood pressure Medication for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), HEADACHE (headache) and PYREXIA (fever). At the time of the report, DYSPNOEA (shortness of breath), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
70 old patient has a prescription for Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 70-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concurrent medical conditions included splenectomy.   On an unknown date, the patient did not receive Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 6-Jun-2022 Reporter's comments: The patient who had her spleen removed had a prescription for Menveo. Pharmacist had not yet administered Menveo to the patient. The consent to follow up was given. Additional Supportive Information: The patient had prescription of Menvevo, which was identified by the pharmacist and did not administered to the patient, which led to intercepted drug prescribing error.
1. Chest pain 2. Elevated troponin 3. Myocarditis Went to hospital first than transported to another facility, then transported to another facility.
24 hrs after initial dose of Moderna vaccine, I QUITE SUDDENLY, felt EXTREMELY ill. I immedently drove home and literally passed out in my front hallway. whwn I came to my senses, I realized that I, obviously had a nigh fever-103.4! Phoned my friend (live alone0 since I was somewhat DELILIOUS -we went to Hospital ER. I was "treated and released". 48 hours later I was (Sunday afternoon). I was forced to go to an Urgent Care facility, as the injection site had developed cellulitis. i was given a 10 day regimine of Ceftin (broad spectfum antibiotic) to combat the infection. NO ONE SHOULD HAVE A VACCINE AT THIS FACILITY! I HAD TO INSIST THAT THE ADMINISTRATOR OF THE VACCINE "WIPE DOWN/DECOMMI
Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th February 2022, the patient received the 1st dose of Shingrix. On 14th February 2022, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: The reporter was patient who called in to report side effect of Shingrix. The patient received dose of shingrix and developed a case of shingles (confirmed by HCP). The reporter consented to follow up and consented to contact HCP.
A Football player ended up and can't run anymore 7 Miles that he used to; when he walks he is trembling only; he doesn't have his life anymore; This is a spontaneous report from a non-contactable consumer (friend's husband).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported, via an unspecified route of administration on an unspecified date as dose number unknown, single for an unspecified indication.  The patient medical history and concomitant medications were not reported.  The patient was a football player ended up and can't run anymore 7 Miles that he used to, he quit football and he was in bed, when he walks he was trembling only, crippled and he doesn't have his life anymore. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Nausea/Gastrointestinal distress, then severe headaches 4 days later. Patient took hydrocortisone 5mg tab daily as needed to treat headache.
Patient came in to clinic on 3/12/07 - 3d after immunization. Mother reports one day after immunization swelling and redness started at Left deltoid imm site, increase swelling x 2 days. On 3/13/07 redness and swelling diminished. She was d/c'd from office.
A few hours after patient received both vaccinations, she went out to dinner. At dinner, she had some wine and at the conclusion of the meal, her leg "just gave out" and she had trouble walking. For the next 4 days, her husband had to help her with walking as she had muscle weakness. In addition, she said there was swelling on her injection site and pain in her shoulder. She informed the pharmacy of this on the fourth day of the reaction, 10/30/17. The pharmacist advised to her seek prompt medical attention. We followed up with her the next day at which point she states that she chose not to visit a doctor because she is feeling much better. We recommended again for her to visit a doctor and she stated that she will bring up the matter with her neurologist at her next appointment on 11/7/17.
My initial dose was the Johnson & Johnson (April 2021). The booster shot was Moderna. I experienced pain at the injection site, extreme fatigue, headache, chills and dizziness.
This is a spontaneous report from a non-contactable physician. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced soreness for 3-4 months on an unspecified date with outcome of unknown. No follow up attempts possible. No further information expected.