chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About a minute or two after receiving the shot and starting to walk away, I began to feel lightheaded and hot. My face felt like it was swelling, particularly my mouth. I felt dizzy enough that I needed to sit down. The swelling sensation went away after 1-2 minutes. I sipped water and remained seated for 10 minutes before feeling decent enough to continue walking, though I still felt weaker and mildly lightheaded. All symptoms subsided within an hour.
Overheated and diaphoretic, syncopal episode, swollen neck lymph nodes, nausea, post-occipital headache, and muscular pain.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks: No. Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=28Jun2022, Treatment stop date=30/Jun/2022. Vaccine administration date=18Dec2019. Took paxlovid, now have rebound COVID 4 days after stopping medication. No Known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed flushing of the cheeks and was a little lightheaded. She was brought to an observation room from 5:15 PM to 6:15 PM and provided with water and snacks. The lightheadedness resolved with water and food. She was monitored closely for respiratory distress, stridor, tachypnea, and accessory muscle use which were not noticed or appreciated during this time period. Denied difficulty swallowing, shortness of breath, tongue swelling, redness, or any other systemic symptoms. By 6:15 PM, the flushing had greatly subsided. If the flushing remained when she arrived home, recommended taking benadryl prior to going to sleep. Advised to go to the ED should she develop shortness of breath, respiratory distress, tongue swelling, hives, and/or increasing redness to other parts of the body. She expressed understanding.
Swelling at injection site with pain and induration.  Then 2 wks of swelling of face, edema of face, redness of face, itching.
Immediately had a soreness from shot (which is normal).  Then that evening it was worse and the next day it was worse and the next day as well.  I took ibuprofen but it really didn't help.  My arm was so painful that it woke me up at nights.  I had sharp shooting pains when lifted a certain way.  I lost strength in the arm.  I have had the flu shot about 6 times now but it was the first time in my left arm.  Normally I get it in the right arm.  After about 3 weeks of it not getting better, I went to the doctor who said that the nurse probably hit a nerve.  I am petite and have very lean arms.  He prescribed vicodin, Gabapentin, and Nabumetone.  I am now on my 2nd prescription of Nabumetone.  I still have pain and it is almost 2 months after the flu shot.  I am very healthy and exercise on a regular basis and have no physical problems.  I know this reaction is from the flu shot because it immediately started bothering me and hasn't stopped yet.  I have lost strength in my arm and it continues to hurt.  I hope it isn't permanent but I am not sure.
Severe anxiety for 24 hours, stared 12 hours after injection Off balance for 24 hours Difficulty concentrating for 3 days
HIT MY ROTATOR CUFF; STILL HAS PAIN; A spontaneous report has been received from a consumer. The report concerns a female patient of Unknown ethnic origin (age 49 years).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    Concomitant medication included influenza vaccine.     The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number Unknown), via nasal route, on an unknown date.     On an unknown date, the patient experienced hit my rotator cuff (preferred term: Rotator cuff syndrome). On an unknown date, the patient experienced still has pain (preferred term: Pain).     The patient recovered with sequelae from the event(s) of hit my rotator cuff on an unspecified date. At the time of reporting, the event of still has pain was ongoing.     The events were considered non-serious.     Minor correction on 19-Oct-2020: Form Completed date updated.Narrative updated.
Pain in the shoulder, unable to lift arm without pain. She has been feeling this way for 13 days now. She expected the pain to wear away by now. No bruising
moderate body aches and fatigue - both reduced within a couple of hours. I took ibuprofen, but I'm not sure what difference it made b/c the pain did not subside as quickly as ibuprofen has historically worked for me in the past (for headaches, cramps, etc.). I felt much better the next morning (today), but this afternoon, I'm starting to feel really tired and a little achey again.
Day after vaccination patient experienced soreness in both arms. Per patient felt like she was punched in arm 100 times. Initially, pain predominantly in Adacel (right) arm. Then alternated back & forth between right & left arm. She has been on Motrin tid since day after vaccination. Patient complains of pain when she crosses arms and states she cannot lift arms above shoulders. No redness, no warmness & no swelling per patient. About 2 to 2 and 1/2 wks after vaccination she went to ER as PCP was out of town. She was told to continue Motrin and give it a few more days. More recently as symptoms are still present her doctor is recommending XRay or MRI to check for muscle involvement or damage.
I do not remember when it started but I had a runny nose. On June 18, 2022 is when it really hit. I got terrible headaches and started remembering the list of things I checked off on symptoms on VSAFE. I had a fever for one day. My asthma started bothering so I slept on 3 pillows for a couple of nights. I went to UTB emergency room. They gave me something for a cough. I was given Robitussin and Malox to coat my throat. I was given Paxlovid prescription and the taste in my mouth was horrendous. I woke up in the middle of the night needing mouthwash. By morning all the symptoms, headache, asthma, all symptoms were all gone. I never finished the Paxlovid. I never had another headache or breathing trouble. I do have a little bit of a cough and my nose is a little stuffy.
pt recv vax;red raised patch at deltoid site where TD given;local cellulitis & hematoma at tetanus site;warm compresses to area;meds given;pt getting better per mom;
Narrative:  72 yo male with prior history of seizures in the last year on current regimen. Patient had 2 seizures, 1 within 24 hours after administration of vaccine and 1 within 48 hours of vaccine dose. Both events resolved prior to medical management. Recent refusal of additional change in AED recommended. Continues on current AED regimen. Patient with note electrolyte abnormalities, low magnesium level when labs checked and adequate keppra levels and continues on gabapentin. Adherence with regimen reported per administration history.
redness; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PRURITUS (itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PRURITUS (itching). At the time of the report, VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Reporter did not allow further contact
pt describes painful rt arm 24hrs p/vax;By 5th day area became red, edematous, & devel into infect according to pt;was seen on ER 24OCT95 where cyst was aspirated;pt was placed on 7 days therapy of Cephalexin; cellulitis
Patient reported a latent reaction to left arm. 4X4 inches erythema at site of injection, warmness at site
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 21st February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st February 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm and injection site erythema were not recovered/not resolved. The reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The circumference of the arm redness was larger than the size of a can of soup. The patient was concerned about the arm redness because, her husband also received the vaccine on the same day and did not experienced arm redness. The call was transferred to the medical information for discussion.
patient felt clammy and light headed. She mentioned this happened before and requested orange juice. I took her blood pressure twice and normalize within 10 minutes. Patient felt comfortable after 25 minutes
Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with influenza virus vaccine 2007/2008 (manufacturer unknown, batch number; unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody at titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 5, 20, 10 and 5 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient did not have 4-fold increase in titer value and tested negative for seroconversion of A/H3N2 strain but PCR (polymer chain reaction) tested positive. Therefore this patient was considered as an LCI case of Influenza A/H3N2. The outcome was not reported.
high temperature for 12 hours; dark red color urine for three days; pimples with whitehead all over face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 17:15 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 10Sep2021 07:30, outcome "recovered" (2021), described as "high temperature for 12 hours"; CHROMATURIA (non-serious) with onset 10Sep2021 07:30, outcome "recovered" (2021), described as "dark red color urine for three days"; ACNE (non-serious) with onset 10Sep2021 07:30, outcome "recovered" (2021), described as "pimples with whitehead all over face". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chromaturia, acne.  Additional information: High temperature for 12 hours dark red color urine for three days pimples with whitehead all over face.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Brain fog; Depression; Anxiety; Elevated mood; Manic episode; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lamotrigine (LAMOTRIGIN) 250mg/day for unknown indication on unknown date and unknown if ongoing. The patient previously received iodine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. On 05Mar2021, the patient experienced brain fog, depression, anxiety, headaches and elevated mood approaching a manic episode. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events and included treatment with psychotherapy and anxiety medication. Since the vaccination, the patient had not been tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events brain fog, depression, anxiety, headaches and elevated mood approaching a manic episode was not recovered at the time of this report. The event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient returned to pharmacy today, 15 days after receiving Shingrix vaccine in her left arm.  She states she has had continued and increasing arm soreness and a large swelling/lump (size of a large lemon) on the inside of left arm above elbow fold in the bicep area.  The pain started after vaccination and the swelling was days later.
No adverse event; Medical Assistant was administered expired VARIVAX on 08/16/2021; This spontaneous report was received from a physician referring to a patient of unknown age and gender.  The patient concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported.  On 16-AUG-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration were not provided) (Lot # S024369, expiration date: 08-JUN-2021) for prophylaxis. It was reported that no temperature excursion for the expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) was confirmed by nurse at that time. No additional adverse event was reported. At the time of the report, the outcome of the event was not reported.  The causal relationship between the event and the expired suspect vaccine was not reported.
Soreness in left arm where vaccination administered. Soreness was at the worst the following day (24MAR21). Soreness is a lot better but still lingering pain as of 26MAR21.
Got COVID, he tested for COVID; He has (COVID) but he has no symptoms; Got COVID, he tested for COVID; He has (COVID) but he has no symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that, got COVID, he tested for COVID; he has (COVID) but he has no symptoms (as reported) on an unknown date. The patient underwent lab tests and procedures which included COVID-19 test resulted positive on an unknown date. The reporter questioned about the working manner of vaccine. The reporter wanted to know the composition of vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not reported. On 02-DEC-2016 (reported also as today), the patient was vaccinated with an expired dose of RECOMBIVAX HB intramuscularly, lot # K022265, expiration date: 22-OCT-2016 (dose and site of injection were not reported). No adverse experience had been reported. Additional information has been requested.
10/20/19 Itching began 10/21/19 Sever ITch & swelling of Left hand, bLotches Arms & Legs 10/22/19 Began taking Methylprednisolone Itching subsided. Swelling Right hand 10/24/19 BLotches on Arms & Legs Started to cLear up  10/25/19 5" bLotches on Torso Appeared 10/28/19 bLotches on Torsso cLeared
Physician ordered a Hepatitis B vaccine to be given and the nurse gave a Hepatitis A instead.
Low grade fever, extreme fatigue that lasted for 3 days, unable to sleep more than 6hrs a night for 2 weeks average was 5hrs, feeling "spacey" for 2 days
No adverse event; HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 04-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023).    No concomitant medications was provided. No treatment medications was provided.  It was reported that, 4 patients, 3 of them received the 2nd dose of the primary series and 1 received a first dose. Information about patient number 2 listed in current case.
Approximately 5 minutes following injection patient began to experience redness and itching to chest and back. Patient denied shortness of breath, no swelling to mouth or lips. Patient denies pain or shortness of breath.  Patient brought to emergency department on campus of vaccine site location.
fever; chills; muscle weakness; diarrhea; basically had the flu; This is a spontaneous report from a contactable pharmacist.    A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unknown route in Dec2020 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, chills, muscle weakness, diarrhea and basically had the flu. The outcome of events was unknown.  Information about the Lot/batch number has been requested.
PHLEGM WITH BLOOD; COUGH; SORE THROAT; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced sore throat. On 17-APR-2021, the subject experienced phlegm with blood. On 17-APR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 15-APR-2021, and had not recovered from cough, and phlegm with blood. This report was non-serious.; Sender's Comments: MAC Comment: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
Dizziness; Headache the night and morning after the vaccine; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 38 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Nov2021 10:00 (Lot number: FF8841) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EL3248), administration date: 01Feb2021, when the patient was 37 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL3248), administration date: 12Jan2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 04Nov2021 23:30, outcome "recovering", described as "Dizziness"; HEADACHE (non-serious) with onset 04Nov2021 23:30, outcome "recovering", described as "Headache the night and morning after the vaccine"; NAUSEA (non-serious) with onset 04Nov2021 23:30, outcome "recovering", described as "Nausea". Therapeutic measures were not taken as a result of dizziness, headache, nausea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received by the patient within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not get covid tested post vaccination. The patient did not have any known allergies.  Follow-up attempts are completed. No further information is expected.