chrisvoncsefalvay/vaers-outcomes huggingface dataset:
autoimmune disease to flare up; tire/run down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 14:00 (Lot number: Ew0151) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hashimito" (unspecified if ongoing); "known allergies: gluten" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Lot number: en6207, Administration time: 02:00 P.M., Dose 1, Single, Vaccine location: Left arm), administration date: Mar2021, when the patient was 42 years old, for Covid-19 immunization.The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 12Apr2021, outcome "not recovered", described as "autoimmune disease to flare up"; FATIGUE (non-serious) with onset 12Apr2021, outcome "not recovered", described as "tire/run down". It was unknown if therapeutic measures were taken as a result of condition aggravated, fatigue.  Additional information: Facility type vaccine was reported as Other. The patient had not received other vaccine in four weeks prior vaccination. The patient was not diagnosed with Covid-19 prior to vaccination. Since vaccination the patient was not test for Covid-19. The patient though it caused her autoimmune disease to flare up. She had hashimoto. She felt tired 24 hours after the shot and woke up the next day fine but now the last almost 20 days she felt so run down and required more sleep and could do less. So she though it causes her autoimmune to flare. She mentioned she would going to consult her endo.  No follow-up attempts are possible. No further information is expected.
After exposure over a week, I felt sore throat & tested positive for Covid, developing cough too, Dr. prescribed Paxlovid 11/29, which I started taking that evening. Symptoms peaked 11/30, then declined. Felt better and tested negative 12/5.
Patient received an influenza vaccine on 10-13-16 and subsequently developed Guillain Barre Syndrome.
Patient is a diabetic and states 20 minutes after injection his blood sugar was low and he was eating. Patient called back around 5pm having chills. Paramedic responded and he did not have a seizure only chills. Wife suspected a seizure. Patient did not go to the hospital.
Patient complained of dizziness about 5 minutes after vaccination. Patient was sitting at the clinic lobby with her mother. I assisted the patient inside the exam room to lay down on the exam table. Patients was so dizzy and about to faint. She could hardly get up to the exam table. I instructed her to get up to the exam table one more time. She was able to get up and lay down on the table. Patient did not lose consciousness. Vitals were taken and were stable. Mother gave patient gatorade to drink. Patient stayed laid down on the table for about 10-15 minutes. Mother was watching the patient. Patient was fully alert and no longer feeling dizzy. Patient walked with her mother. My assistant walked them outside our facility.
pt recv vax 5JAN96 & 23JAN96 pt devel 5 or 6 lesions on shoulder & behind ear;
Per Pt, her injection site is red and itchy. Recommended her ice the area and can put benadryl cream. Seek doc care if worsen.
Intermittent vaginal bleeding. At times, it is very heavy with large dark clots. Around the 18th of January, I had a couple blood gushes and expelled large clots. I never experienced any menstruation like this before. Since Feb 4th, I have had continuous on/off bleeding regardless of what point it is in my menstrual cycle. The morning of Feb 19, 2022, I started passing large clots of blood again.
Pt recvd Hep B vax & following vax exp partial hearing loss, h/a, photophobia, myalgia & constant tinnitus; Pt recvd 2nd dose of Hep B in approx 1989 & exp total loss of hearing, tinnitus & asthenia; dx fibromyalgia;
Autism. Subsequent to vax, pt was dx with autism. Upon the medical review the pt's autism was considered an other medical event. Additional information has been requested.
dizzy; had numbness in my feet; the dizziness prevents me from driving; total fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, After the second booster I got Covid. Then I started being dizzy, and had numbness in my feet), for Covid-19 immunization, reaction(s): "dizzy", "numbness in my feet". The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "dizzy"; HYPOAESTHESIA (non-serious), outcome "recovered", described as "had numbness in my feet"; IMPAIRED DRIVING ABILITY (non-serious), outcome "recovered", described as "the dizziness prevents me from driving"; FATIGUE (non-serious), outcome "recovered", described as "total fatigue".  Additional information: Patient reported that all of vaccines are Pfizer two Covid and three boosters. After the second booster patient got Covid. Then the patient started being dizzy and had numbness in patient feet. Those symptoms eventually decreased. Then the patient got the third booster and the symptoms came back and never went away. There are days that the dizziness prevents patient from driving. Also, days of total fatigue.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300220100 same reporter/patient, different dose/event;US-PFIZER INC-PV202300104567 same reporter/patient, different dose/event;
COVID arm; red spot on skin; red spot is hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), ERYTHEMA (red spot on skin) and FEELING HOT (red spot is hot to touch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), ERYTHEMA (red spot on skin) and FEELING HOT (red spot is hot to touch). At the time of the report, VACCINATION SITE REACTION (COVID arm), ERYTHEMA (red spot on skin) and FEELING HOT (red spot is hot to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported   Reporter did not allow further contact
Extremely heavy and long  periods lasting over a week, , also vaginal bleeding when not on period .
Warm in the chest; Warm in the shoulder; warm in the abdomen; warm in the head; Sensation inside the head felt like was was going to faint; Knuckle started to hurt; This case was received via an unknown source (no reference has been entered for a health authority) on 09-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT, MUSCULOSKELETAL DISCOMFORT, ABDOMINAL DISCOMFORT, HEAD DISCOMFORT, and DIZZINESS in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse events (No reported medical history.).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CHEST DISCOMFORT, MUSCULOSKELETAL DISCOMFORT, ABDOMINAL DISCOMFORT, HEAD DISCOMFORT, DIZZINESS, and ARTHRALGIA. At the time of the report, CHEST DISCOMFORT, MUSCULOSKELETAL DISCOMFORT, ABDOMINAL DISCOMFORT, DIZZINESS, and ARTHRALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Reporter did not allow further contact. Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Reported redness, swelling and pain to (R) arm 2 hours after injection. Evaluated by PCP today 6/13/17 noted erythema, mild swelling and warmth (R) upper arm. Dx Cellulitis vs Allergic Rxn. RX KEFLEX, BENADRYL, Ibuprofen.
None - patient 5 months pregnant and received MMR vaccine on 12/3/07.
His arm got sore; This is a spontaneous report from a contactable consumer (grandparent) via Pfizer sponsored program. A 19-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number and expiration date were not reported) via an unspecified route of administration, on unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Swap from first time caller asking for Grandson 19 yr. On an unknown date the patient took the first vaccine at store, but he thinks it was administered high up on shoulder and his arm got sore. He was not an HCP. The reporter was asking whether the patient should get another first vaccine. Read article. Provided number and transferred to medical information, hold que. Due to long hold times. Will fax to Pfizer from a Pfizer Sponsored program. CEP (Number) for AE. There were no unaddressed medical questions referred or forwarded to medical information. The outcome of the event was unknown.  Information on lot/batch number has been requested.
a 19 year old patient inadvertently receiving a 1mL dose as opposed to the expected 0.5 mL dose; This spontaneous report was received from a nurse prescriber referring to a 19-year-old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On an unknown date, the patient was inadvertently vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (1 mL; strength, route, lot # and expiration date were not reported) as opposed to the expected 0.5 mL dose that was recommended in prescribing information for prophylaxis (incorrect dose administered).
rash on face, lip and tongue swelling, muscle pain, trouble breathing when moving. Sinus and ear congestion that didn't respond to normal medication/treatment (pseudoephedrine, antihistamine, nasal steroid spray and shots, oral steroids) and resulted in blocked eustachian tube.
LFT elevation and leukopenia noted on labs done 3 days after vaccine- these were repeated in 1 week and were normalized - there was no other reason for these lab abnormalities - were done as part of wellness check
13-year-old received an adult dose; 13-year-old received an adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old male patient who received HAV (Havrix 1440 adult) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   On 21st November 2021, the patient received Havrix 1440 adult 1 ml. On 21st November 2021, unknown after receiving Havrix 1440 adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The practice manager reported a 13 year old patient received an adult dose (1ml) of Havrix, which led to overdose and adult product administered to child. The reporter consented to follow up. The case has been linked to US2021241778, reported by the same reporter for patient's sibling.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021241778:Same reporter
Within a minute after the vaccine was administered, I started to sweat a lot, felt hot, and got very dizzy. I was also nauseous. The nurse was very responsive and had me put my jacket on, zip it all the way up, and allowed me to lay down. She provided water and snacks. I was very dizzy for 5-10 minutes. The nurse helped me perform calming excecises, which helped a lot. I then slowly started to feel better. After about 30 minutes I was able to stand up and felt mostly normal. It has been 3 hours and I am only a little fatigued, but otherwise okay. I have not had any issues with shots in my adulthood, but as a child, I remember turning white and vomiting after a flu shot. So I may be subconsciously adverse to shots.
I have a large red circle (about 3?x3?), which is still warm to the touch and often itchy. The circle has gotten larger over the days. I have had these side effects since the day after I received my first shot. I also experienced a lot soreness in my arm for 5 days after my shot.
She received Janssen dose on 7/20/21 and Noticed s/s 8/5/21  tested positive covid 8/6/21
I had Covid-19 in November 2020; isolated and recovered without hospitalization. Had the usual symptoms, high fever, runny nose, and lung difficulties. A few days after my first Moderna shot my lungs began to feel the same feeling as when I had Covid only milder. It was more than just "shortness of breath," often a catch in my breath if breathing deeply and I can only describe it as the feeling of taking a big breath of very cold air when you're on a ski lift. The symptoms after vaccination were milder than actually having Covid but they persisted for 4 months which alarmed me.  Also, I developed shingles 2 months after the vaccination. I only mention it because when back visiting family for the holidays, my family knew of several other people who had developed shingles after the vaccination. I have not heard about anything like that here at home.
Pt recv vax on 10/9/97; on same day pt exp dry cough
5OCT95 vax given;20OCT95 hospitalized for muscle weakness; 22OCT95 dx w/GBS
light headedness, need to clear throat, nausea and vomiting  resolved after epi was given
Sore throat & itchines of mouth 1 min. after administration but not told to medical staff. at 3:30am Pt awoke c/o sore throat, trouble swallowing. Given EpiPen, called 911. Seen at ER & given Benadryl, Pepcid AC & steroids. Pt home & doing well.
Chills.  Temp of 108.  Body Aches headache lasted for 36 hours
2nd dose in primary series was given too early. No adverse reaction is known. Was found on 10/23/2022 when patient came in for Moderna Bivalent Booster. Did not have any other Covid vaccines after initial series. Called for guidance - was directed to call Moderna. Moderna directed this RN to call CDC for guidance. The state reached out to CDC via email and was instructed to repeat 2nd dose as it did not qualify. Second primary dose was repeated on 10/23/2022 and patient was scheduled for Bivalent booster in 2 months.
identified another patient that received the IPOL after the excursion occurred  with no adverse event; temperature excursion that occurred during stocking and inventory/the temperature mentioned 9.9 for 30 minutes no adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid non-serious case received from a pharmacist via call center.  This case involves a 3 years old male patient who received the ipol after the excursion occurred with no adverse event and temperature excursion that occurred during stocking and inventory/the temperature mentioned 9.9 for 30 minutes no adverse event after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria, Tetanus and Acellular Pertussis Vaccine (Adacel) for Immunization; and Tuberculin Test (Tubersol) for Tuberculin Test.  On 13-Jun-2022, the patient received a 0.5 ml {total} dose of suspect IPV (VERO) lot T1E872M frequency: once (strength, formulation, and expiry date: unknown) via intramuscular route in Left thigh for immunization.  On 08-JUN-2022 the patient developed a non-serious event temperature excursion that occurred during stocking and inventory/the temperature mentioned 9.9 for 30 minutes no adverse event (product storage error) latency same day following the administration of IPV (VERO). On 13-JUN-2022 the patient developed a non-serious event identified another patient that received the ipol after the excursion occurred  with no adverse event  (poor quality product administered) latency: 5 days following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.     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 guidelines. 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.
collapses during match with heart problems; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (non health care professional).  This case involves a 32 years old and unknown gender patient who experienced collapses during match with heart problems while receiving vaccine Influenza Vaccine.  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 Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a serious event collapses during match with heart problems (circulatory collapse) (unknown latency) following the administration of Influenza Vaccine.   It was reported that It goes on and on, and on. it's happening everywhere, and is not normal, 32 year old Tennis player collapses during match with heart problems.  Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : Unknown for the event.  Seriousness criteria : This event (circulatory collapse) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 07-Feb-2022. This case involves a 32 years old and unknown gender patient who experienced collapses during match with heart problems while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.
All symptoms started on 2/1/2018 around 2:40pm. It started with extreme weakness & fatigue.  Couldn't keep eyes open. Difficulty moving limbs. Visible muscle tremors throughout my arms and legs when I tried to move. Could not walk without help. Once I started feeling a tight chest, felt like I could not breath, I called 911. Severe body aches. Back and neck hurt. Loss of mental clarity. Difficulty finding the right words to use, would forget what I was talking about mid sentence, trouble understanding questions that were being asked. Nausea. Dizzy. Was taken to the ER via Ambulance. Muscle tremors did not stop until Sunday, 2/4/2018. Still dealing with fatigue and feeling weak as of 2/5/2018.
PATIENT SAID HE WAS IN FOR HIS 1ST VACCINE AND WANTED PFIZER. RECEIVED WITHOUT INCIDENT, BUT WHEN WE WENT TO PROCESS IT CAME BACK SAYING HE HAD A VACCINE ALREADY. I LOOKED ON OUR VACCINE REGISTRY AND SAID HE RECEIVED BOTH VACCINES IN MARCH, BUT AT A FACILITY OTHER THAN THIS PHARMACY SO WE HAD NO WAY OF KNOWING HE HAD RECEIVED THE FIRST TWO ALREADY.
Tachycardia; Blood pressure High; This spontaneous case was reported by a patient and describes the occurrence of TACHYCARDIA (Tachycardia) and HYPERTENSION (Blood pressure High) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0181321A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Drug allergy (Levaquin) and Allergy to antibiotic (Topical ointment creams). Concomitant products included CELECOXIB for Arthritis, HYDROCHLOROTHIAZIDE and LOSARTAN POTASSIUM (LOSARTIN) for Hypertension, TRAMADOL for Pain, LEVOTHYROXINE, ATORVASTATIN and GABAPENTIN for an unknown indication.   On 12-Apr-2021 at 1:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced HYPERTENSION (Blood pressure High). On 12-Apr-2021 at 10:00 PM, the patient experienced TACHYCARDIA (Tachycardia). On 16-Mar-2021, HYPERTENSION (Blood pressure High) had resolved. On 13-Apr-2021, TACHYCARDIA (Tachycardia) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2020, COVID-19: positive. On 12-Apr-2021, Heart rate: 111 High.    Patient's normal heart rate was 77 beats per minute. Patient went to hospital after events and stayed there  for about 4.5 hours in the emergency room. They could not find an issue with heart.  After unspecified tests and blood work, the patient went home at about 05:00 on 13-Apr-2021.  No Treatment information was Reported
This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 08-JAN-2018, the patient was vaccinated with improperly stored VARIVAX lot # N022981, expiration date: 23-AUG-2019, dose 1 for prophylaxis. Concomitant therapies included sterile diluent. The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 135 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001739.
Patient came in with reddish, swollen and warm to the touch arm. She went to her MD and he gave her some prescriptions.