chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a noncontactable consumer (patient). A 28-year-old (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 28, via an unspecified route of administration, on Apr 16, 2021, at 15:15, single dose, for COVID-19 immunisation. Medical history included asthma. The patient has latex and penicillin allergy. It was not reported if the patient took any other medication within two weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination,  patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 17, 2021, patient started feeling unwell (headache and nausea) and had a heightened sense of smell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events feeling unwell (headache and nausea) and a heightened sense of smell: unknown (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Sought treatment at the hospital for what was found to be Hep B. Swollen and inflamed liver and spleen. Liver enzymes were tested. Experiencing exhaustion and fatigue, trying to treat as acute and avoid chronic Hep B
10:03Throat felt like going to closing  like after other reaction to rocephin. 10:05Swallowing ability felt like going to be difficult. 10:06 Immediately to ER from vaccination area at hospital. 10:10 Then coughing from bronchospasm lasting over a minute repeating until  ER meds kicked in . Meds- solumedrol 125 mg IV , Benadryl 50 mg IV , xophenex 1.25 nebulizer
Pain in neck; Shoulder Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in neck) and ARTHRALGIA (Shoulder Joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Immunisation.     Concomitant products included ABALOPARATIDE (TYMLOS) from 28-Oct-2021 to an unknown date for an unknown indication.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced NECK PAIN (Pain in neck) and ARTHRALGIA (Shoulder Joint pain). At the time of the report, NECK PAIN (Pain in neck) and ARTHRALGIA (Shoulder Joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment were provided.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site soreness after 1st dose of SHINGRIX. The reporter did not consent for follow-up.
cough; shortness of breath; runny nose; Neck pain; diarrhea; chills; headache; fever; Joint pain/ Twinge below my elbow; light headed; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), DYSPNOEA (shortness of breath), RHINORRHOEA (runny nose), NECK PAIN (Neck pain) and DIARRHOEA (diarrhea) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (light headed). On 16-Mar-2021, the patient experienced COUGH (cough), DYSPNOEA (shortness of breath), RHINORRHOEA (runny nose), NECK PAIN (Neck pain), DIARRHOEA (diarrhea), CHILLS (chills), HEADACHE (headache), PYREXIA (fever) and ARTHRALGIA (Joint pain/ Twinge below my elbow). At the time of the report, COUGH (cough), DYSPNOEA (shortness of breath), RHINORRHOEA (runny nose), NECK PAIN (Neck pain), DIARRHOEA (diarrhea), DIZZINESS (light headed), CHILLS (chills), HEADACHE (headache), PYREXIA (fever) and ARTHRALGIA (Joint pain/ Twinge below my elbow) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient did not receive treatment.
kid received the ActHIB vaccine and instead of using the diluent, they used sterile water, no AE; Initial information on 11-Nov-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a two months old female patient who received a 0.5 ml dose of HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) vaccine with sterile water instead of using the diluent lot UI973AAA and expiry: 25-JUL-2020 via intramuscular route in the left vastus lateralis on 06-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX), and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL).  It was an actual medication error due to Product preparation error .  At the time of reporting no adverse events was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a physician concerning an 11 year old Hispanic male who on 9/1/00 was vaccinated with the 1st dose of Hep-B. Fifteen to twenty minutes, post vax, the pt fainted and fell straight back onto his head causing a contusion on the occipital region. He immediately, was awake and looked pale and frightened. The child was observed for 30 minutes then sent for a skull series. As per the mother, the skull series was within normal limits. On 9/1/00, the pt recovered. No further information is available.
pt adm for term pregnancy recvd rubella vax 1JUL95; p/discharge, pt exp rash on abd, joint pain, easy bruisability; problem resolved spontaneously;MD not informed of rxn until 4wks later & all sxs gone
Had a fairly mild breakthrough case of COVID; Loss of smell; Loss of taste; runny nose; Nasal congestion; Diarrhea; Cough; Vomiting; Chills; Muscle ache; headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), RHINORRHOEA (runny nose), NASAL CONGESTION (Nasal congestion) and DIARRHOEA (Diarrhea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack in 2016. Concurrent medical conditions included Cardiovascular disease, unspecified (stent implaced).    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), RHINORRHOEA (runny nose), NASAL CONGESTION (Nasal congestion), DIARRHOEA (Diarrhea), COUGH (Cough), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Muscle ache), HEADACHE (headache) and NAUSEA (Nausea). On 22-Jul-2021, the patient experienced COVID-19 (Had a fairly mild breakthrough case of COVID). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency and ASCORBIC ACID (VITAMIN C ASC ACID) for Adverse event, at an unspecified dose and frequency. On 26-Jul-2021, COVID-19 (Had a fairly mild breakthrough case of COVID) had resolved. At the time of the report, ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), RHINORRHOEA (runny nose), NASAL CONGESTION (Nasal congestion), DIARRHOEA (Diarrhea), COUGH (Cough), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Muscle ache), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 13-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. On 22-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. On 26-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant product use was not provided.   Treatment information was not  provided.  Patient is being told  to get a booster right now and not wait the eight months by everyone.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received: Added Patient details, treatment medications, current condition, lab data, events and narrative was updated accordingly.
Bones were hurting him, described as everything was hurting, bone pain; Found to have no Vitamin D in his system; Left arm hurt like a bee sting; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bones were hurting him, described as everything was hurting, bone pain), VITAMIN D DEFICIENCY (Found to have no Vitamin D in his system), MYALGIA (Left arm hurt like a bee sting) and FATIGUE (Tiredness) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ZOLPIDEM TARTRATE (AMBIEN), OMEPRAZOLE and OXYCODONE HYDROCHLORIDE (OXYCONTIN) for an unknown indication.    On 01-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced FATIGUE (Tiredness). On an unknown date, the patient experienced BONE PAIN (Bones were hurting him, described as everything was hurting, bone pain), VITAMIN D DEFICIENCY (Found to have no Vitamin D in his system) and MYALGIA (Left arm hurt like a bee sting). At the time of the report, BONE PAIN (Bones were hurting him, described as everything was hurting, bone pain), VITAMIN D DEFICIENCY (Found to have no Vitamin D in his system), MYALGIA (Left arm hurt like a bee sting) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin D: no vitamin-d (Low) No Vitamin-D.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were reported.
fever of 101-102F; nauseated; felt very, very tired /would not get back her energy for 3 months; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101-102F), NAUSEA (nauseated) and FATIGUE (felt very, very tired /would not get back her energy for 3 months) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced PYREXIA (fever of 101-102F), NAUSEA (nauseated) and FATIGUE (felt very, very tired /would not get back her energy for 3 months). At the time of the report, PYREXIA (fever of 101-102F), NAUSEA (nauseated) and FATIGUE (felt very, very tired /would not get back her energy for 3 months) outcome was unknown.            no concomitant medication is reported no treatement of medication is reported   This case was linked to MOD-2021-371152 (Patient Link).   Reporter did not allow further contact
Information has been received from an unknown reporter referring to unknown number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, unknown number of patients were probably vaccinated with improperly stored doses of PROQUAD (lot# and expiration date not specified; dose, route, site of administration unknown) for prophylaxis. It was reported that PROQUAD lot # K025760 (expiration date 08-JUN-2016), L005297 (expiration date 17-AUG-2016), L030591 (expiration date 10-FEB-2017) and L040413 (expiration date 13-APR-2017) underwent a temperature excursion in 2015. In October, November and December of 2015, the minimal/maximal temperature of the freezer was -2/6, -2/6 and -2/6 (units not provided) respectively. The lot number L046506 (expiration date 17-MAY-2017), M002053 (expiration date 11-JUL-2017), M006102 (expiration date 01-AUG-2017) and M011664 (expiration date 08-SEP-2017) underwent a temperature excursion in 2016. In January to March, May, July to October, and December of 2016, the minimal/maximal temperature of the freezer was -2/10, -7/15, -7/ 9, -4/8, -15/19, -6/7, -5/12, -5/10 and -10/10 (units not provided) respectively. There was no PROQUAD lot number reported in 2017 temperature excursions. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA007740: US-009507513-1705USA007741: US-009507513-1705USA004287: Original Case : 1705USA004287: US-009507513-1706USA001288: US-009507513-1706USA001289: US-009507513-1706USA001287: US-009507513-1706USA001291: US-009507513-1706USA001292.
I was constantly going to the bathroom and having rectal bleeding. I called my doctor and they referred me to a GI specialist and had 2 colonoscopy and endoscopy and was diagnosed with Ulcerative Proctitis. I went back to my doctor, and they put me on Humira because I had inflammation and rectal bleeding. So, now I have been seeing a GI doctor, and seeing a Rheumatologist. I seem to be getting better now, but I was really concerned at first. I thought I was dying.
itching all over the body started about 7:15pm on 4/9/2021 and lasted until 4/11/2021 (took Benadryl and it helped ; Saturday 4/10 terrible lethargy (slept 20+ hours), Sunday 4/11 continued lethargy and new onset nausea and vomiting lasting until 4/12/2021 at 6:30pm
This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 74-year-old female patient who received SHINGRIX. On 26th February 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 12th March 2018, 14 days after receiving SHINGRIX, the patient experienced sunburn. In March 2018, the patient facial swelling, red face and facial pain. The patient was treated with Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the facial swelling, red face and sunburn were unknown and the outcome of the facial pain was unchanged. It was unknown if the reporter considered the facial swelling, red face, facial pain and sunburn to be related to SHINGRIX. Additional details were provided as follows: The patient via chat reported the adverse event. The patient requested the agent call her in relation to reactions to SHINGRIX. The patient stated no additional vaccines were provide at the time of the SHINGRIX vaccine or 4 weeks prior. For seventeen days the patient was fine. The patient received SHINGRIX 17 days later her left side of face swelled, and redness, and slight pain (around 3/4 out of 10). The physician treated her with anti-biotic. The patient did not tell physician about shot (did not occur to her). The physician now wanted to do CT scan of left side of face. The patient stated she will contact physician. The patient had the swelling, redness, pain before she had an anti-biotic. The patient get some sunburn around 12th March 2018. The patient was asking whether the sun affect the shot. The agent informed patient to contact health care professional. The patient had denied permission to contact their physician. Due to call flow, no additional information was available.
Information has been received from a woman from a physician's office concerning a pt who on 5/31/00 was vaccinated with pneumococcal vaccine 23 polyvalent (lot 629883/0042J). Subsequently, the pt experienced redness, swell and pain at the injection site. Another pt was reported with an adverse event following receipt of the same vaccine (WAES 00060352). The pt was lost to follow-up. No further information is expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (arm is inflame, developed redness and an increment on local temperature), RASH (arm developed a rash between the shoulder and the elbow, kind of cellulitis), CHILLS (chills) and FATIGUE (tired) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021 at 7:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). 05-Feb-2021, the patient experienced CHILLS (chills) and FATIGUE (tired). On 06-Feb-2021, the patient experienced ERYTHEMA (arm is inflame, developed redness and an increment on local temperature) and RASH (arm developed a rash between the shoulder and the elbow, kind of cellulitis). At the time of the report, PAIN IN EXTREMITY (sore arm), ERYTHEMA (arm is inflame, developed redness and an increment on local temperature), RASH (arm developed a rash between the shoulder and the elbow, kind of cellulitis), CHILLS (chills) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. For treatment patient reported applying cold compresses as palliative care.   This case was linked to MOD-2021-024720 (Patient Link).
Day of Vaccine- Pain at vaccine point.  Day after vaccine-  overall nausea feeling but, it went away the next day.   Sunday - Itchy all over, Rash on arms and legs and still soreness at shot point.   went away with Benadryl.   Monday- Rash went away but, horrible burning itchy on neck and head.  Tuesday- Still very itchy all over,  at night burning itchy first on hands, then feet, then knees.  Took Benadryl and went away.   I am okay but, I wanted to report this incase anyone else has the same side effects.
Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates in 2016 (reported as starting on or after 06-JUL-2016), the patients were vaccinated with doses of improperly stored PROQUAD (lot# reported as L013600 with expiration date 18-FEB-2017; lot# M006104 with expiration date 01-AUG-2017, dose and route were not reported). The vaccines had been stored under the temperature of 9 Fahrenheit degree for 9 hours. There was no previous temperature excursion. Digital data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sars-COV-2 positive following receipt of first dose; Sars-COV-2 positive following receipt of first dose; This is a spontaneous report from a contactable consumer (Patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported Sars-COV-2 positive following receipt of first dose. Patient has administered a second dose a couple of hours ago before reporting this event. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Immediate onset pruritus following dose of vaccine on left arm where she was vaccinated and also on her back.  No hives, wheezing or difficulty breathing noted.  Vital signs were stable.  Breath sounds were clear.  Recipient was awake, alert and conversing with observation team leader (physician). Was in observation for about 40 minutes. Declined to remain in area for further observation and asked to be released.  Released at 0925 without distress.
Chills / could not stop shivering; muscle aches; soreness; This case was reported by a consumer via other manufacturer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a day after receiving Shingrix, the patient experienced chills, muscle pain and pain. On an unknown date, the outcome of the chills, muscle pain and pain were unknown.   It was unknown if the reporter considered the chills, muscle pain and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  During the night patient experienced chills and could not stop shivering. The patient also had muscle aches and soreness.  The patient knew these events were possible after receiving the vaccine, but the reporter reporting it according to policy.  The reporter did not gave permission to follow up.