chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Dizziness; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6201) intramuscular, administered in left arm on 21Feb2021 09:00 (at the age of 73-year-old) as dose2, single for COVID-19 immunization. Medical history included stroke since 2012. The patient's concomitant medications were not reported. The patient received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection, Lot: EL9263, Expiry: unknown) intramuscular, administered in left arm on 29Jan2021 (at the age of 73-year-old) for COVID 19 Immunization. The patient did not had any additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Feb2021, the patient experienced dizziness and diarrhoea. The patient experienced some dizziness last night that he reports was much better on the day of report. The patient reported that he had the shot yesterday morning (21Feb2021) and by last night around 10 or 11pm, he experienced dizziness. The dizziness lasted through the night sometime and by this morning it has subsided quite a bit. He felt some slight dizziness but nothing like it was last night. The patient also had a small occurrence of diarrhea during the day yesterday, probably around 10 am (an hour after receiving the shot). Vaccination Facility Type was reported as Clinic. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient confirmed that it was just one occurrence of diarrhea. The adverse events did not require a visit to emergency room and physician office. The clinical outcome of dizziness was resolving and diarrhoea was resolved on 21Feb2021.  No follow-up attempts are possible. No further information is expected.
nauseous; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (nauseous) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nauseous). At the time of the report, NAUSEA (nauseous) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-162182, MOD-2021-162197 (Patient Link).
Patient reported fever for 3 days, arm very sore (sensitive to air blowing over area) and hard lump at site of injection. After 7 days an approximately 2.5 inch circular area is still red and there is a painful lump at injection site.
Left arm soreness, myalagias and low grade temp 100.5 the morning after the dose.; Left arm soreness, myalagias and low grade temp 100.5 the morning after the dose.; Left arm soreness, myalagias and low grade temp 100.5 the morning after the dose.; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received the first single dose of BNT162B2 (Lot number: EH9899, exp date not reported), intramuscular (Anatomical Location: Arm Left) on 21Dec2020 13:45 for immunization. The COVID-19 vaccine was administered at the hospital.  The patient was diagnosed with COVID-19 prior to vaccination. The patient had no known drug allergies (NKDA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient experienced left arm soreness, myalagias and low grade temp 100.5 the morning after the doses (22Dec2020, 04:30 AM). Treatment received for the adverse events included paracetamol (TYLENOL) and naproxen (ALLEVE). The event was considered as non-serious by the reporter. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
Left upper extremity has cellulitis. Symptoms started same day as shot. Next day got Rocephin 1 gm IM and Keflex.
On March 19th, 2022 I had headache, sore throat, sinus pressure and congestion, fatigue. I didn't get the infusion since I wasn't a candidate. It went into my lungs and developed an unproductive cough. Mucinex and vitamin c and d. This lasted 16 days before I tested negative. I went on a higher dose of advair for my asthma and albuterol. I was put on steroids for ten days. It finally got better on April 28th, 2022. The fatigue is still here.
This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a adolescent female patient who received BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown, less than a week after receiving BEXSERO, the patient experienced injection site swelling, vomting and nausea. On an unknown date, the outcome of the injection site swelling, vomiting and nausea were unknown. It was unknown if the reporter considered the injection site swelling, vomiting and nausea to be related to BEXSERO. Additional details were provided as follows: The age at the time of vaccination was not reported. The physician reported that one of the her teenage patient had all of the possible side effects of BEXSERO after receiving a second dose and then specifically commented that the patient had swelling at the injection site, nausea and vomiting within 2 days of vaccination. No further related information was provided by the physician excepting that the field representative said that she had asked the doctor if the patient had had any anaphylactic reactions to the second dose of BEXSERO. The physician had responded that the patient had not had any anaphylactic reactions to the BEXSERO dose. It was unknown if the health care professional gave permission for being contacted. The doctor told that she didn't want to report, and then the field representative told the physician that she would be reporting to GSK. The health care professional said that, she did not know at which practice site of the doctor the patient was administered the BEXSERO.
Fever of 102, headache, body aches, chills, fatigue, and weakness that lasted for 24 hours and then headache and weakness that continued for an additional 24 hours.
I was still having arm pain and my left hand clenched and then me left leg went out to the left."; arm became sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (I was still having arm pain and my left hand clenched and then me left leg went out to the left.") in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included VITAMIN D3 and VALACYCLOVIR [VALACICLOVIR] for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm became sore). On 03-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (I was still having arm pain and my left hand clenched and then me left leg went out to the left.") (seriousness criteria hospitalization and medically significant). On 09-Apr-2021, MUSCULOSKELETAL STIFFNESS (I was still having arm pain and my left hand clenched and then me left leg went out to the left.") and PAIN IN EXTREMITY (arm became sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: not provided Results were not mentioned.. On an unknown date, Chest X-ray: not provided Results were not mentioned.. On an unknown date, SARS-CoV-2 test: not provided Results were not mentioned..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient wiped the injection site with alcohol took 2 Tylenol and used a heating pad and ice, with no relief. The patient was given IV and hydromorphone was given for pain management. The patient also mentioned that she was otherwise a healthy person, who exercised well, did not eat meat or drink soda. The patient was scheduled for the 2nd dose of Moderna Covid-19 Vaccine on 26-Apr-2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional by phone. This case involves a female patient (age not reported) who exposed to vaccine ADACEL, while pregnancy on an unknown date. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient that is five weeks pregnant receive a ADACEL. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history included cut and the patient received ADACEL vaccine for tetanus protection. On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date, dose in series, route and site of administration were not reported) for tetanus protection. It was a case of vaccine exposure during pregnancy. At time of reporting, the outcome of the pregnancy was unknown. Documents held by the sender: none.
I experienced mild redness and discoloration around the vaccination site with a really severe headache that brought me to tears in addition, heavy fatigue where I slept twelve hours straight.
Flu vaccine site bled soon after needle was removed from arm after administration.  Bruise was almost immediately observed.  No tenderness to the site. By the next morning, she noticed site of BCG vaccine, inferior to the flu vaccine site was red and indurated and tender and warm.  No fever.
After nurse left room after giving injection child fell forward off the exam table and hit her head on the floor. ? LOC as pt did not try to catch self - bleeding from (R) naris and mouth - small superficial laceration on inner aspect of upper and lower lips. Answered questions appropriately - Pt lying flat x 10 min then sitting x 10 min then DC'd home.
Labored breathing, unable to get a deep breath, and the feeling of heavy weight on my chest.
Pt. states 04/28/2021 horrible headache, vision problems, muscle/joint pain, pain induced vomiting, rash throughout body. Still currently has signs of rash. Brain swelling, 05/02/2021 ER visit. 05/04/2021 Primary visit Ct scans, MRI, blood-work ran. Elevated white-blood count, nuero symptoms similar to ALS. Swelling around abdominal mid-section/ribs area, neuropathy in the legs and feet. Prescribed steroids for swelling 3x. Tramadol prescribed.
This spontaneous case, initially received on 05-Oct-2016, was reported by a health professional and concerns a patient of unknown age and gender. Weight: not provided; Height: not provided. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient experienced seizures that lasted for an unspecified amount of time (medically significant, outcome: not reported).
This spontaneous report as received from a registered nurse refers to herself, her age was not reported. On an unknown date, the patient was preparing LIQUID PEDVAXHIB. On an unknown date, the registered nurse experienced while withdrawing a dose out of PEDVAX HIB vial, she noticed excessive pressure as needle entered the rubber stop and content sprayed out all over and some of it got onto nurse's hand and no adverse effect. A PQC has been reported. The outcome of she was withdrawing a dose out of PEDVAX HIB vial, she noticed excessive pressure as needle entered the rubber stop and content sprayed out all over and some of it got onto nurse's hand and no adverse effect is unknown. The reporter considered that she was withdrawing a dose out of PEDVAX HIB vial, she noticed excessive pressure as needle entered the rubber stop and content sprayed out all over and some of it got onto nurse's hand and no adverse effect to be not related to LIQUID PEDVAXHIB. Additional information has been requested.
Headache, Chills, Body aches, Fever staying at or around 100.3 with ibuprofen. Still having issues on 3/18/2021.  It is starting to ease up just a bit today.
Rash all over the body after eating peanut butter; Rash all over the body after eating peanut butter; Tingling cold in the body; Myalgia; This case was reported by a pharmacist via call center representative and described the occurrence of tingling sensation in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number FE272, expiry date 18th February 2022) for prophylaxis.   On 2nd December 2019, the patient received the 1st dose of Shingrix. On 4th December 2019, 2 days after receiving Shingrix, the patient experienced tingling sensation and myalgia. On an unknown date, the patient experienced rash and food allergy. On an unknown date, the outcome of the tingling sensation, myalgia, rash and food allergy were unknown.   It was unknown if the reporter considered the tingling sensation, myalgia, rash and food allergy to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient developed myalgia and felt tingling cold over the body. The patient developed rash all over the body after eating peanut butter, something that had never happened before receiving vaccine. The reporter was not sure if the expiration date of the vaccine was 18 February 2020 or 18 February 2022. The batch number was updated from  FE277 to FE272 as per sales data sheet. The reporter consented to follow up.
The patient complained of limited ROM and soreness at the site of injection. Treatment consisted of a Medrol steroid pack and cyclobenzaprine. Physician outlook was for the soreness to dissipate within the next 4-6 weeks.
Patient said that when she first received her dose 1, she had a slight tingling in her tongue. She said that is was not anaphylactic, she said she is allergic to bee's and it was nothing like that. She received her second dose today 5-13-21 and had no issues.
22Mar2021: Significant arm pain not just soreness that lasted through the night. I took 600 mg ibuprofen and 50 mg tramadol and applied icy hot with lidocaine. These treatments did not help much. 23Mar2021: arm pain continued. I also developed extreme lethargy and a low grade fever of 99.8 (my normal temp is 97.6) I took more ibuprofen, tramadol at around 2 pm. By 8:00 pm the arm pain finally turned to mild soreness, fever, and lethargy was gone. Only mild soreness remains.
I had a very small, left sided C5 dermatome breakout of a rash that appeared to be herpes zoster (shingles).  I?ve never had a rash like this before.  It?s now been 2+ weeks and is fading, leaving me with mild burning and itching in same area.   I went ahead and had 2cd dose on 1/7/21.    FYI:    I?m an Emergency Physician myself.
body aches; felt dehydrated; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), DEHYDRATION (felt dehydrated) and ARTHRALGIA (joint aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (body aches), DEHYDRATION (felt dehydrated) and ARTHRALGIA (joint aches). At the time of the report, MYALGIA (body aches), DEHYDRATION (felt dehydrated) and ARTHRALGIA (joint aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-084414 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing); "Known allergies : Penicillin" (unspecified if ongoing), notes: Known allergies : Pencillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive test after recovery; Negative, notes: two negative tests; Negative, notes: two negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Clinical course: Patient received Paxlovid treatment for Covid-19 from 14Aug2022 to 18Aug2022. The patient did not receive other medications in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt exp erythema starting @ rt arm; minimal swelling, erythema; rash & swelling resolvings
This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Administered 1ml instead of 0.5ml) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 01-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Administered 1ml instead of 0.5ml). On 01-Mar-2021, ACCIDENTAL OVERDOSE (Administered 1ml instead of 0.5ml) had resolved.        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.   Concomitant medication and treatment information were not reported.   This case was linked to MOD-2021-033777, US-MODERNATX, INC.-MOD-2021-033777 (E2B Linked Report).; Sender's Comments:  MOD-2021-033777:Crosslinked case US-MODERNATX, INC.-MOD-2021-033777:Crosslink case
Pt recvd a series of 3 Engerix-B on 9NOV90, 17DEC90 & 6MAY91 & was a poss non-responder;
Patient received TIV 11/19/03, 10/13/04 and 11/2/05. Patient received LAIV 10/30/06 and 11/1/07. Patient states that he "gets sick" with headache, rhinorrhea, fever, chills, fatigue, diaphoresis, N, V within 24 hours after receipt of the Live, attenuated Influenza vaccine (LAIV) and within 48-72 hours after the Trivalent Influenza Inactivated Influenza Vaccine (TIV). Patient states that he is sick for 48-72 hours requiring SIQ in 2004 and 2005 (documentation is not available). He typically is able to return to work after that timeframe with about 70% improvement of his symptoms. In 2006 and 2007 the patient was at sea so he did not have time off from work while he was symptomatic. Except in 2003 when he received the Influenza vaccination during boot camp there were no coworkers or family members that were also sick with similar symptoms. PMH: The patient states that he has had no adverse reactions to other vaccinations. Patient states that he was not ill at the time of the Influenza vaccinations.
I noticed around March, I kept experiencing body aches & severe fatigue. Almost like I was coming down with the flu. It seemed like it would come on in the evening. I would go to bed & wake up the next morning feeling fine. I didn't report it until now because I didn't think it could be related to a vaccine. I still am unsure if it is related to the vaccine, it might be something else. But I know with certainty, I didn't have these symptoms until 2021. I went to the doctor & they ran blood work but couldn't determine anything. It comes and goes so it is hard to pinpoint what may be causing it? My doctor thought stress.
Information has been received from an office manager, referring to a 2 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-JAN-2018 at a private doctor's office/hospital, the patient was vaccinated with an improperly stored dose of VAQTA lot # N019924, expiration date on 02-SEP-2018, dose 1, intramuscularly (anatomical location was not reported) for prophylaxis. No adverse events were reported. It was reported that the vaccine was purchased with private funds. The vaccine a temperature excursion of 47 Fahrenheit (F) to 77 F, during 35 minutes. It was confirmed that no previous temperature excursions occurred and a digital data logger was involved.
Within 12 hours developed pain, redness and induration at site, Within 24 hours, increased pain, 8 cm diameter induration, increasing cellulitis, spread over posterior upper arm, to elbow and forearm, fever/chills, Temp 101 F, nausea. Treatment: Ibuprofen 400m g tid
This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a female patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th September 2018, 31 days after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that one of the viruses thought to bring on Bell's was the Herpes Zoster Virus. She was just wondering if this could be a side effect of the vaccine. She had done some research on Bells and the vaccine and had not found anything conclusive either way. She was inquiring about any information that could clarify this issue.