chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt bad; This case was reported by a nurse via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine. Previously administered products included Shingrix with an associated reaction of myalgia (1st dose received in March 2019, refer case US2019080731).   In May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: The nurse reported these adverse events experienced by herself. The age at vaccination was not reported. Due to bad experience from 1st Shingrix dose, the patient was very hesitant to get 2nd dose, but followed through with receiving it as she was a registered nurse and recognized the importance of completing the series.   After receiving 2nd dose, the patient felt so bad as like first that she had to take a day off of work. The patient also commented that pharmacist really needs to highlight the horrible side effects of the vaccine.  The patient also asked that, did there was any case of Irritable bowel syndrome (ISB) or Small intestine bacterial overgrowth (SIBO) after receiving this vaccine since the patient developed ISB after her 1st dose. No other details provided.
4 days p/2nd vax pt devel diffuse myalgias that were partly relieved w/motrin; 10 days p/2nd dose pt devel kinetic tremor, w/inc intention in both upper extremities;also had severe lt flexor digitore-weakness;
No adverse event reported. Patient received Pfizer Bivalent 12+ instead of the age appropriate Pfizer 5-11 product.
He got the shot 4:00pm on a Thursday 1-31-13. By evening he had chills the next day same thing and aches all over by Fri 2-1-13 at 7:00pm. His fever was 102.5. He fainted twice took him to the hospital. They hydrated him and release him. Dr said it was definitely the shot he received on Thursday.
This is a spontaneous report from a contactable consumer. A 63-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was EP6955), via an intramuscular route of administration on 24Mar2021 as dose 1, single for COVID-19 immunization. She received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was EP6955) via an intramuscular route of administration on 15Apr2021 for COVID-19 immunization. Medical history includes high cholesterol and high blood pressure. There was no known allergies. Concomitant medications includes rosuvastatin, losartan, amlodipine besylate, multivitamin within two weeks of vaccinations. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested positive for covid-19. On 06Aug2021, 09:00AM patient tested positive for COVID-19 with congestion, runny nose, cough, and mild fever. The patient underwent lab tests and procedures which included SARS-COV-2 RNA, QL, RT PCR COVID 19 positive on 07Aug2021 via Nasal Swab. No treatment received for events.  Follow-up (12Aug2021): Follow-up attempts are completed. No further information is expected.
This 89 year old white  male received the Pfizer Covid shot on 1/20/21    and went to the ED on  4/16/21     and was admitted  on 4/16/21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident) R29.810 - Facial weakness
Left axillary, supraclavicual, and cervical chain lymphadenopathy > 1-week post-injection.; since the vaccination, has the patient been tested for COVID-19?: Yes; since the vaccination, has the patient been tested for COVID-19?: Yes; This is a spontaneous report from a contactable healthcare professional.  A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on the left arm on 21Dec2020 20:00 at single dose for COVID-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced left axillary, supraclavicual, and cervical chain lymphadenopathy > 1-week post-injection on 22Dec2020 16:00. in which the patient received no treatment. It was also reported on Dec2020, "since the vaccination, has the patient been tested for COVID-19?: Yes". The patient has other pending test. The outcome of left axillary, supraclavicual, and cervical chain lymphadenopathy > 1-week post-injection was not recovered and other events was unknown.; Sender's Comments: Based on the information provided, the COVID-19 test positive are possibly related to drug ineffective of BNT162B2 vaccine.
About 24 ours after, I experienced severe headaches, chills and fever. They went on for the next day. Also, my left eye is swollen after I began to experience the symptoms. Later that day, I began to feel horrible pain on left arm. My lymph nodes were swollen on the side of my left arm where they put the vaccine. I had a dry cough that was constant. It wouldn't go away. I was having fever and chills and large swollen lymph nodes and then this cough. So I thought I had COVID. I had to call off the next day. The headache has lingered on since then. I still have the headaches although not as severe as at first. This headache is very different - on the back of my head on the left side. It feels like a burning pain on the back of my head and that's how I felt the headache the very first day. Heart palpitations started 2 weeks after the vaccine. They were happening on and off.  I ended up in the  Urgent Care on the 7th of April- for heart palpitations - They put a heart monitor on me because they couldn't figure out what was going on. Lingering headaches - I woke up with a headache - and that's never happened before all of this - burning sensation on back of my head on left side. Doctor is trying to figure out what is happening. I have been on two courses of antibiotics and they don't resolve anything.
SEVERE EMESIS ALL NIGHT REQUIRING IV MEDICATION'S AND FLUIDS TO BE ADMINISTERED IN EMERGENCY DEPARTMENT.
Spoke with patient and they stated that they did not have any adverse reaction from the shot that was given 1 hour and 45mins out of the 6 hour window. Vial was opened at 8:50am and needed to be used by 2:50pm. It was not thrown away and all 7 rights were checked except with this vaccine we now have to check a time of it being opened and I miss read the time and gave it at 4:45PM that same day. So It was used 1 hour and 45 min out of the 6 hour window.
Hives/almost anaphylaxis; This spontaneous case was received on 15-Jul-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-01739) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included Flucelvax Quadrivalent (influenza vaccine inact sag 4v, bathc number: 252679) received in 2018, after which she developed hives and almost anaphylaxis.  On an unspecified date in 2019, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration, anatomical location, dose and indication: not reported). The batch number reported was 261213.  On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient had reaction of hives and almost anaphylaxis.   The outcome of the event was not reported.  The reporter assessed the event of 'hives' as related to Flucelvax Quadrivalent. She had reactions of hives and almost anaphylaxis and she was asking if Flucelvax Quadrivalent contain any mRNA technology as she heard they snuck mRNA into vaccine starting in 2017.  The event of 'hives' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  This case is linked with case 202202848 (the same patient).  Company comment: A patient of an unreported age developed Urticaria an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent. It is reported that the patient almost had anaphylaxis. The patient's medical history and concomitant drugs were not provided. Due to lack of information and unclear temporal relationship, causality for the reported event is unassessable.; Reporter's Comments: She had reactions of hives and almost anaphylaxis and she was asking if Flucelvax Quadrivalent contain any mRNA technology as she heard they snuck mRNA into vaccine starting in 2017.; Sender's Comments: A patient of an unreported age developed Urticaria an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent. It is reported that the patient almost had anaphylaxis. The patient's medical history and concomitant drugs were not provided. Due to lack of information and unclear temporal relationship, causality for the reported event is unassessable.
Swollen, red and itchy hands. Red blotches on face, neck and trunk.
Large rash? Bump/swollen, red, sore to touch, itchy, hard. Noticeable about 24 hrs after injection, as of 12/28/21 has improved dramatically but is not  gone completely.
Patient had severe vertigo on the early morning of 2/24 @ 2:00 a.m. Pacific time; date of vaccination was 2/18. Patient had never had vertigo in the past. This was the first bout.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: FH8028) in left arm, on 05May2021 as dose 2, single (Lot number: ER8737), in left arm and on 08Mar2021 as dose 1, single (Lot number: ENG199), in left arm at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 28Apr2022, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  clinical course was reported as: The patient did not receive any other medication in 2weeks. adverse event: Symptoms went away two days after treatment and came back a few days, with the same intensity as at the beginning of the infection, after treatment was over. Still testing positive with an antigen test two weeks after the original infection date. The patient did not have any known allergies. Treatment used was Pfizer Paxlovid, treatment start date=19Apr2022, treatment stop date=24Apr2022, indication=Treatment of COVID-19  No follow-up attempts are possible. No further information is expected.
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Nov2021 as dose 3 (booster), single (Lot number: 022C01A), in left arm 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 included: "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 20May2022, outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive; (22May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.The patient was treated with paxlovid for covid 19.It was unknown if the patient received any other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Itching at injection site (DTaP) followed by redness, then whole arm swelling and redness immediately after injection
Grandma called & states fever went up to 104 on night of 8JAN92. States MD refused to see pt & told her to bring pt to Hlth Dept in AM; pt has t103, still has ear infect & bronchitis.
Patient passed out in her chair just moments after getting her Covid -19 vaccine.  Accompanied by her mother who said this happens often during other vaccines and venipuncture.  Mother said patient slid off her chair and landed on her back.  She denied any pain to head, neck, shoulder or any other extremity.  Patient assisted from floor to stretcher.  No report of any difficulty or dizziness upon transfer. Vital signs taken at 1615  BP 111/71 HR 91 O2 99% room air Resp 16 No pain Full ROM of head, neck and all extremities without pain Head to toe assessment negative.  Neuro and vision check negative.  Patient waited 30 minutes and BP rechecked at 1640.   BP WNL at 102/65.  Patient changed to sitting then standing po
Information has been received from a pharmacist concerning an adult patient who on Oct 26 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed an injection site reaction that included local heat, swelling and redness. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Additional information has been received from the pharmacist who indicated that his report originated from an allergic reaction and not from another adverse effect (nothing serious). No additional information is expected.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received  on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309.  This case involves an adult patient of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.   Action taken: Not applicable.  Outcome:  Unknown for both the reported events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 16-SEP-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient experienced syncope briefly he thinks due to sudden drop in blood pressure but recovered within minutes.
This case was reported by a consumer via call center representative and described the occurrence of myelitis transverse in a 85-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included trigeminal neuralgia. On 3rd July 2018, the patient received SHINGRIX (intramuscular) .5 mcg/mg. In July 2018, less than a month after receiving SHINGRIX, the patient experienced myelitis transverse (serious criteria hospitalization and GSK medically significant), unable to walk (serious criteria hospitalization), memory deficit (serious criteria hospitalization), urinary incontinence (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), urinary frequency (serious criteria hospitalization), constipation (serious criteria hospitalization), mobility decreased (serious criteria hospitalization) and bladder dysfunction. On 16th July 2018, the patient experienced appetite lost (serious criteria hospitalization), general body pain (serious criteria hospitalization) and feeling unwell. On an unknown date, the outcome of the myelitis transverse, appetite lost, unable to walk and bladder dysfunction were recovering/resolving and the outcome of the memory deficit, urinary incontinence, balance difficulty and urinary frequency were not recovered/not resolved and the outcome of the general body pain and constipation were recovered/resolved and the outcome of the mobility decreased and feeling unwell were unknown. It was unknown if the reporter considered the myelitis transverse, appetite lost, unable to walk, memory deficit, urinary incontinence, balance difficulty, urinary frequency, general body pain, constipation, mobility decreased, feeling unwell and bladder dysfunction to be related to SHINGRIX. Additional information was reported as follows: The patient had a history of trigeminal neuralgia and it was related to her trigeminal neuralgia.  On 16th July 2018, the patient started feeling very unwell and experienced loss of appetite. The patient stated that something was wrong all over. On 16th July 2018, the patient went to the hospital, she was in great pain, the pain was all over. The patient could not move down from her waist, she was only able to move her toes. The patient was catharized in the hospital. The patient stated that she was not completely recovered. The patient had also lost control on her bladder function, which had left her with incontinency and urinary frequency. The patients' memory function was poor. The patient had to think longer for answers. The patient was diagnosed with transverse myelitis while she was hospitalised. The hospital performed tests and was admitted for a period of 2 and a half weeks as she could not walk and then was a taken to a rehab for a period of 2 and a half weeks again. The patient was suggested with treatment and she had blood removed and plasma exchanged 5 times with 1 day in between each treatment. At the time of reporting, the patient walks with a walker due to loss of balance.
4" rash on arm at injection site.  Hot to the touch. Low-grade fever (99)
Significant hearing loss, itchy skin, joint and muscle pain including arthritis, loss of energy and constant tiredness, difficulty sleeping, vertigo, balance problems and lightheadness, short term memory loss, reduced concentration, rashes not near injection site.
Pt called 7/2/09 stating he became "achy with over all achyness & mostly back aching 5 days after receiving vaccinations. He had a fever of 100 Degrees for one day, 6 days after vaccines. He called his Dr. & was advised to alternate 2 MOTRINS & 2 TYLENOLS every two hours. 7/2/09, pt advised he have continued contact with his Dr or go to stat care if condition worsens. Medical Director at Medical Center notified 7/6/09. Pt called 7/6/09 & condition improved 7/4/09.
pt recv vax & devel rash;this is a poss/mild ADR;1 day later pt was seen @ employee hlth no rash was noted & allowed to return to work in hosp;pt will probably get #2 dose;
pt recvd vax 4FEB92; 4FEB92 reported to ER @ 2355 c/o fever of 104 R & cough; hx of asthma & anemia; dx w/febrile reaction to vax & given APAP for fever; mom reports fever of 105 R rx for Pediaprophen;
Reporting system indicates adolescent received a pediatric dose for first immunization.  CDC card also shows pediatric dose.  Contacted family and will follow CDC guidelines to not repeat dose but to assure adolescent/adult dose at second shot in series.  Family will be provided with written documentation at second shot clinic.