chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 48-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7FF3N, expiry date 30th June 2017. On 29th September 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) 0.5 ml. On 29th September 2016, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and injection site pain. On an unknown date, the outcome of the pain in arm and injection site pain were not recovered/not resolved. The reporter considered the pain in arm and injection site pain to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: It was reported that the patient experienced pain (10/10) radiated down her arm to her elbow. Then the pain moved down the arm to align with the middle finger. The pain subsided in the lower arm but continues in the upper arm above the elbow to the injection site. Pain was 3/10. But, if patient raised her arm pain was 10/10.
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Patient felt lightheadedness and was sweating a lost coloring in is face after his moderna booster.  He needed to lay down on the floor and we did call the ambulance. He was assessed by EMT's and went home on his own with his fiance. He stated that he fainted after he got his first janssen covid vaccine.
low grade fever; fatigue; myalgia; Overdose; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received in fall of 2018) and Shingrix (2nd dose received on 30th January 2019).   On 30th April 2019, the patient received the 3rd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, fatigue, myalgia and extra dose administered. On an unknown date, the outcome of the fever, fatigue, myalgia and extra dose administered were unknown.   It was unknown if the reporter considered the fever, fatigue and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient was forgot that, he received 2nd dose of Shingrix in the month of January. The patient received 3rd dose of Shingrix, which led to extra dose administered. Less than a week after vaccination with Shingrix, the patient experienced low grade fever, fatigue and myalgia. The reporter did not consent to follow up.
Information has been received from a health professional concerning a 50 year old female with no medical history and allergy to PPD (causes redness) who on 21-JAN-2008 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 659698/1770U). There was no concomitant medication. On 23-JAN-2008, 48 hours post vaccination the patient developed a red blotch area at injection site of the deltoid. No diagnostic laboratory tests were undertaken. Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports recovered from the same source.
affected her ability to teach; sick/flu-like symptoms; felt really bad; Sick; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, feeling bad, sickness and activities of daily living impaired. On an unknown date, the outcome of the influenza-like symptoms, feeling bad and sickness were recovered/resolved and the outcome of the activities of daily living impaired was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling bad, sickness and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. The reporter reported that, after vaccination had sick or flu like symptoms for 3 days and then resolved, but it affected the patient's ability to teach. The reporter did not have further information.
BRACHIAL NEURITIS; INJECTION SIDE FOREARM  AND HAND DELTOIDS  WILL BE PRETTY PAINFUL AT THE INJECTION SITE; GRIP STRENGTH IN INJECTION SIDE HAND; This spontaneous report received from a patient via media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. Dose number in series 1. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced brachial neuritis, injection side forearm and hand deltoids will be pretty painful at the injection site, and grip strength in injection side hand. "injection side forearm and hand, lost about 80 percent of strength in grip. "Tell patient to get ready for the brachial neuritis. Hope patient doesn't need any grip strength at the injection side hand for a couple months. The deltoids will be pretty painful at the injection site as well. Now 2 months post not much improvement." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brachial neuritis, injection side forearm and hand deltoids will be pretty painful at the injection site, and grip strength in injection side hand. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient via media concerned a female of unspecified age, race and ethnicity who experienced brachial radiculitis and loss of grip strength after an unspecified duration of vaccination. Medical history and concomitant medications were not provided. The patient experienced loss of 80% grip strength and brachial radiculitis after an unspecified duration of vaccination and did not see much improvement after 2 months of onset of symptoms. No imaging or electromyography details were provided. Outcome is reported as not recovered. Information (medical history, chronology and clinical course of events) is limited in this case. Therefore, the relationship of events to vaccination is considered unclassifiable due to insufficient information
Pain in my arm that did not go away in a day or a week.  Over a month later I still get twinges of pain when I move my arm certain ways.
Healthy pregnancy History 4th pregnancy,  Due Date May 30 2021.  Intense shivers and chills for 2+ hours ~45 min after injection. Shivers controlled with blankets and hot shower. Shivers on and off through the night. By morning, body temp chills and sweats but not as bad as previous evening. Tired and lethargic through the day with low energy.
Chills, fever of 102.3, sweats, nauseau, diarerah,headache, all teeth and gums ached. Light sensitivity similar to a migraine. Starting at 1;30 am
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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 was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 24Sep2023 to 29Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300316460 same patient, different drug/events;
Red, swelling/painful area itching 5 1/2x3 cm. centralized tender to touch. indurated
fatigue/   sever headaches / upset stomach /  heavy feeling in my chest/  fast heart beat/  cough/  sinuse congestion/ swelling of eyes and draining/  blood shot eyes/  joints sore/ ears closed
In August 2022 I started having a tingly and sensitivity to hot water. By September, I had an incident that I had to ice my hand down for over an hour, but it bothered me throughout the night. I called my primary care doctor to make an appointment, he referred me to a neurologist that I have yet to see as there is a long wait time. After using the glove on the one had for a month, I am now using cooler water as I do not want to experience that awful sensation again.
One week after receiving the Moderna COVID-19 Vaccine EUA, I experienced a raised 2" circular area surrounding the vaccination site which was itchy and red in color.  I took Benadryl for 2 days and it was gone in 2 to 3 days.  Then, exactly 2 weeks following the vaccine, I experienced a severe asthma attack at 4:00 am in the morning.  This was extremely unusual, and has not occurred since childhood. My usual meds, ProAir RespiClick & Adair did not appear to work as they normally do and gave me little relief. I saw my doctor the next day and he prescribed ZPAC & Prednisone which improved my breathing within a couple days.
He states that he recieved the flu vaccine ~ 0830-0900 Saturday AM and about 5PM he started to  feel as if he had blisters on his finger tips and then spread to his arms, torso and legs. He tried taking benadryl which helped the pruritis. He denies the use of any new personal hygiene products or changing any detergents and no new animals/pets etc. He presented yesterday and was started on medrol dose pak. He states that it has improved since then. He states that he has had the flu shot in the past but never had a reaction.
Covid symptoms again; Besides losing taste and smell for 3 months; Besides losing taste and smell for 3 months; fever of 105.2; the vaccine induced skin issues; psoriasis; This is a spontaneous report from a contactable consumer or other non-HCP.    A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0153), via an unspecified route of administration, administered in Left Arm on 15Apr2021 02:30 as DOSE 1, SINGLE for covid-19 immunization.  Medical history included thyroid disorder, hypertension, migraine, covid-19 If covid prior vaccination: Yes. On 22Apr2021 the patient experienced covid symptoms again. besides losing taste and smell for 3 months, fever of 105.2, the vaccine induced skin issues, psoriasis. The patient underwent lab tests and procedures which included biopsy: psoriasis on 22Apr2021 now she has had a spot biopsied and she now have psoriasis , body temperature: 105.2 on 22Apr2021 fever of 105.2 for 3 days. Therapeutic measures were taken as a result of covid symptoms again, besides losing taste and smell for 3 months, besides losing taste and smell for 3 months, fever of 105.2, the vaccine induced skin issues, psoriasis. The outcome of all events was recovering.    Follow-Up (01Oct2021): Follow-up attempts are completed. No further information is expected.
Severe headaches, tingle feeling on the left side of the body (injection site) , fatigued.
Information has been received from a physician concerning a 4 year old male who in 2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient "broke out with chicken-pox. The patient had less than 50 lesions. All were maculopapular." Unspecified medical attention was sought. No product quality complaint was involved.  Additional information has been requested.
Patient came to our pharmacy to get a vaccine. Our technician at drop-off window initiated the registration and inputted in the computer for Adacel,  as the technician understood that patient wanted Tdap based on their conversation. The vaccine was submitted to the pharmacist as Adacel in the computer.   Prior to administration pharmacist informed patient that she was getting Adacel  and it is good for 10 years then adminstered the vaccine.  The patient was then given a vaccine record card to take with her. Then she looked at the card and looked over for  the list of other vaccines, then she said I was supposed to get MMR and I got Tdap last week. We then asked where? then she responded at a clinic. We contacted her doctor and informed her that we will report the incident and that will be ok.
Initial information for this case was received from other health care professional on 02 January 2014. This 73-year-old female patient whose medical history included allergic to penicillin, concomitant medications were not reported had received an intramuscular injection of FLUZONE HD (batch number: U4785AA, dose not reported) in her left deltoid on 30 December 2013. On 01 January 2014, the patient developed pink, itchy rash at injection site on left arm which extended to the biceps muscle and felt as if it extended down arm to her wrist. The patient had not seen health care professional (HCP) for evaluation or treatment. The relevant laboratory details and corrective treatment was not reported. The outcome of the event was not reported. The list of documents held by sender: None.
legs were numb; severe dizziness; couldn't walk; fell; was weak; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (legs were numb), DIZZINESS (severe dizziness), GAIT INABILITY (couldn't walk), FALL (fell) and ASTHENIA (was weak) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced HYPOAESTHESIA (legs were numb), DIZZINESS (severe dizziness), GAIT INABILITY (couldn't walk), FALL (fell) and ASTHENIA (was weak). At the time of the report, HYPOAESTHESIA (legs were numb), DIZZINESS (severe dizziness), GAIT INABILITY (couldn't walk), FALL (fell) and ASTHENIA (was weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.   At around 10:30-10:45am patient received vaccine and about an hour later, at 11:30-11:35am he had symptoms.  No treatment medications provided by the reporter.
Pharyngitis; allergy to GARDASIL 9; Reactive Arthritis; This spontaneous report was received from a nurse via a company representative and refers to a 12 year old male patient. The patient's concurrent conditions included mild chest and back pain prior the vaccine administration. The patient did not have any drug reactions or allergies.  On 22-JUL-2019, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported) as age appropriate vaccine. On 29-JUL-2019 (reported as one week after the vaccination), the patient experienced knee pain. On 26-AUG-2019, the patient experienced pharyngitis. On the same date, the patient was seen from pharyngitis and he reported, that his knee pain continued. On 01-SEP-2019, the patient went to the emergency room for his joint pain and was diagnosed with reactive arthritis.  Subsequently, the patient saw a rheumatologist, who did not see a rheumatologic reason for the joint pain and diagnosed the patient with allergic reaction to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  On an unknown date in 2019, the patient had unspecified test performed which showed that he did not have any underlying rheumatoid disease. As a treatment the patient was prescribed a 20 day course of tapering steroids. The joint pain resolved after the patient completed the treatment.  Additionally, the reporter stated that the patient was administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on 18-OCT-2019.   The outcome of the events was reported as recovered on an unknown date in 2019. The causality assessment was not provided, however the relatedness between the reactive arthritis and allergy to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was established as related.      dose 1 for prophylaxis.       On 29-JUL-2019, 8 days after onset of therapy the patient experienced arthritis reactive and hypersensitivity.  On 26-AUG-2019 the patient experienced pharyngitis.    The outcome of arthritis reactive, hypersensitivity and pharyngitis was reported as recovered/resolved.   The reporter considered arthritis reactive and hypersensitivity to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).     {Additional information has been requested. / Additional information is not expected.}
Got the poke and ended up getting shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the poke and ended up getting shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a consumer via interactive digital media. The patient got the poke (shingles vaccine) and ended up getting shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR067341, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR067341:Same reporter
arthritis got my back hurting; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number/Expiry date: Not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced arthritis got her back hurting bad on an unspecified date. The patient received XELJANZ XR 11mg for the treatment of event. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
p/vax pt exp a localized skin rxn blotchy erythema, triangular shaped & 5 inches in length;no tx given & lymerix was discontinued;pt recovered;
Pt states that within 1hr she experienced a headache and chills. This progressed over the next 48hrs to tremors and fever of 104. That is also when Pt noticed the injection site to be red and swollen. Pt went to see PCP, who prescribed keflex and prednisone 5 dose pack.
L arm pruritic rash, developed 1d after injection, treated with ice pack and ibuprofen, mild improvement  Headache, fatigue, nausea over similar time course, also treated with ibuprofen with minimal improvement
Patient received a Moderna covid-19 vaccine booster.  Patient previously received the J&J one dose vaccine.  Patient stated she was "knocked out"  at 21:30 after having received the vaccine earlier in the day and was unable to "wake up" until the following day at 15:30. She stated that she remained sluggish the rest of the day. She reported feeling fine now and only had a slightly sore arm from the injection at this time.
Patient tested positive for covid-19 on 7/25/21 and required admission to hospital secondary to hypoxia and need for supplemental oxygen
Rash on both of my arms; It does feel like there is a little burning to it; This is a spontaneous report received from a contactable consumer (reporting on herself). A 69-years-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EL9269 and Expiry date was not reported), via intramuscular route of administration in Deltoid Left on 06Feb2021 as single dose for COVID-19 immunization. Medical history included urticaria from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that patient have had a reaction to this vaccine. She did a little survey thing and then when she was going to bed, she noticed that she had a rash on both of my arms and its was not terrible, mean she have had hives (Intent: History) before but had a rash on both arms and its was not terribly itchy but basically she want to look at the severity of the reaction and that's one of the most weird one, patient don't have any shortness of breath or swelling of tongue or any of that, just the rash and she am just wondering if I should be concerned about this. It does feel like there was a little burning to it that's the only other thing Ishecan tell. Patient was a medical assistant. Patient going to get the second shot, the second vaccine because now she was at more risk from what she understand. Patient stated, she don't know that either because she don't have the card with her and stated, It doesn't give her the expiration date. The only number which was on the card was the LOT#. Causality mention Yes, most definitely. Patient think it was improving. The outcome of the vents was not recovered.
The provider ordered pediarix and I gave Dtap to patient. She was due for dtap as it is part pf the pediarix vaccine. The Hep B is not still due because she has had 3 doses. Pt will still need a 3rd polio vaccine. Pt's mom was informed of all of the above and will recieve IPV at next OV.
Client has hives on her back and redness in her face.  Client reports that she frequently gets hives and could be coincidence.  SPO2 99%
Muscle twitching and/or spasming in the upper arm that received the Pfizer COVID-19 vaccine
Information has been received from an office manager concerning a 57 year old patient who inadvertently was vaccinated with a dose of GARDASIL by human error. No adverse effect reported. Follow-up information was received from a physician who reported that on 10-JUL-2008 the patient was given GARDASIL, IM, in the left arm instead of ADACEL inadvertently. No further information is available.