chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ABDOMINAL PAIN (A FEELING OF NEEDLES IN STOMACH AND ABDOMEN); FEELING OF BRAIN FOG (DOES NOT FEEL THE SAME); FEELS UNCOORDINATION (FEELS HE WAS NOT AS CONNECTED AS HE WAS BEFORE); BACK PAIN; PAIN IN THE PELVIC REGION; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and other pre-existing medical conditions included: Patient did not have known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced abdominal pain (a feeling of needles in stomach and abdomen), feeling of brain fog (does not feel the same), feels uncoordination (feels he was not as connected as he was before), back pain, and pain in the pelvic region. Laboratory data (dates unspecified) included: PSA (NR: not provided) doubled from 1.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the abdominal pain (a feeling of needles in stomach and abdomen), feeling of brain fog (does not feel the same), feels uncoordination (feels he was not as connected as he was before), back pain and pain in the pelvic region was not reported. This report was non-serious. This case was associated with product quality complaint number 90000210359.
NAUSEA; FEVER; TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a caregiver (PVX2019-661) on 15-Mar-2019. It described a 6-year-old male consumer who experienced nausea and fever following the intake of oral Vivotif (lot number: 3003238) for typhoid fever prophylaxis. The consumer also "took an unrefrigerated dose".  It was reported that the consumer took an unrefrigerated dose of Vivotif on 13-Mar-2019. He experienced nausea at school on 14-Mar-2019. He also had fever (slightly high temperature). By the time he reached home, the caregiver checked his temperature but he had no fever. Both events were resolved on 14-Mar-2019  The action taken with Vivotif with respect to the events nausea and fever was unknown while with respect to the event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the events nausea and fever was resolved while with respect to the event "took an unrefrigerated dose" was unknown.  Company's Comment: In this case, it was reported that a 6-year-old male consumer had nausea and fever after intake of Vivotif. The consumer also "took an unrefrigerated dose". There seems to be a temporal association between the intake of the vaccine and the events. Also, fever and nausea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "took unrefrigerated dose" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that a 6-year-old male consumer had nausea and fever after intake of Vivotif. The consumer also "took an unrefrigerated dose". There seems to be a temporal association between the intake of the vaccine and the events. Also, fever and nausea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "took unrefrigerated dose" was considered as not applicable.
erythematous, lace-like, pruritic rash started 9 days after the vaccine on limbs and trunk
Patient reported mouth/tongue tingling.  Reported she had a h/o malignant HTN.  VS at 1037: 182/94, 93 HR, 98%.  EMS called at 1035.  Physician on site evaluated patient while waiting for EMS.  VS at 1045: 158/100, 81 HR, 98%.  EMS arrived at 1047.  FSBS 140.  VS by EMS 180-90, 87 HR, 98%.  EMS left with pt at 1057 to go to local ED for further evaluation.
Patient was given dose for age 5-11 year old instead of dose for 6month-4 year old.
This spontaneous report was received from a registered pharmacist concerning an approximately 60 year old female patient with no pertinent medical history and no drug reactions or allergies. On 29-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as H019996, and 14-FEB-2014 respectively) subcutaneously in the arm. Concomitant therapy included estradiol. On 29-JUN-2013 (reported as later that same day), the patient got stung by a bee in the same arm, close to the ZOSTAVAX site. The reaction to the bee sting site was encompassed the site of the ZOSTAVAX. The area was very red, painful, a deep burning and itching pain. It was like a big welt and was hard. The patient sought medical attention (called pharmacy). The patient was treated with BENADRYL and topical hydrocortisone. No lab tests were performed. The patient was recovering from all the events. The relatedness for the events was unknown for ZOSTAVAX. There was no product quality complaint. Additional information has been requested.
first dose, felt like heart was racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (first dose, felt like heart was racing) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 immunisation.     Concurrent medical conditions included Caffeine allergy (stays away from these because makes heart race) and Drug allergy (stays away from these because makes heart race).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PALPITATIONS (first dose, felt like heart was racing). The patient was treated with MAGNESIUM for Heart racing, at a dose of 1 dosage form. At the time of the report, PALPITATIONS (first dose, felt like heart was racing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were by reporter.   This case was linked to MOD21-091252 (E2B Linked Report). This case was linked to MOD-2021-139361 (Patient Link).; Sender's Comments:  MOD21-091252:
Patient Arrived at ED on morning of 9/19/17 approx. 3:04am with LLQ abdominal, dysuria, flank pain R, flank pain L and nausea. DX with UTI and renal colic. Prescribed CIPRO, PYRIDIUM, NORCO and ZOFRAN by ED physician. Family called our office again 6:11pm 9/19 stating patient's left arm was swollen and itching at injection sites. Advised TYLENOL or ibuprofen for comfort and cold compress.
Severe ovarian cramping, spot bleeding; menstrual cycle lasts 14 days; prior to vax was 3 days...
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.   In 2010, the patient was vaccinated with a dose of the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, anatomical location and administration route were not reported) at a clinic, for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX inoculation, patient was treated by a physician for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization (on an unknown date), physician care, monitoring, treatment, medications, and supplies. By the time of the report, the patient did not recover from shingles. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Patient was to get Moderna booster 0.25ml and received Moderna 0.5ml. Patient notified. Has no adverse effects
Child arm swollen and warm to touch. Shot was given at right lower triceps area instead of thigh.
fever, headache, muscle pain, joint pain, nausea, conjunctivitis, facial edema,
Information has been received from a father concerning his 6 year old daughter with asthma and allergic to grass who on 30-AUG-2007 was vaccinated with Vaqta (Lot # 656497/1213F). Concomitant suspect therapy included Varivax, (Lot # 649737/0119R). Other concomitant therapy included asthma medications (unspecified). On approximately 31-AUG-2007, the patient experienced muscle spasms and seizures 24 hours after taking Vaqta and Varivax vaccine. The patient was hospitalized twice, the first time was for 4 days and the second time was for 3 days. As of 18-SEP-2007 the patient's muscle spasms and seizures persisted. Additional information has been requested.
Peeling dry, flaking, scaling skin. Large raised dark bumps on arms, legs, and back. Large red raised bumps on face. Trouble breathing through nose, onset of loud snoring. Went to primary DR and sent to dermatologist. Dermatologist prescribed 2 topical creams. Face cream caused skin to lighten on areas where applied. Body cream did minimize the appearance of large bumps.
Developed cancer; This is a spontaneous report from a non-contactable consumer (family member) report from a Pfizer-sponsored program COVAX US Support. A patient of unspecified age and gender received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, 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's medical history and concomitant medications were not reported. The patient experienced developed cancer on an unspecified date. The reporter was unsure of what vaccine they had. 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.
0.3ml vaccine was administered without the diluent. Saturday 2/10/2021 presented with edema and erythema in the punctured area. Evaluated by the Emergency doctor and was diagnosed with cellulitis of the area. Patient is on antibiotics at home.
pt recv vax & devel fever blisters, sore throat, bone aches, tearing, runny nose & was sick; No further details were provided;
Swollen red upper arm w/fever KEFLEX QID at ER cellulitis.
Tinnitus started two days after receiving booster, is constant and has not resolved.  Increased migraines, 30+ migraines from date of injection through  March.  Started nortriptyline which resolved migraines.
arm was a little sore; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team.  A 69-year-old female patient received BNT162b2 (Pfizer-BioNTech COVID-19), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm was a little sore". Therapeutic measures were not taken as a result of pain in extremity. Additional information: Patient received her fourth dose of the Pfizer BioNTech COVID 19 vaccine this past Tuesday. With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 24 year old female who on was vaccinated with two doses of VARIVAX (Merck) and failed to seroconvert. The patient was vaccinated with her first dose on 25-FEB-2008 and her second dose in April 2008. Titer was drawn recently showed zero seroconversion. No product quality complaint. No further information is available.
Whole upper arm swelled up w/in 5 minutes of receiving FLUZONE HD. Put ice on it x 15 minutes and encouraged him to see his doctor.
Within 6 hours of the 2nd vaccine the injection site swelled up/ a "knit the size of a quarter"; Turned feverish; Within 6 hours of the 2nd vaccine. the injection site hurt/ arm hurts where "knit" is located.; "The redness is gone."; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER732) via an unspecified route of administration in the right arm on 09Apr2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included hypothyroidism and arthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN) and montelukast (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously took codeine and experienced a drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6299) via an unspecified route of administration in the left arm on 19Mar2021 at 13:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 19:00, within 6 hours of the second vaccine the patient reported that the "injection site swelled up, turned feverish, and hurt." The patient reported that on 14Apr2021, 6 days after the vaccination (at the time of this report) she had a "knit the size of a quarter." The redness had gone and her arm hurt where the "knit was located." Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events redness was resolved on 14Apr2021; while the clinical outcome of the events injection site swelled up, turned feverish, and hurt, she had a "knit the size of a quarter", arm hurt where the "knit was located" were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Swollen, bleeding gums. Itchy skin all over. Recent hair dye allergy became itchy and irritated again.
exposed more and got a mild case occasionally/ flu; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves elderly female patient (unknown age) who got a mild case occasionally/ flu (influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got a mild case of flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient and her husband every year got the vaccine. At 79 and 81, they get the high dose for senior adults. Her husband has never gotten flu but she was exposed more and got a mild case occasionally, but she would had expected to be seriously ill with her health issues.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
contracted COVID; contracted COVID; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. There was no other vaccine in four weeks. Patient had no COVID prior vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "contracted COVID". The event "contracted covid" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Myocardial necrosis marker: (2022) Elevated, notes: but no sign of CV event; SARS-CoV-2 test: (Nov2022) Positive. Clinical course: Patient contracted COVID in Summer 2022 and then developed chest pain and scapular pain over course of 3 months post infection. Patient went to ER and had elevated cardiac proteins but no sign of CV event. Cardiology consult described cardiac abnormality attributed COVID & vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300054582 same patient, different dose and event;
sz occurred 7 days p/vax;pt had known underlying predisposition to sz, & prev sz;
got ringing in his left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6203, Expiration Date: Jun2021) at the age of 64 years as dose 1, single and administered in arm left, administration date 25Mar2021 (Lot number: EN6205, Expiration Date: Jun2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "got ringing in his left ear".  Additional information: The consumer stated he had the first dose of the vaccine on 04Mar2021 and got ringing in his left ear and wanted to know if he is the only one or if other people have reported this. Consumer stated I had my first Pfizer shot back in 01Mar2021 and I was just curious to see if anybody else complaining about ear ringing, my left ear, right after the shot probably a day or 2 after the shot is been ringing constant for this all time and I just got my second shot on the 25Mar I was wondering if that's the side effect with the shot, anybody else been complaining about. My son was the pharmacist. I actually talked to him about this after I had the shot he looked it up on his phone it did show that people were having some issues with ringing after the Covid shot. So, I want to speak to somebody right from Pfizer to get the accurate report of what is going on. Patient History: No  No follow-up attempts are possible. No further information is expected.
Bell's Palsey; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8734) in the left arm on 01Apr2021 at 13:00 (at the age of 60-years-old)  as a single dose for COVID-19 immunization. Medical history was none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included loratadine (CLARITIN) and fexofenadine hydrochloride (ALLEGRA). The patient previous received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204) on 11Mar2021 at 14:00 (at the age of 60-years-old) in the left arm for COVID-19 immunization. There were no other vaccinations within 4 weeks of the vaccine. On 04Apr2021 at 12:00 (reported as 3 days after the second vaccination), the patient experienced Bell's Palsy and it was difficult to close the left eye and move the left side of his mouth. The patient visited a doctor or other healthcare professional because of this event. It was unknown if the patient received treatment for the event. Since the vaccination, the patient was tested for COVID-19 via a molecular nasal swab on 15Apr2021 with negative results. The clinical outcome of Bell's Palsy was not resolved.
Shingles; A spontaneous report was received from a Nurse concerning a 76-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shingles.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 042620A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 24 Jan 2021, the patient experienced the event shingles.  Treatment details included Anti shingles medication.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, shingles was unknown.
Dizziness; Weakness; Difficulty breathing; Dry mouth; It was harder for her to go to sleep at night; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Mar2021 (Lot Number: ER2613; Expiration Date: 31Jul2021) (at the age of 74 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history included COPD and CHF. She had bad labs in early February (2021) because of COVID and she is still fighting that with meds. The patient confirmed that she did not have COVID, but the bad labs were due to doing things to try to help make sure she did not get COVID like cough syrup, orange juice, chicken noodle soup. She was taking preventive measures, and that was bringing up bad labs. The patient was taking unspecified medications. The patient previously received the first dose of BNT162B2 on 26Feb2021 (Lot number: EN6202; Expiration date: 30Jun2021) (at the age of 74 years old) for COVID-19 immunisation. On 19Mar2021, the patient experienced dizziness, weakness, difficulty breathing, and dry mouth. The clinical course was reported as follows: The patient experienced dizziness and weakness 15 minutes after getting the shot. They brought her some apple juice and a granola bar and things started going away and she was able to drive home. She was just weak, but when she got home she started having some difficulty breathing. The difficulty breathing began on 19Mar2021, the same day as the dose, and was ongoing which has gotten worse and so has the weakness. The dizziness was every now and then. The dry mouth began about a couple of hours after she got home from getting the dose on the same day. She just did what she was told to do, they told her whatever she usually does to fight that, however, each of her symptoms from the first day to 12 or 13 days was still getting worse. On an unspecified date in Mar2021, it was harder for her to go to sleep at night and she was just weak all over. She was taking orange juice and eating a couple or 3 foods that she is not supposed to have, that she knows will get her up, but she cannot keep doing this much longer and running up her glucose. The patient recovered from dizziness on an unspecified date in 2021, recovering from the dry mouth, has not recovered from weakness and difficulty breathing, and the other event was unknown.  No follow-up attempts are possible. No further information is expected.