chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache/different than the headaches before/headache on my temple; May have received full dose for booster dose; Dose-2 (17Mar2021) and Booster (16Aug2022); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache/different than the headaches before/headache on my temple), ACCIDENTAL OVERDOSE (May have received full dose for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-2 (17Mar2021) and Booster (16Aug2022)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A, 045A21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to contrast dye.). Concomitant products included ALIROCUMAB (PRALUENT) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (May have received full dose for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-2 (17Mar2021) and Booster (16Aug2022)). On 21-Mar-2022, the patient experienced HEADACHE (Headache/different than the headaches before/headache on my temple). The patient was treated with BUTALBITAL for Pain, at an unspecified dose and frequency; TRAMADOL for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache/different than the headaches before/headache on my temple), ACCIDENTAL OVERDOSE (May have received full dose for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-2 (17Mar2021) and Booster (16Aug2022)) outcome was unknown.            Concomitant medications also included bone density injection after every 6 months. Treatment also included Excedrin without aspirin for pain.   This case was linked to MOD-2022-516871 (Patient Link).
when mom picked pt up p/school, face was swollen hands swollen, inject site was red, swollen & tender to touch; t101 x 3 days;
Headache, Myalgia, Fever, chills and injection site pain Narrative:
COVID 19 /Sore throat, Weakness; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Dec2022 at 17:00 as dose 4 (booster), single (Lot number: GJ3274) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 29Dec2022, outcome "unknown", described as "COVID 19 /Sore throat, Weakness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: The patient had no known allergies. Patient started COVID symptoms on 29Dec2022 late night with very bad sore throat. The next day on 30Dec2022 patient started feeling weak and tested positive for COVID on 31Dec2022 morning. Patient started taking paxlovid.  No follow-up attempts are possible. No further information is expected.
Headache, Fever, NauseaVomiting, Chills, abdominal pain Narrative:
Information has been received from a licensed practical nurse concerning a 24 year old female with no pertinent medical history and no history of drug reactions/allergies who on 12-FEB-2007 was vaccinated with first dose of Gardasil (lot # not reported) 0.5 ml IM. Concomitant therapy included YASMIN and ULTRAM. On 12-FEB-2007, the patient developed a rash on her chest, low grade fever and she felt like she had the flu after receiving the first immunization with Gardasil. Unspecified medical attention was sought. On 13-FEB-2007, the patient recovered. No other information was available at the time of reporting. Additional information has been requested. Additional information was received from the LPN who reported that the events occurred on 13-FEB-2007. The patient's children were sick at the time. Her symptoms subsided the next day. No additional information  is expected.
Caller stated she looked up information online if Comirnaty contains PEG and found out that it did. Caller said she might have had a reaction with it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation as dose number unknown, single; ABRYSVO. The following information was reported: REACTION TO EXCIPIENT (non-serious), outcome "unknown", described as "Caller stated she looked up information online if Comirnaty contains PEG and found out that it did. Caller said she might have had a reaction with it".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Initial report received from health care professional on 19 November 2013. The 82-year-old male patient, whose medical history and concomitant medication were not reported, had received a dose of FLUZONE HD, batch number U4781AA intramuscularly in the left deltoid on 16 November 2013. The patient had no illness at the time of vaccination and pre-existing, physician diagnosed allergies medical conditions and birth defects were unknown. On 17 November 2013, the patient had sore in her arm symptoms was progress and she was not able to mover her arm. Corrective treatment and laboratory details were not reported. At the time of this report, the patient was not recovered from adverse event. Documents held by sender: none  Follow-up report received from health care professional on 27 January 2014. As of 14 January 2014, the patient was still not recovered from the events.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired vaccine) and PRODUCT STORAGE ERROR (Expired vials stored in freezer) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vials stored in freezer). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired vaccine) and PRODUCT STORAGE ERROR (Expired vials stored in freezer) outcome was unknown. Not Provided. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that, the vials were continuously stored in stable freezer environment and only stored in fridge on date of administration for thaw period. No treatment medication was reported.
Pain at injection site, swelling, painful to move arm. Ibuprofen helps 12/30/03. 12/31/03 right arm injection site red, warm, swollen and painful.
heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine".  Additional information: Caller mentioned that he heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Runny nose; Fatigue; Headache; General malaise; Dose received 3; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 09Dec2021 at 12:30 (Lot number: 1620) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: 6955, Anatomical site: Right arm, Administration time: 13:30), administration date: 18Mar2021, when the patient was 47 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: 6955, Anatomical site: Right arm, Administration time: 11:00), administration date: 08Apr2021, when the patient was 47 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 at 12:30, outcome "unknown", described as "Dose received 3"; RHINORRHOEA (non-serious) with onset 10Dec2021 at 07:00, outcome "not recovered", described as "Runny nose"; FATIGUE (non-serious) with onset 10Dec2021 at 07:00, outcome "not recovered", described as "Fatigue"; HEADACHE (non-serious) with onset 10Dec2021 at 07:00, outcome "not recovered", described as "Headache"; MALAISE (non-serious) with onset 10Dec2021 at 07:00, outcome "not recovered", described as "General malaise". Therapeutic measures were not taken as a result of rhinorrhoea, fatigue, headache and malaise.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Got Guillain-Barre synd; 5-7 days pvax stomach flu; numb in boxer short area, then wst to toes, then upper body.  Intens care 14d, on respirator; still problems-- eyes yes don't close, tape eyes to sleep, mouth tired when eating; tiredness
mild pain on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild pain on the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (mild pain on the injection site). At the time of the report, VACCINATION SITE PAIN (mild pain on the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PT recvd vax on 5OCT92 & 1 mo prior to scheduled treatment date included lovastatin; 6OCT92 exp malaise, weakness & fatigue; pt recovered;
Pt received DTaP-Hib-IPV, PCV13 yesterday.  She developed a fever yesterday evening.  She woke up in the night with a temp of 102-103 with temporal thermometer After giving tylenol, temp is consistently around 101F.  Mom just gave tylenol and will recheck temp in an hour.  Eating and drinking fine.  She is a bit fussy.  No vomiting or diarrhea. Mom says the injection site looks fine, no redness or swelling.
Numbness to the lips, nose, left and right cheeks. Presented 15 minutes after vaccine. Paramedic on site monitored blood pressure and heart rate. Numbness was minimal  after 30 minutes and completely gone after 1 hour
flu; tachycardia; headache; heart rate was 120; This is a spontaneous report from a contactable other healthcare professional (patient himself: family nurse practitioner). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tachycardia on 24Dec2020, and he felt like he had the flu and he checked his temperature and it was fine on 26Dec2020. His heart rate was 120 and he had a headache. Caller states he had a COVID test done and he is not positive. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Patient presented to the ER on the evening of Oct 27th after having her flu shot that morning with difficulty breathing, and swelling of the lips and throat.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: swelling of eye occured a day after vaccine given. patient took benadryl and adverse event resolved in a couple days -Mild
Received influenza injectable vax 11-16-10 reports feeling achy, h/a, malaise, weak, felt like wheezing" evening of vax. diarrhea Temp 96.5 11-17-10 - sent to see occ med dr.
Mom laid child down for nap at 5:00PM, noticed that he "might feel a little warm".  Child slept from 5PM to 6:15PM.  Woke up at 6:15PM irritable and fussy.  Had seizure at 6:45PM, temp 101 after seizure.  Tried to give child Tylenol, but was unable to swallow it.  Went to ER temp was 104.  Child was given Tylenol and monitored and released to parents.
Extreme nausea, vomiting, muscle weakness, and headache. Unable to get out of bed for 2 days and not able to work
Since getting the vaccine my knees have been getting worst and it is harder to walk. I walk slower with pain. I have had arthritis to begin with so I don't know if the vaccine is the cause or not. I am also heavy. I had no adverse reactions to the vaccine except maybe tenderness in my arm for a day. I saw a doctor on June 6, 2022, and they are referring me to a physical therapist. I take my Norco medication as needed.
Pt received full Moderna dose of 100 mcg/0.5 ml for her 4th vaccine
Patient stated prior to administration that she had a history of passing out when she had needles administered, specifically with shots, blood draws, and IVs.  Patient stated she felt fine and appeared normal for the first 10 minutes. After approximately  10 minutes,  the patient was sweaty, hot, and lethargic. Patient was able to respond to verbal commands but was dizzy and speech was slow. Patient stated she felt like she was going to pass out. No person witnessed patient actually pass out. Two EMS personnel and two nurses were present to assist. Patient was able to take sips of water and an IV with fluids was started by EMS. Patient stated she felt better after approximately 20 minutes and was transferred to Emergency Department by EMS.
Facial numbness around right eye; periorbital migration; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 25Jan2021 07:15 (Lot number: EL1283) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Known allergies: dust" (unspecified if ongoing); "Known allergies: pollen" (unspecified if ongoing); "Known allergies: trees, grasses" (unspecified if ongoing). Concomitant medication(s) included: COQ10 [UBIDECARENONE]; VITAMIN D [ERGOCALCIFEROL]; FEXOFENADINE; ATORVASTATIN; MONTELUKAST; SINGULAIR; ALLEGRA. Vaccination history included: Bnt162b2 (lot number: EH9899; administration time: 07:15 AM; route of administration: intramuscular; vaccine location: left arm; dose number: 1), administration date: 26Dec2020, when the patient was 58 years old, for Covid-19 immunization, reaction(s): "Facial numbness around right eye and migrating 11 hours after injection"; Hep b vaccine, administration date: 1984, when the patient was 21 years old, for hepatitis B, reaction(s): "left arm numbness". The following information was reported: HYPOAESTHESIA (non-serious) with onset 25Jan2021 06:00, outcome "recovered", described as "Facial numbness around right eye"; PERIORBITAL DISORDER (non-serious) with onset 25Jan2021 06:00, outcome "recovered", described as "periorbital migration". Therapeutic measures were not taken as a result of hypoaesthesia. Therapeutic measures were taken as a result of periorbital disorder. Additional information: The patient had no other vaccine in four weeks. Other medications in two weeks included multivitamins. It was reported that the patient had facial numbness around right eye and migrating 11 hours after injection. Onset was 12 hours after vaccine, was later, resolved and recovered 3 hours after. Similar sensation 2 weeks after first vaccination was reported. Prior to vaccination, the patient was not diagnosed with COVID- 19. Since the vaccination, the patient has not been tested for COVID-19. The event did not require a visit to the hospital. No follow-up attempts are possible. No further information is expected.
I?ve had a persistent rash for 5 months and counting - still present. Started mid March after my two dose series. I have seen a dermatologist who was unable to diagnose the condition. Rash is itchy and located primarily on the extremities. Hands and feet get itchy blisters. Arms get itchy areas that look like hives and do not go away. Rash does not come and go - present all the time. Also noted - I have new onset joint pain in my thumbs.
Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Additional Details: patient report generalized myalgia, fevers, severe fatigue, severe headahe, dizziness. says feels like a bad flu. unable to get out bed since day of administration and he is generally very active.
Staff reported widespread rash (raised pink spots) over trunk and face while bathing her. Temp/Pulse/Resp 97.7 deg/84/18 BP 96/65 SpO2=92% > 30 lesions especially on back, a few on face. Had Varicella Vaccine on 7/25/12- rash reported on 8/15/12. Placed in droplet isolation in the facility, no other treatment at this time. No signs of distress.
Approximately 3 hrs after vaccine pnt felt ill - was admitted to hospital with cardiac arrhythmia. Cardiologist stated he has seen a number of similar cases and felt the vaccine is a factor. Pnt put on XARELTO 20mg and DILTIAZEM XT 120mg.
Pt. swelling to left anterior lateral thigh extending to left inner thigh. Area tender and warm. Improved with KEFLEX. No improvement in first 24-48 hrs with BENADRYL
received an expired dose of imovax today with no reported adverse event; Initial information received on 10-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 25 years old male patient who had received an expired dose of imovax today with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect RABIES (HDC) VACCINE lot T1B813M via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious received an expired dose of imovax today with no reported adverse event (expired product administered) (unknown latency) following the administration of RABIES (HDC) VACCINE.  Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  It was not reported if the patient received a corrective treatment for the event (received an expired dose of imovax today with no reported adverse event).  At time of reporting, the outcome was Unknown for the event received an expired dose of imovax today with no reported 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 the 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.
Dose 1,2,3 were Moderna with no reaction Dose: 4 was Phizer  with reaction  Woke up with a very swollen and tingling lip. In addition, my right arm pit was severely swollen into my chest area as well all under my arm so lymph were inflamed
5 days after vaccination, dev temp 103+ for 48 hrs - 2 seizures related to temp elevation. Treated for otitis media at Hospital 2 days later
Had three blood clots within 36 hours.  One in left leg, one right leg and one in groin. Also, rheumatological problems in tendons in arms and legs.Hearing in left ear diminished by 10%.
This spontaneous report as received from a medical assistant refers to a 14 year old female patient. Patient's medical history was unknown. On an unknown date, the patient started GARDASIL, one injection for unknown indication. On 30-JUN-2014, the patient was vaccinated with the second GARDASIL injection, lot # J012212; expiration date: 18-FEB-2016, (dose, frequency and route were unknown) which had a cold temperature excursion. The patient did not have any problems after receiving the injection. At the time of the report was unknown if the patient continued to get GARDASIL injections. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 58-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Methotrexate (patient was on Methotrexate a couple of years before the reporting date she had the same reaction as the Shingrix). On 9th October 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th October 2018, less than a day after receiving Shingrix, the patient experienced nausea, vomiting and stool discolored. On an unknown date, the outcome of the nausea, vomiting and stool discolored were not recovered/not resolved. It was unknown if the reporter considered the nausea, vomiting and stool discolored to be related to Shingrix. Additional details were provided as follows: The patient reported that she received the Shingrix vaccine on left arm around 1:45 pm and she was concerned because on her way home she became nauseous and her bowels were fluorescent yellow last night and next morning. The patient also vomited twice the same color.