chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was nervous getting the shot and stated he had a history of severe anxiety.  During his observation period he reported that he had a racing heart, shaky hands, and was sweating.  Staff monitored him and got him some water.  He stated that he had a history of hypoglycemia as well but had not had issues with it in a while.  Patient reported that his BG had been 80 that morning and that he had eaten Chick Fil a prior to coming for the vaccine.  We offered a snack or glucose tablet but patient refused.  We did recommend that the patient remain in our observation are a for an extra 15 minutes and he agreed.  After monitoring and water the patient felt better and purchased glucose tablets when he left.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:46 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temp was 34, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vial was moved to clinic. Vaccine BUD date was 29-Apr-2021.  Vial was stored on cooler 1 , on 03-Apr-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM : 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41.  Vials only punctured right before administration  It was reported that patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Bump on shoulder occurring in 24 hours after administration Mildly painful, with pain extending to elbow for a while Lump has persisted for almost a year
Patient reports severe arm soreness radiating from her left shoulder through her left wrist. The soreness started the morning after administration and has not yet subsided. She states she could not lift her arm or use her arm to open her car door.
Dose was given too early - only 5 months between 1st and 2nd dose instead of 6 months.
PT WENT TO ER 11/4 PM "OUT OF HIS HEAD,' CHILLS AND SWEATING. ER STAFF CONDUCTED LABS/CLINICAL TESTS AND COULD FIND NOTHING WRONG. TOLD HIS WIFE HE MUST HAVE HAD REACTION TO PREVNAR.
(R) leg patchy red area with hives locally at site of Dtap and flu - cool compresses, MOTRIN as needed.
She reported having injection site swelling; the second shot hurt her; her arm was swore 2-3 days/arm a little sore after second shot; and was tired after; right hand swollen/Her index finger on the left hand is swollen back to the palm; right ankle swollen/swollen down to her wrist; thumb swollen and stiff; left index finger swollen/thumb swollen/her middle finger swelled; This is a spontaneous report from a contactable consumer or other non healthcare professional. An 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in left arm on 30Apr2021 at 15:00 (Batch/Lot Number: ER8735) (at the age of 84 years) as 2nd dose, single dose for COVID-19 immunization. Medical history included arthritis, patient's mother had arthritis but she had it much younger than patient's age. Concomitant medication(s) included ubidecarenone (COQ 10) 100mg, once a day for health reasons and ongoing, acetylsalicylic acid (ASPIRIN (E.C.) 81 mg, once a day for heart and ongoing, losartan (LOSARTAN) for cardiac disorder and ongoing (Had been taking over 10 years), carvedilol (CARVEDILOL) for cardiac disorder and ongoing (Had been taking over 10 years). Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm 02Apr2021 (at the age of 84 years) as single dose for COVID-19 immunization. On 14May2021, patient experienced, left index finger swollen/thumb swollen/middle finger swelled. She went to the doctor on 14May2021, when she showed the doctor her finger they said it could possibly be arthritis. On an unspecified date, patient experienced injection site swelling, the second shot hurt her, her arm was sore 2-3 days/arm a little sore after second shot, was tired after, right hand swollen/her index finger on the left hand is swollen back to the palm, patient had to take her rings off, it hadn't gotten as bad as the index finger but it was swollen, it was not as stiff to bend as the index finger, it was hard to bend and was stiff when she got up right ankle swollen/ swollen down to her wrist, thumb swollen and stiff. She thought that the doctor said to take Tylenol as treatment, but she didn't care for Tylenol, so she didn't take anything. The outcome of the left index finger swollen/thumb swollen/middle finger swelled was not recovered while for the events was unknown.  No follow-up attempts are possible. No further information is expected.
shortness of breath; Patient had cross reactivity of Darbepoetin to the Moderna vaccine; diarrhea; fatigue; muscle aches; fever; headache; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (shortness of breath), DRUG INTERACTION (Patient had cross reactivity of Darbepoetin to the Moderna vaccine), DIARRHOEA (diarrhea), FATIGUE (fatigue) and MYALGIA (muscle aches) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DARBEPOETIN ALFA for Anaemia NOS.    Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Anemia.  Concurrent medical conditions included Anaemia NOS.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DARBEPOETIN ALFA (unknown route) at an unspecified dose. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), DRUG INTERACTION (Patient had cross reactivity of Darbepoetin to the Moderna vaccine), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (muscle aches), PYREXIA (fever) and HEADACHE (headache). At the time of the report, DYSPNOEA (shortness of breath), DRUG INTERACTION (Patient had cross reactivity of Darbepoetin to the Moderna vaccine), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (muscle aches), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist reported that, in their medical records, there was a flagged report on a patient who had gotten the Moderna COVID-19 in Apr-2021 who was on Darbepoetin for anemia who came down with fatigue, muscle aches, fever of 103, diarrhea, headache and shortness of breath. It was not considered as an allergy but a cross reactivity to the vaccine.  No treatment medications were reported.
COVID-19 BIVALENT BOOSTER DOSE.   Pain at injections site, headaches (began 5 hrs after injection)   sleepy & tired.   Could not stay awake by 5pm day of shot.   Headache continued to next day
Narrative:  68 year old male admitted on 1/11/22 with SOB and treatment of COVID-19 infection. He had been vaccinated x 2 with Moderna (1st dose: 2/11/21, 2nd dose 3/10/21). He received 5 days of remdesivir and 6 days of IV dexamethasone for treatment and was discharged on 1/18/22.
HCP has no further AE information; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; This spontaneous report was received from a medical assistant concerning to an approximately 4-month-old (also reported as 5-month-old) male patient.  Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 19-SEP-2023, according to a digital data logger, there was a temperature excursion in clinical practice at 9:28, temperature was 8.3 Celsius degree and at 10:02 the temperature was 7.5 (units not provided) for a total excursion time of 34 minutes for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number reported as 1933911 (expiration date 18-APR-2024) and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot  number reported as W001598 (expiration date 14-JAN-2024), albumin status was not provided, however, upon internal validation it was stablished as rHA. On 20-SEP-2023, the patient received the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, and route of administration were not provided) and the improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, and route of administration were not provided) (product administered to patient of inappropriate age) (product storage error) both of them administered as prophylaxis. It was reported that the patient received the vaccination in a private doctor's office.  No adverse effect was observed (no adverse event). On 25-SEP-2023 at 11:08 temperature was at 9 Celsius degree and at 15:01 it was at 8.0 Celsius degree, for a total excursion time of 4 hours.       This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA002929: US-009507513-2311USA002928: US-009507513-2311USA002927: US-009507513-2310USA010775: US-009507513-2311USA002932: US-009507513-2311USA002930: US-009507513-2311USA002931: US-009507513-2311USA003147:
full brown chicken pox; The spontaneous report was received from a physician referring to a 12-month-old infant patient. The patient's previous adverse drug reaction history and family adverse drug reactions were unknown. The patient's concomitant therapies, medical histories and drug allergies were not reported.   On an unknown date, the 12 months old patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VAVIRAX) (dose, route, lot# and expiration date were not reported) as prophylaxis .  After 5 days, the patient developed full brown chicken pox, the patient was seen in an outpatient setting and was considered to be otherwise healthy. On 23-MAY-2023, the vesicle/lesion sample was obtained (also reported as 24-MAY-2023, conflicting information) and sent to laboratory for polymerase chain reaction (PCR) analysis, the patient was not on an oral antiviral prior to the specimen collections, the results showed cycle threshold value was 17.5 (units not reported), and the presence strain of varicella-zoster virus (VZV) was identified as wild-type strain.   The outcome of event chicken pox and the causal relationship between suspect vaccine and the event was not reported.
PT STATES SHOT HURT. SHE CAME TODAY TO REPORT THAT OVER A MONTH LATER HER ARM STILL HURTS AND IT IS DIFFICULT TO USE IT FOR ACTIVITIES OF DAILY LIFE AND TO SLEEP. SHE HAS A DR APPOINTMENT ON NOVEMBER 1 FOR THIS ISSUE
Around 5:55 I felt a numbing at the top of my leg while seated while waiting my 15 minute wait time.  The numbing continued down the right side of my right leg. I didn't think much of it because I thought it was the way I was sitting.  I didn't report it to anybody at that time.  I got in my car and my three right toes started to numb.  Then I felt it down my arm and the right three fingers.  About 15 minutes later my jaw muscle, then up to my temple and across the fatty area of the eyebrow went numb.  Several minutes later  I noticed my nostril and right side of my tongue numb.  It felt like my tongue and face were swollen but  when looking in the mirror they were not and there was no drooping when I smiled and raised my eyebrows.  It was a similar feeling that I have had when a shot has almost worn off from a dental procedure.  The feeling and the movement is there but still tingly.   The arm, leg, and toe numbness went away 2-3 hours later on the same day of the shot.  I had no numbness on the left side.    Two days later I still have the same numbness on my right two fingers, tongue, jaw, eyebrow area, and nostril.
After getting the dose of my vaccine my menstrual cycle became very intense. I have a lot more cramping and my mood swings are very intense. I feel very depressed and I have extreme mood swings. They seem to be regular 23-28 days but the bleeding is much worse. The pain is keeping me from working sometimes. I have not had cramps like this in the past and they were not as heavy. It has been six months since my vaccine and there has been no improvement.
Redness from the top of the leg to the arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness from the top of the leg to the arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness from the top of the leg to the arm). On 28-Jul-2021, ERYTHEMA (Redness from the top of the leg to the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up information received :Outcome of the event updated
Since the Covid shot I was diagnosed with RA.; severely fatigued; headaches; muscle weakness/soreness; muscle weakness/soreness; This is a spontaneous report from a contactable consumer (patient herself).  This 44-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FC3183), via an unspecified route of administration administered in the left arm, on 17Sep2021 14:30 (at the age of 44-year-old) at single dose for COVID-19 immunisation, administered at clinic. No relevant medical history was provided. The patient did not have COVID-19 before the vaccination. Past drug history included benzylpenicillin potassium (PENICILLIN). Relevant concomitant medications included gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Sep2021, the patient was diagnosed with rheumatoid arthritis (RA). From 18Sep2021, the patient was severely fatigued, she had headaches, muscle weakness/soreness, joint pain and joint swelling. The patient was not treated for the events. No COVID-19 test was done post vaccination. The patient had not recovered from the events.
damage to his ear; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received first dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration in Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient incurred damage to his ear in Mar2021. His doctor prescribed a tapering high dose of prednisone 10 mg tablets over the next 7 days. He had not started the medication yet. He received his first dose of the Pfizer Covid 19 vaccine one week ago today. The outcome of the event was unknown.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 11-DEC-2012 was vaccinated with an improperly stored PROQUAD (dose and route unknown, Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Moderna 8/19/21 and 10/4/21. Positive on 1/13/22
Of reports sore, red, hot left upper arm, also pain on the left side of her neck, fatigue and body aches.
Pt recvd 1st dose of Hep B vax in AUG91 & approx 5 to 6 hrs following vax exp vertigo & malaise; tx Chlor-Trimeton & vertigo spontaneously resolved w/in 5 to 6 hrs; malaise lasted about 1 day;
After injecting patient with the  moderna covid-19 vaccine the  needle became detached from the syringe and fell in the technicians  leg
Itchy; Swelling/ Raised up; Redness; A spontaneous report was received from a consumer concerning a 56-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling,raised up/ vaccination site swelling, redness/ vaccination site erythema, itchy/ vaccination site pruritus.  The patient's medical history was not provided. Concomitant medications reported were diabetes medication and high blood pressure medication(not specified).  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events swelling, redness, itchy and raised up at the injection site.  No treatment was taken.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events swelling, redness, itchy and raised up were unknown.
Localized erythema, pain, induration. Increase in warmth on the site of vaccine >10 inches in size.
About 12 hours after receiving the vaccine, I developed a red rash in a circular shape, below the injection site, but above the elbow.  This morning (about 20 hours after the vaccine), my arm was swollen.  It is swollen in the area where the red rash appeared last night.  Since noon, the swelling has spread so that the entire area from my shoulder to my elbow is swollen, with a defined margin.  My arm hurts and feels like it has a tight band around it.
Initially when I first got the vaccine, within 10 minutes, I felt a little bit dizzy and a little nauseous. After that, I felt okay until the 9:30PM event. It was like a light switch, I felt nauseous and felt dizzy. And the strange thing was that my tongue went numb, and my speech was very slow and slurred. I felt like I couldn?t talk with a regular sentence and my tongue was numb. This lasted for approximately 10 minutes and then it disappeared. The symptoms completely disappeared and I had very minor flu like symptoms for a few days after that.
A non-serious report of expired FluMist administered was received from a nurse concerning a four-year-old unreported gender.  This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical or drug history was reported.  The patient received FluMist on 02-Jan-2008.  The product had an expiration date of 27-Dec-2007.  Follow-up twelve days after the FluMist dosing, the child had not experienced any adverse event.  A follow-up call to the reporter on 22-Apr-2008 confirmed that the patient did not experience any adverse events. The event was resolved. The reporter did not provide a causality assessment.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Additional information received on 22-APR-2008 and incorporated in above narrative: reporter confirmed patient had no adverse event.
This case was reported by a nurse via sales rep and described the occurrence of passed out in a child patient who received FLULAVAL QUADRIVALENT (batch number Z39X5, expiry date unknown). In November 2017, the patient received FLULAVAL QUADRIVALENT .5 ml. In November 2017, less than a week after receiving FLULAVAL QUADRIVALENT, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was not reported to anyone previously. The age at vaccination was not reported. It was reported that, five school-age patients passed out following vaccination with FLULAVAL QIV at different sites, during the week of 6th to 10th November 2017. No further information was provided. This is 1 of 5 cases reported by the same reporter.