chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; more of a tingle; like a nerve, "maybe she hit a nerve"; This is a spontaneous report received from a contactable consumer. The consumer reporting for his friend's mother-in-law. A female patient of an unspecified age received unspecified dose number of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm, more of a tingle and like a nerve, "maybe she hit a nerve". It took over 6 weeks to resolve. The outcome of the events was resolved.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021406507 Same reporter/drug, different event/patient;US-PFIZER INC-2021400811 Same reporter/drug, different event/patient
A Spontaneous report has been received from a Pharmacist concerning a 7 year old, Male patient, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. It was reported that the patient was accidentally administered expired FLUMIST which started on 19-Dec-2014. The outcome of the event of patient was accidentally administered expired FLUMIST is unknown. The report was considered to be non-serious.
Information has been received from a physician concerning an 18 year old female with no known drug reactions/allergies who on an unspecified date was vaccinated with a third dose of GARDASIL vaccine (yeast) (lot# 660620/0571X) IM. There was no concomitant medication. On 29-AUG-2008 the patient fainted, fell and hit her head. The patient was taken to the Emergency Room where she had a computed axial tomography (CT) done. The CT result came back negative. The patient was released. The patient did not faint after the first and second dose. Additional information has been requested.
erythema over left deltoid on 1/11/02 where #4 DTaP given on 1/08/02
3d after vaccine was was fatigued & sleepy & agitated. On 4th or 5th day, she became aggressive with raising voice to her parents, abrupt & didn't want to be around her family members. This was a sudden change.
never received a 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st on an unknown date in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: Medical Assistant reported that a patient never received a 2nd dose.  The reporter did not consent to follow-up.  Health care professional (HCP) wanted to remain anonymous Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
A report has been received from a Health Professional concerning a 6 year old, male subject, who had been receiving nasal FLUMIST. FLUMIST started on an unknown date. The reporter stated that the patient blew nose after receiving FLUMIST and it irritated his nose and which started on 14-SEP-2013. The outcome of the event of irritated his nose and blew nose after receiving flu vaccine is unknown. The event of blew nose after receiving flu vaccine was assessed as non-serious by the reporter. The event of irritated his nose has been identified by the company physician from the source documents and added as a non-serious adverse event.
Positive Covid test after negative Covid test (rebound); Positive Covid test after negative Covid test (rebound); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "not recovered" and all described as "Positive Covid test after negative Covid test (rebound)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Positive COVID test after negative, COVID test (rebound); (May2022) Negative, notes: Positive COVID test after negative, COVID test (rebound). Therapeutic measures were taken as a result of covid-19.  Clinical course: Anti viral details, product: COVID 19 Treatment, treatment start date: 20May2022, treatment stop date: 25May2022, indication: Treatment of COVID-19 (as reported). Adverse event: Positive Covid test after negative Covid test (rebound), adverse event start date: 30May2022, if patient recovered: Not recovered, if treatment ae: No (as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I felt no side effects at time of shot, but that evening approx 8 hrs later I developed a sore arm so bad that I could not move it, not even my fingers without excruciating pain. I had soreness in the rest of my body as well, extreme exhaustion, extreme headaches, neck ache, joints and muscles hurting everywhere, dizziness and confusion. Intensity lasted for 36 hours and then began to come down to only dizziness, exhaustion, arm pain and confusion for 9 days. Still have fatigue and confusion 1.5 months later.
Headache & Fever Narrative:  day after receiving vaccine, felt headache at work, difficulty concentrating on tasks, went home early and stayed out the following day. Also experienced a temperature of 100.4 overnight, and as high as 101.3.
Onset of chills at 4:45pm, followed by fever of 104 degrees, heart palpitations and tachycardia, red rash on cheeks from fever, severe headache and body ache, random spasms in arms and legs. These symptoms were intense and lasted throughout the night. Headache, muscle aches and spasms lasted three days.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 27-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 23-JUN-2016, 0.5 ml (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 168 hours with a lowest recorded temperature of 1 Fahrenheit (F) (1 Celsius (C)) and other one of 96 hours with a lowest recorded temperature of -1 Fahrenheit (F) (-1 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient received the Flublok vaccine but is only 16yrs old.  Spoke with mother and she will monitor her son.  No adverse side effects at this time
I began feeling chills around 9pm and continued until bed, woke up several times in the night in puddles of sweat, all parts of my body were hot to the touch.  Also had pain under my left armpit, like there were marbles underneath my skin, I'm assuming lymph node swelling, also same feeling in my right groin. Headache and general body ache all over. Fatigue. Slept until around 11am next morning, May 4. Took Advil and felt somewhat better until evening of May 4, when I started chilling again and armpit soreness and headache. Took more Advil and went to bed. Better next morning May 5.
symptoms started spreading from the injection site to the whole arm; Worried about the side effects; Red injection site; Itchy injection site; Swollen injection site; It is very itchy, symptoms started spreading from the injection site to the whole arm; she cannot sleep at night; some of the red spot in her right arm, symptoms started spreading from the injection site to the whole arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (some of the red spot in her right arm, symptoms started spreading from the injection site to the whole arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced ERYTHEMA (some of the red spot in her right arm, symptoms started spreading from the injection site to the whole arm) (seriousness criterion medically significant) and INSOMNIA (she cannot sleep at night). On an unknown date, the patient experienced PRURITUS (It is very itchy, symptoms started spreading from the injection site to the whole arm), SWELLING (symptoms started spreading from the injection site to the whole arm), FEELING ABNORMAL (Worried about the side effects), VACCINATION SITE ERYTHEMA (Red injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, ERYTHEMA (some of the red spot in her right arm, symptoms started spreading from the injection site to the whole arm), PRURITUS (It is very itchy, symptoms started spreading from the injection site to the whole arm), INSOMNIA (she cannot sleep at night), SWELLING (symptoms started spreading from the injection site to the whole arm), VACCINATION SITE ERYTHEMA (Red injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen injection site) had not resolved and FEELING ABNORMAL (Worried about the side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication information was provided  treatment products for the symptoms were Cortisone cream , prednisone tablet ice affected area.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-141702 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 1st of two reports. A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown) via unspecified route of administration on 23Jan2021 as 1st dose single for COVID-19 Immunisation. Medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced sore arm. On an unknown date in 2021, the patient underwent antibody test after 1st dose and the results were negative. Caller asked for information about antibody testing and if he should be concerned the vaccine isn't working properly since he read after 1st dose of vaccine he should have approximately 50% protection. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021167494 same drug/AE, different patient
I am reporting vaccine administration error that occurred on 10/21/2023 patient was given the pediatric dose of the XBB Moderna vaccine today but  patient previously  received  Pfizer vaccine series. since patient is under 5 years old no mix and match is allowed for this age group.  parents were informed that PCP will be contacted .
Pt. recieved 1st dose of Moderna vaccine on 3 Feb and presented to the ED with syncopy on 4 Feb.  Patient was discharged on 7 Feb.  Home course unknown
Patient's second vaccine was taken from vial open on 6/21/21 at 4:45 pm.  The vial was at room temperature.   This has been reported to Moderna (Case #MOD21-115097) for further medical input.
1/13/22-1/15/22 Tingling of the tongue and lips after eating cold cereal and milk containing almonds and/or foods with crunchy texture. Lasted less than 1 hr. 1/18/22 Tingling of lips, tongue and numbness on right side of face after eating peanuts. Mild diarrhea later in the day. 1/21/22 Tingling of lips and tongue after eating cereal with almonds. I took a generic Claratin-D 10mg to ease the symptoms.
Patient was admitted because of URI type symptoms started on January 9th.  He was having a cough congestion and headache,.  Symptoms did not improve so he did home test for COVID-19 that was positive on January 15th.  Had a fever up to 100.1 degree.  He is using a CPAP machine with 3 L of oxygen at night for obstructive sleep apnea routinely.  He has a previous history of myasthenia gravis was on a prednisone up until October 2021.  Monoclonal antibodies were ordered that was scheduled yesterday 1/20/2022.  He was also advised if his oxygen saturation goes below 90 then he should come to the emergency department.  Patient presented to the emergency department by ambulance because his oxygen saturation was 87%.   Patient was on a non-rebreather mask during the transfer in emergency department he was switched over to nasal cannula.  Oxygen per protocol. IV dexamethasone. Vitamin-D vitamin-C and zinc.  DVT prophylaxis with Lovenox. Patient completed IV Rocephin and doxycycline for total 7 days.
Pleuritic chest pain. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
started having a red  at injection; started having  bumped arm at injection; Pain at injection; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (started having a red  at injection), VACCINATION SITE SWELLING (started having  bumped arm at injection), VACCINATION SITE PAIN (Pain at injection), PYREXIA (Fever) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced VACCINATION SITE SWELLING (started having  bumped arm at injection), VACCINATION SITE PAIN (Pain at injection), PYREXIA (Fever) and NAUSEA (Nausea). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (started having a red  at injection). At the time of the report, VACCINATION SITE ERYTHEMA (started having a red  at injection), VACCINATION SITE SWELLING (started having  bumped arm at injection), VACCINATION SITE PAIN (Pain at injection), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment drugs included no concomitant drugs included
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case was created for 51st of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Rash on left arm and back, accompanied by mild muscle soreness. Rash not itchy but slightly painful to the touch.
NAUSEOUS WHEN STANDING, ACHES  STILL 6  DAYS LATER
Pt received MMR, VAR and PCV on 8/21/2003. On 9/03/03 pt's mom brought her in to the office saying she took her to the ER 8/30/03 and ER said she had measles. Dr said it was also measles on 9/3/03.
Patient tested via PCR / Result SARS Covid - 19 Detected on 3/4/2021
Patient fainted shortly after vaccination and hit head causing a lesion on eyebrow. Patient regained consciousness shortly after and appeared very pale and disoriented. Doctor and EMTs on site immediately responded instructing patient to remain on the ground for about 30 mins and monitored her pulse and blood pressure. Patient reported feeling well enough to  sit up on the floor after about 30 minutes after which she remained sitting for several more minutes before finally standing up and being picked up by relative to drive back home.
Unable to sleep, concentration issues, high anxiety. After second dose, 4/13/21 patient became paranoid, not sleeping, severe anxiety and on 4/23/21 was admitted to psychiatric facility with severe depression, no sleep, paranoia, loss of twenty pounds, severe anxiety, suicidal thoughts.
?Sunburn? sensation on skin of torso and thighs, body  aches, shivers, stomach discomfort, low-grade fever (100.2), fatigue .  The skin sensitivity began within 20 of injection and remaining symptoms were present upon awakening 12 hours later.  Low-moderate pain at site of injection and skin sensitivity continues 36 hours later.  No fever 36 hours later
Pt vaccinated with DTP/OPV developed prolonged screaming 22OCT90-23OCT90.
Moderna 18+ administered to 17 yo on 08.24.22 - no immediate reaction/symptoms;  followup on 08.25.22 - arm soreness, no other symptoms
Client came to drive through clinic requesting FIRST Covid vaccine.  All assessment questions asked and documented.  No reports of receiving any previous Covid vaccine.   Internet access not available.  Paper used to complete service.  Once back inside office and entered information into system, client had two previous doses of Moderna at other sites.  Telephone call to client.  While informing client of the previous doses on her record the phone immediately disconnected.  Several more attempts made to the same number in which I talked with client and call was sent immediately to voicemail.  Client did receive Moderna fact sheet and VAERS reporting information if has any reactions.
3 cm tender erythematous indurated hot patch at site of injection 2 days after injection fever.
slight coughing; sore throat; slight chest tightness; tiredness; tested positive for COVID-19; tested positive for COVID-19; 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 received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EP6955), on 16Apr2021 as dose 2, single (Lot number: EP6955) and on 24Nov2021 as dose 3 (booster), single (Lot number: 330308D) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06May2022 at 19:30, outcome "unknown" and all described as "tested positive for COVID-19"; COUGH (non-serious), outcome "unknown", described as "slight coughing"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "slight chest tightness"; FATIGUE (non-serious), outcome "unknown", described as "tiredness". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive.  No follow-up attempts are possible. No further information is expected.
No adverse effects reported; an expired dose of MMR II (N009168, 3/20/2019) which was administered to a patient; Information has been received from a nurse, referring to a patient of unknown age or gender. Information of concurrent condition, medical history and concomitant therapy was not provided.    On 03-MAY-2019, the patient was vaccinated an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA) (strength unknown; lot # N009168 and expiration date 20-MAR-2019) subcutaneously for prophylaxis (expired product administered). No adverse effects reported.
my husband was tested and was positive for covid; my husband was tested and was positive for covid; This is a spontaneous report from a contactable consumer (patient's wife).  A 64-years-old male patient BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration in May2021 (Batch/Lot number was not reported) age at vaccination of 63-years-old, as single dose, dose 1 via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) age at vaccination of 63-years-old, as single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus. The patient received concomitant medication (he was treatment for diabetes, he takes some medication). The patient received two doses of the Pfizer vaccine and he had no side effects from the vaccine but he was tested positive on 15Oct2021 for Covid-19. No treatments were given. Outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.