chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaginal pain on labia, not cramping; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 22Apr2021 at 11:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypothyroidism and allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC), montelukast (MANUFACTURER UNKNOWN) and thyroid (ARMOUR THYROID); all for an unspecified indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 29Mar2021 at 11:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 01:00, the patient experienced vaginal pain on labia, not cramping. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vaginal pain on labia, not cramping was resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 14-AUG-2014, the patient was vaccinated with GARDASIL lot # J006850 for prophylaxis. Other suspect therapies included GARDASIL 9. It was considered interchange of vaccine products, no adverse event and inappropriate schedule of drug administration. The outcome of interchange of vaccine products, no adverse event and inappropriate schedule of drug administration was unknown.
Acute myositis of lower extremities; pain and swelling. CPK up to 15,000 07/18/06-records received from Lakeland Regional Med Ctr. DC DX: Myositis             Poor p.o             Dehydration             Reactive airway disease Presented to hospital with viral type symptoms began 6/5/06 and 24 hours prior to admission c/o severe leg pain with inability to stand and fever. Presented to ED. Admitted. Hospital Course: IV fluids, Motrin, morphine, Tylenol with Codeine, CPK monitored. Coughing with some wheezing. PMH: HX of reactive airway disease. Hospitalized with gastroenteritis DC Meds: Albuterol RX, Motrin, Tylenol with Codeine.
patient experienced: COVID; patient experienced: COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN4484000 (Genentech).  A 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Transverse Myelitis" (not ongoing); "Exacerbations" (not ongoing); "Detached Retina" (not ongoing); "New Lesions" (ongoing); "Common Cold" (ongoing); "Blocked Sinuses" (ongoing); "Deviated Septum" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 10Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 10Nov2021, outcome "recovering" and all described as "patient experienced: COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Nov2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt had hx of anaphylactic rxn involving chest tightness and SOB within minutes after receiving Typhoid and Yellow Fever vaccines the same day in 1995, and since had a negative challenge vaccination with Typhoid.  On 15 Dec, 2005, the patient received a cutaneous prick skin test to full strength Yellow Fever vaccine.  Ten minutes after the skin prick, he had 6x6mm of induration and large erythema at the site of the test, as well as with his histamine positive control, and no induration or erythema at the site of his saline negative control, and began to experience nasal congestion, chest tightness, and shortness of breath.  He had some mild and very transient neck and chest erythema, no evidence of swelling, hives, or other rash.  He was treated for presumptive anaphylaxis to the prick skin test with Epi-pens (0.3mg) IM x 2 as well as PO Prednisone and Benadryl.  His symptoms resolved over the next 30 minutes, and he was observed two additional hours before being driven home.
69y.o. male who presents after syncopal episode. Patient was recently in another country when he had an episode of syncope. Per family, he was hospitalized overseas and workup was unremarkable. Family brought him to the hospital yesterday for further evaluation. While in the ED waiting area, patient complained of sudden abdominal pain and immediately after had a witnessed seizure. No falls, trauma or injury. He does not have history of seizures. Patient deemed medically stable for discharge by physician. Patient discharged to home with outpatient follow-up
30 min after getting vax I had extreme pain in my right leg as well as nausea, diarrheas and headache. On the 15th, I began experiencing abdominal pain. On 2/20th I went to emergency room and was dx'd with viral gastroenteritis, and that my abdominal organs were all having muscle spasms at the same time. I received medicine there and went home w/ 3 prescriptions. I went to my PcP shortly after that and received.
Asymmetric polyarthritis involving right ankle, left wrist, left elbow, left shoulder and neck
Moderna Covid vaccine administered to 16 yo, currently approved for only 18years and older.
when she was 4 she had chicken pox and did not get the second dose of the vaccine; This spontaneous report was received from a consumer, referring to herself, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient got the first shot of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, anatomical site of injection, route of administration, lot number and expiration date were not reported) as prophylaxis.  On an unknown date (reported as when she was 4), the patient had chicken pox and did not get the second dose (varicella).  The outcome of varicella and the causal relationship between the suspect therapy and varicella were not reported.
No Adverse Reaction. No Adverse Reaction after 48 hrs. Pt. was just given an extra dose of DTAP-IPV-MMR-Varicella.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided          No relevant concomitant medications reported.  No treatment information was provided.
5APR93 screeching, high pitched scream; high pitched scream lasted 3 days; pt did not sleep or eat for 3 days; did not go to ER; did have 101 fever; cried for a wk when leg was moved;
Patient came to the pharmacy the afternoon of Wednesday 10/10/18 complaining of redness and soreness in his left arm; the patient had received two vaccines in his left arm on Monday 10/08/18 from the same pharmacy. The vaccines were administered by staff pharmacist. Upon seeing the large red area on the patient upper left arm, I (floater pharmacist/reporter) reviewed the patient's vaccination sheet and determined that the patient may be experiencing a reaction to one or both vaccines. The patient was not experiencing itching at the site, therefore; I helped him find an over the counter 24 count bottle of ibuprofen to take to help relieve the inflammation and pain. I advised the patient to contact his primary care physician as soon as possible. I followed up with the patient before the end of my shift on 10/10. The patient reported that the size of the red are on his left arm had increased within the few hours since we last spoke. The patient also stated that he had made an appointment to see his doctor the following day, Thursday 10/11/18. According to the patient's medication profile, he saw Dr. on 10/11 and was prescribed doxycycline hyclate 100mg - one capsule twice daily for 10 days.
2 hours after the vaccine she began having a migraine. The next day she started having flu-like symptoms and progressive shortness of breath.
Pt. at 8:40 am at observation began to feel dizzy and light headed.  Paramedic assessed pt. and vital signs were stable.  Once pt. felt better and paramedics cleared her she was released to leave.
Pt was given a Tdap (ADACEL) at age 10. He will be 11 in 2 mo. Here for 6th grade PE.
Case completed primary Covid vaccine series in April 2021, then was hospitalized for Covid in February 2022. Hospitalized at: Hospital.  * Toxic encephalopathy Assessment & Plan Resolved, was due to combination of alprazolam, oxycodone and COVID. COVID-19 Assessment & Plan Has had a fever, but otherwise symptoms of hypoxia and shortness of breath seem more c/w acute CHF. She received 5 days of remdesivir, dexamethasone was causing hyperglycemia.
Fever, chills, severe headache, muscle aches, numbness in hand (side of injection), sore arm
shakes, tremors, difficulty walking, back pain, confirmed Cytokine storm by PCP
Patient experienced dizziness, vomiting, difficulty breathing, sore arm, red arm, swollen arm, itchy arm.
7/4/2011 got vaccine 7/6/2011 woke up and left calf muscle was tight and looked a little swollen 7/7/2011 left calf muscle felt tight, but didn't look or feel tight, I had a cold sensation in the front of my lower leg, sometimes am getting it in my left upper leg, the muscles on the left side of my spine, and occassionally in my left arm as well. The muscles on the left side of my spine are tense and also have the cold sensation at times. I am not in pain, nothing is swollen or stiff, I am still exercising daily, but the cold sensation is not going away and my calf still feels tight even thought its not.
Patient reported feeling itchiness the next day after Shingrix vaccine in the right hand, leg and thigh as well as a sore injection site.  Also reported red dots on right hands and very bad headache. She took generic equate brand Benadryl and symptoms improved. Patient also reported swelling in eye area that started & resolved on 10/31/22. Patient has contacted her PCP.
Definite tingling in hands to elbows and in feet. From time of shot to present.
SPLENIC VEIN THROMBOSIS; PORTAL VEIN THROMBOSIS; RECEIVED THE DOSE OF THE PFIZER COVID VACCINE THAT WAS NOT RECONSTITUTED; This spontaneous report received from a health care professional (nurse) concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 2 diabetes since 2012, diabetic neuropathy, and hypertension since 2007. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: unknown) dose was not reported, 1 total, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Pfizer COVID Vaccine (BNT 162) for booster on 25-OCT-2021 administered to left arm deltoid. On an unspecified date, the patient had splenic vein thrombosis and portal vein thrombosis. On 21-SEP-2021, the patient was hospitalized for 2 days and discharge on 23-SEP-2021. On 25-OCT-2021, the patient received the dose of the pfizer covid vaccine that was not reconstituted (Inappropriate schedule of vaccine administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the splenic vein thrombosis, portal vein thrombosis and received the dose of the pfizer covid vaccine that was not reconstituted was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211110785-COVID-19 VACCINE AD26.COV2.S-splenic vein thrombosis, portal vein thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Tired for 1 or 2 days (dose 1 and 2)/very fatigued for 1 or 2 days (dose 1 and 2); nausea for 2-3 days after second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Tired for 1 or 2 days (dose 1 and 2)/very fatigued for 1 or 2 days (dose 1 and 2)) and NAUSEA (nausea for 2-3 days after second dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0018(B)21A and 006M20A) for COVID-19 vaccination.     Concomitant products included ACYCLOVIR [ACICLOVIR] and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired for 1 or 2 days (dose 1 and 2)/very fatigued for 1 or 2 days (dose 1 and 2)) and NAUSEA (nausea for 2-3 days after second dose). At the time of the report, FATIGUE (Tired for 1 or 2 days (dose 1 and 2)/very fatigued for 1 or 2 days (dose 1 and 2)) and NAUSEA (nausea for 2-3 days after second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included  supplements.   This case was linked to MOD-2021-378065, MOD-2021-378118 (Patient Link).
Around 1am Saturday morning, I began with a 101.7 fever, muscle aches, joint pain, headache, and chills that lasted 36 hours.  For the next 12 hours after fever subsided, I was fatigued.
pt stated the next day after receiving the 2nd dose of covid vax her temperature was 101.7, she felt bad w/flu   like symptoms, fatigued, head ache, stuffy nose and her arm was sore at the injection site.  Pt states by the second day that all of her symptoms disappeared.
Fever of 104.5, swelling, redness, pain left shoulder.  Headache.  IV Ancef, oral Keflex
Mom called concerned that patient possibly had a reaction to the PREVNAR she had the previous day. She was holding her mouth open very widely and tensing her entire body. This happened 4 times within a few minutes. Mom described the tensing as if she was having a BM but she didn't have a BM. She didn't cry afterwards. She didn't run a fever. When it occurred, her eyes were open and a little watery but not staring, she tensed but no posturing. Dad was the one who was home with patient when it happened and called mom. Since then she has been eating and drinking  and acting normally. The reaction occurred at 1:30p in the afternoon the day after the vaccine. I instructed mom to go to the ED or come to the office if another episode should occur. I spoke to mom again on 3/29/2019 and she states patient continues to act normal and has not had anymore episodes.
Her period had advanced and the bleeding persisted; Headache; This is a spontaneous report from a contactable dentist (Patient's mother reported for her daughter) via medical information team. A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on an unspecified date (at the age of 13-year-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation and her period had advanced. Patient's mother reported that she was a dentist, and a mother of 13-year-old. She took her daughter to get the COVID-19 vaccine and noticed that she did not show any reaction during the first dose only her period had advanced. On arrival the second dose plus a reported headache the bleeding persisted. Patient's mother took the patient to doctor yesterday and learned that this was a severe vaccine reaction in her opinion. The patient's mother would like to know if this could compromise patient's health in the future (mainly reproductive) because patient's mother not calm in knowing. The patient's mother reported events as non-serious. The outcome of the event headache was reported as unknown and for another event outcome was reported as not recovered.   Information regarding the lot/batch number has been requested.
Severely ramped up Alpha Gal symptoms: restricted airway in throat and palpitating heart Ongoing as of today--March 3, 2022  Using Benadryl to try to lessen severity of symptoms
As reported and diagnosed by Cardiologist, following the 3rd (Booster) Injection of Pfizer Vaccine, problems began with Anxiety, Shortness of Breath, Loss of Appetite, Loss of Sleep, Decreased motivation to exercise, walk any distance, heart pain.
Taken to ER at 17:45 on 2/13/01 with seizure which began 1 hour before that and lasted approx. 10 minutes. At daycare when seizure started. Had a temperature 102.3F, was P-140 and R-40. Dx'd febrile seizure.
sore arm that hurts to the touch; On both upper legs, itchy red welts; little red spot the size of a quarter at the location of the dose; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm that hurts to the touch), URTICARIA (On both upper legs, itchy red welts), RASH (Rash) and VACCINATION SITE ERYTHEMA (little red spot the size of a quarter at the location of the dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), CLONAZEPAM and BUPRENORPHINE for an unknown indication.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced RASH (Rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm that hurts to the touch), URTICARIA (On both upper legs, itchy red welts) and VACCINATION SITE ERYTHEMA (little red spot the size of a quarter at the location of the dose). At the time of the report, PAIN IN EXTREMITY (sore arm that hurts to the touch), URTICARIA (On both upper legs, itchy red welts), RASH (Rash) and VACCINATION SITE ERYTHEMA (little red spot the size of a quarter at the location of the dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   It was reported that the patient experienced very itchy red welts that looked like poison ivy on both upper legs either the same day as the vaccination or the next day.  Treatment included over the counter medication (soothing spray) for itchiness and an unknown ointment.  Patient consented for safety team to follow up via email.
vaccination site swelling; Injection site is itchy; Raised rash at injection site; vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site is itchy), VACCINATION SITE RASH (Raised rash at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Raised rash at injection site) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003CZIA) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site is itchy), VACCINATION SITE RASH (Raised rash at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Raised rash at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Injection site is itchy), VACCINATION SITE RASH (Raised rash at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Raised rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  Treatment medication like BENADRYL was included.   Reporter did not allow further contact