chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Persistent crying for 3 hrs, with fever".  "Also short of breath & irritability".  Child had previous immunizations in another country but did not have records.
Temp 103.9 degrees Pulse 100bpm BP: 124/78. Achy, fever & inject site swelling & pain (skin & soft tissue infection). BACTRIM DS 2 tabs po bid x10 days.
Pain in his joints and muscles; Pain in his joints and muscles; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received booster dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (brand and manufacturer not specified), via an unspecified route of administration, on an unspecified date at a SINGLE DOSE for immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included pneumococcal 13-valent conjugate vaccine on an unspecified date for immunization. On an unspecified date, patient had two days of a lot of pain in his joints and muscles, then it went away. Outcome of event was recovered.   No follow-up attempts are needed. No further information is expected.
Measles- Information has been received from a physician concerning a patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Subsequently the patient experienced incidences of breakthrough measles.  Additional information has been requested.
She has COPD.  She is a little more out of breath than usual.  It is more pronounced late in the day.   First day at 7 pm.  I put her to bed because she was exhausted.  Second day.  Became worse at 10 pm.  I think it?s at its worst when she has sat the longest.
>3 Hrs after the vaccine patient developed swelling of bilateral lower extremities, hands and slight edema of the upper extremities. She denies development of any itching, rashes, fever/chills, body aches, discoloration of the skin or pain. No GI or upper respiratory symptoms reported. Symptoms resolved over the following 3 days.
Felt dizzy after getting Pfizer vaccine. BP - 161/77, pulse 62, O2 sat 97%. Patient lay down and rested. Offered water/juice, but refused. BP 157/80, pulse 62, O2 sat 100%.
A consumer reported that her 17 month old son received Prevnar, diphtheria and tetanus toxoids and acellular pertussis (DTAP) and "other unknown vaccines" on the afternoon of 5/15/01. At that same time and date, the child was dx'd with sinusitis and started on amoxicillin therapy. The following day, the child felt warm in the morning and that afternoon experienced a fever of 104.9F. The fever lasted 4 days. The child also would hit his head with his hands during those 4 days. As of the date of this report, no further information was available.
dry mouth; drinking a lot of water; achy; headache; flu like symptoms; felt sick in stomach; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach) and DIARRHOEA (diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history information was reported.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach) and DIARRHOEA (diarrhea). On 21-Jan-2021, the patient experienced DRY MOUTH (dry mouth) and THIRST (drinking a lot of water). At the time of the report, MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach), DIARRHOEA (diarrhea), DRY MOUTH (dry mouth) and THIRST (drinking a lot of water) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication report was not provided.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach) and DIARRHOEA (diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history information was reported.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach) and DIARRHOEA (diarrhea). On 21-Jan-2021, the patient experienced DRY MOUTH (dry mouth) and THIRST (drinking a lot of water). At the time of the report, MYALGIA (achy), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (felt sick in stomach), DIARRHOEA (diarrhea), DRY MOUTH (dry mouth) and THIRST (drinking a lot of water) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication report was not provided.  No treatment information was provided.
pt had allergic react,  urticaria. Had resolved by time got to ER. difficult to tell what caused it in addtl to vax given in am & had tylenol p/vax & similac for 1st time.vax at 10:20am Urticaria developed; 3:30. no treatment in ER needed;
Fever; Chills; This is a spontaneous report from a contactable consumer (patient).  A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date was not reported) via an unspecified route of administration on 02Jun2021 as unknown dose single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On Jun2021, the patient experienced fever and chills. The patient wanted to know what to do with the side effects. The patient received information that, these side effects usually start within a day or two of getting the vaccine. Side effects might affect ability to do daily activities, but they should go away in a few days and get tips on what to after getting vaccinated. The outcome of events was unknown.  Information about batch/lot number has been requested.
Post vaccine EE began experiencing tachycardia.  Vital signs at 11:52am BP 175/93 HR 141. Vital signs at 12:00pm 156/88 HR 105. HR also noted to be 156 (unsure of time). HR later noted at 107 and BP 154/86. EE transported to ED via EMS. Medical director Dr. notified.
Headache, Arthralgia, Fever,  Pain in arm, chills, fatigue Narrative:
Patient came to the Flu POD event, and did not inform us that she had received a High Dose Flu vaccine from her Pharmacy 4 days prior to getting this Flu vaccine. It was discovered the next morning, while we were adding this vaccine into our state vaccine database that we noticed her previous High Dose Flu vaccine. I contacted the patient and she stated that she only had a mild sore arm, and no other symptoms. She stated that she forgot she got the flu vaccine 4 days prior.
This spontaneous report as received from a nurse refers to a 69 year old male patient with hypertension. On 10-JUL-2013 the patient was vaccinated with PNEUMOVAX23 injection with valid lot # H013847 (expiry date 15-MAR-2014), intramuscularly. Concomitant therapy included hydrochlorothiazide, triamterene. On 10-JUL-2013 in the evening, the patient developed redness and tenderness at the injection site with swelling in the entire arm down to his fingertips. He could not lift his arm. The patient called the physician's office for medical attention and was prescribed TYLENOL for treatment. On an unspecified date the patient recovered. No causality assessment was provided. Additional information has been requested.
Eye began to water, nose dripped, choking, coughing, diarrhea x 3 1/2 days, achy and stomach hurt.
ActHIB was reconstituted with 0.7ml of sterile water of Merck diluent, no adverse event; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 13 months old female patient who was vaccinated with a 0.5 ml fourth dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot UI918AA and Exp. Date 05-Dec-2019) via intramuscular route in unknown administration site on 07-May-2019 which was reconstituted incorrectly.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  It was an actual medication error case due to wrong solution used in drug reconstitution. Act-HIB was reconstituted with 0.7ml of sterile water of Merck diluent and they have them re-administer the ActHIB vaccine with the proper 0.4% Sodium Chloride diluent.  The patient did not experienced any adverse event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  List of documents held by sender: none.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender (reported as possibly a newborn). Patient medical history, concurrent conditions and concomitant medications were not reported. On unknown date in May 2016 (also reported as 05-MAY-2016 or 06-MAY-2016), the patient was vaccinated with first dose of RECOMBIVAX HB, (lot # L039660, expiry date: 04-FEB-2018) (route, dose and frequency not reported), which had previously undergone a supported temperature excursion. As of 06-May-2016, it was unknown if the patient continued to take RECOMBIVAX HB, and the outcome of receiving a vaccine that had undergone a temperature excursion was unknown. This is one of the five reports received from the same reporter. Additional information has been requested.
Approximately 10 days after receiving vaccine began developing rash (raised and red) on chest and back.  Continues to develop more on arms and legs.  Areas are itchy and not resolving.  Do not consider serious however uncomfortable.   Seen by PCP 2-2-21; prescribed antihistamine and topical ointment.  Cause unknown.  Scheduled for second dose 2-11-21 (if available)
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 64-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported.  The daily dose of Moderna was reported as 1 in 1 once.  Patient had discontinued RINVOQ for two weeks and no dechallenge. Causality is not reported for drug RINVOQ  It was unknown if patient was enrolled in COVID-19 vaccine trial.  Treatment information was not provided by the reporter.  Company comment: This spontaneous case reported by a consumer concerns a 64-year-old-female patient, with medical history of Rheumatoid arthritis in treatment with Upadacitinib, who experienced the unexpected non-serious AESI of COVID-19. Onset date of vaccination with mRNA-1273 vaccine and date of event were not provided; hence, latency cannot be assessed. Vaccination schedule and interval between doses was not reported. It was reported that patient discontinued Upadacitinib for two weeks after COVID19 was diagnosed. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer concerns a 64-year-old-female patient, with medical history of Rheumatoid arthritis in treatment with Upadacitinib, who experienced the unexpected non-serious AESI of COVID-19. Onset date of vaccination with mRNA-1273 vaccine and date of event were not provided; hence, latency cannot be assessed. Vaccination schedule and interval between doses was not reported. It was reported that patient discontinued Upadacitinib for two weeks after COVID19 was diagnosed. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient experienced left arm swelling and pain where the immunization was given and left arm pain. She noted that 2/3 of her upper arm became hard, warm, and swollen.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 03Jan2021 as dose 1, single (Lot number: EL1284), on 24Jan2021 as dose 2, single (Lot number: EN5318) and on 27Aug2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 46 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: COVID 19 Treatment; (02Jun2022) positive, notes: COVID again. Therapeutic measures were taken as a result of covid-19. The patient did not received any other medications within 2 weeks. The patient did not reported any known allergies.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. The unspecified patients received improperly stored unspecified doses of GARDASIL 9, (lot # L043213, expiration date 28-AUG-2017; lot # M003659, expiration date 20-SEI-2017), (dose, frequency and route not reported) on 16-JUN-2016 and 17-JUN-2016. The vaccines were exposed to temperature 70 F for 45 minutes. There was no previous temperature excursion. No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Beginning 3 days after shot, chills; 4 day migrane; muscle aches; nausea; fatigue; diarrhea; vertigo lasting approx. 8 days.  As of today feeling great
Mom reports rash covering entire body; Infant has been afeb; Rash began 4-6hrs post adm ofvax;
Bell's palsy left side. Medicine: Prednisone20mg 1 tablet a day for 5 days Acyclovir 800mg 1 tablet 4 times a day for 10 days Ibuprofen 600mg 1 tablet every 6 hours
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
Generally feel awful; Worse than first shot; Slept all next day; site pain (left sholder) is bad; Keeps me awake; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 63 year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 22Apr2021 11:45 (Lot number: EW0158) at the age of 63 years as DOSE 2, SINGLE for covid-19 immunisation. Relevant medical history included: "Slight sensitivity to shellfish" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Dyslexia" (unspecified if ongoing); "Dyscalculia" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing). Concomitant medications included: ASPIRIN [ACETYLSALICYLIC ACID]; ADDERALL; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 01, Lot Number: ER8734, Administration Time: 02:45 PM, Anatomical location: Right Arm), administration date: 31Mar2021, when the patient was 62 years old, for Covid-19 immunization, reaction(s): "Feeling poorly 2 hours after shot", "Slept next 2 days", "Injection site pain worse than broken", "Pain", "Nauseous", "No appetite", "Body, Joint aches", "Body, Joint aches", "Pounding head ache", "Groin ache", "Penis ache", "Testicles ache", "Hot flashes", "Sweating", "Chills", "Light sensitivity", "Orientation and navigation issues (L|R, Up|Down)", "Bouts of intense diarrhea", "site pain (right shoulder) also aches", "Pallet (roof of mouth) puffy. Hurts to touch", "Substantial dry mouth", "Dizzy", "Ringing/hiss in ears", "Wobbling sound". The following information was reported: FEELING ABNORMAL (disability) described as "Generally feel awful"; CONDITION AGGRAVATED, (disability) "Worse than first shot"; SOMNOLENCE (disability), described as "Slept all next day"; INJECTION SITE PAIN (disability), described as "site pain (left shoulder) is bad"; INSOMNIA (disability), described as "Keeps me awake", all with onset date of 2021 and outcome of unknown. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Apr2020) negative; (08Oct2020) negative; (10Feb2021) negative; (19Aug2021) negative.
Onset date: 9/8/2022; No additional AE reported; Caller reported VARIVAX that had undergone temperature excursion was administered to a patient.; This spontaneous report was received from a nurse regarding a 1-day-old patient of unknown gender. There was no information about the patient's drug reactions or allergies, medical history, concurrent conditions, nor concomitant medications.   On 08-SEP-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # U016065, expiration date 20-MAY-2022, (formulation, strength, dose, dose number, route of administration and anatomical site of vaccination were not reported) for prophylaxis (improper storage of product in use) (inappropriate age at vaccine administration). The vaccine administered was stored with an unknown temperature for a time frame of 1 hour and 45 minutes. It was not reported if a data logger was used. There was a previous temperature excursion. No additional adverse event (AE)were reported (no adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2210USA000872: US-009507513-2210USA000877: US-009507513-2210USA000999: US-009507513-2210USA001062: US-009507513-2210USA001209: US-009507513-2210USA001524: US-009507513-2210USA001533: US-009507513-2210USA001538: US-009507513-2210USA001904: US-009507513-2210USA000872:
Initial report received on 10 October 2009 from a consumer. A male patient had received a flu vaccine on an unspecified date, and subsequently his INR level "skyrocketed." The trade name, manufacturer name, lot number route and site of administration for the flu vaccine was not provided. The patient had called to report that after receiving a flu vaccine and starting MULTAQ in preparation for cardioversion a week prior, his INR readings skyrocketed. The INR level was not reported. No other information was provided. The recovery status of the patient was not reported. Documents held by sender: None.
felt nauseated, weak in legs & pain, rt arm red to side @ knot noted & some swelling became hot & cold; MD stated react to diptheria;
Five minutes after receiving dose two of current vaccine series, this patient developed hives near bilateral wrists and a growing erythematous area around vaccination site. Site is warm to the tough and slightly swollen, reaching to lymph nodes near left armpit.
Information was received concerning several children that were vaccination with varicella live. The pt's developed a mild breakthrough varicella. It was reported that it appeared to be a wild type exposure. Additional information has been requested.
Induration and pain 1 day post injection. Resolved by Day 5, and itching, induration and erythema returned Day 10 post injection.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of currently 77 years old. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On or about 15-SEP-2016, the pt was vaccinated by a healthcare provider with a dose of zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dosage schedule, route, lot number and expiration date were not provided).  On an unknown date, the pt developed shingles, therefore was treated by physician. The outcome of shingles was unknown and the reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).
At moment of shot, sharp electrical pain from injection site up to my ear felt like electrical shock. Each month since then, the pain in my shoulder and neck, and into my scalp has a tight pinching feeling causing aching and headaches daily. here are other documented cases of intense agonizing shoulder and neck pain called SIRVA,
In July I started hearing tinitus and thought it would go away. When it didn't, I scheduled a health check up and all blood work came back normal (high cholesterol--only). Then scheduled an appointment with an EN&T specialist. He didn't come up with any cause. That same day I got my 3rd vaccine booster. Within a week after booster, the tinnitus got worse (still is) so I Googled "vaccine and tinitus". This was the first time I heard (pun not intended) there could be a correlation between the vaccine and tinnitus.
Fever of over 100.  Headache, body aches.  Lasted about 36 hours.
Patient developed an exanthem to extremities, and abdomen 6 hours after influenza vaccine receipt. Lesions are flat, pruritis, erythematous and a paired 6x8 cm symmetric fixed patches to anterior medial thighs.
A report was received from a health care professional on 10/23/2002, concerning a female vaccinee of unknown age who inadvertently received frozen Fluvirin vaccine on 10/23/2002. The vaccinee did not experience any adverse event. There was insufficient information to determine the reporters causality assessment. Cross Reference with: PJP200200629, PJP20020774, PJP200200775. Update1. 12/23/2002: A report from a health care professional which indicated that the event was reported to be resolved on an unspecified date.