chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pneu poly vaccine administered along with a Td, Zostavax and a TB Skin Test. Client reported redness to area (left arm). Pneu poly given at this site. Client states no cold/warm compresses were applied on the day of. Clent denies any pain, headache, area not warm to touch during the assessment.  Assessment done 6/10/2010.  Client will see physician for a medical evaluation and contact Clinic afterwards.  Follow-up done 4 days after adverse event began and he stated his arm was fine and did not go see the doctor.
Mild Petechia on torso 3 days after DTAP, MMR, Varicella, HepA and PEV 13
Facial numbness/tingling. 1/28 woke with lower jaw and lip numbness w/gradual improvement throughout the day. 1/29 facial numbness/tingling from lower jaw to cheekbones, back of tongue became numb around 1100 and by 3:00 pm the entire tongue felt numb along with numbness/itchy-tingly feeling in the upper part of the throat.  No difficulty with swallowing/breathing. Speech was only slightly effected. Complete symptom resolution by 2/1/21
Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) on 07-Apr-2021 for Headache, at a dose of 500 mg. At the time of the report, HEADACHE (Headaches) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.
Elderly female over 65 years age Fluzone Quadrivalent rather than the indicated fluzone high-dose quadrivalent, with no reported adverse event; Initial information received on 17-Oct-2022 along with live follow-up of same RA regarding an unsolicited valid non-serious case received via consumer/non-hcp. RA number: 01324598 and 01324661.  This case involves Elderly female over 65 years age to whom vaccine INFLUENZA QUADRIVAL A-B VACCINE [Fluzone Quadrivalent] rather than the indicated Fluzone high-dose quadrivalent, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient over 65 years was administered suspect Fluzone Quadrivalent rather than the indicated Fluzone high dose quadrivalent at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination with no reported adverse event (wrong product administered) at unknown latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
One day after booster, got Covid Toe in left foot, #2 toe.  Purple, red swollen toe. Still in recovery.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (felt nauseated) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and NAUSEA (felt nauseated). At the time of the report, HEADACHE (headache) outcome was unknown and NAUSEA (felt nauseated) had resolved. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. The patient was a foot doctor. Reporter did not allow further contact.
Brain fog; brain zaps; lightheaded; a bit of confusion; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11May2021 at 09:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included sertraline hydrochloride (ZOLOFT) 250 mg and ibuprofen (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Apr2021 at 09:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. On 12May2021 at 09:00, the patient experienced brain fog, and brain zaps. It was reported that zaps similar to when ZOLOFT dose was off but she was 100% certain, she had taken meds correctly. Also lightheaded and a bit of confusion. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events brain fog, and brain zaps, zaps similar to when ZOLOFT dose was off, lightheaded and a bit of confusion was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt received vaccine on 10/22/01. On 10/25/01 c/o flu like symptoms, cough, hoarseness, SOB upon exertion decreased energy. Afebrile. Monitor S/S, rest. Teacher to F/U with PCO if S/S persist.
COVID 19 Treatment; COVID 19 Treatment; I have rebound covid now, five days after completing paxlovid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "not recovered", described as "I have rebound covid now, five days after completing paxlovid."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Pyrexia: (Aug2022) slight fever, notes: I have a slight fever, and cough and cold symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: No, Other medication in 2 weeks. Anti-viral medication for COVID-19 Treatment, brand Paxlovid, Treatment started on 02Aug2022 and stop on 06Aug2022. No, treatment for AE. No known allergies. patient had rebound covid now, five days after completing paxlovid. Patient had a slight fever, and cough and cold symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2nd dose not given at day 36; shingles on her face; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (shingles on her face) and PRODUCT DOSE OMISSION ISSUE (2nd dose not given at day 36) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced HERPES ZOSTER (shingles on her face). On 28-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not given at day 36). On 28-Jun-2021, PRODUCT DOSE OMISSION ISSUE (2nd dose not given at day 36) had resolved. At the time of the report, HERPES ZOSTER (shingles on her face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Patient missed her second dose because she still had shingles on her face.
pain at injection site; redness at injection site; swelling at injection site; pain that radiates down arm; decreased range of motion in arm; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the injection site swelling was unknown and the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient who received Shingrix at the end of November 2021 and she developed pain, redness and swelling at the injection site.  The pain and redness had since resolved, but she continued to have pain that radiated down her arm and she had decreased range of motion in the arm. The physician did not have lot or expiry date. The reporter consented to follow up by email.
Patient was entered into wrong scheduling book and received the second dose of Moderna 7 days early.
Blood sugar rose from 120-140- to consistently 300 -400 with normal meds. Unable to compensate with Insulin increase
Pfizer COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/17/2021 and 4/14/2021. Presented to ED on 1/5/2022 and diagnosed with COVID-19, received monoclonal antibody treatment on 1/10/2022. Returned to ED 1/12/2022 with complaints of worsening shortness of breath, cough, altered mental status and weakness two weeks in duration. Per EMS SpO2 on room air was 78% and improved to the 90s on 2 L NC. Additionally, patient has not been eating or drinking. Continued to decline and expired on 1/17/2022.
C/o rash forming a ring approximately 4 inches below site of injection on left arm.  No fever, no difficulty breathing.  L arm is swollen & itches.  Recommended BENADRYL & ice pack to the patient.  (after 24 H, pt still had a rash in the same spot not itchy.)
Dizziness, heart palpation, fever, chills, fatigue, headache, swollen arm, extreme itchiness, bruising, numbness, huge rash
pt recv vax & devel 3-4 papules;also exp pruritus @ the papule site;4mo p/vax pt devel a total of approx 60 papule on soles of feet & on hands & trunk;
Patient received a half dose of Moderna 0.25ml instead of the full dose 0.5. As per DOH, patient to receive 0.5mL dose and then make the second dose appointment 4 week after.
PPV dose at appox. 3:30pm on 11/3/08.  Severe pain in upper right arm developed approx. 5 hrs. later.  Much difficulty sleeping and extending upper right arm throughout the night and this morning. Some pain relief afforded through use of over-the-counter muscle soreness relief salve but still much pain and motion limitation.
Nurse calling for TE evaluation on frozen products states products have been administered.     Names of vaccines involved (including lot/exp) PROQUAD   W004029   8/1/2023        ?    Temperature 6°F up to 14°F (8F) for 0 hours 18 minutes 0 second; No additional AE details; This spontaneous report has been received from a nurse, regarding a 4-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On unspecified date, the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) lot # W004029 experienced a temperature excursion of 6 grades fahrenheit (F) up to 14F (8F) for 0 hours 18 minutes 0 seconds, and another of 14 F up to 46 F (18.40F) for 0 hours 45 minutes 0 seconds. No additional temperature excursion. If a digital data logger was involved was not reported (product storage error) (product storage error).   Consequently, on unknown date, the patient was vaccinated the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD)  (lot number reported as W004029 confirmed as valid, expiration date reported and stablished as  02-AUG-2023) administered as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).; Sender's Comments:  US-009507513-2206USA002264: US-009507513-2206USA002231:
PT HAD MENVEO 11/14/18 AT VACCINATION FAIR. PT C/O FEVER, HEADACHE, AND SORE ARM AT SITE OF INJECTION. SUBJECTIVE FEVER AND CHILLS AT HOME. HIGHEST DOCUMENTED TEMP IN CLINIC IS 100.7; SUPPORTIVE CARE AND MONITORED SYMPTOMS. NSAIDS AS NEEDED. REASSURANCE. F/U IF SYMPTOMS WORSEN. PT COMFORTABLE WITH PLAN AND AGREES TO RTC IF NOT IMPROVING. RTC TOMORROW FOR PPD READ.
I received my Pfizer (1st shot) 4/12/21 @10:30 Am  Later that evening around 8 PM I had a sore left arm felt weak stayed that way of filling week that whole week. But I did notice that I cannot smell and still cannot as of today?s date 4- 19 -2021. I lost my sense of smell and taste but I can taste very little the flavor of any food. And I cannot smell. I was advised to report.
pt broke out w/chickenpox lesions despite varivax 6SEP96;no adverse rxn mild case varicella;
On the 25th, she woke up from her nap. On the back of her right leg was a large bruise and some petechiae   spotting. There was a larger purpura as well. She had what looked like a bug bite 24 hours prior but it progressed rapidly to the petechia. We went to the urgent care and they were concerned about a possible tick bite so they tested her for some tick-borne illnesses. She was acting normally throughout. They called 24 hours later and her initial tests for Lyme came back equivocal. It was early exposure and she's taking Doxycycline and she was sent for confirmatory testing. The bruising improved within 24 hours and there was one persistent spot that got better a week later.
Swollen, red, itchy at injection site, joint pain, fever, chills, swollen lymph nodes in neck and arm pits, hard lump in left neck vein, chills, headache, nausea, rash
Fever, severe headache, muscle aches, nerve pain in extremities and back, pai in entire arm of injection site, cannot lie on that side, extreme fatigue.
11/11/99:MMR administered at school clinic.Pt. developed swelling and redness at site.15 min. after administration the swellling spread to his neck & face.Treated with Benadryl and Steroids.
low energy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (low energy) and FATIGUE (Fatigue). The patient was treated with CYCLOSPORINE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ASTHENIA (low energy) and FATIGUE (Fatigue) had resolved.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up : Updated patient info and events outcome as resolved.
Itchy rash; Warm ears; Feeling tired; painful rash; This case was reported by a other health professional via call center representative and described the occurrence of itchy rash in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 377MK, expiry date 25th September 2021) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix. On 27th July 2019, 3 days after receiving Shingrix, the patient experienced itchy rash, skin warm, tiredness and painful rash. On an unknown date, the outcome of the itchy rash and painful rash were not recovered/not resolved and the outcome of the skin warm and tiredness were unknown.   It was unknown if the reporter considered the itchy rash, skin warm, tiredness and painful rash to be related to Shingrix.  Additional details were provided as follows: The pharmacy intern reported the patient experienced approximately 3 days after receiving 1st dose of Shingrix, a rash, warm ears, and feeling tired. The health care professional described rash as itchy and painful. rash was not resolved. The outcome of warm ears and feeling tired was unknown. The reporter consented to follow up.
Feeling dizzy; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male 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 22Mar2021 at 15:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 17:30, the patient experienced feeling dizzy. The patient did not receive any treatment for the event. The patient was feeling dizzy after an hour took a nap and felt better after. The clinical outcome of the event feeling dizzy was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
pt fussy after vax, then 48 hrs unconsolable crying, stomach felt hard, no fever
Approximately 3 to 4 was after shot I noticed drooping left eyelid.  It worsened in spite of treatment by ophthalmologist.  Great difficulty swallowing, talking, much muscle weakness in neck & shoulders, and all over.  Unable to eat much  because of  weakness in  throat.  Have lost 23 pounds in six weeks. Very week, unable to drive or do much of anything. Husband has become caretaker. Initial diagnosis is mysthenia gravis. Have been referred to neurologist for treatment. Appt June 7.. I am miserable, having anxiety attacks., worried. Doctor advised me report this.
Information has been received from a health care professional concerning a 69-year old male who in 1993 and on 13-APR-1999 was vaccinated with PNEUMOVAX 23. April, 1999, several days after the vaccination, the patient experienced tenderness at the injection site. Additional information has been requested.
No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant male patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported.  This is one of several reports received from the same reporter.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication use was provided by the reporter. Treatment for dizziness was reported as meclizine 12.5mg on unknown dates. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up TCR: Patient reported all adverse events resolved. Declined to provide any further information and requested not to be called.
following vax 28MAY92 pts t1-3 ran fever 103-104.6 ax for 3 days; slept continuously until next AM; cried high pitched cry for 8 hrs; appeared limp;
April 1: Started to shiver between 6:00 and 7:00PM. Temperature rapidly increased from 99.2 to above 101. Peaked at 102.9 around 8:15PM, then hovered between 102.0-102.7 until 2:30AM. Starting  at 7:45PM, I took acetaminophen and kept a washcloth with cold shower water on my neck. I also drank a lot of water and some Powerade and orange juice. April 2:  I continued to take acetaminophen every 6 hours. Temperature stayed between 100 and 102 until noon, then between 98.9 and 99.5 until evening.
On 10.12.11, after receiving the flu shot during a business sponsored wellness fair, I had an allergic reaction.  Between 10/10:15 AM I received the flu vaccine in my right arm. With in a brief period of time my injection site became itchy which then spread to my head arms and entire body.  I took 25 mg of Benadryl by mouth with no relief after 10 minutes so I took a second 25 mg Benadryl.  After another/15 minutes I was wheezing so the nurse gave me an Epi injection in my left arm.  Just prior to receiving my injection my co-worker called 911. I was transported by ambulance via ambulance.