chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); Headache; Chills; Nausea; swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686), via an unspecified route of administration on the arm/deltoid, on 07Jan2021, at single dose, for covid-19 immunization. Medical history included suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP). The patient had questions about some side effects from the COVID vaccine. She stated she received the first dose on 07Jan2021. About a week after that or maybe 7 to 9 days after the first shot, she started having side effects and was given a handout of a different side effects and risk of the vaccine and; she had like 4 or 5 of the side effects on Jan2021 such as headache, chills, nausea and swollen lymph node. She started with the headache initially then the chills, and nausea, and then lymph node. Her lymph nodes were still swollen. She informed was due to get the "booster" vaccine this Thursday (28Jan2021) and she just wanted to call and see if she should still go and get the booster vaccine with the swollen lymph nodes. She added she did get a test for the COVID this past Thursday (21Jan2021), because of the symptoms, and it was negative. She had the test because she didn't know if it was the vaccine side effect because the side effect also fell in line with actual COVID symptoms. She wanted to make sure that she didn't have the virus. At the time of the report she had not recovered from the adverse events headache, chills, nausea and swollen lymph node and she did not receive any treatment for these. The outcome of the other remaining events was unknown.
Caller said he only got a "sore arm" in the first 2 shots of the Pfizer-BioNTech COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 84 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 19Feb2021 (Lot number: EN6198) at the age of 84 years as dose 1, 0.3 ml single and administered in arm right, administration date 12Mar2021 (Lot number: EN6206) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Caller said he only got a "sore arm" in the first 2 shots of the Pfizer-BioNTech COVID-19 Vaccine".  Additional information: With first 2 doses of the Pfizer COVID vaccine the patient only got a sore arm. He had the sore arm for about 2 to 3 days on both the first and second dose and he really couldn't say that he had any ill effect from it, it came and went and was just there for a few days and then he was fine. He did not think so, he was a pretty healthy guy for the most part. He did not take any prescription drugs or anything, he just was taking his regular vitamins.  No follow-up attempts are possible. No further information is expected.
Having issue with my left ear (feel swollen/clogged); Having issue with my left ear (feel swollen/clogged); This spontaneous case was received on 09-Dec-2020 via Communications (reference number: SEQW20-05657), reported by other non-health professional (consumer) and concerned a male patient of an unreported age.  The patient's relevant medical history and concomitant medications were not reported.  On an unreported date in Sep-2020, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose, anatomical location, indication and route of administration: not reported). The batch number was not reported.  On an unreported date in 2020, about one week after receiving influenza virus vaccine, the patient experienced issue with his left ear (feel swollen/clogged).  On an unreported date in 2020, the patient went to ear, nose, throat (ENT) doctor who confirmed there was no infection.  At the time of initial reporting on 09-Dec-2020, the patient did not recover from the events, since he was having symptoms for about three months.   The reporter did not provide a causality assessment to influenza virus vaccine.  Company comment: A patient experienced ear discomfort and ear swelling one week after administration of influenza virus vaccine polyvalent. The patient's relevant medical history and concomitant medications were not reported. ENT doctor confirmed there were no presence of infection. Causality is assessed as possibly related to vaccine due to lack of confounding factors.; Sender's Comments: A patient experienced ear discomfort and ear swelling one week after administration of influenza virus vaccine polyvalent. The patient's relevant medical history and concomitant medications were not reported. ENT doctor confirmed there were no presence of infection. Causality is assessed as possibly related to vaccine due to lack of confounding factors.
immed p/vax devel hives; resolved w/in 15mins p/vax;
Symptoms began approximately 7 - 14 days after taking the injections. First symptoms were tingling in her feet and legs which quickly traveling to my hands, arms and most of my body. This followed with a weakness in my left knee which gave me a feeling that it would collapse, my right ear feeling "clogged with water", every little bump or touch went right through me. Left for Florida on 11/23, and was seen by a vascular doctor who ordered an MRI of the lower spine and an arterial doppler which were negative. Went to a neurologist and initially had a lyme titer, Western Blot was positive while the ELISA was negative. Ana was positive on one occasion and then negative. Electrodiagnostic studies were performed showing slow nerve conduction velocities with absent reflexes. CBC, sed rate, thyroid profile, random glucose, B12, folate acid, VDRL, Lyme's screen, conduction velocities (electromyograms) were all performed. Started on Doxycycline. Referred to Infectious Disease doctor and had a lumbar puncture on 01/26/95 followed by motor problems and pain which lasted some 3-4 weeks. Returned to NJ and was re-examined by my neurologist there who determined polyradiculoneuropathy. He started Elavil which I could not tolerate. I have all the records from all the doctors with test, dates, and results. I still suffer with constant pins and needles which lately has become more noticeable and annoying, with stronger throbbing radiating from the feet to the legs. Most of the other symptoms have all disappeared.
Soreness, redness and swelling of right arm,  from shoulder to the elbow. On 10/5 the area was slightly red and there was some swelling near the elbow. Pt said it did not hurt, she was just concerned that there was a cellulitis. Did not appear infected, not warm to the touch and she said the swelling had gone down significantly. She stated that she wanted the pneumovax in left arm and flu in right. I have documented that we gave pneumo in right arm and flu in left so I am not very confident that the flu is the vaccine that caused the problem. I believe it was pneumovax, but patient is insisting that it was the flu shot
No additional AE reported.; Patient was accidently administered an expired dose of MMR II on 17-MAY-2022. Product expired on 11-MAY-2022.; This spontaneous report has been received from a licensed vocational nurse, concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 17-MAY-2022, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin (rHA)) (M-M-R II) at a frequency reported as once, for prophylaxis (dose, vaccination scheme, route of administration, and anatomical site of injection were not reported; lot number T016196, that was verified to be a valid lot number with an expiration date reported and established as 11-MAY-2022) (expired product administered).   No additional adverse event (AE) was reported (no adverse event). The product had no prior temperature excursions.
PAINFUL FOR THE 1ST 2 DAYS THEN SWELLING STARTED 4 DAYS AFTER, FOLLOWED BY BRUISING THAT STARTED ON THE INJECTION SITE AND EXTENDED TO THE WHOLE RIGHT ARM. TO DATE, 06/08/20, THE SWELLLING AND PAIN IS ON THE FOREARM BUT THE WHOLE ARM IS STILL BRUISED.PX JUST INFORMED US ABOUT HIS REACTION TODAY. PX IS JUST TAKING IBUPROFEN,ADVISED PX TO PUT ICE AND SEE HIS PRIMARY DR FOR CHECK UP AND WILL FF-UP WITH PX
Later in the evening after her 1st COVID vaccination (Friday night 9/17), patient did not feel well. Developed mouth sores / fever / chills / headache.  Symptoms resolved by Sunday night except for the headache which turned into a migraine. At the time of this report, this was day 11 of migraine. Her MD prescribed Maxalt  which did not work. She is waiting on a prescription of prednisone at this time.
Hospitalized - pregnant, Term pregnancy, hospitalized for vaginal delivery;  COVID-19 positive (4,9.22);  Fully vaccinated (no booster)  Hospitalized at Hospital OB:  MD (DC summary, MD - physician, obstetrics)  BRIEF OVERVIEW: Admission Date: 4/9/2022 Discharge Date: 4/11/2022  DETAILS OF HOSPITAL STAY: SUBJECTIVE: Patient is a 24 y.o. G2P2002 female at 39w4d with Estimated Date of Delivery: 4/12/22 who presents today with reported fever and body aches at home.  She has also had some diarrhea.  Presented to triage and tested positive for COVID.  Elected to stay for IOL. Pregnancy has been complicated by recurrent UTIs. PRESENTING PROBLEM:  Term pregnancy [Z34.90] SVD (spontaneous vaginal delivery) [O80] INTRAPARTUM COMPLICATIONS: Medical Problems (from 04/08/22 to present)    No problems associated with this episode.  PROCEDURES PERFORMED: Vaginal delivery  HOSPITAL COURSE: Patient is a 24 y.o. female G2P2002 who wast admitted for IOL due to new diagnosis of COVID at term She was also vaccinated.  She received one cytotec then spontaneously ruptured, making quick progress to 10/+2.  She pushed with 3 ctxs to deliver a liveborn female in a compound presentation with the hand as well as a body cord.  Cord clamping delayed.  Placenta delivered spontaneously and was intact with 3VC.  2nd degree lac repaired with 3-0 vicryl under local anesthesia.  EBL 100cc.  both went home on PPD #2 in stable condition. Covid sxzs improving. Edinburgh Edinburgh Postnatal Depression Scale Total: 4  DELIVERY DETAILS: DELIVERY TYPE: Vaginal, Spontaneous   ESTIMATED DUE DATE: Estimated Date of Delivery: 4/12/22 GESTATIONAL AGE AT DELIVERY: 39w4d  G2P2002 DELIVERY PROVIDER:   ASSISTING PROVIDER(S):   FINDINGS: NEWBORN STATUS: Living  NEWBORN SEX:  girl  Baby Girl A  Delivery Date/Time:    9:40 PM  WEIGHT: 3.23 kg  APGAR:  1 minutes 5 minutes 10 minutes  8  9
Broke out in hives on arms, shoulder, abdomen, left leg, and face with swollen lips. After going to the Clinic at the facility I received the vaccine, I was prescribed a Medrol dosepak, told to keep taking Benadryl, and to continue using Calamine lotion for the itch.
Dose #2 12:15 p.m. on 04/12/2021 1:30 a.m. 04/13/2021 - Sore Arm; Fever, Body Aches, Chills - fever between 100-101 until 4:30 p.m. 04/13/2021 04/14/2021 - Sore Arm; Fatigued in a.m.; Ear pain left side and flushed ~ 4:00 p.m.; low grade fever 99.9 04/15/2021 - Headache in a.m.;  Left arm slight hive-type spots; fatigue; arm soreness subsiding a little
Patient had influenza vaccine on 10/10/13 and had abnormal reaction. According to the patient, the reaction began between 8-9pm that evening. Patient said her arm began to hurt and could not raise it. Next day, got progressively worse. Patient said the inflamed area of the arm was swollen approximately 1/4 inch compared to the rest of arm and redness almost circled arm. Patient was treated with prednisone at local ER on 10/12/13. Patient states it took between 7-10 days for arm to appear normal but about 2 weeks for pain to subside.
Chills; Fever; Exhaustion, fatigue; Malaise; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills, fever, exhaustion and malaise. On an unknown date, the outcome of the chills, fever, exhaustion and malaise were unknown.   It was unknown if the reporter considered the chills, fever, exhaustion and malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comments:  This case was received from  consumer via interactive digital media. The patient was scheduled for a second dose. The patient had quite severe symptoms initially, chills, fever and fatigue. It then went on for several weeks of exhaustion, fatigue and malaise.  The reporter wanted to know was the patient likely to experience the same if she gets a second vaccine.
Patient admitted as emergency 2/4 and upgraded to inpatient on 2/5 with SBO. Patient was tested for COVID-19 and was positive on 2/4.  61 y.o. female with a history of ulcerative colitis s/p total colectomy with ileal pouch (2002) complicated by chronic pouchitis, as well as recurrent SBOs s/p exploratory laparotomy in 2011 and 2014. She presents with abdominal pain which started around 4pm
Fever; Chills; muscle aches; This is a spontaneous report from a contactable pharmacist. A 41-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EJ1685, Expiry Date: not reported), intramuscular, administered in left arm on an unspecified date (at the age of 41 years 2 months, as reported) as dose 1, single for covid-19 immunization. Medical history included allergies to medications, food or other products: Fava beans, Sulfa, Bactrim, Iodine contrast, Tegretol, ASA, Clindamycin, Hydroclorothiazide. GERD, Asthma, Bipolar Dusorder, High blood pressure. Type of facility was workplace clinic. Prescription, over the counter medications, dietary supplements of herbal remedies being taken at the time of vaccination included quetiapine fumarate (SEROQUEL), Gabapentin, omeprazole (PROTONIX [OMEPRAZOLE]), Lamotrigine, cariprazine hydrochloride (VRAYLAR), Metoprolol, Hydralazine, escitalopram oxalate (LEXAPRO), fluticasone propionate (FLOVENT). She received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EJ1685, Expiry Date: not reported), intramuscular, administered in left arm on an 09Jan2021 at 15:00 (at the age of 41 years 2 months) as dose 2, single for covid-19 immunisation and experienced fever, chills, muscle aches, tingling numbness in feet which moved up to her abdomen and Guillan-barre. On 09Jan2021, patient developed fever, chills, muscle aches after dose 1 vaccination. The outcome of events fever, chills, muscle ache was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from a consumer reporting on herself (age not reported). Caller stated that the "varicella vaccine" (manufacturer unknown) was causing an epidemic of Shingles, and she knows 7 people under the age of 50 who have Shingles, including herself, and that it was caused by an unspecified varicella vaccine (manufacturer unknown) being given to children. She stated she knows of a child who got Shingles, but didn't say the child had received this vaccine. She also didn't state that she knew whether these people, or herself, had actually received the vaccine at all. Patient's outcome was unknown. Additional information is not expected. This report is linked with MARRS cases 1304USA001476 and 1304USA001477, same reporter.
Tinnatus in both ears. Ringing was mild at first during March , but became more pronounced with 2 boosters
Info has been received from a physician concerning a 7 year old white female pt with no medical history who on 6/3/99 was vaccinated, SC, in the right arm with a 0.5ml, 1st dose of varicella virus vaccine live (lot 629615/0310J). Concomitant vaccination given on that same day included a 1st dose of MMRII (lot 630629/0352J) given, SC, in the left arm. There was no illness at the time of vaccination. On 10/3/05, the pt developed breakthrough chickenpox characterized by less than 15 papules/vesicles on her trunk and extremities. Unspecified medical attention was sought. It was reported that the pt fully recovered as of 10/15/05. No product quality complaint was involved. Additional info is not expected.
The patient stated that her right arm became red and swollen about 2 days after she received the vaccine.  The reaction is located about midway between her shoulder and elbow, below the injection site.
Severe allergic reaction causing severe status asthmaticus with hives and fever leading to emergency treatment of 3 epi pens , 80mg kenalog , 50 mg of Benadryl and a duo neb
Severe abdominal pain the night of followed by myalgias in arms and legs for more than 7 days.
Brain filled with blood clots; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. On an unknown date, the patient's brain filled with blood clots. The caller states that she was at a pharmacy with a group of employees and was told by the pharmacist that the BioNTech vaccine was the one that was not FDA approved, and the vaccine that was approved, was not in stock, so she wants to asks, was the approved vaccine on the market yet or not. She clarifies she was calling about the Pfizer BioNtech Covid vaccine and also stated that they also told her that another employee, male, his brain was filled with blood clots, and there were two of them, and they both got the Pfizer vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness and swelling of right arm Nausea Fever of 100.0-101.0 Severe chills
pt recvd vax & 3 days post vax exp muscle spasms in arm, numbness & tingling @ inj site, & nausea;
Shortness and breath and wheezing - about 5 days after receiving the vaccine; it worsened and I took Prednisone for 10 days to treat it and my Dulara Inhalation was increased to treat it. Symptoms resolved with this treatment.
swollen lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced LIP SWELLING (swollen lips). At the time of the report, LIP SWELLING (swollen lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
His son had a sore arm too; This is a spontaneous report received from a contactable consumer (parent/father). A male patient of unspecified age received unknown number dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, after receiving vaccination patient experienced sore arm. Outcome of the event was unknown.  No Follow-up attempts are needed. No further information expected. Information about lot/batch number cannot be obtained.
after pt recv vax 7 days later devel redness, swelling on both thighs at inject site. saw m.d. 5/18, not treatment.
FELT LIKE HAVING THE FLU (EVERYTHING HURT, CONGESTION, FEELING FLUSHED, FEVER GOT UP TO 102 F, AND WENT BETWEEN THAT AND 100 F, HEADACHE, MUSCLES ACHED, FELT WEAK WHOLE TIME); FELT REALLY TIRED WHOLE TIME AND DID NOT WANT TO GET OUT OF BED; EYES BURNING 10 HOURS AFTER VACCINATION; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-JUL-2021 10:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-JUL-2021, the subject experienced eyes burning 10 hours after vaccination. On 27-JUL-2021, the subject experienced felt like having the flu (everything hurt, congestion, feeling flushed, fever got up to 102 f, and went between that and 100 f, headache, muscles ached, felt weak whole time). On 27-JUL-2021, the subject experienced felt really tired whole time and did not want to get out of bed. On 29-JUL-2021, Laboratory data included: Body temperature (NR: not provided) 102 F, 100 F. On 04-AUG-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 05-AUG-2021, treatment medications included: chlorphenamine maleate/paracetamol/pseudoephedrine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt really tired whole time and did not want to get out of bed, and felt like having the flu (everything hurt, congestion, feeling flushed, fever got up to 102 f, and went between that and 100 f, headache, muscles ached, felt weak whole time), and the outcome of eyes burning 10 hours after vaccination was not reported. This report was non-serious.
I am having diarrhea ; even after I eat or drink something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 IMMUNIZATION; Covid-19 vaccine (first booster, COVID-19 VACCINE [unknown manufacturer]), for COVID-19 IMMUNIZATION. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "I am having diarrhea; even after I eat or drink something". Additional information Reporter stated, I do not want to leave my name but I just wanted to be calling about my side effect that I had from my 2nd booster. So, I have my 2nd booster on May 11th and couple days later I am having diarrhea I still have the once even after I eat or drink something. The first booster did not cause that I don't know why and I take anti- viral (Further clarification unknown hence, captured as unspecified medication) at night so I don't know if that's related to that. Reporter stated, I take it every night anti-viral but the first booster did not do that. So, I don't know why 2nd have like this because doctors aren't really helping me so I thought I am calling you guys may be you guys can explain it to me better.  No follow-up attempts are needed. No further information is expected.