chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cobblestone throat/Cobble stone pharynx; Cobblestone throat painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A 62-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: OROPHARYNGEAL COBBLE STONE MUCOSA (non-serious), 7 days after the suspect product(s) administration, outcome "unknown", described as "Cobblestone throat/Cobble stone pharynx"; OROPHARYNGEAL PAIN (non-serious), 7 days after the suspect product(s) administration, outcome "unknown", described as "Cobblestone throat painful".  Additional information: 7 days after Pfizer bivalent. Patient got cobblestone throat. Its painful.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a health professional concerning a 12 month old female who on 29-MAR-2007 was vaccinated intramuscularly, into the right leg, with a 0.5 ml dose of PEDVAXHIB (OMPC) (lot #653523/0063U).  Concomitant suspect vaccination given on 29-MAR-2007 included a dose of MMR (MSD).  Other vaccination given on 29-MAR-2007 included a dose of PREVNAR.  On 29-MAR-2007 the patient developed injection site reaction described as red, warm, swollen and a painful knot the size of a half dollar.  The patient was seen in the physician's office on 30-MAR-2007.  The patient was treated with cephalexin (KEFLEX).  The physician's office requested a lot check.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
It is believed that pt. was given a second booster from a vial that had been at room temperature for over the recommended amount of time.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. On 20-MAY-2015, the patient was vaccinated with a dose of PROQUAD (Merck) (dose and route were not reported), which underwent supported temperature excursions (date the excursion occurred was on 14-MAY-2015). The patient might have received the following lot numbers and expiration dates of PROQUAD (Merck): lot# L002419 with expiration date 23-JUL-2016 or lot# reported as L005293 with expiration date 17-AUG-2016. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
bagan with unsteady gait when he got out of bed he fell to floor. unable to walk and tremor like movements to the body 12/29/09 and 01/04/09.  Discharge Summary and Hospital records received for DOS  10/22/09-10/23/09. Pt. presented with 3 day h/o ataxia. Initially diagnosed with strep infection by PMD two days following immunizations.  Treated with Keflex, did not improve.  Then diagnosed as labyrinthitis by PMD, referred pt. to ENT who did not think it was ear problem and  referred pt to ED again for further management. Admitted overnight  and had LP done, neuro consult. Gait improving upon discharge home with instructions to f/u with PCP.   DC DX: aseptic meningitis, cerebellar ataxia
15 minutes post vax, the pt "didn't feel well" and was dizzy. She collapsed to the floor, was unresponsive, but respirations and pulse were ok. Face was pale but cyanotic. She experienced eye twitching with eyes rolling and then bilateral upper extremity stiffening and jerking. She then became alert.
red, raised, itchy rash surrounding the injection site that appeared 6 days after vaccine administered, rash has expanded in the last 24 hours to approx. 5"  long by 3 inches wide on upper arm
Healthcare provider is reporting administration of vaccines involved in a temperature excursion. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp) PEDVAXHIB W021183 2/22/2025  Temperature/Time frame 35.2F for; No additional AE reported.; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (1 dosage form, upon internal validation, lot #W021183 was valid for suspect vaccine, expiration date: 22-FEB-2025; strength, anatomical location, and route of administration were not provided) for prophylaxis after a temperature excursion (temperature: 35.2 Fahrenheit (F); time frame: 23 minutes) (product storage error). There was previous temperature excursion: temperature: 35.2 Fahrenheit (F); time frame: 9 minutes. No additional adverse event (AE) reported (no adverse event).
S/E From Tdap & MENACTRA given both at LD - red, swollen, warm to touch, area about 2" x 3". Mom call advice nurse. Applied warm compress, gave Ibuprofen. Pt was relieved. No itchiness. Seen MD. Ordered to apply cold packs within 48 not relieved, SEPTRA ABX.
after the first vaccine he had a headache for a few days also but it was not bad at all; This is a spontaneous report from a contactable consumer or other non-HCP (patient's mother). A 14-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EWO177), via an unspecified route of administration, in Arm Right on 01Jun2021 (age at the time of vaccination 14-years-old), as a single dose for COVID-19 immunization. The patient's medical history included allergies. The patient's concomitant medications included Cetirizine Hydrochloride (Zyrtec Allergy) for allergies, one tablet, 10 mg, as needed, He has been taking it since he was six about; and Ferrous Fumarate, Vitamins Nos (Flintstone Vitamins with Iron), 2 gummies once a day, He started taking last year for health. On an unspecified date the patient experienced after the first vaccine he had a headache for a few days also, but it was not bad at all. On an unspecified date, the patient underwent lab tests and procedures which included clotting, Coagulation time: Unknown result; took some blood they are checking, Investigation: Unknown result; and Platelet count: Unknown result. The patient visited to physician office. Caller stated, when the headaches got bad, he would take Tylenol the first few days and then he took Motrin. Caller corrects this and states he took Ibuprofen, not Motrin. The outcome of the event was unknown.  VACCINE SUPPLEMENTAL FORM 1.: Patient details, dose details, concomitant, adverse events, visited to Physician Office, patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine, Patient's Medical History, and Relevant Tests was included.  The information about lot umber was provided. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021868617 similar report from same reporter
vaginal bleeding/bleeding for 7 days; other typical stuff; sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding/bleeding for 7 days), VACCINATION SITE REACTION (other typical stuff) and MYALGIA (sore arm) in a 38-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding/bleeding for 7 days), VACCINATION SITE REACTION (other typical stuff) and MYALGIA (sore arm). At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding/bleeding for 7 days), VACCINATION SITE REACTION (other typical stuff) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient went through IVF in the past, but not right now. She is not on any other medications. She has an antibody titer of 28.5 on the Siemens test and worried about getting the second dose.  no treatment medications are provided.
seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml
Tic disorder Repetitive neck movements developed after 12 days of vaccine administration He had a cervical lymphadenitis developed on left anterior neck after vaccine as described by mother (not evaluated in clinic) and she thought he started making the neck movements because it bothered him but the lymph node improved and the movements persisted. the neck movements get worse when he gets anxious.
I experienced an allergic reaction after receiving the vaccine and took Claritin until the symptoms cleared up. I will be going to see an Allergist  on 09/22/2021 who will be testing me for all the ingredients in the vaccine or a bee sting. The Pharmacy Technician was concerned that I did not have full range of motion when moving my arm because the symptoms should have subsided but did not and was not comfortable giving me my 2nd dose until I sought care from a healthcare professional.
Patient developed neuropsychiatric symptoms starting 2 weeks after the 2nd shot of the Moderna COVID vaccine. He was subsequently diagnosed with Hashimoto's Encephalopathy after extensive diagnostic workup.
COVID-19 - asymptomatic, on room air - enhanced precautions while in the hospital - will not need isolation upon discharge for home health
I developed sudden-onset, severe, crushing pain in my left shoulder, radiating down my left arm.  This is the location where I received my vaccine one month prior.  The pain was 8/10 and lasted approximately 7 hours.  It woke me from sleep.  I also experienced nausea.  I tried Tylenol 1000mg, ice, and heat.  Nothing helped.  I went to the Urgent Care.  They did multiple EKGs and lab tests.  They ruled out a heart attack and pulmonary embolism.  There was no injury.  They were unable to find any cause for the pain.  They administered aspirin, protonix, and nitroglycerin.  The pain resolved after the third dose of nitroglycerin.  (I was told by the cardiology PA that this was probably a coincidence.)
Only liquid portion of vaccine was administered; Only liquid portion of vaccine was administered; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-MAY-2022 Reporter's Comments: The other health professional reported that a patient received only the liquid portion of the Menveo vaccine and the product was not reconstituted with both vials and then administered.  Medical information had also been contacted to assist with next steps. No specific patient or product information (lot number) was shared. Reporter did not agree to follow up from GlaxoSmithKline. Additional Supportive Information: The patient received only the liquid portion of the Menveo vaccine and the product was not reconstituted with both vials and then administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Tested positive for COVID; Coughing; Very fatigued; Headache; Slight fever 99.8/f ever went to 102-103; Started to get congested; Slight redness and tenderness at injection site; Slight redness and tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID), NASAL CONGESTION (Started to get congested), COUGH (Coughing), VACCINATION SITE ERYTHEMA (Slight redness and tenderness at injection site) and VACCINATION SITE PAIN (Slight redness and tenderness at injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Slight redness and tenderness at injection site) and VACCINATION SITE PAIN (Slight redness and tenderness at injection site). On 11-Mar-2021, the patient experienced NASAL CONGESTION (Started to get congested), HEADACHE (Headache) and PYREXIA (Slight fever 99.8/f ever went to 102-103). On 12-Mar-2021, the patient experienced COUGH (Coughing) and FATIGUE (Very fatigued). On 13-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID), NASAL CONGESTION (Started to get congested), COUGH (Coughing), VACCINATION SITE ERYTHEMA (Slight redness and tenderness at injection site), VACCINATION SITE PAIN (Slight redness and tenderness at injection site), HEADACHE (Headache), PYREXIA (Slight fever 99.8/f ever went to 102-103) and FATIGUE (Very fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   On 14 Mar 2021, patient felt better and symptom free by 18 Mar 2021. No treatment information was provided.   This case was linked to MOD-2021-067569 (E2B Linked Report).; Sender's Comments:  MOD-2021-067569:Wife case
Area crew 8cm x 6cm. Hot, red oval patch. Had fever and chills, headache, and cough. Pt iced area. Advised continuation of icing, BENADRYL, TYLENOL/ Ibu for pain. RTC if worsens. Signs and symptoms of infection reviewed.
Chills, fever, muscle spasms, convulsing, splitting headache, bone and joint aches, muscle aches, rash on neck, chest and back, itchy back, swollen lymph nodes (under jaw) really large lymph node in groin area appeared 10 days post vaccination, trouble breathing, exhausted, light headed, nausea, white chalky furry tongue., diarrhea.
Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: FH8020), in left arm, on 24Feb2021 as dose 2, single (Lot number: E6198), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: EL9261) at the age of 53 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Patient received vitamins as other medications within 2 weeks of vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jul2022 at 17:00, outcome "not recovered" and all described as "Covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as a treatment for Covid-19.  No follow-up attempts are possible. No further information is expected.
allergic rxn w/in 5min of receiving vax;911 called; immed given epi & 02 mask;began shaking all over, difficult to breathe, cyanotic, jerking movements of extremities; given DPH in amb by EMT, IV's given, steroids given & released from ER;
Wheal formation same day as vaccines on b/l arms. ER visit included Benadryl orally and this improved symptoms. No latex gloves in office. Nurse - did well per mom. Never had concerns with vaccines before, No fever - pain has subsided. no itch. right arm hurts but also side for Td shot.
Broke out in hives x 4 (3 on forehead and one  on left cheek) within 15 min. and he experienced itching on neck. No resp. distress. Offered Epinephrine for anaphylactic reaction-mother refused. Signed waiver Instructed to immediately go to ER or doctor's office. Mother states that she did not want any further shots to be given to her son. Treatment: Discussed providing Benadryl. Mom said she would buy it and provide it to her son but then she was worried about him getting sleepy. Reassurance provided. Parents left immediately with their son to seek medical attention from their MD or ER. They said they would be back later to get the WIC coupons. Spoke to MD today re: client's reaction. Plan: F/u with family to see how pt is doing. On 4/25/06; spoke to (nursing supervisor) today re: event. Telephone call made to client's residence. Spoke with pt's mother. She states "we took him to MD. He didn't give him anything, but we got a script for Benadryl that we're going to have filled today. He's doing fine.
Nine days after receiving injection: 3 1/2" x 4 1/2" area; red, swollen, warm to touch, itchy Benadryl taken orally, Hydrocortizone cream topically, and ice packs
On 4/8/2021, she received her first dose of the Pfizer COVID-19 vaccine.  She felt a little tired after and achy at the injection site but otherwise vaccination was uneventful.  On 4/29/2021, had lunch. Then in the afternoon around 1:30 or 2 pm, she received her second dose in the series.  About 15 to 30 minutes later she had a hive or 2 on her face, so she took Benadryl.  About 4 hours later, upon waking up from a nap, she felt funny.  She had chest pain, dyspnea, throat restriction, panic/anxiety, and the hives were all over her torso and face.  There was no swelling or hives at the injection site.  While en route to the hospital, she used her EpiPen, which helped her symptoms.  In the ED, she was noted to have hives and tachycardia, and was given Ativan.  It took about 3 days for her to feel back to baseline.
After receiving Booster shot on 12/6/2021, had no signs or symptoms.  On 1/29/22, unexpectedly lost all physical movement on the left side of my face.  A doctor diagnosed me with Bell's palsy.  There has been no change in symptoms. I was prescribed VALACYCLOVIR HCL 1 GRAM TABLET to be taken three times a day.  I was also prescribed PREDNISONE 20 MG to be taken 2 times a day.  Both prescriptions are ti be taken a total of 7 days maximum.
Information has been received from a pharmacist concerning an 80 year old male who on 27-NOV-2006 was vaccinated with a dose of PNEUMOVAX 23. Concomitant medication was not reported. On 27-NOV-2006 after receiving the PNEUMOVAX 23 vaccine, the patient had an allergic reaction. The patient swelled up and went to the emergency room. Subsequently, the patient recovered from the events and was release after his recovery. The reporting pharmacist felt that allergic reaction and swelled up were related to therapy with PNEUMOVAX 23 vaccine. No product quality complaint was involved. Allergic reaction and swelled up were considered to be immediately life-threatening. Additional information has been requested.
Pinpoint appearing rash on torso but not hands or feet. Mother reported subjective fever at home.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # M045545 with expiry date:10-JUN-2018 (dosing details unknown) orally for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32F to 35F (35F) for 4 minutes; 32F to 35F (34.7F) for 11 minutes and 32F to 35F (35F) for 4 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1708USA009622: US-009507513-1708USA011662:
Immediately after getting the vaccine I felt really sick like I had the flu. I had an extreme drop in my blood pressure, I felt like I was going to pass out. It lasted for three to five days, I stopped taking my blood pressure medication for those days. The psoriasis on my skin started getting worse. I tried red light therapy and sunbathing. My doctor has helped me to get approved for a biologic that has made life more bearable.
ringing in both ears/ rinigng in one ear; arm was sore; given intramuscular instead of subcutaneous; special senses- ear nerve deafness; otitis media; This spontaneous report was received from a 59-year-old female patient who was referring to herself. The patient's concurrent conditions included hypertension and sleep apnea. The patient had no drug reactions or allergies. The patient mentioned prior to vaccination, she was tired, but at the reporting time she was not.  The concomitant medication included lisinopril (manufacturer unknown).  On approximately 22-JAN-2021 (reported as about 2 weeks ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) intramuscularly (lot #, expiration date, strength and site of administration was not provided) for prophylaxis (reported as vaccination). The patient received the vaccine intramuscularly instead of subcutaneously. On the day the patient received the vaccine, the her arm was sore but it went away the next day. On approximately 25-JAN-2021 (reported as about 3 days after the vaccination), the patient experienced ringing in one ear and then the ringing moved to both ears. The ringing in both ears was ongoing. On an unspecified date, in 2021, the events of nerve deafness and otitis media as a side effect of the vaccine were reported. The outcome of nerve deafness and otitis media was unknown. The outcome of pain in arm was recovered. The outcome of ringing in the ears was reported as not recovered.  The nerve deafness and otitis media was reported as related to the vaccine. The relationship between the pain in arm and ringing in the ears and the vaccine was not provided.   Upon internal review the event of nerve deafness was considered to be medically significant.
No pain or symptoms, but wanted to report an observation: My mensural cycle started a day early after getting the first vaccine, which has not happened in over 10 years.  I am on birth control and my cycle has occurred on the same date and around the same time for 10 years.  A possible link to the vaccine?
While waiting during the initial 15 minutes, I began to feel lightheaded with slight shortness of breath for about 3-5 minutes, The symptoms wore off I waited additional 15 mins with no issue. While driving home face became slighty numb for nearly 20mins. Decided to rest later that evening felt flu like symptoms.  Never had issues with needles or lightheaded issues