chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt.'s Mother states that after receiving the 2nd dose of Phizer 09/14/2021, started experiencing symptoms 10/2021 of nausea and fatigue. Scheduled for Primary visit 12/20/2021.
Local reaction at injection site with pruritis, edema, & erythema.  L upper arm w/ erythematous macular rash. 3.5 x 3" in total size. Slightly firm portion 1 x 3/4 x 3".
it will cause recurring shingles/suspected vaccination failure; shingles; Dont get the shingles shot while you have the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and drug administration error. On an unknown date, the outcome of the vaccination failure, shingles and drug administration error were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had shingles and received shingles shot. The patient was experienced recurring shingles. The patient's physician did not have clue about shingles. The patient advised that don't get the shingles shot while you have the shingles it would cause recurring shingles. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not provided.
pt recv vax; exp gastritis & was seen in er;15apr94 recv Hep B vax;
fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches; This is a spontaneous report from a contactable consumer or other non hcp. A 46-year-old male patient received second dose bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP6955), via an unspecified route of administration in arm left on 13Apr2021 at 12:15 (at the age of 46-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient was not reported. The patient had no known allergies. The concomitant medications of the patient were not reported. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP6955), via an unspecified route of administration on 23Mar2021 at 12:30 (at the age of 46-years-old) as single dose for COVID-19 immunisation. 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 had been tested negative with covid-19. On 18Apr2021, the patient experienced fatigue- sensitive under arm glands- shortness of breath-pressure in chest-abnormal heart rate- headaches. The patient underwent lab tests and procedures which included nasal swab sars-cov-2 test: negative on 18Apr2021. Therapeutic measures were taken as a result of events that included aspirin. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Less than 12 hours after Pediarix/ Hib/ PCV-7 administered, redness and swelling at injection sites of Hib/ PCV-7. "Splotchy red" patches down leg. Associated with irritability. No fever. Resolved with antipyretics and Benadryl.
Client was vaccinated with Moderna vaccine for Covid x 2 in March 2021.  Developed symptoms (mild- nasal congestion) on 11/2 and tested + on 11/2, 11/3, and 11/4.  Received antibody infusion on 11/4.
Chills, fever, body aches, dizziness reported at 9pm 12/30/20. Continued throughout the night. Fever 100.0 reported at 6am 12/31/20
rash; itchy; swelling; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), PRURITUS (itchy) and SWELLING (swelling) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE, CALCIUM, MULTIVITAMINS & MINERALS PLUS LUTEIN, Bupropion XL, Adderall XR,  REPAGLINIDE (PAGE) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced RASH (rash), PRURITUS (itchy) and SWELLING (swelling). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I started having serious suicidal thoughts out of nowhere on Saturday evening. I started fantasizing about suicide. I have anxiety and depression, but they?ve been well controlled and my therapist appointment earlier that week was going so well that we pushed our appointment out to a month. I was not actually feeling sad or depressed, just having repeated episodes of fantasizing about suicide. This is never happened to me before. I?ve had anxiety and depression for 20 years but this was like a switch went off. This was very distressing to me, the only new thing in my life was the Covid vaccine the day before.  I was happy and I had a great day before this
Not reconstituting the vaccine; Only adjuvant administered; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-Feb-2023 Reporter's Comments: A physician stated in his office one day before the reporting date that a nurse that no longer worked at the practice, administered the Shingrix adjuvant only, without reconstituting the vaccine, to 3 different patients in the physician's office.  The reporter did not have any further information about this incident, nor any information about lot number, date this happened or any differing factors for any of the 3 patients.  The reporter told to the GlaxoSmithKline field representative that the physician's office did contact the 3 patients, and it had all been taken care of.  The reporter consented to follow up with health care professional was obtained.  Additional supportive information: The patient received only adjuvant of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This 1 of 3 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2023AMR026705:Same reporter US-GSK-US2023AMR026706:Same reporter
Left arm swelling, erythema 2" X 2" at site of IPV shot.
6/23/10 developed hives on arms and legs.  Treated with BENADRYL.
Stroke; Pain in his mid-section shoulder; Pain in his mid-section shoulder and left arm; Probably shingles; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2020, 7 days after receiving Shingrix, the patient experienced shingles. On 24th May 2020, the patient experienced shoulder pain and pain in arm. On 17th June 2020, the patient experienced stroke (serious criteria hospitalization and GSK medically significant). On 24th August 2020, the outcome of the stroke was recovered/resolved and the outcome of the shoulder pain was not recovered/not resolved. On an unknown date, the outcome of the pain in arm and shingles were unknown.   It was unknown if the reporter considered the stroke and shingles to be related to Shingrix. The reporter considered the shoulder pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: About one week later he began to experience pain in his mid-section shoulder and left arm.   The physician said it was probably shingles.  The patient then had a stroke in June and was hospitalized.  He was still experiencing the pain and wanted to know what he could do for it.   The reporter consented to follow up.
Moderna dose 1 was given 12/19/21. Dose 2 was due 1/16/22 and was given 1/9/22. Client tolerated well, no adverse event was noted during 15 minute observation period.
urticaria on face & cheek 1/2hr p/vax;given dose of DPH cleared in 1/2hr;
Information has been received from a female consumer who in August 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number unknown). Concomitant therapy included SYNTHROID. The consumer stated that in February 2010 she experienced shingles. The doctor believed the patient suffered only a mild episode and this was triggered to stress. The consumer was recovering from shingles. The consumer sought unspecified medical attention. Follow up information has been received from the consumer who reported that she had no further information. No further information is available.
After receiving my second Covid booster on the above date 05/13/22- I now have constant ringing in both my ears.  I have visited an ENT and audiologist on 06/06/22  - and have some hearing loss relating to certain sounds which are drowned out by the ringing in my ears.
Heart disorder/Heart Issue; Palpitations/HEART PALPITATIONS; Plaque psoriasis bad flare up that was triggered from injury; Injury; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart disorder/Heart Issue), PALPITATIONS (Palpitations/HEART PALPITATIONS), PSORIASIS (Plaque psoriasis bad flare up that was triggered from injury) and INJURY (Injury) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Patient was diagnosed with plaque psoriasis at about 10 years old.) since 2010.   On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) (Subcutaneous) 1 dosage form. In 2018, the patient experienced PSORIASIS (Plaque psoriasis bad flare up that was triggered from injury) and INJURY (Injury). On 31-Oct-2021, the patient experienced PALPITATIONS (Palpitations/HEART PALPITATIONS). On an unknown date, the patient experienced CARDIAC DISORDER (Heart disorder/Heart Issue). At the time of the report, CARDIAC DISORDER (Heart disorder/Heart Issue), PSORIASIS (Plaque psoriasis bad flare up that was triggered from injury) and INJURY (Injury) outcome was unknown and PALPITATIONS (Palpitations/HEART PALPITATIONS) had not resolved.            Concomitant medication was not provided. Patient still gets palpitations about every other night on an average. He tried several things for plaque psoriasis. Treatment information was not reported. For drug Skyrizi, the reporter causality was given as not reported for Palpitations and Mfr. causality reported as No reasonable possibility for Palpitations. It was unknown if patient was enrolled in a covid-19 vaccine Trial.
Immediately after the shot, she complained of numbness to her upper right arm around the area of the shot. Next, she requested to sit down because she was feeling sleepy drowsy. She felt like she was going to pass-out. She was covered with sweat. She sweated profusely. We called 911 because she looked sleepy or drowsy. We kept calling her name to keep her awake. I administered epinephrine as we continued to fan her. She was still sweating profusely and feeling like passing out at the same time. She recovered fully before EMS arrived. She told EMS she felt fine, and did not need to be taken to the emergency room. She later drove herself home.
her arm was very sore; felt bad; nauseous; dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Some allergies" (unspecified if ongoing), notes: not aware of specifics. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "recovered", described as "her arm was very sore"; FEELING ABNORMAL (non-serious) with onset Feb2021, outcome "recovered", described as "felt bad"; NAUSEA (non-serious) with onset Feb2021, outcome "recovered", described as "nauseous"; DIZZINESS (non-serious) with onset Feb2021, outcome "recovered", described as "dizzy". Therapeutic measures were not taken as a result of pain in extremity, feeling abnormal, nausea, dizziness. Additional information: Patient reported that her arm was very sore the next day after vaccine administration. She said she felt bad and took a 2 hour nap the day after her vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash itches; sore arm; scarlett red rash down both arms,entire trunk of body, and both legs; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash itches), PAIN IN EXTREMITY (sore arm), RASH (scarlett red rash down both arms,entire trunk of body, and both legs) and CHILLS (chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (rash itches), PAIN IN EXTREMITY (sore arm), RASH (scarlett red rash down both arms,entire trunk of body, and both legs) and CHILLS (chills). At the time of the report, RASH PRURITIC (rash itches), PAIN IN EXTREMITY (sore arm), RASH (scarlett red rash down both arms,entire trunk of body, and both legs) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
I had a sore throat, cough, congestion, body aches, lethargy, low-grade fever, and body chills. I decided to take an at-home COVID-19 antigen test the next day on 01/01/2023 which came back positive because the initial one the day before came back negative. I called my doctor and one of the physicians prescribed me PAXLOVID on 01/03/2022 so I started my treatment on the same day after picking up my prescription. As of right now, I'm improving; I still have congestion, cough, very mild body aches, headache, and low energy/fatigue. The PAXLOVID prescription has left a metallic taste in my mouth and triggered an upset stomach.
localized red, swollen, sore, feverish for 2 days & PCP;warm pads & DPH;
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 10-NOV-2016, the patient was vaccinated with a dose of M-M-R II (dose not reported), lot # L028273, expiry date: 28-JUL-2017, intramuscularly to the left deltoid in error. The pharmacist believes that he made the error because he also administered a dose of BOOSTRIX (dose, route, lot number and expiry date were not reported). There is no product quality complaint involved. Additional information has been requested.
Red induration & welt on right arm. Diffuse redness across entire body. Right arm welt is raised, warm.
Woke up approximately 11:50 PM. Severe pain in stomach area. Nausea. Used bathroom to defecate. Took Gasx.   Went back to sleep and woke again approximately 1:20 AM. Continued stomach pain, nausea. Violently vomited small amount. Went back to sleep.   Woke 5:30 AM. Mild nausea.
Patient came to drop off window stating he had completed his primary series and had received a booster but now wanted his additional dose because he has cancer, is receiving treatment for cancer and is immunocompromised. We processed the additional dose for the patient. After the shot was administered (full additional dose) I made the patient a new vaccine record card. Upon reviewing patient's clinical services history, the patient had received the primary series and had already received the additional dose and was due for a booster. But patient received a 4th (full dose) instead of booster (half dose). All 4 covid vaccines given were Moderna.
Extreme body/joint aches and very sore arm. Lasted about 18 hours. Ibuprophen helped, but could not sleep with the pain. Acetaminophen did not help.
pt recvd vax on 2nov94; 4nov94 pt called w/ swelling from inject site to elbow; area red; warm to touch; no limp; plan tx: ice to area x 24 hrs; apap for discomfort; cleared in 24 to 48 hrs;
At injection site: Swelling Redness Hard Very hot Tender to touch Started as triangular spot1/25 Doubled in size 1/26  Dispersing  1/4 larder at bottom 1/27 *coincidentally or not I got an irritation under my upper right lip 1/25 To present.  Painful somewhere between a canker and a cold sore (no tingling).
This spontaneous case reported by a consumer, describes the occurrence of ocular hyperemia (red eye) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 29, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unspecified dose. On Apr 8, 2021, patient experienced ocular hyperemia (red eye). At the time of the report, ocular hyperemia (red  eye): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant product use or treatment information provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Jul2023 at 10:15 as dose 6 (booster), single (Lot number: Gj3268) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Sep2022 at 10:15 as dose 5 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course : Patient had no allergies. Patient started paxlovid treatment from 27Jul2023 to 31Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300269488 same patient different drug/event;
[Vaccinated at another site] -- 24 hrs after first COVID dose, she had several days of dyspnea, tremors, headache, tachycardia, and hypertension, all without fever.
Client, was less than 18 years of age when she received the vaccine at the Campus MPOD.  Mother's consent /approval was obtained by her aunt and was physically present during the vaccination.  No adverse affects were noted.  Mild to moderate right arm soreness was experienced the day after the vaccination was given.
T2 and T3 dermatome involvement. Onset rash 4/19/08. (L) lateral back w/ 20 clustered red papules. (L) post arm w/ 20 clustered red papules. Resolving at 5/14/08 visit.
pt stated she started having body aches, headache, chills same day after vax. 3 days after vax pt started having extreme back muscle spasms.  4 days after vax pt had crushing feeling and sensation in back. 5 days after vax pt is not able to touch spot where she had her epidural and started having electrical shocking sensations down her back.  pt visited a message therapist that said her back was inflamed and to see a chiropractor which did an adjustment and was told to keep back iced.  pt has kept her PCP informed w/ symptoms so Dr. ordered her an MRI.  Results did not show any reason to have electrical shocks so  pt was told to take ibuprofen and keep back iced. On 1/19 pt is still having electrical shocks and stated she feels like her nerves are going haywire.  Pt said her skin feels like bugs are crawling on her.  Pt is in a lot of pain and was told to get a referral to see a neurologist in a week if not any better.
This spontaneous report as received from a pharmacist refers to a 56 years old female patient. The patient had no pertinent medical history and no drug reaction. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot number reported as H011052, expire date 05-SEP-2013) subcutaneously on 16-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist mentioned the patient received ZOSTAVAX around 1:30pm on 16-OCT-2012 and the patient called 1 hour later to report cramps in the left ankle that was pretty painful and radiating from the site. No treatment was given for adverse event. No laboratory diagnostics studies were performed. The outcome of adverse events was reported as not recovered. The patient had sought medical attention via phone call to pharmacist. Additional information has been requested.
Loss of mobility in my left arm. Pain in my upper left arm. Loss of range of motion in my left arm. Loss of strength in my left arm. It has not recovered.