chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax 23OCT92 non-stop, hard crying from 5PM-8PM, inconsolable; then cried on & off 2 more hrs; elected to give DT for 2nd dose of 16DEC92;
Developed Covid in Dec after receiving  booster vaccine in Sept.  I have had all Covid vaccines offered
Moderna COVID-19 Vaccine EUA Adverse events:  moderate injection site soreness, beginning 30 minutes after shot, lasting 3 days Foggy head, dizzy beginning 30 minutes after shot lasting 12 hours
p/vax pt chills, fever, nausea, severe h/a; lt arm became swollen & red around inj site; lasted 1wk; chills, fever, h/a, lasted approx 24hr;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EJ1686), in left arm, on 13Jan2021 as dose 2, single (Lot number: EJ1686), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 22Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperthyroidism" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Sulfa meds" (unspecified if ongoing), notes: Known allergies: Sulfa meds. Concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event VACCINATION FAILURE  and COVID 19 cannot be ruled out.
PT was administered Dtap instead of Tdap - No adverse effects as of 04/12/2007
Information has been received from an 84 year old female consumer reporting on herself with no allergies or drug reactions and no pertinent medical history who in July 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (route and lot number not reported). The patient stated as concomitant medication "creams". In September 2010, the consumer experienced itching all over her body after receiving ZOSTAVAX (Merck). The patient sought unspecified medical attention. The patient received as treatment for the event "heat treatments" and 3 biopsies were performed (no results were provided). At the time of the report the patient had not recovered. Additional information has been requested.
This is a spontaneous report from a contactable physician. A currently 79-year-old female patient of an unspecified ethnicity started to receive levofloxacin (MANUFACTURER UNKNOWN), MOBIC, and CELEXA; all via unspecified routes of administration on unspecified dates at unspecified doses for unspecified indications and received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) via an unspecified route of administration at a single dose for immunization on an unknown date. The patient's medical history and concomitant medications were not reported. On unknown dates, the patient experienced drug allergies to levofloxacin, meloxicam, pneumococcal 13-valent conjugate vaccine, and citalopram hydrochloride. The action taken in response to the events for levofloxacin was unknown, for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) vaccine was not applicable, for meloxicam was unknown, and for citalopram hydrobromide was unknown. The clinical outcome of the event, drug allergies to levofloxacin, meloxicam, pneumococcal 13-valent conjugate vaccine, and citalopram hydrobromide, was unknown. Pfizer is Marketing Authorization Holder of levofloxacin and pneumococcal 13-valent conjugate vaccine in the reporter's country. This may be a duplicate report in situations where other Marketing Authorization Holder(s) of levofloxacin and pneumococcal 13-valent conjugate vaccine has/have submitted the same report to the regulatory authorities.
After approximately 6 hours, upper arm was sore, headache started.  Sweated out a temperature during the same night.  Headache has continued for 2 days
Developed hives below the elbows on both arms on the Friday-after the vaccine, then  progressed  each day to the left side and lower abdomen, then the right side of abdomen, then to the outside area of each thigh and lower legs around each ankle.   Some have lead to pustules which opened up and are scabbed and others remain small and under the surface and continue to itch with redness and are raised/swollen.
pain in injection site; fatigue; migraine; joint pain; extreme nausea; extreme vomiting; fever of 103; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in injection site), FATIGUE (fatigue), MIGRAINE (migraine), ARTHRALGIA (joint pain) and NAUSEA (extreme nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced FATIGUE (fatigue), MIGRAINE (migraine), ARTHRALGIA (joint pain), NAUSEA (extreme nausea), VOMITING (extreme vomiting) and PYREXIA (fever of 103). On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in injection site). At the time of the report, VACCINATION SITE PAIN (pain in injection site), FATIGUE (fatigue), MIGRAINE (migraine), ARTHRALGIA (joint pain), NAUSEA (extreme nausea), VOMITING (extreme vomiting) and PYREXIA (fever of 103) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-079130 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079130:second dose
Developed left arm numbness and tingling distal to site of injection on the radial and ulnar side and entire hand. Preserved grip strength and sensation.  Symptoms began to improve in ~15 minutes but did not resolve. Instructed to go to the ER if developed weakness, worsening signs/symptoms, or any new concerns.
Maybe had covid; lethargic; achy; Major abnormality positive for Epstein Barr virus identified; Incredibly fatigued; General malaise; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General malaise), SUSPECTED COVID-19 (Maybe had covid), LETHARGY (lethargic), EPSTEIN-BARR VIRUS TEST POSITIVE (Major abnormality positive for Epstein Barr virus identified) and MYALGIA (achy) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Loratadine (Claritin) for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced MALAISE (General malaise) and FATIGUE (Incredibly fatigued). On 02-Jul-2021, the patient experienced EPSTEIN-BARR VIRUS TEST POSITIVE (Major abnormality positive for Epstein Barr virus identified). On an unknown date, the patient experienced SUSPECTED COVID-19 (Maybe had covid), LETHARGY (lethargic) and MYALGIA (achy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MALAISE (General malaise) and FATIGUE (Incredibly fatigued) had not resolved and SUSPECTED COVID-19 (Maybe had covid), LETHARGY (lethargic), EPSTEIN-BARR VIRUS TEST POSITIVE (Major abnormality positive for Epstein Barr virus identified) and MYALGIA (achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 24-jun-2021 patient's mother took her daughter to the pediatrician and he confirmed that the patient may have COVID so she had a lengthy response to vaccine. on 30-jun-2021 her mother also stated that she had not improved at all and which was the biggest complaint that that there was no improvement at day 14.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant follow-up added on 30-JUN-2021 and updated reporter information, patient  initials,age at vaccination,  start date of both doses of vaccine , batch number and anatomical location of vaccine administered , concomitant, treatment medications, events and outcome of the event were added. On 06-Jul-2021: Significant follow up received on 06-Jul-2021, new event added.
Pt recvd 2 doses of Engerix-B 22JUL92 & elevated liver enzymes; did not receive treatment;
Breast Tenderness, bi-laterally left greater than right; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BREAST TENDERNESS (Breast Tenderness, bi-laterally left greater than right) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 BREAST TENDERNESS (Breast Tenderness, bi-laterally left greater than right). At the time of the report, BREAST TENDERNESS (Breast Tenderness, bi-laterally left greater than right) had not resolved. happened approximately 5 days after injection      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
pt recv vax & devel numbness & tingling down arm to wrist;sx lasted for one day, & the pt recovered;
Patient reported feeling flushed and anxiety. She indicated she had not taken her clonazepam this morning but had it with her. Pt was given water at 1;40 to take her medication. Also took first set of vital signs 156/8 pulse 90 and 02 sat 100. After 20 mins patient reported anxiety was gone and no longer flushed. Second set of vitals 145/75 pulse 71 and 02 sat 100. Pt then waited another 10mins and reported feeling okay to leave with no symptoms or anxiety. Pt verbalized understanding of signs and symptoms to call 911 for.
Throat felt tight a couple hours later. Body aches and terrible headache. She had had this reaction 2 years ago from flu vaccine. Took BENADRYL and felt better w/in 24 hrs.
Shingles .  Confirmed with doctor visit on Saturday 4/21. One side of body abdomen and back (right side)
Information has been received from a nurse concerning a 21 year old female with no medical history who in December 2007, was vaccinated with a 0.5 ml first dose GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). On the day the shot was given, the patient experienced severe nausea and diarrhea for four days. No diagnostic laboratory studies were performed. The patient did not seek medical attention. About 5 days after receiving the shot, the patient recovered. No PQC was involved. Additional information has been requested.
I have reported my 5th Moderna COVID shot and the dizziness reaction.  Please note that my last name was erroneously entered that report. Sorry. I had the same reaction after this 6th shot. It was less severe, but I needed a cane to feel safe walking. I was extremely dizzy, unable to eat, nauseous for two days. As of  8/16/23 I cannot ride a bicycle. I saw my physical therapist and continue with a course of exercises she gave me. I have discussed with my doctor.
Adverse event yet to be determined.   According to patient's chart, patient received Pfizer vaccine on 5/27/21 but received Moderna vaccine on 6/24/21. Error discovered today 8/11/21 and could not reach patient to further investigate whether adverse events experienced.
Began with a headache when I went to bed that night (after getting the shot earlier in the day) that developed into a fever with chills. Every hour throughout the night I woke up freezing and it felt like my whole head was throbbing and in a vise. I also had a slight fever. The fever finally broke in the morning sometime but the body aches and headache lasted for about 36 hours even though I began taking Advil as soon as I got up the next morning. Because I didn't get a restful sleep due to the chills/fever, I was exhausted that day, all day. A full 48 hours later all symptoms were gone.
Patient is under 18 and was given Flublok  No initial adverse effects. Parents notified of Flublok incorrectly administered and institutional event report done.
At about 12:00pm while I was sitting at my desk working, my heart started beating really hard and faster. I could feel it beating through my chest. I had received the 1st dose of the Moderna vaccine at about 8:15am. I watched my heart rate on my watch heart rate monitor and it was staying consistently above 120 bpm. It is usually around 60 at rest. I tried to drink a lot of water as the physician advised.  I was having some chest pain, and it continued to beat hard for the next 6 hours. I felt like my vision was also blurry, and it was hard to read on my computer screen. I was trying to keep an eye on my heart beat and make sure I wasn't having a heart attack or stroke. I was trying to do breathing exercises to calm my heart down, and stay relaxed. Nothing seemed to help my heart rate go down. Luckily at about 6pm I started to feel like my heart rate had gone down. Then my heart rate went super low, and I almost couldn't feel it beating. I kept checking my watch and it was down below 50 bpm. I felt super exhausted and fatigued and just went to bed early. I am usually a very healthy active individual and this was very uncommon for me to feel. I'm sure it was an after effect of the vaccine, and I was told I needed to report it.
3/24/2021 Received Vaccine at 0933 then had a reaction after lunch at 2:30 PM.  She stated that she went to her car and it was very hot that day.  She started to feel itchy.  She came back to the Vaccine clinic with a rash on her chest, arms, and legs.  She stated that her throat felt itchy too.
Booster dose given 12 days too early (Ie less than 5 months). She is doing well.
Patient passed out approximately 10 minutes after injection. Face pale; continued to talk. B/P 90/60 Complaint "lights going out." Complaining of difficulty focusing. Approximately 5 minutes later B/P 120/72. Given juice and crackers. After sitting in chair 10 minutes escorted to friends car at 12:30 PM.
Following the vaccine nothing immediately happened. The next day around 11:30am I started feeling hot and took my temperature. It was at 100.4 degrees. Later that evening, i noticed some swelling in my armpit and thought it was unusual. Later that night it got even more swelling and very uncomfortable to sleep in my normal position. Three days have since past and the swelling has gone done significatly but not all the way. I looked it up and it appears my lymph nodes were reacting to the shot under my arm pit. No other swelling in any other part of my body. Only under my arm where I got my shot. Left hand, left side of chest.
Persistent pain of L deltoid at administered site. Pt reports persistent pain to L deltoid for 2 month S/P Flu vaccine. Patient will need to go on temporary disability as he is unable to complete tasks at work due to pain.
Shot was given, injection site bled a small amount (but did not need more than 1 cotton ball), dizziness began about 1-2 minutes post-injection, patients head dropped and she passed out. She was immediately guided to the ground to lie down, she was tense and had few small jerks. Syncope did not last longer than 30 seconds, she was given a water and pharmacy intern sat with her for 10 minutes until she no longer felt dizzy and lightheaded.
Vaccine was diluted with 0.8 ml of sodium chloride instead of 1.8 ml.  The recommended dose of 0.3 was drawn from vial and given.  It was noted after the 3rd dose was given, that insufficient doses remained in vial.  Amount of diluent added was verified with the contents remaining in used diluent vial, when compared to contents of new diluent vial. Patient was advised of situation approximately 6 hours and denied any undue side effects.
Patient complained of tingling in the neck, shoulder & arms. onsite EMS was called vitals BP 168/78   96% O2. Diphenhydramine 25mg orally griven. she was monitored, felt better, released againt medical advice.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 08-MAR-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F -2.7 Celsius) for 1764. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
2-6-14 pt presents to Hosp. with resp s/s dx with bronchitis and allergic rhinitis tx with amoxicillin, ZYRTEC and Guaifenesin. On 2-9-14 back to Hosp dx per CT scan with early pneumonia aspiration or atelectasis pulse ox 88-92. Pt given tetracycline, FLAGYL and IMODIUM in addition to other meds given early pt d/c to home. On 2-11-14 pt presents to another Hosp. Dx with double pneumonia, admitted 2-18-14 placed on vent, 2-22-14 pt died.
My mother had the vaccine and now has Influenza A and is fighting for her life in the hospital. She was a fully active person. She is a mess now! Her blood pressure, which was always high..she is on meds, is now VERY low. Today is day 4 in the hospital, with no sign of being released.
hasn't received a second dose yet; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received 1st dose on 1st July 2023).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: hasn't received a second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-Oct-2023 No lot number was reported, the reporter stated vaccination happened in a different facility. The reporter consented to follow-up via email. Till the time of reporting, the patient did not receive second dose of Engerix-B, which led to incomplete course of vaccination.
From initial information received on 11/25/03 from a claims representative, regarding an adverse event, it was reported that a female patient received FLUZONE, lot number and administration information not provided, on 10/22/03. An unspecified amount of time later, the patient experienced a rash and swelling in the face, which required hospitalization. The recovery status of the patient was not reported.  Follow up on 12/05/03: "From additional information received on 12/01/03 from the pt, it was reported that the vaccine was administered at a drug store.  About 30 hours later, on 10/25/03, the pt developed hives all over her body, shortness of breath and difficulty breathing.  The pt was seen in the ER and was admitted to the hospital.  She was hospitalized for one day.  The pt has recovered from these events." 29Mar04: Further attempts to contact responsible physician for this case were unsuccessful. Further information is not anticipated, this case is considered closed.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 53.21 years Concomitant products were not provided. On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.