chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 14 November 2012 from an investigator participating in a study. A 49-year-old female subject had severe headache on 02 November 2012 after receiving first dose of the study vaccine QIV-ID. This vaccine is thimerosal-free) or control product TIV-ID1. This vaccine is thimerosal-free) or control product TIV-ID2. This vaccine is thimerosal-free) on 02 November 2012 (Route and site of administration and batch number not reported). The subject had no reported medical history. The subject had no reported concomitant therapies. The subject experienced the associated symptom of severe headache on 02 November 2012. The subject went into the hospital with complaint of severe headache as a reaction to TOPAMAX. Hence she was hospitalized on 03 November 2012. The subject stayed two days in the hospital. Hospital discharge reports were awaited at the time of this report. Laboratory investigations and corrective treatments were not reported. Outcome of the event of severe headache was not reported. According to the investigator, the event was related to the study vaccine and it was not related to the trial procedures. It was not reported whether the event led to the termination of the subject from the study or not. List of documents held by sender: None. Medical Assessment: This case of "severe headache" experienced by a 49 year old female subject on the same day of vaccination was assessed as related by investigator based on temporal relationship. The event of headache within seven days of vaccination is also captured as solicited systemic event in this study. The subject went into the hospital with complaint of severe headache as a reaction to TOPAMAX. It is not clear if TOPAMAX was given because of partial seizure (its indicated use) or for cluster headache (investigational use), when it was given in relation to the vaccine (before or after) and the reason for giving it and by whom, since there is no reported medical history of seizure or prior therapies. Further details on the pre-existing medical history, especially of the medication of TOPAMAX as well as diagnostic test results (if any) during hospitalization may be informative in the assessment of alternative etiologies. The sponsor assesses this event as related to study vaccine based on temporal relationship. Cumulative Assessment: This is the fourth case of severe headache as the main manifestation reported from any clinical study of FLUZONE vaccines (FLUZONE IM, HD, ID and QIV) conducted by the sponsor. The other three cases of severe headache as the main manifestation occurred more than 7 days post vaccination and were considered as unrelated by investigators. There were 34 cases of severe headache event reported as co-manifestation of other diseases in the clinical studies of FLUZONE vaccines (FLUZONE IM, HD, ID and QIV) conducted by the sponsor and all events were considered as unrelated to study vaccine by investigators. There were 75 cases of severe headache received from spontaneous sources after administration of standard FLUZONE or FLUZONE High Dose or FLUZONE Intradermal seasonal vaccine during the period of around 2 decades i.e. from 1993 to 2012.
About 5 to 10 minutes after receiving her first dose of the Pfizer covid vaccine, the patient reported slight difficulty breathing, throat/tongue swelling and a flush face. She said that she felt the same as when she eats peppers, which is a known allergy to her. We administered an epipen and called 911. Medics arrived in about 10 minutes and took the patient off in the ambulance.
Pt had a simple febrile seizure with cyanosis, resolved by time they got to ED for further evaluation.  No evidence of infectious etiology to fever at ED evaluation or PCM f/u on 04/07/2016.
no adverse event; reported excursion on 14Feb2023; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (no adverse event), PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023) and PRODUCT STORAGE ERROR (Product storage error) in a child female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event), PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, NO ADVERSE EVENT (no adverse event), PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported.  Maximum temperature: -1.8 C Storage at time of excursion: freezer Excursion duration: unknown for each day starting on 01-Feb-2023 and continued until 14-Feb-2023. HCP can confirm it was not out of range the entire day.   No treatment drugs were reported.
swollen glands in neck, both sides, overnight large ulcer developed in mouth with no previous issues
Erythema of the thigh area both surrounding the injection site and the rest of the thigh. Papules/patches on the (R) lower ext. within 5 mins of vaccine.
early 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number YA39L, expiry date 08-JUL-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 16-MAY-2023, the patient received the 2nd dose of Shingrix. On 16-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: early 2nd dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 29-JUN-2023 A pharmacist reported that a patient received the 2nd dose of Shingrix only 1 month and 3 days after the 1st dose which led to lengthening of vaccination schedule. The reporter consented to follow up.
Red, raised rash on upper right arm around injection site. Three to four inches by two to three inches. Lasted beyond 24 hours.
Sinus infection; Sneezing; Cough; Posterior nasal drip; Ear congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021SA369081 (Sanofi).  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation; dupilumab (DUPIXENT), subcutaneous since 16Sep2021 (Batch/Lot number: unknown) at 300 mg (300 mg, once in every two weeks) for asthma. Relevant medical history included: "Influenza" (ongoing); "Asthma" (ongoing); "seasonal allergy" (ongoing), notes: Allergic rhinitis due lo pollen.; "upper abdominal pain" (ongoing), notes: Epigastric Abdominal Pain; "Hypothyroidism" (ongoing); "Type V Hyperlipidaemia" (ongoing); "Obesity" (ongoing); "Hypersensitivity" (ongoing); "Sinus infection" (unspecified if ongoing); "allergy" (unspecified if ongoing), notes: Notes: allergies: perfume, propolis,; "propolis" (unspecified if ongoing), notes: Notes: allergies: perfume, propolis.; "Gastro-esophageal reflux disease" (unspecified if ongoing); "fatty change of liver" (unspecified if ongoing). Concomitant medication(s) included: FLUARIX; PREDNISONE [PREDNISONE ACETATE] taken for asthma; HALOBETASOL PROPIONATE; DOXYCYCLINE HYCLATE; AZELASTINE; SALBUTAMOL [SALBUTAMOL SULFATE] taken for asthma; IPRATROPIUM BROMIDE IVAX; CIPROFLOXACIN [CIPROFLOXACIN HYDROCHLORIDE] taken for sinusitis; LEVOTHYROXINE SODIUM; SYMBICORT taken for asthma; MONTELUKAST SODIUM taken for asthma. The following information was reported: SINUSITIS (non-serious) with onset 26Oct2021, outcome "unknown", described as "Sinus infection"; SNEEZING (non-serious) with onset 26Oct2021, outcome "unknown", described as "Sneezing"; COUGH (non-serious) with onset 26Oct2021, outcome "unknown", described as "Cough"; UPPER-AIRWAY COUGH SYNDROME (non-serious) with onset 26Oct2021, outcome "unknown", described as "Posterior nasal drip"; EAR CONGESTION (non-serious) with onset 26Oct2021, outcome "unknown", described as "Ear congestion".  Additional Information:The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event the patient had ongoing Flu, Allergic rhinitis due to pollen, Asthma, Epigastric ache, Hypothyroidism, Mixed hyperlipidemia, Obesity and Hypersensitivity,Notes: allergies: perfume, propolis, Allergic rhinitis due lo pollen, Asthma, Epigastric Abdominal Pain, Fatty (change of liver, Gastro-esophageal reflux disease, Hypothyroidism, Mixed hyperlipidemia, Obesity.Concomitant medications included:BUDESONIDE.Action taken with DUPILUMAB (DUPIXENT) was unknown.It was not reported if the patient received a corrective treatment for the events (sinus infection, sneezing, cough, post nasal drip).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
when I have allergies my phlegm is clear and now it is yellowish green in color; dizzy shortly after dose.; This has since subsided but she the started to experience allergy like symptoms; chills; cough; fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 07May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient became dizzy shortly after dose. This has since subsided but she then started to experience allergy like symptoms. She states, she was very concerned because she thought it was allergies to begin with but when she has allergies her phlegm was clear and now it was yellowish green in color. She was experiencing chills, cough, fever, and the yellowish green phlegm on an unknown date. The patient enquired whether she should take the second dose of the vaccine since she had side effects from the first dose, is the second dose the same thing as the first dose and will her side effects be worse with the second shot. The response is provided to the patient that the first shot primes the immune system, helping it recognize the virus, and the second shot strengthens the immune response. The outcome of the event dizzy shortly after dose was recovered and the outcome of remaining events was unknown.  Information on the lot/batch number has been requested.
Felt suddenly faint. Have hx of vasovagal syncopy and when I faint my blood pressure goes very, very  LOW. I moved to a armchair near the window thinking if I fainted I would not fall on floor and I mentioned to a nurse that I was feeling off and have a hx of vasovagal syncopy and if my BP dropped very low to not worry, I'm fine and it will readjust. They sent medic over and took BP which was 200/120. I have NO hx of high blood pressure. He took it repeatedly and it remained at least 200/120 and he wanted me to get it checked out so I was taken by ambulance to hospital. Pressure normalized a short time later w no intervention. Purchased good BP cuff and that night BP was average 118/84 and now 99/68 (it tends to run low to normal in general)
after pt recv vax some of the vax spilled out of the syringe. A titer was done 6 wk p/vax & no detectable VZV antibody was found
Since the shot I have been having excruciating back pains. Seems the pressure builds up near the center of my back and just throbs and eases a little.
inflammation/swelling starting in lips and expanding to cheek/chin on right side of face for 48 hours.   zyrtec 10mg and 25mg benadryl and 3 advils only mildly improved symptoms
This is a spontaneous report received from a contactable pharmacist (other healthcare professional). A patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), as single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient experienced sudden one sided weakness with loss of strength that occurred 2 days after 2nd dose of vaccine and resolved one own. This resulted in a hospitalization. Outcome of the event was recovered.  Information on Lot/Batch number has been requested.; Sender's Comments: As there is limited information in the case provided for Hemiparesis the causal association between the event and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Lack of appetite.; Extreme fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: not reported) via an unspecified route in the left arm on an unknown date (at the age of 40-year-old) for COVID-19 immunisation. Medical history and concomitant medications were not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient developed extreme fatigue and lack of appetite. The patient did not receive treatment for adverse events. The outcome of the events was reported as not recovered. Since the vaccination, the patient had not been tested for COVID-19.   Information about lot/batch number cannot be obtained. No further information is expected  Amendment: This follow-up report is being submitted to amend previously reported information: added "patient" as primary reporter additional qualification; added patient's name, patient's age at event onset; added dose number (dose 1); added Vaccination Facility Country; removed 'none' for concomitant therapy as it's not reported if the patient received concomitant drugs.  No follow-up attempts are needed. No further information is expected. Information about lot/batch number cannot be obtained.
Scattered lesions (25-50), Dx: chicken pox post vaccination, Tx: Acyclovir 200/s, 2tsp PO qid x 5 days.
Pt received Prevnar #1 on 12/15/00. Pt started with fussiness and vomiting. Came into our office on 12/18/00. Physician felt vaccine related. No redness or swelling at the injection site. Pt slightly dehydrated with fussiness.
Case number PHEH2015US022019, is an initial spontaneous report received from pharmacist on 26 Oct 2015. This report refers to a patient of unknown demographics. Historical condition and concomitant medication were not provided. The patient was vaccinated with a partial dose of FLUVIRIN (batch number: not provided) due to administration error on an unspecified date. It was reported that needle was not fixed tightly, subsequently majority of vaccine dripped out on arm, due to which patient received a partial dose. No further adverse event was reported.
Third Nerve Palsy; vision was double; vision problems which was like little blurry; Myasthenia gravis; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported), at the age of 58-year-old, as SINGLE DOSE for covid-19 immunisation.  Medical history included thyroid disease and asthma. Concomitant medication included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported.  The patient received dose 1 of the vaccine on 12Jan2021 and developed Covid symptoms and on 18Jan2021, the patient was tested positive, was sick from all and had fever (stopped at end). On an unspecified date, the patient stated she was just at the hospital on Tuesday, in emergency room and they told me that she should report possible side effects from the Covid vaccine. The patient have the Third Nerve Palsy they think this might be connected to the vaccine they are not sure. When paraphrased the concern, consumer stated, "They said I should just report that there was a reaction and they don't know if the Third Nerve Palsy is due to the vaccine or just something freak that I got."  When probed if patient was a Health Care Professional, consumer stated, "I am not, I am a manager." The patient also added, "Can I give you the Path Gram, on the 9th I had my first shot on the 12Jan, I developed Covid symptoms and on 18Jan I was tested positive, I was sick from all and finally got tested on the 18 and was Positive and finally stopped my fever at end, I think may be 01Feb, and they told me to get my second shot I got my second shot on 05Feb and on 15 I started having vision problems which was like little blurry and I went to my eye doctor and they didn't think anything else he said that it could be something from Covid like what they called continuing symptoms but not having Covid, I don't know what the terminology is or it could have been from vaccine then that was the 15, the following Monday I went to my Primary because my vision was double at this point in my right eye and they thought it might be sinus related I had a CT done came back normal they told me that they thought it was Third nerve palsy and I had a MRI in the meantime they told me to go back to my Ophthalmologist which I did on Tuesday as soon as he see my he sent me to emergency room cause he thought it was an Aneurysm, so I was in the Emergency room being examined in hospital in (withheld) when I spoke to the Doctor they said I should advise Pfizer that they can't prove but it's vaccine related." When the patient was asked about teatment: she stated, "Well right now what they are doing is they had an had a MRI to be sure it was not Aneurysm or brain tumor which thank God came back negative and they did blood work so they are assuming it's third Nerve Palsy at this point but I have to see in 4 weeks it clears up or it could be Myasthenia gravis." The outcome of the events was unknown.
Five days after receiving the vaccines, patient developed urticaria over her trunk and thighs. No other issues at the time. They were itchy and patient was uncomfortable.
about 2 months later, vertigo that will not go away, with tinnitus and migraines
covid arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (covid arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm). At the time of the report, VACCINATION SITE REACTION (covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications was reported Treatment information was not provided
Ocular migraine headaches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 17Mar2021 at 11:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid issue, blood pressure high (HBP), high cholesterol and high sugar. The patient had known seasonal/yearly allergies, allergy to dust, dust mites and pollen. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), omeprazole (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), alprazolam (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and atorvastatin calcium (LIPITOR), all for unknown indications from an unknown date and unknown if ongoing. On 17Mar2021 at 20:00, the patient experienced ocular migraine headaches. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event ocular migraine headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Case number PHEH2014US020240, is an initial spontaneous report from a health care professional (also patient) received on 01 Oct 2014. This report refers to an approximately 45-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. Vaccination history included administration of FLUVIRIN and tetanus. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date in the last year (2013). On an unknown date after vaccination in the last year (2013), her arm was swollen, red and hot. It was the same reaction every year and get increasingly worse every year. This ws probably happening for eight years (see case: PHEH2014US020232, PHEH2014US020234, PHEH2014US020235, PHEH2014US020236, PHEH2014US020237, PHEH2014US020238 and PHEH2014US020239). It was reported that the reaction does not happen immediately but builds up. However, last year was the worst as it spread and was probably four or five inches. She states that she had other vaccines that did not bother her for example tetanus booster. She reported that the last year reaction as pretty bad reaction and was told she would not be vaccinated with FLUVIRIN. The final outcome of the events was unknown. Seriousness and causality was not reported.
Horrific rash that comes and goes all over my body, I have now had it for 4 weeks and it started the night of the 3rd dose.  I had no reaction for first 2 vaccines.  More than likely I did not need the booster but was never checked for antibodies prior to 3rd vaccine which is probably necessary.  There are thousands of people with exactly the same reaction as I as I am in a group with them which grows daily.  Presently I am on steroids to try and halt the reaction.  These have helped though I hate to take steroids but had no choice and am hoping that when I finish the steroids tomorrow (01.16.22) that rash does not come back.  It was very itchy and caused me 3 weeks of sleepless nights.