chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got vaccine on 1/28/21, felt tingly in his lip.  At the night progressed he had muscle weakness, lip tingling, eyelid droop, loss of bowel and bladder function, moreso bladder.  He was slow in his responses, and his wife noticed that was getting weaker and could not get up from the bathroom.  She feels it was more muscle weakness than anything.    On 1/29/21 he was bad most of the day  1/30/21 he started to come out of it little and knew what she was saying.   Now today 2/8/21 he is about 93% back to his baseline.  Nothing taken, but did speak to the doctor and he at that time told him not to take the 2nd vaccine.
Persistent 8x4 inch bruise around area of the injection site. Seen by PCP on 5/31/2017 to report.
fatigue; low grade fever up to 99.5; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and PYREXIA (low grade fever up to 99.5) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FATIGUE (fatigue) and PYREXIA (low grade fever up to 99.5). At the time of the report, FATIGUE (fatigue) and PYREXIA (low grade fever up to 99.5) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  A HCP friend of the patient said that they were intending to receive the Spikevax vaccine and instead received a bivalent vaccine. The patient received a second shot. He had a mild reaction for an afternoon following the second dose. He was having fatigue and a low grade fever up to 99.5. Probably would have taken Tylenol with those symptoms if he took anything but did not remember.   Most recent FOLLOW-UP information incorporated above includes: On 25-Sep-2023: On 25-Sep-2023: Live Follow-up contains, patient DOB, Initial and events outcome updated.
This case was reported by a consumer via call center representative and described the occurrence of infection in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced infection and generalized erythema. On an unknown date, the outcome of the infection and generalized erythema were recovered/resolved. It was unknown if the reporter considered the infection and generalized erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. It was reported that the patient used to normally get red when she used to recover from an infection. The patient stated that with example, if the patient was recovering from a sinus infection then she turns all red. Two to three days after vaccination, the patient looked all red like a boiled lobster. The patient assumed that, she was recovering from an infection from the SHINGRIX vaccine. The patient spoke with her a physician and the physician advised her not to receive the 2nd dose of SHINGRIX.
Started with headache then fatigue towards the end of the day. Overnight low grade fever, chills, severe myalgias and joint aches. In the morning nausea and dry wretching. Symptoms Vaccination was given around 10AM, Headache started immediately and the rest of them about 8-10 hrs later
Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ears, swollen lymph nodes in neck and groin area
No additional AE details are available; AE for ROTATEQ which was administered after improper storage; This spontaneous report was received from a medical assistant and refers to a 6-month-old patient.   The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported.   On 01-FEB-2021, the patient was vaccinated with an improperly stored dose  of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 milliliters, orally, lot number 1742461, and expiration date on 17-NOV-2021 (formulation, strength,  frequency, and anatomical location were not reported) for prophylaxis.  No additional adverse event details were available.     The administered dose of vaccine experienced the temperature excursion of 9.9 degrees Celsius for 35 minutes. The previous temperature excursion was not reported. Data logger was involved.
Patient developed severe shortness of breath, wheezing, crackles and coughing.  She had to receive emergency breathing treatment of Albuterol and Atrovent as well as oral steroids.  She had to be transfered from emergency room to PICU where she spent 1 day.  After that she spent 2 more days in hospital.  Upon discharge she was diagnosed with asthma from which she never recovered.  04/08/08 Reviewed hospital medical records of 6/14-6/15/2006. FINAL DX: RAD exacerbation. Records reveal patient experienced cough, wheezing, respiratory distress, increased work of breathing, SOB x 1 day after vaccinations. Went to outlying ER & tx w/nebs, antibiotics & steroids.  O2 sats 89-91 on 2L O2.  Temp 100.6.  CXR there revealed pneumonia.  Transferred to higher level of care.  Exam revealed belly breathing w/mild retractions, wheezing, coarse breath sounds.  Continued tx w/steroids, nebs & O2.    4/8/08 Reviewed Peds allergy consult of 12/7/2007. FINAL DX: mild to mod asthma, allergy & non-allergy triggers. Records reveal symptom onset 1/2006 w/exposure to cats.  Seen in ER for nebs & did well until current episode.  3rd episode 11/06 s/p URI & hospitalization.  Meds were adjusted. 01/25/2010 She still has asthma exacerbations just like after the vaccination.  My daughter got an asthma attach 6 hour after vaccination and has asthma since. She did not have asthma before.
Narrative:  Pt received 1st dose of COVID-19 VACCINE (Pfizer) on 12/27/21. Within 10 mins, complained of "knot in chest" and some "difficulty breathing." Reported to ED, ECG done and no STEMI. No meds or treatment given, improved on own and discharged home.
vomited x 2, appeared cool & pale w/in 1st 2 hrs p/vax then inc crying for 6-8 hrs; no fever;
DTap given at left thigh- 3-29-07. 3-30-07 Today appt- with Dr left thigh swollen, warm to touch. Played last night and had scrapes on the site.
Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an adult patient (age reported as 40's) who was vaccinated once with an 0.5 ml expired dose of MENACTRA (Batch number: U5539AB, expiration date: 25-Apr-2018 via intramuscular route in the right deltoid on 25-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS (TDAP) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation. It was a case of actual medication error due to expired product administered. It was not reported if the patient 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 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. Documents held by sender: none
Moderna COVIDF-19 Vaccine  Came down with Shingles 17 days after 1st dose
Fatigue; Chills; Joint pain/ankle pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills) and ARTHRALGIA (Joint pain/ankle pain) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and ARTHRALGIA (Joint pain/ankle pain). At the time of the report, FATIGUE (Fatigue), CHILLS (Chills) and ARTHRALGIA (Joint pain/ankle pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Initial additional information included updated Email .
Started tingling lips, mouth, nasal cavity, then felt pressing on throat, nausea x 5 hrs after vaccination - recording to report by mother.
This spontaneous report as received from a registered nurse 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 15-JAN-2014, the patient was vaccinated with  ROTATEQ lot # J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored oral ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm ) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperature was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a female who on approximately 05-JUL-2007 was vaccinated with a first dose of Gardasil.  The patient did not have an allergic reaction with the first dose.  On 06-SEP-2007 the patient was vaccinated with a second dose of Gardasil.  On 06-SEP-2007 within 24 hours the patient had a rash, swelling throughout the face, and redness on the left arm.  The physician prescribed ATARAX and corticosteroids (unspecified) as needed and instructed the mother to have the patient take take the corticosteroids (unspecified) if the swelling did not go down.  The patient reported that she felt she truly had an allergic reaction.  The physician reports that the patient "really did seem to have an allergic reaction" due to Gardasil.  Additional information is not expected.
pt recvd vax & noticed small lump at right thigh day after inject; lump getting smaller over past wk; advised to watch closely;
he has been ill with every possible side effect listed; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced unwell. On an unknown date, the outcome of the unwell was not recovered/not resolved.   It was unknown if the reporter considered the unwell to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient was ill with every possible side effect listed, after the vaccination. The reporter wanted to know about the studies of vaccine effectiveness. The follow-up was not required.
Within 5 minutes of vaccine administration patient began to feel lightheaded and passed out in waiting room. Patient lost consciousness several times for intervals of one minute or less. Patient was very sweaty and urinated on herself. We called EMS who took patient to local hospital.
8NOV sore throat in bed x 3 days, muscle fatigue cont weakness, muscle joint pain; to MD 26NOV mono test CBC-WBC 10,000 mono neg; no improvement numbness, coldness, tingling of fingertips; low grade temp;
Pt received vaccine on 6/14 at 2 pm. Pt woke up that night with arm pain but thought it was normal injection site reaction. She woke up 6/14 with a swollen arm, unable to lift or move arm, wit radiating pain to the head, neck, and chest.
This spontaneous report as received from a certified medical assistant refers to a 6 month old male patient. The patient had no pertinent medical history and no drug reactions or allergies. On 08-DEC-2015 and on 02-MAR-2016, the patient was vaccinated with the first and the second dose of PEDVAXHIB, respectively (dose, route of administration, lot # and expiry date were not reported). On 08-APR-2016, the patient inadvertently received both the third dose of PEDVAXHIB (lot # L042835 and expiry date 19-AUG-2018; dose and route of administration were not reported) and PENTACEL (dose, route of administration, lot # and expiry date were not reported). No concomitant medications were administered. On 25-APR-2016, the patient's mother took him to emergency room (ER) and he was diagnosed with croup. The symptoms of croup were unknown. In the ER, the patient received the treatment with epinephrine nebulizer and dexamethasone (manufacturer unknown). The patient was not admitted to hospital. On 26-APR-2016, the patient was brought in to the physician's office for follow up visit. No lab diagnostic studies were performed. The outcome of croup was reported as recovered on an unknown date in 2016. The relatedness between the event of croup and PEDVAXHIB and PENTACEL was not reported. Upon internal review, the event of croup was considered to be medically significant. Additional information has been requested.
30 minutes after flu vaccine left deltoid.  She began to itch in nose IM Benadryl 25mg left hip.  125 mgm solu medial IM right hip.  Tagamet 400mg.  O2 2<min canned.  Hard to swollen blood pressure 28/74, pulse: 75; respiratory 18; 11:40: feeling better. Pulse Ox 99%.  Stable to home.
Had redness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Had redness on the injection site) in a 70-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 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Had redness on the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Had redness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
arm where Td given went completely numb, n & profuse vomiting, parent kept pt out of school all wk; unable to seek med assistance due to finances;
Dizzy; pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and HEADACHE (pounding headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (Dizzy) and HEADACHE (pounding headache). At the time of the report, DIZZINESS (Dizzy) and HEADACHE (pounding headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Patient began vomiting approximately 15 minutes after vaccine administration. Later in the evening developed  diarrhea and clammy skin . Patient slept from 7/20/23 at 9pm until 7/21/23 at 2:00 pm. Upon waking symptoms had resolved
Information has been received from a physician concerning a female who was vaccinated with zoster vaccine live (Oka/Merck) on approximately 15-FEB-2008. On approximately 07-MAR-2008, the patient developed shingles. Additional information has been requested.
DVT right common femoral vein, sent to hospital for Heparin, transitioned to Eliquis. Monitoring. Will follow-up with vascular specialist.
10-14-15 To doctor for annual wellness checkup. Lab report came back normal. Received my annual influenza shot and my third pneumonia vaccine. 10-15-15 Noticed severe soreness in both upper arms. Checked temperature - subnormal (97). 10-17-15 Had mild pain in hip joints (not in spine or coccyx region) so, at night I applied medicated "Equate" pads and "ICY HOT", a topical  medication. This has continued through present. However, my usual activities were curtailed, such as walking up and down stairs and around 5-acre apartment complex. 10-25-15 Attended church (drove car) but could not walk as briskly as before. As pain increased, I cancelled dental appointment for next week (11-02); and, since then cancelled 11-09 but have 11-16 scheduled if better by then. 10-26-15 Increasing pain. Went to a massage therapist. Had to roll off the table. No better. Continued self treatment; drank sufficient water.
Pt was given dose of Janssen Covid Vaccine on 05/27/21 by an MA, but it was given 20min outside of the 6 hour range after being drawn. No adverse reaction noted with pt.  Medical Director informed and Pt aware.
Felt Cold; Chills; Aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt Cold), CHILLS (Chills), MYALGIA (Aches) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced FEELING COLD (Felt Cold), CHILLS (Chills), MYALGIA (Aches) and HEADACHE (Headache). On 19-Feb-2021, FEELING COLD (Felt Cold), CHILLS (Chills), MYALGIA (Aches) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Tylenoll
Pt went to hospital after receiving 1 yr. vaccines possibly from DTaP vaccine given on 6/19/07. Has fever up to 105, had seizures. 2/11/08-records received for DOS 6/21/07-DX: Cough. Seen in ED presented with 3 day H/O fevers and runny nose and emesis times 1. Temp 38.2 (R). Follow-up: Have repeatedly called the nurse and she has been unsucessful in reaching the mother of the patient. The one time the nurse was able to talk to the mother, the mother didn't have the papers to give the nurse the information.
Severe headache on the way home from the office. Patient slept for 1 hour awoke with severe back pain and difficulty moving her legs. Mom gave Tylenol. 30 minutes later severe pain persisted accompanied by shortness of breath, gasping for air and numbness in hands. 911 was contacted. Patient was given pain medication in the ER and monitored. She was discharged home later in the evening. Hip and back pain continue but was well enough to attend school today (6/14).
Developed Hemophilia. Starting treatment. 4 hour infusions once a week. Prednisone daily.
Mother noted redness at site lft. thigh evening of vaccination & pain. Increased heat, redness, swelling & pain on 2/18/10. Reports "soft ball sized" lump. Warm packs & ADVIL improved by 2/19/10. Mother did not seek treatment or evaluation by physician.
SPRING 95-22APR95 pt recv vax & 2wk p/vax pt felt overwhelmingly tired & exhausted for 6wk then joints became painful, stiff, fatigue cont as well as joint pain, stiffness;sx cont for over 1yr;dx polymyalgia rheumatica
Left thigh redness and swellling. A line was drawn aroung redness and the father was instructed to return in the morning if swelling or redness increases.
Pt is a resident at an assisted living facility, developed s/s of confusion and syncope.  Tested positive for COVID on admission to the hospital
spike in his blood pressure readings from his normal of 130/80/48 to 152/85/58; spike in his blood pressure readings from his normal of 130/80/48 to 152/85/58; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received booster (third dose) of BNT162B2 (brand=Pfizer), via an unspecified route of administration (right arm) on 11Oct2021 14:45 as single dose for COVID-19 immunization. Facility type vaccine: military base. The patient previously received the first dose on 24Jan2021 09:15 AM (lot number: EL9263) and second dose on 14Feb2021 09:30 AM (lot number: EN6200), both in the right arm at 78 years of age for COVID-19 immunization. Medical history included known allergies to lisinopril, ongoing high blood pressure, and 1 heart blockage 20yrs ago (from 2001). No Covid prior to vaccination. Concomitant medications were not reported. No other vaccine in four weeks. With other medications in two weeks (unspecified). The patent experienced a spike in his blood pressure readings from his normal of 130/80/48 to 152/85/58 on 12Oct2021. No treatment the event. No Covid test post vaccination. The patient recovered from the event on an unspecified date.
Patient waited his 30 minutes in clinic due to an adverse reaction to codeine. He left and went and to lunch. He then returned to the clinic because he stated he was not feeling well. He reported concerns with his lungs and heart rate.
My heart rate went up 170/min, 5 mins after taking the vaccine, my heartrate sustained 130-160 for 72 hrs. I contacted my cardiologist who I see for my intermittent sinus tachycardia, he suggested to take metoprolol which helped. I took metoprolol on post vaccine 3rd day as my heart rate wasn?t coming down. Along with bad tachycardia, ectopic beats, high fever 102, chills, headache.
Received vaccine on Thurs 9/8/16 about 1:00pm Started S&S within approx 5 hrs. Went to a local walk in clinic on Friday-MD took quick look and recommended to monitor. Reaction became worse so went to ER at hospital. Diagnosed as "cellulitis". Antibiotics prescribed. (Doxycycline).