chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was tested for Covid post vaccination/ Covid test on 28Dec2020 and resulted positive; Patient was tested for Covid post vaccination/ Covid test on 28Dec2020 and resulted positive; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK7530) solution for injection, intramuscular on left arm on 16Dec2020 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. It was reported that patient was tested for Covid post vaccination. Nasal swab for Covid test was done on 28Dec2020 and resulted positive. Outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Case previously recorded as MA2009-4055. Initial case report received from a physician via MedCom, on 11 NOV 2009. A 3-year-old male patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 10127601) i.m. on 11 NOV 2009. No adverse effect was reported. MedCom reference no.: NA09-008017.
PATIENT HAS SOME REDNESS ON THE ARM, SLIGHT RAISED AREA AT THE INJECTION SITE & COMPLAINS OF ITCHINESS.
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 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown since unable to locate or read the details) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment).   No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.
He got his vaccination, his arm started swelling up and got hot.  Then he started getting nauseated and he called over to where he got the vaccine, and they told him that it would be alright.  He kept getting worse and he was tired.  He was working on a project at home, and complained of a terrible headache.  His mother kept asking him if he needed anything to eat or drink and he said no.    He had been throwing up apparently, but did not know when  possibly in the middle of the night.  This continued for the several days, and he told her to leave him alone.     Four days later his mother went to check on him, knocked on his door, there was no answer, and her son and daughter broke the door down and he was dead on the floor.
Approximately 7 minutes after the patient received the Pfizer COVID-19 vaccine, she reported feeling very hot, was sweating, had visual disturbances (tunnel vision), and ringing in her ears. She was seated at the time, was conscious, and aware of her surroundings. She was provided cold water and a towel, and was given and agreed to take 10mL of diphenhydramine based on a possible injection arm reaction. After about 5 minutes of me talking with her, the sweating resolved and her body temperature returned to normal, including the color in her arm. I kept her for observation for an additional 15-20 minutes and confirmed she was ok upon leaving the pharmacy.
interchange of vaccine products; Revaccination with different covid-19 vaccine; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    Concurrent medical conditions included Drug allergy. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) from December 2017 to 12-Jun-2022, BUPROPION from December 2017 to 12-Jun-2022, TADALAFIL from October 2021 to 09-Jun-2022 and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from December 2017 to 12-Jun-2022 for an unknown indication.   On 13-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 23-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No treatment medication were provided.   This case was linked to MOD-2022-595341 (Patient Link).
Exacerbated Lupus flare-up  to include severe muscle ache, joint stiffness, fatigue, headache for approximately 24 hours. Experienced heart palpations a couple of different occasions while at rest (sitting) in the 3-4 days following.
Chills, Fever,  Pulmonary Infiltrate , elevated D Dimer and ESR ONE WEEK LATER- Hypotension Aflutter N and vomiting  Weakness
This report describes an exacerbation of multiple sclerosis in a female of unspecified age who received Hep B vaccine recombinant (Engerix-B). This report was received from a lawyer and has not been verified by a MD or other healthcare professional. The medical history included multiple sclerosis. Concurrent conditions and concurrent medications were not specified. On an unspecified date, the vaccinee received an injection of Engerix-B; it was not known if she had received previous injections of Engerix-B. It was reported that, "shortly after" immunization, the vaccinee experienced an exacerbation of multiple sclerosis. Treatment and outcome were not provided. Exacerbation of multiple sclerosis is considered GSK medically serious.
Patient had severe tenderness, swelling, hand 'shingle' looking hives come out on her body the same day as the injection.
Pseudotumor cerebri Log  Feb 16,2022  s/s: neck pain 6/10, left shoulder, left arm pain 6/10, numbness/tingle to fingertips 2,3,4. TX: Bio freeze to neck, ibuprofen 2 tabs, appoint scheduled with Dr. Feb 23, 2022 Dr. - X-ray C-spine C-5 stenosis.  Ordered Physical Therapy  March 5, 2022 PT @11:30 March 10,2022 PT@12:30 March 17,2022 ***PT@8:30-first time with mechanical machine traction on cervical neck Massage ***March 18,2022***ER visit @0430 woke up with left facial tingle and numbness in addition to left sided numbness Worked for 11 hoursincreased blurred vision, headache, left sided increased numbness, severe neck pain and shoulder pain, tinnitus. ER  March 24, 2022- Lumbar Puncture opening pressures 24cm /H2O 30cc removed 11cm/H2O.  All symptoms subsided. Medications:  Diamox 750mg BID PO Foricet PRN ***March 30-31,2022***ER visit CT negative EKG 49 VBGH-Lumbar Puncture opening pressures 19 cm/H2O 30 cc removed 6 cm/H2O April 5,2022 PCP appointment- Sleep study appointment, cardiology appointment April 6, 2022 Mammogram- negative April 14, 2022 Dr.- Changed Diamox to Topamax d/t side effects of Diamox  April 15,2022 Cortisol 10.2 April 22,2022 Dr.- Order rotational CT scan for possible Craniocervical instability and EMG May 2, 2022 Cervical Spinal flex/ext:  moderate C5/6 degenerative disc disease. Slight subluxation at some levels during flex/ext, without sign instability. Ext: slight retrolisthesis at c3/4 (2mm) C4/5 (1.5 mm) and C5/6 (1.5 mm) May 3, 2022 Dr.- pulmonologist/sleep study  May 13, 2022 MRI-mild straightening of cervical lordotic curature. No large disc herniation, cord compression or cord signal adnormality. C5-6 degeneratie disc disease w/mild diffuse disc bulging. C6-7 mild central disc bulge No significant facet arthropathy, foraminal stenosis or nerve root compression. May 25, 2022 Nuclear stress test:  Normal study, low risk, LVEF 69% May 26, 2022 Woke up this morning feeling almost normal, slight headache to left but energy uplifted.  HR check 65 compared to 45 as before.  Only difference was the cardiolite medication given yesterday for the nuclear stress test to raise my HR. LABS: TSH, T4, T3, Mag Stopped Topamax. Only on Diamox June 1, 2022 DR. (cardiac)- Echo rescheduled due to wearing Zio Holter monitor for 14 days. (SR 43-168 HR with x1 episode SVT) June 7, 2022 DR. (Neurosurgeon)- Improved symptoms so no shunt at this time. June  DR.-reorder Diamox medication. Annual training waiver June 29, 2022 Covid symptoms July 3, 2022 Tested positive for covid July 12, 2022 Future fitting
Bell's Palsy; This serious case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's Palsy) (serious criteria GSK medically significant).  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.     It was unknown if the company considered the bell's palsy to be related to Shingrix.   Additional Information: GSK receipt date: 28-Aug-2023 The Field representative called in to report that a healthcare professional reported that a patient suffered from Bell's Palsy after receiving a dose of Shingrix.  They provided limited information and gave the e-mail of the aforementioned healthcare professional. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date, multiple unspecified patients were administered with improperly stored doses of ZOSTAVAX (lot # L032402, expiry date 26-NOV-2016 and lot # L031273, expiry date 19-NOV-2016) dose, route unknown. Concomitant medications were not reported. During the storage the vaccine was exposed to temperature of 70 degrees F for a time frame of 60 hours and later the storage temperature was back in range. It was reported there was previous temperature excursion where the same vaccine was exposed to -11.9 degrees C for 44 hours on 14-DEC-2015. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
vitals: 15:27 patient complained of dizziness, slight head ache, sweaty, light headed. Dr was made aware, checked BP. 162/114, HR 108, 02 99%. Advised patient lay down and 15:35 bp went down to 156/103, HR 79, 02 100%. at 15:40 while laying BP 144/87, HR 70, O2 100%. 15:45 laying BP 123/75, HR 77, O2 100%. 15:50 while sitting BP is 134/82, HR 82, O2 98%. at 16:00 BP is 129/84, HR78, O2 99%. Patient stated dizziness was gone.   Dr charted: dizzy and lightheaded after 1st shot, bp elevated over baseline. Monitored and transfered to stretcher. BP improved and symptoms resolved with rest. No itching, rash, shortness of breath or chest pain. Patient was able to walk around asymptomatic prior release.
Weak; shoulder and arm pain/pain behind ear and back of neck; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), PAIN (shoulder and arm pain/pain behind ear and back of neck) and FATIGUE (Very tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weak), PAIN (shoulder and arm pain/pain behind ear and back of neck) and FATIGUE (Very tired). The patient was treated with NAPROXEN for Pain, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weak) and FATIGUE (Very tired) outcome was unknown and PAIN (shoulder and arm pain/pain behind ear and back of neck) had resolved.            Symptom text:
Pt recvd pneumococcal vax in the rt arm on 27JAN92, presented 30JAN92 w/redness & swelling to posterior aspect of rt arm; tx: moist heat & Motin for local rxn to immun;
red raised facial rash/hives, facial edema, tingling of throat and tongue, inflamed armpits, chest, and face, enlarged lymph nodes
Extreme flu like symptoms, fatigue, headaches, whole body joint pain, chest pain, and sore throat for 3 days post shot. Mild symptoms for following week followed by another week of severe joint pain, fatigue, headache, flu-like symptoms, sore throat, dizziness and inability to get out of bed due to illness. 2 weeks later, still dealing with these symptoms and they don't seem to be resolving.
I have a huge wart or skin lesion that won't go away due to the vaccine.   Taking cream and ointment for treatment.   Not working.
Pt recvd 3 doses of Engerix-B 8MAY91, 5JUN91, 11NOV91 & 11NOV91 immed p/3rd inject pt exp burning while inject was being given which cont for a few hrs;
Information has been received from a nurse practitioner of unknown age and gender referring to her/himself. On an unspecified date, "over 1 year ago", in approximately 2014, the patient was inadvertently administered with ZOSTAVAX (strength, dose, route and lot # not reported) which had been improperly stored. No adverse effects were reported. Additional information is not expected because the reporter was not consent to contact her physician.
Swollen left deltoid muscle site of injection, state 1 hr later swelled. ER precautions for cellulitis. RTC PRN. (Ice pack, Ibuprofen).
19FEb94 pt had a sz was taken to hosp sx w/febrile sz, mild strep throat was given ATB;
Patient reported developing chest pain, was seen in ED, followed up by cardiologist and internist and diagnosed with pericarditis.
Arm reported was swollen and warm to the touch on 11/5 after vaccine. Patient came into pharmacy to report. Pt reported are was felling much better and looked visibly ok at the time of reporting.
Transient red rash on right arm and most of chest and abdomen, face, well-demarcated, no induration.  Rash started around 4:30 pm, resolved by 6:15 pm.
Fever, chills, body aches and sore throat. Treatment: Tylenol, Outcome: body aches, chills and fever improved,  report of sore throat and not feeling  2 weeks later. Referred for  testing.
No Adverse event; 9 individuals that received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose).    No concomitant medications were reported. No treatment medications were reported.  This is patient number six out of nine.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live Follow-up  Significant information accepted (Batch/lot number has been added)
ashen, eyes rolling back in head, confused, ap-48, BP 112/60; Epi given @ clinic site;
Pt went in May for device check and found out that exactly 3 weeks after her vaccine, she went into a-fib and has stayed in a-fib. She hasn't been in a-fib since having her pacemaker placed 2 years ago. medications haven't kept her out of afib. her amiodarone was d/cd since her a-fib wasn't being managed by it any longer.
Was reported by mother that child started "losing hearing after shots on 7/25/06." "Crying most of the time." No other symptoms (i.e. fever) reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with GARDASIL (lot # (661953/1130X), expired on 13-MAR-2011) on 20-SEP-2012. No adverse effect reported. This is one of several reports received from the same source. (MARRS 1210USA006583). Additional information has been requested.
Wednesday morning about 2:30 AM I woke up with a burning sensation in my left under arm and into my breast. I went to the bathroom, and I could see a lump in my left arm pit, and I could feel it.  It kept me up all night. It was itching and painful. The next morning, I called my OBGYN, Dr. She saw me on that Friday, she did a breast exam, and she felt a lump in my left armpit. She did not feel anything in the left breast. She did advise she has seen these before after the vaccine. She advised to get a ultrasound on my left armpit. On Monday, I went to the Medical Center, and they did an ultrasound. They did not find anything under my arm and did not find anything worrisome. I have a mammogram scheduled. It is not something that keeps me up at night, but it is still sore and hurts.
Rash developed on upper back. Dermatologist prescribed lotion. Rash on upper back is almost healed, but has now moved to lower back.
This spontaneous report as received from a consumer of unknown age and gender. Patient's current conditions and medical history were not reported. On an unknown date in 2011, the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (Lot number, expiry date, route and dose were not reported). Concomitant medications were not reported. On an unknown date in 2013, the patient had shingles. The outcome of shingles was unknown. The causality was not reported. Additional information has been requested.
Heart Palpitations,  arm pain, swollen lymph nodes in arm injection was given, headache, chills
Patient had received two Sinovac COVID-19 in home country. On 1/27/22, patient given a Moderna booster dose of 0.5 ml
Moderate fever, hoarseness, paleness, weakness, and dizziness.  started 9:30 pm on July 14, 2009, and ended 1:30 am July 17, 2009. treatment:ibprophen, tylenal, and acedominophen.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity necessary to protect against Covid 19 at time of administration. Also patient did not call in with adverse event.  This is an administrative error without adverse event.
Information has been received from the mother concerning her 16 year old daughter who on 23-MAR-2007 was vaccinated with Gardasil. The patient fainted a few minutes after being vaccinated. No injury was noted due to the fall. The patient also stated that the vaccination was very painful. Medical attention was sought. At the time of reporting, the patient had recovered. No further information was available at the time of reporting. Additional information has been requested.
36 year old female airport employee with medical history signficant for chronic focal seizure (diagnosed for 15 years, taking lamotrigine, gabapentin, and pregabilin daily), transient hypertension, and food allergies who presents for Johnson and Johnson vaccine.. She was given vaccine to her left arm and was sent to the observation area. Approximately 10 minutes after vaccination, patient was seen slouched over and slightly shaking. She was responsive with nods and simple yes/no questions. Pt reported ?feeling hot?, ice pack applied to back of neck until she felt more comfortable. No loss of consciousness.
Still swollen, painful glands/lymph; Still swollen, painful glands/lymph; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient non-pregnant of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 06Feb2021 16:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took sulfa drugs and experienced allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 15Jan2021 04:30 PM (Batch/Lot Number: was not reported) for covid-19 immunisation. On 06Feb2021 20:00 the patient experienced Still swollen, painful glands/lymph nodes, a week after vaccination. The clinical outcome of the events was not recovered at the time of vaccination.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
hives 2 hours post injection at injection site and above arm, shoulder, neck and chest and head.    Itching.     later feeling fatigue, body aches and headache.
Outbreak of Shingles upper back and left side.  Pain, itching, rash started about April 3rd 2021.  Seen at Dermatology on April 12th, 2021.  Anti-viral medication started IC Valacyclov-IR HCL 500 MG 2 X's day for ten days.