chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 45 year old female patient. Patient's medical history and concurrent condition was none. On 16-JUN-2014 the patient was vaccinated with ZOSTER, 65 ml, subcutaneous. Patient's concomitant medication was reported was reported as none. On an unknown date approximately in June 2014 the patient developed a reddened injection site the size of a silver dollar with one lesion at its border the size of the head of a pencil and that her eyelids felt heavy, but she was not tired. The reporter stated that the patient reported that she had seen an unspecified physician who prescribed prednisone and Loratidine. PQC was not filed. The outcome of the event was reported as not recovered/not resolved. Reporter's causality assessment was not provided. Additional information has been requested.
Vaccine Given after Beyond Use Date.  BUD of 10/09/2021, dose given 12/01/2021.  Multiple other occurrences  of this same scenario with the exact same lot number at 9 other clinic dates.  193 persons affected.
Presented to ED 12/18/21 with RUQ discomfort for ~1 day prior; R shoulder and flank pain. CTA shows right sided pulmonary embolism. Not on oral contraceptives, does not smoke, no family history of DVT/PE and no recent hospitalizations. Started on enoxaparin in the hospital. Discharged 12/20 with apixaban prescription. Followed up with PCP on 12/21/21; PE thought to be related to COVID vaccine. Refered to hematologist.
See note attached. Called patient 1/23/09 return call from patient. Swelling decreased still sore and itchy, still taking BENADRYL and antibiotic.
Sore arm traveling under arm, ribs, breast and other arm, headache ear pain on 06/05/2020 . Went to hospital by ambulance from work. On day two , 06/06/2020swollen face, sore ears, headache, flushing and itchy face, itchy throat, muscle aches, stomach ache, ears ache,fatigue, dizziness, weakness. Went to hospital the second day and given IV meds.  Day three 06/07/2020 still low energy and weak with facial flushing , headache  and ears ache, stomach pain, in afternoon. Day 4, 06/08/2020 still weak and dizzy, body rash headache and ears ache. Went to doctor for follow up and being referred to allergist.
Not an adverse event an administration error.  On 08/14/21 Patient came into the pharmacy for her second Pfizer COVID-19 vaccination, she thought that you got the 2nd shot 14 days after the first shot and did not look at her appointment on her card that specified 08/21/21 for her 2nd shot appointment.  The pharmacist who gave her the shot did not realize that the patient was early for her COVID-19 vaccine and gave her the shot on day 14 instead of day 21.  We were made aware of the issue by a family member who came to the pharmacy on 08/17/21 to get his second covid shot but was informed he was too early for the vaccine until saturday and he stated we gave patient her shot on saturday 8/14 and they got their 1st shots on the same day.  We contacted patient and informed her that she got   the shot early.  We also contacted Pfizer to see if the patient would need to be revaccinated and the guidance from them was to not revaccinate.  Patient stated that she has had to adverse effects from the early shot
inc temp to 104 & coalescent evervescent rash face/trunk approx 6-8hr p/vax;
Onset of tingling/numbness the day following 2nd covid vaccine. Diagnosis sensory ganglionopathy following a "GBS like" episode.
ON TRIP CAUGHT FLU. BY 12/25/09 I HAD PNEUMONIA AND TREATED WITH ZITHROMAX. MY MEDICAL HISTORY WILL SHOW IN 69 YEARS I NEVER HAD CHEST OR LUNG ISSUES. I BELIEVE THE VACCINATION WEAKENED MY IMMUNE SYSTEM. I HAVE NOW HAD PNEUMONIA 3 TIMES LASTLY APRIL 6 2013.
back pain; leg pain; headache; rash developed on stomach; bump at injection site; arm was painful; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (bump at injection site), PAIN IN EXTREMITY (arm was painful), BACK PAIN (back pain), PAIN IN EXTREMITY (leg pain) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE INDURATION (bump at injection site) and PAIN IN EXTREMITY (arm was painful). On 11-Feb-2021, the patient experienced BACK PAIN (back pain), PAIN IN EXTREMITY (leg pain), HEADACHE (headache) and RASH (rash developed on stomach). At the time of the report, INJECTION SITE INDURATION (bump at injection site), PAIN IN EXTREMITY (arm was painful), BACK PAIN (back pain), PAIN IN EXTREMITY (leg pain), HEADACHE (headache) and RASH (rash developed on stomach) outcome was unknown.            No treatment or concomitant medications were reported.
Pt has a history of fainting after receiving I.M. Injections. Pt states she is feeling faint and would like to lay down. Pt was moved to the exam room and monitored. Pts vitals are stable. Pt didn?t require transport to hospital.
Initial pain at the site of injection. About 12hrs later, fever, chills, headache, nausea, pain under the arm. Overall feeling of have been hit by a semi. Joints aching, hard to clench a fist of the left hand.
blood pressure is sky high/ BP was over 200; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient sister).A female patient of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number was not reported and Expiry date was reported), dose 1 via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.The patient experienced blood pressure is sky high and bp was over 200, headache on an unspecified date. She wonders if that is related to the vaccine; caller states she does not have the lot number to provide for the sister's Pfizer Vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: over 200. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe body ache; fever; fatigue; no energy; no appetite; Massive headache; Mild headahe; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Mild headahe), MYALGIA (Severe body ache), PYREXIA (fever), FATIGUE (fatigue) and LETHARGY (no energy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee surgery NOS on 13-Jan-2021. Concomitant products included APIXABAN (ELIQUIS) and PARACETAMOL (TYLENOL) for Knee surgery NOS, MULTIVITAMINS, VITAMIN B COMPLEX and VITAMIN D for an unknown indication.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced HEADACHE (Mild headahe). On 26-Jan-2021, the patient experienced MYALGIA (Severe body ache), PYREXIA (fever), FATIGUE (fatigue), LETHARGY (no energy), DECREASED APPETITE (no appetite) and HEADACHE (Massive headache). On 27-Jan-2021, HEADACHE (Mild headahe), MYALGIA (Severe body ache), PYREXIA (fever), FATIGUE (fatigue), LETHARGY (no energy), DECREASED APPETITE (no appetite) and HEADACHE (Massive headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature increased: Initially Temperature was 99.5 and the got up to 103.5.     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.   Treatment included Tylenol 1000mg q 6 h
Pt was brought back in by teacher approximately 10-15 mins after vaccine was given. Pt was flushed in face, pale and hyperventilating. Pt denied any itchiness. No apparent rash. I sat with pt and had her take deep breaths and do some breathing in a paper bag. Breathing normalized after 5 minutes. Facial flushing continued for about 30 minutes sent to clinic with mom.
Swelling of right thigh and going down leg to knee. Child limping on right leg according to mother.
3 Quarter size red circles opposite arm of shot; Itching like crazy; hives; This spontaneous case was reported by a consumer and describes the occurrence of RASH (3 Quarter size red circles opposite arm of shot), PRURITUS (Itching like crazy) and URTICARIA (hives) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (3 Quarter size red circles opposite arm of shot), PRURITUS (Itching like crazy) and URTICARIA (hives). At the time of the report, RASH (3 Quarter size red circles opposite arm of shot), PRURITUS (Itching like crazy) and URTICARIA (hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   .   This case was linked to MOD-2021-085686 (Patient Link).
Started to get very sick like bad flu. Shivers, prickly skin, fiver, stomac problems
pt recv vax 26DEC95 & 24MAY97 pt devel a gen rash that consisted of 100-150 lesions;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 30th April 2019). On 24th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 25th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site itching were not recovered/not resolved. The reporter considered the injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient reported that the day after she was vaccinated with SHINGRIX on, she experienced injection site soreness. The patient took BENADRYL and it helped but she called the pharmacy on the day of reporting and stated that the redness comes and goes and the area was itching.
Body aches, chills, low-grade temperature, very sore arm at injection site, very tired
Patient was given 12+ dose instead of 5-11 dose. Patients mother was notified to watch for reactions
Patient signed  up for an appointment early for second dose. First dose was administered on 3/18/2021 and second dose was administered on 4/8/2021, which is 21 days as opposed to the requisite 26 days from manufacturer.
shortness of breath; Lungs hurt when she breathes in and out; fever; Chills; Severe Headache; Body aches with muscles in legs and arms; Back pain; Lymph nodes on both sides of neck are slightly enlarged; Fatigue; Slight pain at injection site on left arm; This is a spontaneous report from a contactable other Health Care Professional.A female patient of 68 years-old age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number : EN6205 and Expiry date: Unknown), dose 2 via an unspecified route of administration on 08Mar2021 at the age of 68-years-old as DOSE 2, SINGLE for covid-19 immunization. Medical history included systemic lupus erythematosus from Feb1992 to an unknown date Verbatim: Systemic lupus erythematosis , Sjogren's syndrome from Jan2020 to an unknown date Verbatim: Sjogren's disease , inflammatory bowel disease from Feb1997 to an unknown date Verbatim: Inflammatory Bowel Disease and Ulcerative Colitis. Concomitant medication included salmeterol xinafoate (SEREVENT) taken for an unspecified indication from 02Mar2021 and ongoing. Patient stated she does not feel very well. She has been in quarantine since Mar of 2020.On 08Mar2021 the patient experienced fever, chills, severe headache, body aches with muscles in legs and arms, back pain, lymph nodes on both sides of neck are slightly enlarged, fatigue, slight pain at injection site on left arm, lungs hurt when she breathes in and out, shortness of breath. The outcome of events fever, severe headache, lymph nodes on both sides of neck are slightly enlarged , fatigue , slight pain at injection site on left arm , lungs hurt when she breathes in and out not recovered and the outcome of events chills, body aches with muscles in legs and arms, back pain was recovering while the outcome of events shortness of breath was unknown.  No follow-up attempts are possible.No further information is expected.
a couple small rashes started to develop, 2 on the stomach area, one mid back.  Over the next week it continually got larger, darker, more raised, more spots developed until my entire torso, front and back, was covered.  started to move to upper arms and legs, so I tried taking benadryl as directed for about 3 to 4 days, no improvement.  Then about a week after that started to fade.  some days it is mostly gone, other days the rash is a bit more pronounced.  No pain or itching, just rough raised skin and redness
Information has been received from a 24 year old female who on an unspecified date, was vaccinated with her first dose of Gardasil. Subsequently the patient experienced rash that went up from her arm to her shoulders. On 12-APR-2007 was vaccinated with her second dose of Gardasil. On 12-APR-2007 the patient experienced rash that went up from her arm to her shoulders. Subsequently, the patient recovering. Additional information has been requested.
Patient admitted as inpatient on 1/22 due to atrial fibrillation with RVR. Patient was tested for COVID-19 and was positive on 1/22.
felt not so great; This case was reported by a consumer and described the occurrence of feeling bad in a elderly female patient who received Herpes zoster SHINGRIX. On 31st August 2021, the patient received the 1st dose of SHINGRIX. On 31st August 2021, less than a day after receiving SHINGRIX, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were reported as follows: The case was reported by patient. Age at vaccination was not reported. The patient got dose 1 of SHINGRIX on the day of reporting. The patient felt not so great for 3 hours and at the time of reporting, felt great. The patient was expecting the worst but it was not bad. No contact details were available. The case had been linked with US2021AMR187289 reported by same reporter. Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR187289: same reporter.
I had a breakthrough case of Covid chills body aches flu like symptoms, sore throat cough and headache. Had digital vaccination with no lot #
Severe pain (8 out of 10) at injection site for 6 days with no lessening of pain as of this submission
patient fainted five minutes after receiving the first Pfizer Covid-19 vaccine. Patient lost consciousness for few seconds.
arm is really sore; hands were swollen, real tight; fever; vomiting; a little bit of a cough; hurt all over; has a really bad spot where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hands were swollen, real tight), PYREXIA (fever), VOMITING (vomiting), COUGH (a little bit of a cough) and PAIN (hurt all over) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03/L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PERIPHERAL SWELLING (hands were swollen, real tight), PYREXIA (fever), VOMITING (vomiting), COUGH (a little bit of a cough), PAIN (hurt all over) and RASH MACULAR (has a really bad spot where she got the shot). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm is really sore). On 25-Feb-2021, PERIPHERAL SWELLING (hands were swollen, real tight), PYREXIA (fever), VOMITING (vomiting), COUGH (a little bit of a cough) and PAIN (hurt all over) had resolved. At the time of the report, RASH MACULAR (has a really bad spot where she got the shot) and PAIN IN EXTREMITY (arm is really sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 14-AUG-2012, the patient was vaccinated with the first 0.5ml dose of GARDASIL intramuscularly. On 25-MAR-2014 the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular late. No adverse effects reported. Additional information has been requested.
On February 20 I woke up and noticed a large circular rash at the injection site. It does not hurt or itch.
Day 1 of Dose 1: intermittent neck muscle tightening that I had never had before. It continued throughout the night. I woke up with horrible chills in the middle of the night. When I woke up Saturday morning it felt like somebody was stabbing my brain with a knife. I vomited that afternoon and slept most the day. My head was hazy and I was extremely tired for about five days after dose one.  I also suffered from muscle and joint pain for a week.   Day 2 Dose 2:  Started having vaginal bleeding in the middle of the afternoon that continued until Tuesday.  Then on Wednesday, October 20 I started having horrible muscle and joint pain in the afternoon.
pt recvd vax;to er w/ febrile sz; eyes rolled to back of head;shaking of all limbs; concurrent BOM found;pt recvd IV & was prescribed vantin x 10 days;
I was really sick on 05Jun2022 and tested positive for covid; I was really sick on 05Jun2022 and tested positive for covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6199), in left arm and on 24Sep2021 as dose 3 (booster) , single (Lot number: FC3184) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 05Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 05Jun2022, outcome "not recovered" and all described as "I was really sick on 05Jun2022 and tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (05Jun2022) Positive, notes: I was really sick on 05Jun2022 and tested positive for covid; (15Jun2022) Positive, notes: I tested positive for covid today, 15Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was really sick on 05Jun22 and tested positive for covid. Started Paxlovid that same day from 05Jun2022  to 09Jun2022. Patient was miraculously better the next day (06Jun) and felt great for the next 8 days. Then 9 days after first testing positive for covid on 05Jun, Patient started feeling stuffy and extremely tired on 14Jun. Patient tested positive for covid today, 15Jun. Patient relapsed and not sure why.  No follow-up attempts are possible. No further information is expected.
We gave a 14 year old the Moderna Shot; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (We gave a 14 year old the Moderna Shot) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (We gave a 14 year old the Moderna Shot). On 29-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (We gave a 14 year old the Moderna Shot) had resolved.        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.