chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe headache; Fever; Chills; Weakness; Muscle pain; Joint pain; Extreme exhaustion; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2022 (Lot number: FF2590) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC. Past drug history included: Bactrim, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot number: ER8736, Location of injection: Arm Left), administration date: 30Apr2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (Dose 2, single, Batch/Lot number: EW0178, Location of injection: Arm Left), administration date: 22May2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "Severe headache", "fever", "chills", "weakness", "muscle pain", "Joint pain". The following information was reported: HEADACHE (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Severe headache"; PYREXIA (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Fever"; CHILLS (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Chills"; ASTHENIA (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Weakness"; MYALGIA (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Muscle pain"; ARTHRALGIA (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Joint pain"; FATIGUE (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Extreme exhaustion". Therapeutic measures were taken as a result of headache, pyrexia, chills, asthenia, myalgia, arthralgia, fatigue.  Additional information: Treatment received: Pain pills (unspecified). Events were reported as non-serious. No other vaccines received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
3 days of diarrhea, dizziness, sleepiness. (Same adverse effects as Shingles vaccine in 2018
Patient reports blood pressure elevation beginning 12/30/2020, approximately 190's/90's, and continues to this current date. Headaches began 1/4/21 and occur approximately 5 times per week along with diminished cognitive ability reported by patient as "brain fog". Patient also reports a "hung over" feeling as well.
Information has been received from a physician concerning a 97 year old female patient with no pertinent medical history who was vaccinated with a 0.5 ml IM dose of PNEUMOVAX greater than 5 years ago (lot # 658555/0964U).  Concomitant therapy included influenza virus vaccine (unspecified).  About 24 hours after receiving PNEUMOVAX the patient experienced cellulitis of the arm at the injection site characterized by a very swollen, red and tender arm.  No lab diagnostics studies were performed.  At time of reporting, the adverse event is ongoing.  The patient sought medical attention via office visit.  Cellulitis of the arm at the injection site was considered to be disabling.  This is one of the several reports from the same source.  Additional information has been requested.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 08-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Dizzy, nauseous, heart racing and my left upper arm was twitching uncontrollably. Pounding headache, nauseous, dizzy, achy and malaise.
1st shot in right arm.  After 24 hrs sore arm then intense headache on right side.  Took 200mg Advil.  Very tired with intense lack of focus.  Mental cramps on 5th & 6th days.  Most symptoms lasted 2 weeks.  2nd shot 05/06/2021 in AM in left arm.  2nd day started having pain in chest on left side, lungs heavy, like couldn't catch breath, very weak in the knees and very tired.  I am a non-smoker, healthy, only take vitamins and only have an occasional drink with alcohol 1x or 2x per week.
Severe muscle and joint pain in both pelvic joints and in the right hip, leg and calf.
This spontaneous report as received from a pharmacist refers to a 62 year old male patient. On 25-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot number and dose not reported), subcutaneous. The patient experienced leakage of clear fluid, at the injection site, when the patient received ZOSTAVAX on 25-JUN-2013. There were no other adverse events reported. The outcome of leakage of clear fluid, at the injection site was unknown. The causal relationship was not reported. Additional information has been requested.
Pt developed fever 101 x 3d with pursed lip breathing x 48 hours. Was admitted x 18 hours.
Itchy raised rash on injection spot day after received and then appeared again 7 days later.
symptoms started 3/14/2022 ;she received 1 year vaccines 3/9/2022            daycare called and stated that she developed a "raised red rash" from her head to toe             it has been on her face, arms, legs, and diaper area            mom did notice some swelling around bilateral wrists and lower legs             mom denies any changes to diet, laundry detergent, or recent abx/medication use            it does not appear to itch her             mom has been giving her benadryl.
Patient was behind on immunizations and provider was trying to develop a catch up schedule for him.  She order Pediarix which was administered by her MA with written order.  It was identified after the fact that Pediarix is not recommended for patient over the age of 7 years.  Patient did not experience any adverse affects, however, has not been immunized as expected due to the components of the Pediarix and those recommended for the patient's age group.
Left arm pain; This is a spontaneous case initially received from a pharmacist on 24-Nov-2018, concerning a 25-year-old adult female patient.  The patient did not have any relevant medical history. The patient did not administer any other vaccines or medications.  On 12-Nov-2018, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid left arm, batch number: 252665 and expiration date: Nov-2018) for influenza prophylaxis.  On the same day, after the administration of the vaccine, the patient experienced left arm pain. Pharmacist assessed the site and there was no redness, bruising or swelling, no streaks or numbness or tingling in the arm or fingers. Patient has not tried any over the counter medicines or taken any treatment and was applying ice to site.  The outcome of the events was not recovered.  The reporter assessed this case as non-serious.  Follow-up received from the pharmacist on 28-Dec-2018: The med info number was added in the additional information tab. The reporter advised the patient to follow-up with primary care physician (PCP) and she did not call back with any other complaints. The description as reported for the event (pain in extremity) was changed changed from pain in arm' to painful L arm' in the events tab.; Reporter's Comments: A 25-year-old, female patient experienced left arm pain on the same day after administration of suspect vaccine Flucelvax QIVc. The company assessed the causality of the event as related to the suspect vaccine due to plausible temporal relationship between the event and suspect vaccine.
Jynneos administrated intradermally; Case reference number US-BN-2022-004063 is a spontaneous case report initially received on 17-Oct-22 from a nurse via agency (reference number: USBAV22-1723) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medications details were not provided.  On an unspecified date, the patient was vaccinated with Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00019), at an unknown dose, administrated intradermally, for monkeypox prophylaxis (explicitly coded as 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse event.  This case is linked with the case US-BN-2022-004064 (same reporter).  Additional information received from Bavarian Nordic on 18-Oct-2022 included the local BN case ID.  Non-significant case correction received on 08-Nov-2022 from agency included new reference number.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos vaccine on unspecified date. The dose was unknown, but the vaccine was administered intradermally for monkeypox prophylaxis, which is coded as intradermal injection. The event is listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with Jynneos vaccine on unspecified date. The dose was unknown, but the vaccine was administered intradermally for monkeypox prophylaxis, which is coded as intradermal injection. The event is listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.
Facial droop; Left sided Bell's palsy; This serious case was reported by a consumer and described the occurrence of facial droop in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number Y433H) for prophylaxis.   Concomitant products included acetaminophen-codeine# 4, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall), fluoxetine, fluticasone propionate, ibuprofen, lamotrigine, ethinyloestradiol, ferrous fumarate, norethisterone acetate (Lo Loestrin Fe), metoprolol and metronidazole.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced facial droop (Verbatim: Facial droop) (serious criteria GSK medically significant and clinically significant/intervention required) and bell's palsy (Verbatim: Left sided Bell's palsy) (serious criteria GSK medically significant).  The patient was treated with prednisone (Deltasone) and valaciclovir hydrochloride (Valtrex). The outcome of the facial droop was resolved and the outcome of the bell's palsy was not reported.   It was unknown if the reporter considered the facial droop and bell's palsy to be related to Shingrix.     It was unknown if the company considered the facial droop and bell's palsy to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-SEP-2023 The reporter reported that the seriousness for facial droop was intervention required. The reporter stated that he or she was afraid to get new immunizations.
Right deltoid red, swollen, itchy measured 8cm x 9cm. Rx given for BENADRYL 25 mg one po every 6 hrs.
Fever of 102.6 reported by parent about 2 hours after administration of vaccine. TYLENOL was given by parent and fever went down to 101.7 within an hour. By 9:00 PM temperature returned to normal.
Information has been received from a registered nurse (RN) concerning a 22-week-old female who on 04-AUG-2006 was vaccinated by mouth with first 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  It was unknown if medical attention was sought and no adverse events were reported.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/8/2006.  Information has been received from a registered nurse (LPN) concerning a 22-week-old female with no medical history who on 04-AUG0-2006 was vaccinated PO with the first 2.0 mL dose of ROTATEQ (Lot #653915/0389F).  Concomitant vaccinations administered on that same day included the second IM dose in the left thigh of PEDIARIX (Lot #AC21B065AA, the second IM dose in the right thigh of ACTHIB (Lot #UE858AA) and the second dose in the right thigh of PREVNAR (Lot #B08658C).  Medical attention was not sought and no adverse events were reported.  Additional information is not expected.
Within 24 hrs post vaccine, developed local redness and swelling, seen by outside physician on 10/19/16, dx'd w/cellulitis, given ROCEPHIN injection, and KEFLEX 500mg bid x 10 days. On 10/20/16 site of local reaction measures 5"x6" across (R) upper arm.
Arm was really sore and hurting when I touched; arm was really red; Feeling itching; Hardness; A spontaneous report was received from a Healthcare Professional concerning a 74-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was really sore, really red, hurting when touched, still have redness today after 12 days, itching, hardness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch:  043L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced arm was really sore, really red, hurting when touched, still have redness today after 12 days, On 21 Jan 2021, the patient experienced itching, hardness.  Treatment details not ncluded   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events arm was really sore, really red, hurting when touched,still have redness today after 12 days,itching, hardness as unknown..
Red itchy rash about 4-5 inches across near injection site. Feels warm to the touch and slightly swollen. Painful similar to a bruise when poked or actually pushed on.
Approximately 7 days after receiving the Pneumovax vaccine, the patient presented to the Hospital ED 12/2/22 at 18:27  with atypical chest pain. Patient reported bilateral burning leg pain that started ~1 week prior to admission. She states she has also been experiencing full body chills and generalized body aches, and recalls these symptoms starting after receiving her pneumonia vaccine the week prior. In the ED, she was found to have uptrending troponins (583 ->780-> 1019 ->1843 ->2048), hyperkalemia (7.5), and  severely elevated CK (8000s).  Cardiology was consulted 12/2 and found that EKG was notable for peaked T waves and ST depressions in lead II and AVF. Differential diagnosis included ACS vs myocarditis vs elevated troponins secondary to rhabdomyolysis with PE being less likely.  She was given a short course of HD, aspirin, started on a heparin drip, and admitted to the CCU for further management of possible NSTEMI. In the CCU, she received another round of HD, however her potassium remained persistently elevated and troponins continued to climb. On 12/3, the patient went into PEA arrest after which a code blue was called and ROSC was achieved. Patient went into Vfib arrest later the same night and ROSC was achieved again. She was then placed on CRRT for persistently elevated potassium with future planning for an Impella heart pump. Patient went into PEA arrest several more times on the morning of 12/4/22 and the family ultimately decided to make the patient DNR. After the decision was made, the patient went into PEA arrest again and death was pronounced at 14:21 on 12/4/22.
I suddenly had blurry vision with dots and squiggles in front of my eyes to the point I couldn't even see. It then turned into a raging headache. I went to bed, where I had terrible, restless sleep. I woke up feeling as if I was awake all night and very woozy and weak. It went away by early afternoon the following day, so a total of about 20 hours.
Acute urticaria - swelling and hives Treatment includes: Xolair, Zyrtec, Allegra, Benadryl, Hydroxyzine, prednisone
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant therapy was not provided. On 28-MAR-2016 the patient was inadvertently administered an expired dose of ROTATEQ (lot # K006456; expiration date: 08-MAR-2016; dose not reported). No adverse effects were reported. Additional information has been requested.
patient received a dose of Menactra after the vaccine was exposed to a temperature excursion of 22.7°F with no AE; Initial information regarding this unsolicited valid non-serious case was received from Other Healthcare Professional via Medical Information (Reference number- 00418272) and transmitted to Sanofi on 06-Jan-2021.  This case is linked with 2021SA005526, 2021SA006661(same reporter).  This case involves an 18 year old male patient who received a 0.5 ml second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot: U6827BA, expiration date: 18-Feb-2022) once via unknown route at right deltoid for prophylactic vaccination on an unknown date which was exposed to a temperature excursion of 22.7 degree Fahrenheit (product storage error).  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant therapies were not asked.  It was an actual medication error due to product storage error temperature too low.  The reporter stated that the facility initially reported temperature excursion of 32.5 degree Fahrenheit and were cleared to immunize based on that temperature. However, on further review, it was discovered facility made a mistake and the actual temperature the vaccines were exposed to was 22.7 degree Fahrenheit. During that time period, three patients received vaccines that were actually unsuitable for use. The reporter wanted to know how they should proceed and if they should revaccinate the patient.  No adverse event reported to the patient at the time of reporting.  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.
Post vax, the pt's upper arm felt funny. Awoke on 11/10 with red arm, nausea, malaise,and headache. Dx with left upper arm erythematous indurated dermatitis. Treated with Benadryl, elevation, and cool compresses.
Left arm became red, swollen, and hard around injection area. Each day the swelling and redness would grow until it encompassed my entire upper left arm. The arm had a temperature of approx 100 degrees and was still and swollen. It was very uncomfortable to move that arm.
Suspected vaccination failure; Shingles rash on the calf of leg and  ankle/ still got shingles after receiving the; Shingles rash on the calf of leg and  ankle; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.    Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was the reporting physician assistant's wife. The reporter thought the patient was 64 years old at time of vaccination. The patient received the Shingrix vaccine series (both doses) years ago (no specific date) and still got shingles after receiving the vaccine (did not know the timeline). The patient had shingles rash on the calf of one leg and on the ankle of the other leg. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided. The reporter did not want to be contacted at the time of reporting, but said that, the patient might want to be contacted, so the reporter would speak to the patient.
Information has been received from a nurse concerning a female who patient who on an unspecified date was vaccinated IM with her second 0.5 ml dose of GARDASIL (lot number and site not reported). The day after she got her second dose of GARDASIL, the patient's "heart fluttered", and it happened again "a month later". Her doctor later verified that she had two heart murmurs. The nurse didn't know if the patient had the murmurs before getting vaccinated. Additional information has been requested.