chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. The patient's medical history included chickenpox in childhood. The patient had immunity to Varicella as shown by a Varicella titer test (performed on an unknown date). Concomitant therapies were not reported. On 05-AUG-2015, the patient was inadvertently vaccinated with the first dose of (Oka/Merck) VARIVAX (lot # L004652, exp. 11-FEB-2017, dose and route of administration not reported) instead of MMR II. No adverse effect was reported. Additional information has been requested.
Redness , left deltoid; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient of an unspecified age (reported as 71, unknown unit) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: W62465), via an unspecified route of administration on 26Feb2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness, left deltoid on an unspecified date. Nurse practitioner prescribed Keflex.
Trouble Breathing, worsening as time goes by. Dr's unable to pin point what is causing it.
Information has been received from a registered nurse (R.N.) concerning a 12 year old female who on 18-DEC-1998 was vaccinated subcutaneously with a first dose of VARIVAX (Oka/Merck) (lot # 628147/1262H) in his left thigh. There is no illness at the time of vaccination. On 21-AUG-2008 the patient felt warm. The patient took "vonceted" one time and the symptom improved. On approximately 24-AUG-2008 the patient's mother noted that the patient developed rash. The patient was seen in the office. More than 50 vesicles of varying sizes staged on trunk with face were found. At the time of this report, the events persisted. Additional information has been requested.
Caller is past 35 days from first dose; Soreness to arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Caller is past 35 days from first dose) and MYALGIA (Soreness to arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller is past 35 days from first dose) and MYALGIA (Soreness to arm). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Caller is past 35 days from first dose) and MYALGIA (Soreness to arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
severe redness in left eye; the eye was sore and itching; the eye was sore and itching; pink eye; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 06:15 (Lot number: FK5127) at the age of 11 years as dose 1 (tris), single and administered in arm left, administration date 03Dec2021 17:45 (Lot number: FK5618) as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported OCULAR HYPERAEMIA (non-serious) with onset 15Nov2021 09:30, outcome recovering; EYE PAIN (non-serious), EYE PRURITUS (non-serious) all with onset 15Nov2021 09:30, outcome recovering; CONJUNCTIVITIS (non-serious) with onset 15Nov2021 09:30, outcome recovering. The events severe redness in left eye, the eye was sore and itching, the eye was sore and itching, and pink eye were evaluated at the physician office visit. Therapeutic measures were taken as a result of ocular hyperaemia, eye pain, eye pruritus, and conjunctivitis. No other vaccine in four weeks. After the first dose, on day three appeared to get symptoms of what we thought was pink eye. No fever, no discharge, but had severe redness in left eye. Later in the evening, the eye was sore and itching. Went to Urgent Care and was given drops and cleared with a few days. After second vaccine, the same thing has occurred again but in the right eye this time. This is the first time ever experiencing issues with eyes, so not a normal occurrence. Resulted in Doctor or other healthcare professional office/clinic visit. Treatment included eye drops. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter knew the 3 people who got shingles days after getting the vaccine. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case has been linked to the case US2019AMR070828 and US2019AMR070827, reported by same reporter.
got flu; Initial information received on 18-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who got flu after receiving vaccine Influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor   On an unknown date, the patient received a  dose of suspect Influenza vaccine produced by unknown manufacturer (dose, strength, form, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient got flu (influenza) (unknown latency) following the administration of Influenza vaccine.   It was unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got flu).  At time of reporting, the outcome was Unknown for the event got flu.  The patient was hospitalized for this event.; Sender's Comments: Sanofi Company Comment dated 18-Jan-2023: This case involves an unknown age and gender patient who got flu after receiving vaccine Influenza vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Approximately 12 hours after the vaccination was administered I began to feel chills and then sweats. Fever ranged anywhere from 101-102. Was vomiting and the nausea lasted for about 6 hours.  Currently still feel achy and have pain in stomach, chest and jaw.
Extreme pain at injection site, sharp intermittent head pain  on left side, stomachache
A physician reported that a 5 or 6 month old infant received Rota Shield and subsequently became lethargic and vomited 1 to 2 weeks following receipt of the vaccine. The infant was hospitalized. Abdominal x-ray was neg. The infant was discharged from the hospital. No further information was available at the date of this report.   Follow up information received form the physician indicated that the infant recovered.
diarrhea; This is a spontaneous report from a contactable consumer (husband) or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 30Jan2021 as DOSE 1, SINGLE for covid-19 immunisation (Age: 70; Unit: Unknown). The patient medical history and concomitant medications were not reported. The patient experienced diarrhea on 04Feb2021. Therapeutic measures were taken as a result of diarrhea (still trying to treat the diarrhea). Caller states that the patient is supposed to receive the second dose on 20Feb. Caller asked if the patient can receive the second dose safely or if they should hold off on the second dose. Outcome of the event was unknown.  Information about lot/batch has been requested.  Follow-up attempts are completed. No further information is expected.
Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd December 2019 16:30, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, 23 hrs 30 min after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. At around 4:30 PM, the patient received a dose of Shingrix. On 23rd December 2019 at 4:00 PM, the patient experienced diarrhea. The reporter stated that her pharmacist told her not to be around any babies for about 2 weeks after the vaccine.   The discussed vaccine not being live and advised caller that her pharmacist could call for more information. The reporter consented to follow up.
Patient had routine MMG that picked up breast mass, DCIS by bx. She has no family hx of breast CA and has had 5 covid mRNA shots (Moderna), last one was 10/6/22.
I had fatigue, yeast infection, congestion, Covid positive, insomnia and swollen lymph node.
Patient had pain at the injection site for three days. Starting on 9/13/2021, he had his first allergic reaction. A rash (red pimples beneath the skin) started on his ankles and wrists. The rash was itchy and scratching led to small scabs. The rash then spread to the area between his abdomen and knees. It then spread to his upper chest. Most of the rash was gone by 9/28/2021 (15 days). The second allergic reaction occurred at the injection site. On approximately 9/17/2021 he had a reoccurrence of a pain at the injection site. He described it as a "joint like pain." It was painful enough that it made sleeping on his right side uncomfortable. This pain lasted until 10/11/2021 (25 days). No treatment.
Moderna COVID-19 Vaccine EUA Extreme soreness in shoulder & achy, but then a red rash developed under injection site. It lasted for about 24 hours, staying relatively the same size (approx 3.5" around) Sore & swollen but not burning or itchy feeling.
Nausea, vomiting, sore arm, redness, swelling, warmth, headaches, body aches, hot flashes, mind fog, fatigue, racing heart lasting 5 days.
tingling; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was apprx 54 year old activities coordinator at a long term care facility. She had first dose of vaccine and had tingling. She was wondering how long the tingling will last and will it ever go away? She was also asking what did the expiration date mean. The event outcome was not resolved.  Information on the Batch/Lot number has been requested.
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (frequency: one, route: subcutaneous or intramuscular, lot # L022262 with expiration date 05-NOV-2016; dose was not reported). No adverse effects were reported. Additional information has been requested.
I did not have an adverse reaction to the vaccine. I have tested positive for COVID-19 twice since receiving the vaccine. Tested positive for COVID-19 on 10/02/2022, I had a telehealth with my provider. I did not get a prescription. I was advised to rest and take over the counter medication. Tested positive for COVID-19 on 02/15/2023, I did not seek medical care after testing positive for COVID-19. I was very tired for two days and had brain fog. I had minor cold symptoms with a cough, congestion and coughing. I had a weird, odd symptom with each COVID-19 infection and that was sadness. As of today, I did not have any lingering symptoms.
arm soreness; pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and pain. Shingrix was discontinued. On an unknown date, the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix.  Additional details were provided as follows: The age was not reported but capture as an adult as per vaccine indication. The reporter reported that he knows 5 different people who did not got second dose of shingrix due to arm soreness and pain. He also reported that one patient was at the clinic but had no information about that patient. The reporter consented to follow up. This is 1 of 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021054377:same reporter US-GLAXOSMITHKLINE-US2021AMR055619:Original Case : US2021054379 US-GLAXOSMITHKLINE-US2021AMR055620:Original Case : US2021054379 US-GLAXOSMITHKLINE-US2021AMR055618:Original Case : US2021054379
Fever, headache, chills , sore arm with swelling , redness, painful to touch and hot on injection site.
Dizziness and vertigo starting 30 mins after injection and continuing intermittently for 12 hours
Experienced chest tightness and heaviness and asthma like symptoms starting about 45-60 minutes after vaccination. Went to the Emergency Room for testing and treatment.
Pt developed an injection site reaction characterized by pain, redness and swelling.  Pt also developed painful axillary lymph nodes.
Was seen for WCC on 5/17/12 & vaccinated with VARIVAX. Seen again in office 5/25/12 and diagnosed with chickenpox. Also diagnosed with impetigo from scratching sores. Currently infected.
Employee complains of pain and stiffness in left shoulder joint that did not resolve after one month after receiving flu vaccine injection. She stated she is concerned it was administered too high. Symptoms not relieved with home care of alternating heat and ice to affected area, rest, and taking usual over the counter pain medications.
Post vaccination the pt had a reaction from the injection site and down. the pt's arm was sore, red, and warm to the touch. Follow up information indicated that the patient also experienced edema. the symptoms occurred not just at the injection site but from the upper arm to the elbow. The pt was treated with a cold compress to the area and he was given Benadryl and Advil. Upon receipt of returned correspondence the pt is no longer symptomatic.
Per mother, the child woke up the next morning with excessive pruritis of the injection site. She was scratching at the area incessantly. She also developed a "raised, red, sore" area at the injection site  that remained for around 10 days. Since then, the edema and itching has been coming and going. Appears better one day and then returns.
Felt a little off; Pneumonia; This is a spontaneous report from a contactable consumer (patient's daughter). A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 16Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history included deaf. Concomitant medications were not reported. Reporter stated that a week and a half after his first vaccine he had pneumonia (Mar2021); but that they didn't think it was related to the vaccine. The patient also felt a little off on 16Mar2021 and required a visit to the emergency room and physician office. The facility where the vaccine was administered was in a clinic. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no family medical history relevant to events and no relevant tests done. Outcome of the event pneumonia was unknown while not recovered for the other event. The reporter mentioned that they didn't think that pneumonia was related to the vaccine.   Information about the Lot/batch number has been requested.; Sender's Comments: Based on available information, pneumonia is assessed as unrelated to BNT162B2, this is an intercurrent medical condition. Potential contributors include patient's advanced age as the risk for infections is higher in this population. Case will be  reassessed if additional information is received
Pt received a flu shot on 10/19/2010. He went to see ARNP on 11/17/2010 with c/o tingling and numbness in his feet, from his ankles down. Pt stated that these symptoms started approx a week ago. He also c/o some visual disturbances at times; left lower lip numbness. He was also experiencing some difficulty with walking d/t the numbness. He had just returned from a trip the day before he went to doctor. His wife stated that she had to assist him with walking while on their trip. Labs were done after doctor visit: CBC, CMP, TSH, D-Dimer, UA, HgA1C and a CT of his head was also ordered to rule out a CVA. Family requested that he follow up with a neurologist. Neurology consult was done on 11/23/2010. He had an MRI done that showed multilevel spinal stenosis. His CBC, Sed rate, Creatinine, T4, TSB and B12 were all normal. His Glucose was mildly elevated along with his BUN. Calcium levels were elevated. Albumin level down and his CPK was elevated. He was sent to a rehabilitation facility where his condition continued to decline. He returned to the neurologist on 12/07/2010 where he had a lumbar puncture done with the results being normal. The doctors felt he had acute inflammatory demyelinating polyradiculoneuropathy and chronic inflammatory demyelinating polyneuropathy. An EMG was conducted that showed significant demyelination. Patient has NKDA. Diagnosis: DM II, HTN, BPH. Currently medications: ASA 81 mg PO daily, Vit DS 1000unit PO daily, SENSIPAR 30mg PO BID, PEPCID 20mg PO BID, PROSCAR 5mg PO daily, NEURONTIN 100mg PO daily, Heparin 5000units sq every 12 hours, PRIVIGEN (IG) 40gram IV every Monday and Thursday, MIRALAX 17grams every day, Hydrocodone5/325mg PO 2 tabs every 6 hours as need for pain, MOM 30cc PO prn daily at HS, LEVAQUIN 500mg PO daily for 5 days (starting 12/28- has UTI), Metformin 500mg PO BID.
Fast Heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced HEART RATE INCREASED. At the time of the report, HEART RATE INCREASED outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 26-Feb-2021, Heart rate increased to 100-105 (High). Patient had increased heart beat ranging 100-105.         No concomitant medications were reported  No treatment medications were reported
Started with pain at injection site that radiated across back neck into other shoulder first night after injection. First full day after injection joint pain in elbows and lower back, extreme tiredness. The second full day the top of my foot was in excruciating pain to the slightest touch. I could not put any weight on my foot. The third day the pain in my foot was improved. By the fourth day my foot felt back to normal. I had a 3 inch by 3 inch red, raised, warm to the touch area right above the injection site that appeared within hours of the shot that last for 4 days.
Booster; sick; fever; flu like symptoms; blood pressure has been high ever  since 140's over 80's; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 14:00 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "CPTSD" (unspecified if ongoing), notes: other medical history: CPTSD; "Asthma" (unspecified if ongoing); "Auto immune illness" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing), notes: Known Allergies: Sulfa. Concomitant medication(s) included: SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLOVENT; FIORICET. Past drug history included: Tegritol, reaction(s): "Known allergies: Tegritol", notes: Known Allergies: Tegritol; Haldal, reaction(s): "Known allergies: Haldal", notes: Known Allergies: Haldal. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534,, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 22Mar2021, when the patient was 49 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EWO158, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 12Apr2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Nov2021 14:00, outcome "unknown", described as "Booster"; ILLNESS (non-serious) with onset 01Nov2021, outcome "unknown", described as "sick "; PYREXIA (non-serious) with onset 01Nov2021, outcome "unknown", described as "fever"; INFLUENZA LIKE ILLNESS (non-serious) with onset 01Nov2021, outcome "unknown", described as "flu like symptoms"; HYPERTENSION (non-serious) with onset 01Nov2021, outcome "unknown", described as "blood pressure has been high ever since 140's over 80's". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine; List of any other medications the patient received within 2 weeks of vaccination: Singular, Zertec, Flovent, Fiorcet. Patient stated that she was sick for a week, fever, flu like symptoms, her blood pressure has been high ever since 140's over 80's.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.