chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced absence seizure, about 5 mins post COVID vaccination. Patient was laid on the floor, and pulse checked . Patient was breathing and had a pulse, but was "out of it momentarily". Patient was revived after about 5-10 minutes, drank water, sat and waited for about 15 minutes more before being allowed to leave
Unspecified patient had an unspecified anaphylactic reaction to an unknown vaccine on unspecified date; This spontaneous report was received from a nurse regarding an unspecified patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies were unknown by the reporter.   On unspecified date (reported as "in the past"), the patient was vaccinated with an unspecified therapy (MK-0000) (strength, dosage, frequency, indication, route of administration, lot number and expiration was not reported), and the patient had an unspecified anaphylactic reaction to an unknown vaccine. Also, the patient received sought medical attention, but details were unknown by the reporter.  The outcome of the event was reported as recovered. The causal relationship between the event and therapy unspecified (MK-0000) was not reported.   Upon internal review, the event anaphylactic reaction was considered to be medical significant.   Follow up information was received from a nurse on 12-DEC-2019, regarding a female patient.  On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dosage, frequency, indication, route of administration, lot number and expiration was not reported) for prophylaxis.     The patient (an employee) reported that her mother had verbalized to her that on an unknown date, when the patient was a child, she had experienced and anaphylactic reaction with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No further information was received.   This case was previously considered to be non-valid as no patient identifier was reported and no specific Merck therapy was involved.
Spiked a fever of 105 degrees and has a seizure.  Was transported to hospital via ambulance.
Covid returned 6 days after treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid returned 6 days after treatment) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid returned 6 days after treatment). At the time of the report, COVID-19 (Covid returned 6 days after treatment) had resolved. Not Provided          No concomitant medication was reported.  The patient previously received a COVID-19 Vaccine.  The COVID-19 treatment started on 4-Apr-2022 and stopped on 9-May-2022 but treatment drug was unknown and COVID returned 6 days after treatment.  Company Comment:  This is a spontaneous case concerning a 68-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of a dose of mRNA-1273 as third dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the diagnostic procedures were provided. Patient was given with unknown COVID-19 treatment, however patient reported that COVID-19 returned 6 days after treatment. Patient reported that the event COVID-19 had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 68-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of a dose of mRNA-1273 as third dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the diagnostic procedures were provided. Patient was given with unknown COVID-19 treatment, however patient reported that COVID-19 returned 6 days after treatment. Patient reported that the event COVID-19 had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
About 2 hours after injection, my upper 4 front teeth began to hurt/ache, not like a toothache. Today, February 11, there is still some discomfort but is now limited to one tooth.
Myalgia & Arthralgia Narrative: Arthralgia, mylagia; recovered
Information has been received from a healthcare student referring to a male patient of unknown age. On an unspecified date in December 2014 the patient was vaccinated with ZOSTAVAX strength and lot# unspecified, 0.65 ml once, subcutaneous in the arm. On an unspecified date in December 2014 the patient experienced injection site pain after receiving ZOSTAVAX. The injection site pain resolved after 3 weeks on an unspecified date. Patient then developed new pain in this same arm in which he had received ZOSTAVAX which radiated down through the entire arm, and also developed numbness in the fingertips of this arm, all since an unspecified date. The patient called pharmacy to seek medical attention. The outcome of new pain and numbness in the fingertips was not recovered. Additional information is not expected because the reporter did not know physician information and did not wish to be contacted for follow up.
hospitalized 9/19/21 with COVID-19 pneumonia, received dose of vaccine at the same time that he became sick with COVID-19 on 9/6/21
With in 10 minutes of receiving the shot vomited in class, hot flashes, pale. Apical pulse 120-130  irregular. Stomach ache, SOB, B/P 120/80 -90/68 crying and restless Epi Jr Rt thigh and 13 mins later. Called amb prior to Epi.
Uncontrollable chilling-profuse sweating frequent urination-fever of 102-103.
1 week after shot developed a 3 cm in diameter area or erythema at injection site
Myalgia & Arthralgia experiencing severe to moderate myalgia and arthralgia since vaccine was administered over 20 days ago. covid test for rule out with negative result
This event occurred after receiving the Moderna booster on 10/29 (I had 6 months prior had the regular 2 doses of pfizer) and was limited to my menstrual cycle beginning 4 days early. I track my cycle very closely using a digital app and have for years. It is very regular and consistently 26 days.
"Staff member reported after having her first dose felt lightheaded. Vaccinator called for help. Staff member laid on the floor. Elevated legs. Was AO x3. Slowly sat staff member up and then stool. Staff member report ""feeling fine"". Transfer staff member to a cart to monitor.   Vitals signs   1745 BP 109/71 HR 64 Ox 99 1750 BP 100/60 HR 87 Ox 99 1755 BP 109/70 HR 66 Ox 100  Patient reported feeling better. Waited for about 30 min.
Soreness; Slightly tired; A little pressure in the sinus area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness), FATIGUE (Slightly tired) and NASAL DISCOMFORT (A little pressure in the sinus area) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (Soreness), FATIGUE (Slightly tired) and NASAL DISCOMFORT (A little pressure in the sinus area). At the time of the report, PAIN IN EXTREMITY (Soreness), FATIGUE (Slightly tired) and NASAL DISCOMFORT (A little pressure in the sinus area) outcome was unknown. Not Provided      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.   Treatment The consumer is taking Aleve, and Advil PM to try to alleviate the symptoms.
Pt had muscle weakness in arms and legs and facial muscles. He also had double vision, and trouble walking and could not lift arms, within 10 days of MMR shot.
pt recv vax 1DEC97 & 1 day later 2DEC98 from 8:00 to 12:00 pt devel weakness in legs;felt as if legs would not support her & were unsteady;also felt weakness in the other areas of body during those 4 hr;
C/O L arm pain post flu shot. C/O decreased ROM and pain into shoulder and neck. Took Advil without relief. Refused Medrol dose pack. Referred to neurologist. Ordered Mobic and MRI, labs. Never had MRI. Thinks shot was given "too high."
She had 2 red hives around the injection site. Prescriber treated her with BENADRYL and ice packs. Her hives have almost disappeared today (4/26/13).
Case vaccinated with Janssen on 5/28/2021. Tested positive for COVID on 9/16/2021. Admitted to Hospital on 9/21/2021 and expired on 10/02/2021 while still hospitalized.
24 Hours after vaccine administered pt developed 10cm x 10cm erythema, warm, swelling over left deltoid.
Information has been received from a 64 year old female with diabetes mellitus insulin-dependent and allergies to diphenhydramine hydrochloride (Benadryl), tetracycline, and PCN who on 10/28/03 in the AM was vaccinated IM in the left arm with a first 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 642749/0111M). There was no concomitant medication. Subsequently, after vaccination, the pt experienced soreness at the site of injection. The pt also reported a rash that developed "two days later" that eventually spread from her arm to her neck, back, stomach, and face. The pt indicated that the rash was "now beginning to peel". Diphenhydramine hydrochloride (Benadryl) was used as treatment for the rash, however the pt experienced a rash from that as well. Medical attention was sought. No diagnostic tests or lab data were reported. The outcome was reported as recovered with sequelae. There was no product quality complaint involved. Follow up information received from the physician indicated that on 10/30/03 the pt was initially swollen and erythematous at the injection site. The pt then developed a widespread diffuse, erythematous urticarial type rash with desquamation. The pt recovered on 11/14/03.  Follow up information received on 12/04/03 indicated that the pt's skin "is now very rubbery feeling". It was noted that "her physician says that it looks like she will be having new skin." No further information is expected.
Pain and numbness in the left arm, from the shoulder to the fingers.; Pain and numbness in the left arm, from the shoulder to the fingers.; Pain and numbness in the left arm, from the shoulder to the fingers.; Cannot raise arm, nor leave it down.; This is a spontaneous report from a contactable pharmacist. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 17Dec2020 14:15 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The COVID-19 vaccine was administered at Hospital.  Medical history included Right breast cancer. Concomitant medication included vitamin Vitamin C, Vitamin D, anastrozole (ARIMIDEX). The patient experienced pain and numbness in the left arm, from the shoulder to the fingers. Can not raise arm, nor leave it down on 19Dec2020. Relief with a sling. Also, to manage pain she was taking Tylenol every four hours. By medical order she started diclofenac potassium 50 mg tablet. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was unknown if the patient was been tested for COVID-19. The outcome of the events was unknown.
Vaccine administered at .2ml as ordered however, vaccine vial was not reconstituted prior to administration.
This spontaneous case, initially received on 13-Jul-2016, was reported by a non health professional and concerns a 67-year-old male patient. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced drug reactions/allergies (outcome: not reported). Follow-up receive 15-Jul-2016: The patient has had allergic reaction to flu shots in the past and now refused to get them. No information on which flu shot was received in the past.
he had a terrible reaction for a week, he had muscle aches, pain and joint pain and everything hurt.; he had a terrible reaction for a week, he had muscle aches, pain and joint pain and everything hurt.; he had a terrible reaction for a week, he had muscle aches, pain and joint pain and everything hurt.; This spontaneous report was received from a consumer via other company (Pfizer) concerning himself, a currently 65-year-old male patient. The patient's concurrent conditions included hypertension and stage 3 renal failure. Information regarding the patient's medical history, historical drug and concomitant therapies was not provided.  On approximatelly 2017, (reported as "about 4.5 years ago"), the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (dosage regimen, route of administration, lot number and expiration date were not provided) for prophylaxis.  On an unknown date, the patient had a terrible reaction for a week, he had muscle aches, pain and joint pain and everything hurt.  It was reported that the adverse events "eventually  went away". The causal relationship between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and the events was not reported.
Cracks and sores in the mouth; Cracks and sores in the mouth; Extreme pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 17:00 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN; ACETAMINOPHEN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE Lot Number: UNKNOWN, Anatomical location: Left armAdministration time: 17:00), administration date: Aug2021, when the patient was 12 years old, for COVID-19 immunization. The following information was reported: STOMATITIS (non-serious), ORAL PAIN (non-serious) all with onset 01Sep2021 13:00, outcome "not recovered" and all described as "Cracks and sores in the mouth"; PAIN (non-serious) with onset 01Sep2021 13:00, outcome "not recovered", described as "Extreme pain". Therapeutic measures were taken as a result of stomatitis, oral pain, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 12-NOV-2015, the patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot number L019126 and expiration date 27-MAY-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Shot given in left arm. Pt had MD appointment after vaccines were given, arm was swollen, as reported by physician's office. Mom swelling was gone within an hour, mother was unsure of why physician was concerned. Tylenol was only med given.
0.2mL of undiluted Pfizer Orange Cap (GK0876) was injected to a patient 11 years, 8 months old.  Error was noticed around 2:00pm, approximately 2.5 hours after injection. Patient was phoned around 3:50pm on 7/16/2023. Spoke with patient's guardian, and told him about the error and provided counseling on adverse effects both local and system. He said patient was resting right now.
Employee has had shoulder pain and decreased range of motion for one month. Physician feels this could be a sterile abscess or supraspinatus tendinitis. Conservative treatment for now and then possible referral to orthopedics if pain worsens.
Narrative:  82 year old male, received his first dose of COVID-19 vaccination (Pfizer) on 2/25/2021. Patient has a PMH of lung cancer, HTN, BPH, OA and dementia. Per wife, patient had been feeling cold and increasingly confused since vaccination. Patient woke up disoriented, unable to focus, weak on 3/8/2021 and was admitted to hospital ICU hypotensive and unresponsive. Patient passed away shortly afterwards.
Several Seizures episodes, fever/chills vomiting, severe headache, stuffy nose and extreme high blood pressure.
Within 2 hrs of Pfizer covid injection I developed chest tightness with difficulty taking a full breath. Significant substernal chest pain radiating to between shoulder blades. Sent to ER around 6:30 pm. Cardiac ez troponin negative, CBC, BMP normal, 2 12 lead EKGs normal, CXR normal. BP and HR slightly elevated but stable. Acetaminophen 650 mg po given. ER physician dx vaccine adverse effect.
This case was reported by a physician via call center representative and described the occurrence of ophthalmic herpes zoster in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and product supply issue. On an unknown date, the outcome of the ophthalmic herpes zoster, shingles and product supply issue were unknown. It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient developed a mild case of Shingles, which involved minimal eye involvement. The patient had missed second dose of SHINGRIX due to lack of availability.
slight swelling; arm redness at injection site; chills; fever 103.8; weakness; headache; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9262 and expiry date unknown, via unspecified route of administration at the left arm on 28Jan2021 11:15 at single dose for Covid-19 immunization in a hospital. Medical history included high blood pressure, depression, asthma, wheat allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included lisinopril, paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), cyanocobalamin (VIT B12), ergocalciferol (VIT D); all from unspecified date for unspecified indication. The patient previously took amoxicilin, morphine, vicodin; all experienced drug allergy. Historical vaccine included first dose of BNT162B2 lot number EH9899 at the left arm on 07Jan2021 11:15 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 19:00, the patient experienced chills, fever 103.8 (temperature), weakness, headache, until 30Jan2021 6:30 am. Then again, on 30Jan2021 11 pm, the patient experienced fever, chills headache until 6:30 am. On 30Jan2021, the patient experienced arm redness at injection site. On 31Jan2021, the patient continued to experience redness and slight swelling (injection site). The patient has the patient been tested for COVID-19 since the vaccination. The patient did not received treatment for the events. The outcome of the events was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
Within 48 h of administration, developed red papules and a pruritic vesicle at the injection site.  No constitutional symptoms. Received both injections in the same arm, so unsure which vaccine was responsible.
DTaP-IPV component of PENTACEL given without the ACTHIB component, with no reported adverse event; Initial information received on 15-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old and unknown gender patient reporter stated dtap-ipv component of pentacel given without the acthib component, with no reported adverse event. (diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine) [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Nov-2022, the patient received 2 dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine at a dose of 0.5 ml Total with standard strength (form, strength,  expiry date: unknown) via intramuscular route in unknown administration site for Immunization.   On 10-Nov-2022 the patient was given dtap-ipv component of pentacel given without the acthib component, with no reported adverse event (product preparation error) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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.
I received the shot around 11AM on the 11th. By 5PM that evening I was beginning to have a headache and chills. I drove home from work and by 6PM I had severe chills, I was shaking so bad I could barely fill a cup of water and take ibuprofen, the water was sloshing out of the cup. I had a fever of 102 and spend the rest of the evening in bed, shaking. By around 10 PM the severe chills had subsided and my fever was 101.  I did not sleep much during the night due to a headache and alternating chills/sweating. This morning it is 7 AM and my temperature is 99.5 and I am beginning to feel more normal. I took advil at first and then tylenol every 4 hours during the night.
From initial information received on 11/19/2004 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a six month old female patient received her third dose of Daptacel, lot number C1700AA, administered in the right thigh, a dose of IPOL, lot number X1212, administered in the left thigh, a dose of Comvax (haemophilus B conjugate + Hep B) lot number 0567P, manufacturer Merck, administered in the right thigh and a dose of Prevnar, lot number A57562A, Manufacturer Lederle, administered in the left thigh on 11/16/2004. Routes of administration were not reported. Two days later, the patient developed redness and edema on bilateral thighs, but primarily on her right thigh, as reported by patients mother. The patient has no known allergies. It is unknown if whether she recovered from these events. The reporter of this case is the same reporter as cases 200403769, 200403770, 200403771, 200403772, and 200403773.