chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 29-NOV-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R018731, expiration date: 27-FEB-2020, strength, dose, frequency and route unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
The initial side effects were headache, dizzy, chills, shivering, they subsided in a day. Pain at the injection site right arm.  Two days later large swelling and redness, tender and hot to the touch. Called the location where I had the Covid shot.   Was advised to contact my PCP if pain persists, I contacted Dr.s office, they advised me to come to the office.  I met with  Nurse Practitioner, and was diagnosed with Cellulitis, which is a skin infection caused by the puncture by the Covid-19 vaccination in my right arm.  I was prescribed an antibiotic Cephalexin 500MG to take twice a day with meals for 7 days.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 08-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000862: US-009507513-1907USA000923: US-009507513-1907USA000938: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924: US-009507513-1907USA000937:
Thursday August 3rd 2006 appx. 1500 hrs. wife noticed an abnormal looking patch of skin on right shoulder blade.  Pt. sought treatment at provider and was told it was nothing.  4 August 2006 2nd visit to provider the site had grown and was told it was "a contagious bug bite" and put on an antibiotic.  7 August 2006 3rd visit to ER Patient was counseled about a possible Smallpox (Vaccinia Transfer) and told to seek attention at the medical treatment facility.   Patient reported to the Immunization clinic today 8 August 2006 complaining of neck sorness (possible swollen lymph nodes) and patch of skin on right shoulder blade that looks exactly like her husbands vaccinia vaccination site.   Patient was extensively counseled about how to not transfer the vaccinia to another living being watched 28 minute video about smallpox vaccinations and this vaers was submitted.   Patient was asked to not be around small children for 2 weeks and asked to f/u in 3 days to the treatment facility.
given a dose of Fluzone MDV from a vial that was at 18.6 C for 6.5 hours; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143997, 2019SA144005, 2019SA144004, 2019SA144008, 2019SA144007 and 2019SA144006 (same reporter).  This case involves a 5 years old female patient who received 0.5 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] which was stored at 18.6 degree C for 6.5 hours.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 16-May-2019, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Formulation: unknown, lot: UJ005AE, expiry date: 30-Jun-2019) via intramuscular route in the right arm.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
kind of felt run down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: EM9810) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "RA", start date: Feb2020 (ongoing); "autoimmune disorder", start date: Sep2005 (ongoing), notes: he would assume his diabetes is the autoimmune disorder; "Hairy Cell Leukemia", start date: 1992 (unspecified if ongoing), notes: he states this was the start of his problems, he had it twice, 1992 and then again JUL2005; "Hairy Cell Leukemia", start date: Jul2005 (unspecified if ongoing), notes: he states this was the start of his problems, he had it twice, 1992 and then again JUL2005; "Neuropathy" (ongoing); "bad knees" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, LOT: EM9810, injection, left arm, unknown dosage, No events reported .), administration date: 19Feb2021, when the patient was 65 years old, for COVID-19 Immunization; Flu shot (After the Covid shot, it was almost exactly a month after he come out of it, that was only 2 weeks ago or something), for Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 18Mar2021, outcome "recovered" (20Mar2021), described as "kind of felt run down".  Additional information: Caller states he has an autoimmune system disorder and RA, both of which puts him in the high risk category so he got the third vaccination, the first one, nothing, second one, kind of felt run down for a couple days, the third almost killed him, he thinks anybody else would have been to the hospital but he didn't want to, he was down for 2 weeks and 3 days of that he doesn't even remember those days. No visits of Emergency Room and Physician Office (he called his doctor and that was about it). It was unknown if the patient had prior vaccinations within 4 weeks.   Follow-up attempts completed. No further information is expected.
patients who received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.  On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Vaccines were placed in refrigerator On 13-Jan-2022.  The treatment information was unknown.   This case was linked to MOD-2022-491752 (Patient Link).
One round flat lesion on my left breast appeared. I was originially misdiagnosed as having ring worm and was given 10 day course of treatment. At end of 10 days the spot had not resolved and I was given a 10 day steroid cream. Within 3 days after starting the steroid cream, I broke out into an itchy red rash on my torso and back. Another trip to the doctor for a steroid shot and 7 day oral steroid. After another 7 days there was slight relief but it had not cleared. I then went to a dermatologist who believes that it could be pytariasis rosea and may have been an adverse reaction brought on by the H1N1 nasal mist. She prescribed another round of steroid foam and antihistimines. It has been over a month and I still suffer with this and am told that it could last for up to 6 months. It is uncomfortable, unsightly and incredibly inconvenient (affecting my work, travel and psychological state). Had I known the result I would have never chosen to get this vaccine and won't again.
Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, severe muscle pain, and large swollen lymph node (size of golf ball under left arm/near injection site) 12 hours after second shot. Adverse events diminished 12 to 48 hours later.
Metallic taste in her mouth; FELT LIKE HIT BY A TRUCK; SPLITTING HEADACHE; TOUNGE STARTED TO ITCH; Fatigue; PAINS; CRAZY DREAMS; Sore arm; Face little flush; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm), FLUSHING (Face little flush), ORAL PRURITUS (TOUNGE STARTED TO ITCH), FATIGUE (Fatigue) and PAIN (PAINS) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO MEDICAL HISTORY WAS PROVIDED.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and LOSARTAN for Product used for unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 ml. On 25-Mar-2021, the patient experienced MYALGIA (Sore arm) and FLUSHING (Face little flush). On 21-Apr-2021, the patient experienced ORAL PRURITUS (TOUNGE STARTED TO ITCH), FATIGUE (Fatigue), PAIN (PAINS) and ABNORMAL DREAMS (CRAZY DREAMS). On 22-Apr-2021, the patient experienced FEELING ABNORMAL (FELT LIKE HIT BY A TRUCK) and HEADACHE (SPLITTING HEADACHE). On 23-Apr-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth). On 25-Apr-2021, ORAL PRURITUS (TOUNGE STARTED TO ITCH), FATIGUE (Fatigue), PAIN (PAINS), ABNORMAL DREAMS (CRAZY DREAMS), DYSGEUSIA (Metallic taste in her mouth), FEELING ABNORMAL (FELT LIKE HIT BY A TRUCK) and HEADACHE (SPLITTING HEADACHE) had resolved. At the time of the report, MYALGIA (Sore arm) and FLUSHING (Face little flush) outcome was unknown. Not Provided          CONCOMINANT MEDICATIONS LOSARTAN AND ASPIRIN WERE USED.  GATORADE ,WATER AND TYLENOL WERE USED   This case was linked to MOD-2021-090828, MOD-2021-090828 (Patient Link).
Patient had a seizure that night and didn't have a fever and never had that vaccine had MRI EEG and CAT scan and blood work all come back normal and the EEG had no seizure activity on it.
Starting 04/23/2022, I started getting a runny nose and mild cough. I thought it was just allergies because they act up around this time of the year. On 04/24/2022, I had no energy, a bad migraine, my cough was bad and I just felt very off. It rolled over into the early week and by 04/26/2022 the dry patch cough would be intermittent. On 04/27/2022, my cough was so bad that I ended up calling out of work that day. I was coughing so hard that I thought I would cough up blood. So, I made an appointment for Urgent care for 04/28/2022. On 04/28/2022, I was tested for COVID-19 which was positive. My whole family then tested positive for COVID-19. For the rest of the family, they had intermittent cough but that's it. To this day, the cough is lingering on for me but varies in intensity. My husband tested again today, and he is still positive.
Chills, low grade fever to start at 98.1, full body aches, fatigue, temperature rose to 101.1 then about 9:00 pm fever broke and back down to 98.0 and felt fine ever since.
pt recv vax & exp pain @ inj site;pt was nauseous, diaphoretic, & felt that pt was going to have diarrhea;pt then felt cold, clammy & sweaty;pt was conscious;radial pulse was imperceptible;pt had no BP;carotid pulse 40/min
Presents w/SOB & diarrhea x 1 wk also w/progressive weakness and congestion.  Upon arrival to the emergency department patient was found to be COVID positive. Admitted for COVID-19 pna, tx w/abx, steroids, remdesivir, zinc; dc'd home
nausea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Feb-2021, the patient experienced NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-037329 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 77-year-old male patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th April 2018, several hours after receiving SHINGRIX, the patient experienced muscle pain, tiredness, pain in arm, shivering and sleeplessness. On an unknown date, the outcome of the muscle pain, tiredness, pain in arm and shivering were recovered/resolved and the outcome of the sleeplessness was unknown. The reporter considered the muscle pain and shivering to be related to SHINGRIX. It was unknown if the reporter considered the tiredness, pain in arm and sleeplessness to be related to SHINGRIX. Additional information was received as follows: The patient reported that he received a dose of SHINGRIX in the afternoon. On the same evening, the patient experienced tiredness, muscle pain, and shivering. The patient stated that he was not able to sleep because of the shivering. The patient stated that he emailed his physician to let him know about the symptoms.
Pt. complaint of dizziness, itching, and difficulty breathing. Administered 0.3mg Epipen once.
ITP platelets dropped to less than 40. Petechial rash over arms trunk and legs, with nose bleeds x 2.
Welt at injection site for about 1 week.  Itching at injection site.  Warm to touch at injection site.
Information has been received from a registered nurse (R.N.) concerning a 7-year-old female who on 10-OCT-2007 was vaccinated inadvertently with a dose of ZOSTAVAX (Oka/Merck). No adverse symptoms were reported. No outcomes were reported. No product quality complaint involved. Additional information has been received on 06-FEB-2008 via a telephone call with R.N. She explained the reason for product confusion was that they had not received a varicella virus vaccine live (Oka/Merck) shipment but received a ZOSTAVAX (Oka/Merck) shipment instead. The nurse said she did not know that ZOSTAVAX (Oka/Merck) had been ordered and read "varicella zoster" on the vial label and thought it was for chicken pox and administered it to the child. The R.N. explained that it would have helped if the sales rep had done a phone conference prior to them receiving the ZOSTAVAX (Oka/Merck) so that she would have been aware that it was for shingles. She also reported that it "would have helped if the ZOSTAVAX (Oka/Merck) vial indicated shingles. The child is fine and had no adverse experience." Additional information has been requested. Additional information was received from the registered nurse concerning a 7-year-old Female stundent with no pre-existing allergies, birth defects or medical conditions who on 10-OCT-2007 at 07:27 am was vaccinated subcutaneously in the right arm with a first dose of ZOSTAVAX (Merck) (lot# reported as 04560) instead of VARIVAX (Merck). No adverse reactions occurred and no relevant diagnostic tests were performed. No additional information was reported.
Employee began receiving IZ's on 3/11/98 as requirement of employment. In April, 1999, he noted symptoms of swelling and pain in his hands. In September of 1999, he was dx'd with rheumatoid arthritis. Through the fall and winter of 1999-2000 he had occasional episodes of joint pain and swelling, though less frequent and less severe than over the summer of 1999. These episodes of joint pain and swelling affected mainly joint; hands, wrists, elbows, shoulders, knees and hips. In the spring and summer of 2000, the frequency and severity of joint pain and swelling increased. By August, 2000, he was having longer lasting and severe pain and swelling. He had fluid aspirated from his left knee. His RA factor was elevated. He began oral and IV steroid therapy. In August, 2000, he started Embrel injections with good response. Symptoms have been decreasing in frequency and severity. He is currently taking Embrel, Azulfidine, Plaquenil and Celebrex.
Muscle ache; headache; chills; temp of 99.3; This is a spontaneous report from a contactable 62-year-old non- pregnant female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 08Feb2021 14:45, at single dose in right arm for covid-19 immunization. The patient medical history included migraines. The patient had no known allergies. Historical vaccine included bnt162b2 (product: Covid-19, brand=Pfizer, lot unknown-False, administration date-18Jan2021, administration time-02:45 PM, vaccine location-right arm, dose number=1). The patient took the vaccine at workplace clinic. Concomitant medications were not reported. On 08Feb2021 at 23:45, the patient experienced muscle ache, headache, chills, and temperature of 99.3. The patient did not take any treatment for the events. The outcome of the events was recovered on an unknown date.  Information about lot/batch number has been requested.
Patient complained of dizziness about 5 minutes after shot. Also stated felt shortness of breath described as chest tightness but no wheezing. Offered water, Gatorade, and Benadryl. Patient took water and Gatorade. Stated was feeling better. Checked on patient minutes later and had another wave of the feeling. Spacing was further and less severe. At 9:53 am patient got another wave of dizziness/tightness and 911 was called at 9:57am. Patient reported no side effects to first dose but when EMS arrived they claimed experiencing this with the first dose but less severe. EMS took to ambulance to further evaluate.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose number unknown, single (Lot number: EN6021) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing); "COPD" (unspecified if ongoing); "asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.
both vaccines were given into the left arm; on the next day had swelling left arm, swell 3 times the normal size, began at the top portion and then extended to the fingertip end; Initial information received on 05-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 73 years old male patient who was administered vaccines Influenza Quadrival A-B High dose HV vaccine [Fluzone High-Dose Quadrivalent] given into the left arm; on the next day had swelling left arm, swell 3 times the normal size, began at the top portion and then extended to the fingertip end.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Tozinameran (Pfizer Biontech Covid-19 vaccine) for Prophylactic vaccination.  On an unknown date in Oct-2022, the patient received 0.7ml dose (frequency: once; strength: standard) of suspect Influenza Quadrival A-B High dose HV vaccine of lot UG919AC and expiry: 30-Jun-2023 via intramuscular route in the left arm for immunization.  On an unknown date in Oct-2022, the patient developed both vaccines were given into the left arm; on the next day had swelling left arm, swell 3 times the normal size, began at the top portion and then extended to the fingertip end (peripheral swelling) (latency: 1 day) following the administration of Influenza Quadrival A-B High dose HV Vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (both vaccines were given into the left arm; on the next day had swelling left arm, swell 3 times the normal size, began at the top portion and then extended to the fingertip end).  At time of reporting, the outcome was Unknown for the event both vaccines were given into the left arm; on the next day had swelling left arm, swell 3 times the normal size, began at the top portion and then extended to the fingertip end.