chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Asthma attack; trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER-8730), via an unspecified route of administration, administered in arm left on 22Mar2021 at 12:00 (at the age of 51-years-old), as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included ongoing asthma, obesity, and seasonal allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 22Mar2021 at 12:00, the patient experienced trouble breathing the same day. And next day and 48 hours after the vaccine , on 24Mar2021 at 12:00, she had asthma attack. Adverse events resulted in emergency room/department or urgent care visit. As corrective treatment she received nebulizer, magnesium, and steroids. Outcome of the events was not resolved.   No follow up attempts are possible. No further information is expected.
1st MOderna vacinnation was followed w accute onset of severe vertigo and fatigue requiring 4 days of hospitalization.  2nd and 3rd injections were followed w cold-like symptoms.  4th injection (2nd booster) followed with severe fatigue, cold-like symptoms, and severe weakness and loss of appetite.
Tongue swelling, Benadryl was given and symptoms resolved. was observed for  3 hours with no further swelling.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer, Inc.) concerned a 48 year old white female of an unspecified ethnicity.   The patient's height, and weight were not reported. The patient's past medical history included: cancer survivor, and concurrent conditions included: asthma, penicillin allergy, and sulfa drugs allergy. The patient was not pregnant at the time of vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (dose number in series 1), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination (dose number in series 1). The patient received second dose with covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered to right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included estradiol.  On 2022, the patient experienced suspected covid-19 infection (dose number in series 2) and had suspected clinical vaccination failure (dose number in series 2). On 1-MAY-2022, patient was treated with Paxlovid for covid-19 and last administration was taken on 6-MAY-2022. On 15-MAY-2022, patient experienced resurgence of covid-19 after treating with Paxlovid within 1 week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested.; Sender's Comments: V0: 20220542436-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient received FLUZONE high dose vaccine in error. He is of inappropriate age for the vaccine. No adverse events reported by the patient as a result of this incorrect vaccination.
Congestion, pain in lymph nodes in neck, joint pain, muscle pain, dizziness (subsided after approx 15 min).
Due to medical evaluation of new information received for this case on 7/31/06, this case had been upgraded to serious (OMIC). Initial report received from a health care provided on 6/1/06. A 26 year old female pt had received an IM, right deltoid injection of Menactra, lot number U1809AA, on 4/28/06. It was subsequently determined that the pt was pregnant. The pts last menstrual period was 4/2/06. An ultrasound ordered secondary to spotting and to confirm pregnancy, on 5/30/06, showed a nine week pregnancy. Per the reporter, the pt had three previous pregnancies resulting in two full term deliveries. The outcome of the third pregnancy was not reported. The estimated date of delivery was not reported. Per the reporter, there was no adverse event. Follow up information received on 7/31/06. The vaccination with Menactra on 4/28/06 was the first dose for the pt. The pt had no illness at the time of that vaccination. Per the reporter, the date of the pts last menstrual period was on 4/26/06, not 4/2/06 as previously reported. The pts expected date of delivery was to be 1/1/07. The pt has not received any treatment for infertility and it was reported she had a history of 5 previous pregnancies, with three live births and one spontaneous abortion prior to 20 weeks gestation. The outcome of the fourth pregnancy was not reported. This pregnancy ended in a first trimester, incomplete, spontaneous abortion of one single fetus on 5/30/2006, 32 days post immunization. The pt subsequently had a D&C of the uterus on 6/23/06. Per the reporter, there were no known risk factors or health problems during this pregnancy. The pt had one prenatal visit with a physician.
Severe chest pain early in morning of Dec 11 2022. Took emergency vehicle to Hospital where I had multiple tests: blood work (no viral infections present); x ray; CT scan; echo cardiogram; heart catheritization. Pain went away during morning in the emergency room but was admitted to hospital and stayed two days for observation.
Patient works store, came to the pharmacy a few hours into her shift and said her arm was swollen, red, and she felt very achy all over. From what she described it did not sound like anaphylaxis, just very severe processing of a flu and pneumonia shot. I checked her temperature (98.4), and she said she wasn't having any rash, trouble breathing, swollen tongue, glands, etc. I recommended that she alternate tylenol and ibuprofen, as well as take benadryl. I recommended that she go home, get some rest, and call me if anything got worse. I spoke to her around 3pm and 6pm for follow up calls, and she did say she felt a little worse, but the reaction didn't really seem to be spreading. I told her to keep an eye on her breathing, skin, and temperature, continue with the medication, ice her arm, and to go to an urgent care or ER if anything progressed. I also left a note for the RPH in the AM to call her at 9am for a follow up call.
blood clots in right leg; This is a spontaneous report from a Non-contactable consumer (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 03Apr2021 (Batch/Lot number was not reported) at the age of 55-year-old as single dose for covid-19 immunisation. Medical history included covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medication included etodolac taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blood clots in right leg on 23Apr2021 with outcome of recovered with sequelae on an unknow date. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included apixaban (ELIQUIS). Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 19NOV98 & 1040Am pt presented w/ c/o burning sensation & heaviness @ lt deltoid inj site; pain progressed down to lt forearm;c/o dizziness;lt arm looked red;swelling seen around lt upper arm;blotches extend down to fingers of lt
Child began showing symptoms currently being considered as seizures. That night he broke out in hives with difficulty breathing. The "allergic reaction" type symptoms persisted 4 days despite treatment with prednisone. The "seizures" are ongoing as of this report. Child will be having EEG and neuro consult.
Acute Myocarditis - no etiology identified on discharge from hospital however few viral studies were pending.  Pt admitted with chest pain and elevated troponin.
Headache after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after the vaccination) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache after the vaccination). At the time of the report, HEADACHE (Headache after the vaccination) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-028247 (E2B Linked Report).; Sender's Comments:  MOD-2021-028247:1st dose
From initial information received on 07/21/04 from the patient's parent regarding an adverse event occurring in the USA, it was reported that an 18 year old male patient received his first dose of Menomune A/C/Y/W-135, lot number UE306AA, in the deltoid on 06/30/04. Thirteen days later, on 07/13/04, the patient developed severe headaches that lasted from three days and were treated with Tylenol #3. On 07/19/04, the patient experienced severe itching and erythema from knees down to feet bilaterally, which was relieved by Benadryl. On 07/21/04, the patient experienced joint pain and neck pain. He is scheduled to see a physician. Recovery status was not reported. From additional information received on 09/30/04 from a physician, the patient's full name was provided. It was reported that the patient was vaccinated at a private doctors office/hospital. Reportedly, the patient developed rash on his lower legs instead of erythema. The patient did not have any illnesses at the time of vaccination. He was seen by a physician, who did not feel that this was an adverse event due to the length of time between vaccine administration and development of symptoms. The physician felt that the symptoms were most likely viral. Reportedly, the patient recovered from the events. No further information is anticipated. This case is considered closed.
I began having electric shocks all over my body so my Dr did skin biopsy because she believed I have Small nerve Fiber Neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 17:00 as dose 2, single (Lot number: EN6207) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "Since that time I have also been diagnosed with PsA, Fibromyalgia" (unspecified if ongoing); "Since that time I have also been diagnosed with PsA, Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE; LISINOPRIL; LANSOPRAZOLE; OXYBUTIN. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6200, Vaccine Administration Time: 05:00 PM), administration date: 23Feb2021, for COVID-19 immunisation. The following information was reported: SMALL FIBRE NEUROPATHY (disability) with onset 30Apr2021 at 13:00, outcome "not recovered", described as "I began having electric shocks all over my body so my Dr did skin biopsy because she believed I have Small nerve Fiber Neuropathy". The event "i began having electric shocks all over my body so my dr did skin biopsy because she believed i have small nerve fiber neuropathy" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy skin: (30Apr2021) Positive, notes: Dr did skin biopsy because she believed I have Small nerve Fiber Neuropathy. Both locations came back positive; SARS-CoV-2 test: (05Jan2022) Positive. Therapeutic measures were taken as a result of small fibre neuropathy.Clinical course: Patient took daily medicines for the symptoms caused. Patient began having electric shocks all over her body so her Dr did skin biopsy because she believed she had Small nerve Fiber Neuropathy. Both locations came back positive. she began having numbness and pins and needles.
Received less than 1/2 a dose. Immediately received full dose in right arm. No adverse events.
Patient experiencing "tingling sensation around my lips and fingers. Symptoms have not gotten worse but they are not getting better.  I also feel more anxious and like my heart rate is definitely faster."
Patient received vaccine on11/15/2023 and reported adverse event to pharmacy on 11/17/2023. Patient reported injection site pain and inflamation.
Documented fever of 105F (digital axillary) within 8 hours of vaccine administration. No rash or other symptoms.
administered boostrix instead of Infanrix; 18 month patient received boostrix; 18 month patient received boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KP547, expiry date 29-NOV-2024) for prophylaxis.   On 04-AUG-2023, the patient received Boostrix. On 04-AUG-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: administered boostrix instead of Infanrix), inappropriate age at vaccine administration (Verbatim: 18 month patient received boostrix) and underdose (Verbatim: 18 month patient received boostrix).  The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and underdose were unknown.   Additional Information: GSK Receipt date: 25-AUG-2023 A medical assistant reported that an 18 month old baby was administered boostrix instead of Infanrix which led to wrong vaccine administered. The 18 month patient received boostrix which led to Inappropriate age at vaccine administration and underdose. The reporter consented to follow up.
Patient was at Dr.'s office on 3/19/19 for 18 month wellchild checkup Hep A #2 was given with no complications. Parent states the reaction started at 4:30pm with swollen eyelids, puffy eyes, hives and penis swelling, no fever. Patient was taken to ER. Patient was prescribed Diphenhydramine and was advised to F/U with PCP, Mom was instructed to apply calamine lotion topically and to give BENADRYL every 8 hrs as needed. Patient F/U with Dr. Today 3/20/2019.
Fever, chills, extreme fatigue, rash all over body, aches.  Rash lasted 5 days and skin continues to burn and itch.  Fatigue has lasted 7 days
BACK PAIN; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 30/JUN/2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain. This report was non-serious.
Left upper arm muscle soreness which has gradually improved overtime.  No loss of range of motion.  Patient is thin and frail.
This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # L037921 expiration date: 31-MAY-2017 (dose, strength, and route unknown) (incorrect product storage). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Admit Date: 10/11/22   Discharge Date: 10/17/22   Discharge Condition: Stable    Discharge Diagnosis:   # Nephrostomy tube dispolaced  # AKI # COVID 19 infection  # Chronic Obstructive Pulmonary Disease # Coronary Artery Disease # Dyslipidemia # Obstructive Sleep Apnea # History of liver cancer # History of tubular adenoma  # History of prostate, bladder, and liver cancer # Overweight  # ETOH Use Disorder # Hx of Urosepsis w/Septic Shock
no adverse event; daughter received on 23Oct2022 a Monovalent Moderna vaccine instead of a Bivalent Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (daughter received on 23Oct2022 a Monovalent Moderna vaccine instead of a Bivalent Moderna vaccine) and NO ADVERSE EVENT (no adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (daughter received on 23Oct2022 a Monovalent Moderna vaccine instead of a Bivalent Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (daughter received on 23Oct2022 a Monovalent Moderna vaccine instead of a Bivalent Moderna vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (daughter received on 23Oct2022 a Monovalent Moderna vaccine instead of a Bivalent Moderna vaccine).    No concomitant medications were reported.  No treatment medications were reported.
Shingles 3 days later.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Mar2021 at 19:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. Prior to the vaccination; the patient was diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Since the vaccination, patient had not been tested for COVID-19. On 27Mar2021 at 20:00, 3 days after receiving the vaccine the patient developed Shingles. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for the reported event and included treatment with viral medication. The clinical outcome of the event Shingles was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
big lump underneath her left armpit; feeling muscle tightness; Muscle tightness began yesterday and feels it especially in legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A 29-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 (Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: AXILLARY MASS (non-serious) with onset 06May2021, outcome "not recovered", described as "big lump underneath her left armpit"; MUSCLE TIGHTNESS (non-serious) with onset 06May2021, outcome "not recovered", described as "feeling muscle tightness"; LIMB DISCOMFORT (non-serious) with onset 06May2021, outcome "not recovered", described as "Muscle tightness began yesterday and feels it especially in legs".  Additional Information: Expiry Date of COVID vaccine: Unknown. The patient did not receive other Products. The patient had no history. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Reason for no lot number of COVID vaccine was Other: Caller does not have her COVID vaccine record card at this time. This dose was caller's first dose. Patient took COVID vaccine (Verbatim) because of military action. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks), no other vaccinations taken within four weeks prior to the first administration date of the suspect vaccine(s). Relevant Tests were none. The thing is, when she raises her arm, you can notice the big lump under her arm. The events did not result into emergency room and Physician office visit. No PQC Present.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.