chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on SEP-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blood clots, and smells like diesel. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and smells like diesel was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220322002-COVID-19 VACCINE AD26.COV2.S- Blood clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Fever; Neck pain; This is a spontaneous report from contactable other-HCP via Pfizer Sales Representative.  A male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever and neck pain on an unspecified date with outcome of unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Widespread bumpy rash all over her body; Arm and legs were weak; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MUSCULAR WEAKNESS (Arm and legs were weak) and RASH PAPULAR (Widespread bumpy rash all over her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DILTIAZEM, GUAIFENESIN (MUCINEX), OMEPRAZOLE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), SUCRALFATE (CARAFATE), DOCUSATE SODIUM (COLACE), MONTELUKAST SODIUM (SINGULAIR), IPRATROPIUM BROMIDE (ATROVENT), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), CALCIUM CARBONATE (GAVISCON ACID BREAKTHROUGH FORMULA), CYCLOBENZAPRINE, CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 09-Jun-2021, the patient experienced MUSCULAR WEAKNESS (Arm and legs were weak). On 16-Jun-2021, the patient experienced RASH PAPULAR (Widespread bumpy rash all over her body). At the time of the report, PAIN IN EXTREMITY (Sore arm), MUSCULAR WEAKNESS (Arm and legs were weak) and RASH PAPULAR (Widespread bumpy rash all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Injection site erythema and induration approx. 4" x 4" swelling of eyes, lips, nasal congestion, indurated area on back of head with erythema approx. 1" x 1" small red areas on forehead and (R) hand and forearm. Itching all over.
On the day after vaccines - child complained of pain in left leg where MMR was given.  Mom noted 4 1/2" x 3 1/2" area on upper thigh that was red, warm to touch and swollen.  Child complained of itching at site; Mom reports child also complained of pain, he was fretful, irritable, and crying.  Advised to see PMD.  Mom to take child to doctor.
Pain, itching, redness, swelling, rash within 48 hours after injection. Prescribed Keflex 500mg for "cellulitis"
Shingles diagnosis due to Pfzier shot lowering immune system; Shingles diagnosis due to Pfzier shot lowering immune system; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 11:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received acetylsalicylic acid (ASPIRIN) on an unknown date, for unknown indication and experienced upset stomach. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. On 31Mar2021, at 17:00 the patient experienced shingles diagnosis due to Pfizer shot and lowering immune system. The event resulted in emergency room/department or urgent care visit. Therapeutic measures were taken as a result of lowering immune system and included treatment with injection and prescribed prescription. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles diagnosis due to Pfizer shot lowering immune system was recovering at the time of this report.  No follow-up attempts are required; information about lot number cannot be obtained.
Shortly after receiving vaccine, experienced scratchy throat, difficulty swallowing and tingling of lips. EpiPen administered x 1 without improvement of symptoms. 911 called transferred to hospital by ambulance.
1. Persistant rash and itchiness at the sight of the injection. Swelling and rash was noticed the afternoon after getting the shot. The itchiness started six days after receiving the shot. It's not horrible or unbearable. 2. Persistant fatigue and sporatic dizziness. This has been the worst side effect. I've felt drained every day and still feel the same, even after getting some sleep. The dizziness is like experiencing tunnel vision without actually seeing tunnel vision. It comes on suddenly and goes away after a few moments. This has not abated; I am still going through this today. 3. Nausea for the first couple of days. This was mild. But there has been a reduction in appetite for the past week.
Information has been received from a pharmacist concerning a 72 year old male who on 28-DEC-2010 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # 669192/1457Z exp 29-JAN-2012). On 28-DEC-2010, soon after receiving the ZOSTAVAX (Merck), the patient experienced hypersensitivity in lower back nerves, which was describes by the patient on "like the nerves were on the skin surface". The patient said it was no pain or burning. He had itchiness, but no redness or rash. The patient did not seek medical attention, but wanted to make the pharmacist aware of the situation. No treatment was given for the event and no lab diagnostics studies were performed. At the time of the report, the status of the patient was not reported. Additional information has been requested.
SHOULDER JOINT SORENESS AND TIGHTNESS IN EXCESS OF WHAT THE PATIENT THOUGHT HE SHOULD HAVE PATIENT VISITED FAMILY DOCTOR
Chills, sweating, mild fever (100F), joint aches starting the night of the injection through 7pm the following day. Starting on Saturday (2 days after the injection, I developed a rash on my belly and had diarrhea. Sunday, developed an itchy rash on the tops of my feet and hands, in addition to the belly. Another bout of diarrhea.
**case was admitted to ICU 12/03/2022, tested positive for COVID-19 12/04/2022, died 12/06/2022.** Was not able to interview case or POA.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  It was reported that Date of refrigeration was 07-May-2021.
Vaccinated but recently contracted COVID; Vaccinated but recently contracted COVID; High fever of 103°F; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Vaccinated but recently contracted COVID"; PYREXIA (non-serious), outcome "unknown", described as "High fever of 103°F". Reporter's friend who was vaccinated but recently contracted COVID with a really high fever of 103 degree F. The patient underwent the following laboratory tests and procedures: body temperature: 103 Fahrenheit, notes: High; fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and covid19 cannot be totally excluded
Pt received two Fluzone HD doses instead of just one.  Pt was aware, ok and showed no symptoms
Pfizer-BioNTech COVID-19 Vaccine EUA Extremely sore arm Ipsilateral neck stifness/soreness for greater than 72 hours Headache for 72 hours
Patient states she felt dizzy and lightheaded then stumbled: Mom reports child was unconscious less than one minute: Pt hit her head against a car door when she stumbled.
Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2021 at 11:15 as dose 1, single (Lot number: EL9263), in right arm, on 14Feb2021 at 09:15 as dose 2, single (Lot number: EN6201), in right arm, on 18Aug2021 at 00:45 as dose 3 (booster), single (Lot number: PC3181), in right arm and on 26Feb2022 at 11:45 as dose 4 (booster), single (Lot number: FJ6369) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no other medication in 2weeks and no known allergies. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022 at 16:00, outcome "recovering" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive with a rapid antigen test on 25Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).  Additional information: I started having Covid symptoms on 24Jul; tested positive with a rapid antigen test on 25Jul, started Paxlovid on 25Jul2022.
Pt received vaccines on the morning of 8/10/22. Pt developed itchy hives on the evening of 8/11/22 and was advised to give a dose of benadryl. Hives resolved the morning of 8/12/22. The afternoon of 8/12/22 mom again called stating itchy hives were back and worse. NO labored breathing, wheezing, swelling to face/lips/tongue, difficulty breathing/swallowing. ONLY sxs was itchy hives. Mom was advised to give children's Zyrtec or Claritin daily, Benadryl as needed, cool compresses/baths, avoid heat, apply cool hydrocortisone and call back for new/worsening sxs.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 12-JAN-2015 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
103.5 for 4 hours. Then 104 for 8 hrs. Shortness of breathe & rash on neck.  Husband had to submerse into ice cold tub to break fever. Tylenol did NOT work. Only happened with Booster
Pt called on 6/29/21. Pt received 1st dose Pfizer vaccine on 6/28/21 at Clinic and noticed her left side of the face is swollen/feels numb but both sides of the face are symmetrical. Pt denied difficulty breathing/wheezing. Pt also complains of sore throat and headache. Advised pt to go to nearest ED immediately and pt states she will go to get evaluated.
His grandfather tested positive in early March/received first dose of the vaccine and immediately after, tested positive for covid; His grandfather tested positive in early March/received first dose of the vaccine and immediately after, tested positive for covid; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer (patient's Grandson) reported that a 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient's family medical history included his mom tested positive for Covid-19 and eventually passed it on. The patient's concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced, tested positive in early March/received first dose of the vaccine and immediately after, tested positive for COVID. Caller states a week after that, they decided for him to get a monoclonal antibody infusion. Agent states he read something about a ninety-day interval for patients who received antibody infusion before receiving the second dose, and since ninety days has passed, he wants to know if his grandfather can get the second dose, or if the antibodies are enough. Agent states he also wants to know was he still needs the second dose and will it be effective since so much time has passed or if he needs to start the whole vaccination periods all over again. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of events was unknown.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. The patient was vaccinated with first dose (intramuscularly, Lot# unspecified) and second dose (Lot#, dose/frequency, route unspecified) of VAQTA on 02-APR-2012 and 07-Sep-2012 respectively. No known adverse effects. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Received Pfizer bivalent 10/23/22 10 am( this is my 5 th shot) 430 am 10/24/22- woke up with severe vertigo and nausea, helped by meclizine eventually it improved over a period of 10 days. Mainly positional vertigo, when I was laying down and turning my head
Patches of bumps - on right bottom side - cheeks on face - also on arms and shoulder.
Woke up the morning of 3/14/21 and noticed a large reddened circular area on the left arm about 2 inches below where the vaccine was given in the Deltoid muscle.  Area was warm to the touch but no itching.  Area was quite large in circumference (approximately 3 inches long by 3 inches wide).  Have heard this reported in the media as "Covid arm".   Area is less red as of 3/17/21 but is still noticeable.
Brief headache when standing up from bent over position (like when I am touching my toes, then stand up).  The headache is a burning feeling that lasts a few seconds and radiates from the left-top of my head, down to the lower-left are of my head. It lasts for  a few seconds.    Pain in left ankle, left wrist, left neck muscle.  All these pains are on the left side, which is the same side where I got the shot (left arm).  I never had these pains on previous shots.  Also, previous shots didn't make me feel bad, but this bivalent shot
started with slight pain in left cheek and then had swelling with no pain. started approximately 3 hours after injection.
Chills and light fever occurred 9:00 am on 1/6/2022.
Fever, t102-101, more irritable, dec in appetite; tx APAP; On 23MAY91 rt eye swollen, red dots all over; Seen in ER; dx hives given DPH; rash gone in 2 days;
sore left injection site arm; fever; fatigue; joint pain; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left injection site arm), PYREXIA (fever), FATIGUE (fatigue), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (Swollen lymph nodes) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced PAIN IN EXTREMITY (sore left injection site arm), PYREXIA (fever), FATIGUE (fatigue), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (Swollen lymph nodes). On 04-Sep-2021, PAIN IN EXTREMITY (sore left injection site arm), PYREXIA (fever), FATIGUE (fatigue), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (Swollen lymph nodes) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included Birth Control. No treatment information provided.   This case was linked to MOD-2021-343341 (Patient Link).
Pt experienced flashing lights in the right eye as well as a shadow in her vision in the right eye for 3 hours starting 5/10/21 am. In addition she had mild eye pain.   She was seen in the ER and dx with ocular migraine and told to f/u with our Ophthalmology practice.  We saw pt on 5/11/21 and vision was 20/20.  She was diagnosed with a mild Central retinal vein occlusion in the right eye. On exam pt had hyperemia of the right optic nerve and a few small intraretinal hemorrhages in the periphery.  She also had engorged and dilated retinal vessels.
I have been having pain in the shoulder of my right arm which has not gone away. It limits my ability to lift. Heavier objects, raise my hand above my head in a natural motion, stretch or reach across my chest, exercise and work as a dental professional. It also hurts whenever I lay on my right side. I had soreness  from the shot which never fully dissipated. About 2 months after is when I realized that it was just not getting any better.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 9:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:51 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's age was reported as 62.91 years.  No concomitant medications were reported.  Batch number 031A21A administered on 20-Mar-2021 underwent temperature excursion with temperature of 34 degrees Fahrenheit at 09:00 am and 37 degrees Fahrenheit at 10: am. This vial was moved to fridge on 09-Mar-2021. Product moved to clinic on 20-Mar-2021. Beyond use date for the vial was reported as 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Fever, diarrhea, body nausea, aches, headache, tired.  2-3 days
Noticed swelling when changing diaper after patient woke up in the morning. Swelling was worst after 2 days where the entire upper leg was swollen and discolored. It began going away on the fourth day after the shot. This was her third DTaP shot since she was born.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapy and medical history provided. On 13-JAN-2017, the patient was vaccinated with an expired dose of VAQTA injection, lot # L048222, expiration date: 19-DEC-2016 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Additional information has been requested.
Loss of balance, severe muscle pain all over my body, sever nausea, massive headaches, exhaustion, trouble staying awake, nightmares, sweats, chills, abdominal pain, excessive thirst.  As of this writing going on for more than 24 hours.
After first dose while sitting in observation chair turned pale and diaphoretic. Loss of conscious, woke immediately. Vitals stable and left on own.