chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient had no drug allergies. On 12-APR-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in the left arm (LOT # reported as J00443, which is not a valid lot number for ZOSTAVAX, expiry date was reported as 11-APR-2014). Concomitant therapies included ALLOPURINOL, METFORMIN, ZOCOR, ALDACTONE TABLETS and TRICOR. Approximately on 14-APR-2013 (within 48 hours of receiving ZOSTAVAX), the patient developed nausea, diarrhea, pain all over her body, and redness and pustules on the left side of her body. The patient had sought medical attention. She was evaluated at a medical center. It was unknown if the patient was seen in the emergency room and then discharged or if she was admitted as an in-patient. The patient received FAMVIR, hydrocodone and ZOVIRAX cream as treatment. Patient outcome was not reported. Reporter did not assess relationship between the events and ZOSTAVAX. Additional information has been requested.
is late for the 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 27-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received first dose on 8th February 2021) and Engerix B (received second dose on 9th March 2021).   On an unknown date, the patient received the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that a patient received the first and second dose of Engerix and was late for the 3rd dose. Till the time of reporting, the patient did not receive the third dose, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with US2021174366, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021174366:same reporter
Patient presented 2/21/21 with large hives on front/back of legs and stomach
This patient developed fatigue/pallor and felt cold and shaky a few hours after receiving Bexsero. She did not feel like eating dinner so Mom and Dad were helping her up to bed when she fainted in their arms. She regained consciousness and vomited x1. She felt better the following day.
Administration following temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 26-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5S945, expiry date 6th April 2023) for prophylaxis.   In November 2021, the patient received Boostrix (intramuscular). On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient inadvertently received the Boostrix via intramuscular route in the left deltoid after being exposed to below freezing temperatures, which led to incorrect storage of drug. The reporter consented to follow up.
mild tinnitus right ear began 6 days post first dose, continuous sx for 3 hours, then intermittent for next week, including post 2nd dose
severe chickenpox;then severe h/a, slurred speech, ataxia, n/v, diarrhea,confusion x 24hr;loss of rt side motor control, aphasia;Acyclovir for T102;disch hosp p/ PT, OT, speech rehab;dx viral encephalitis;
rt eye-lid became red & swollen 24hrsp/vax;still swollen 2 days p/vax steadily decreasing in edema
Fatigue, chills, cold sweats. Low grade fever. Lasted around 15 hours
This spontaneous report was received from a healthcare worker/medical assistant and refers to a currently 60 years old female patient with codeine and morphine hypersensitivity. The patient's medical history included Hepatitis C. On 01-APR-2015, the patient was vaccinated with PNEUMOVAX23 (route of administration, dose were not reported, arm, lot number: K009874, expiry date: March 2016). Concomitant therapies included LOTREL, LEXAPRO, hydromorphone, diazepam (manufacturer unknown) and atenolol. On approximately April 2015, the patient experienced pain, redness and swelling that spanned over the entire injection arm. The patient sought medical attention (phone call to the physician). No lab diagnostic test was performed. The patient was advised to apply ice to her arm and call back if the patient would experience fever. It was reported that the patient did not call back. The patient's outcome was not reported. The relatedness between the therapy with PNEUMOVAX23 and the adverse events was not reported. Additional information has been requested.
Tender hyperemic area of 2 x 2 on left arm, site of immunization.
Developed Neuropathy in my feet and hands, which I never had before, to the point I can no longer drive a car. Developed Shingles during the second week of March 2021, and  Suffered a minor Stroke (TIA), during the third week of March 2021.
Pain in the arm of the injection; Tenderness in the arm of the injection; fever; chills; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm of the injection), VACCINATION SITE PAIN (Tenderness in the arm of the injection), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included VITAMIN D NOS and CALCIUM for an unknown indication, LEVOTHYROXINE for product used for unkown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm of the injection), VACCINATION SITE PAIN (Tenderness in the arm of the injection), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown. On 14-Jan-2021, VACCINATION SITE PAIN (Pain in the arm of the injection), VACCINATION SITE PAIN (Tenderness in the arm of the injection), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Palms of hands and fingers got red.  No other rash, no hives.   No symptoms at discharge.  Recovered completely.
Skin condition Morphia showing approximately 1 month post vaccination of Td. Client did not seek medical care until March of 2006. Disclosed to me at visit on 8.15.06 - Client receiving medical care at this time.
Inflammation and pain at the site of vacc, mild subjective fever with bone pain 9/10. Vaccine was applied 09/27/16. Pt came back next day 09/28/16. Ibuprofen 800mg 1 PO q6h PRN. QTY 90.
diffuse erythematous macules numbering 20-30 <1cm scattered on torso, some with 1-2mm central pustules
This spontaneous report as received from a physician assistant, an approximately 33-year-old male who refers to himself. There was no information about the patient's concurrent conditions and concomitant therapies. On an unknown date, the patient was vaccinated with a dose of rabies vaccine (unspecified) before he was vaccinated with HEPTAVAX-B. After he received rabies vaccine (unspecified) he began to feel Guillain-Barre like symptoms with numbness and tingling that started in his feet, which traveled up to his mid-thighs and then went away. On an unknown date (reported as during the Fall 1988 through March 1989), the patient was vaccinated with a dose of HEPTAVAX-B (dose, route of administration, lot # and expiration date were not reported). On an unknown date in late 1989, after receiving HEPTAVAX-B, the patient developed "neurologic issues", which included hand tremors, fatigue in the muscles of his right forearm during writing,  and leg fasciculations. The patient sought medical attention by office visit.  He had performed an electromyogram and a nerve conduction velocity study (dates and the results were not reported). There was no intervention to prevent serious criteria. The outcome of event was reported as not recovered/not resolved. The relatedness between the event and HEPTAVAX-B and rabies vaccine (unspecified) was not reported. Additional information has been requested.
Woke up around 2:00 am on 4/14 with leg pain on left side of lower left leg above the ankle in the calf area.  Felt like pain was moving up leg.  Pain was strong enough to wake me up and was something I never experienced before. Leg is still tender in that spot but there is no bruising or discoloration.
2APR92 mom reported t102 noc of 1APR92; some high pitched screaming; approx 1in redness of rt thigh & firmness; t98 now; advised mom to have pt checked by MD;
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided. The vaccine was administered after 4 days from  time from first puncture.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contain no new significant information,but the event onset and therapy onset date added and  vaccine was administered after 4 days from  time from first puncture was missed and added in narrative
Patient stated he stopped his blood pressure medications 3 days prior to vaccination due to a previous reaction to losartan, a medication he was no longer taking. Patient took aspirin and a MVI on day of vaccination and drank lemon water. Patient developed tingling sensation in his mouth after eating dinner around 18:00. Patient stated he ate tacos with apple cider and noticed tingling after dinner. Patient stated he took two benadryl with no relief. His tongue continued to swell  and he took two additional benadryl at 22:00. Once he developed difficulty swallowing  he went to the emergency department. Patient presented to the ED with tongue swelling and difficulty swallowing.  At 23:57 he was adminsitered 0.3mg of epinephrine IM, diphenhydramine 25mg IV, famotidine 40mg IV, dexamethasone 10mg IV at 0114, methylprednisolone 60mg q6hrs started at 0417, diphenhydramine 25mg q6hrs IV started at 0416, albuterol 2.5mg via neb q6hrs started at 0710
Information has been received from a pharmacist referring to 10 patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (Lot # K021483, expiration date 03-NOV-2016 and Lot# L000456, expiration date 06-JAN-2017), (dose number, route, dosage and frequency were not provided). There was no concomitant medication reported. No adverse event was reported. This is one of two reports received from the same source. Additional information has been requested.
30 min after shot hand began to feel numb & tingly.  Went away.  No treatment.
On 01/25/21, 53 yo F received the Pfizer BTN162b COVID-19 vaccine. ~2-3 hours after the injection, pt developed swelling of eyelids, lightheadedness and nasal congestion. Pt reported similar symptoms related to seasonal allergies which she also experiences at this time of year. Pt self-medicated with fexofenadine (Allegra). Pt notified primary care provider. Pt denied any shortness of breath, difficulty swallowing or rash. Pt was advised to take diphenhydramine 50 mg. In no improvement in swelling, pt was advised to go to urgent care.
Chest discomfort with high heart rate and shortness of breath, dizzy upon standing. In ER HR was 156 with atrial fibrillation with RVR. BP 146/89.  2/7/21 1546 - Patient complaining of left side peripheral field deficit, CT showed subacute right occipital lobe infarct
Information has been received from a physician concerning an 18 month old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 18-OCT-2007 "the patient broke out in varicella-like rash that looked like a breakthrough of chickenpox." Medical attention was sought through the physician. The outcome was unknown. There was no product quality complaint. Additional information has been requested.
Extreme fatigue started around 7:00 PM followed by headache, nausea, feverand pain at the injection site. I slept until 5:00 AM Thursday morning.
No additional AE reported; Nurse reported that PNEUMOVAX 23 was administered to a couple twice. This AE is for the husband. Please see AE case  02256651 for the wife. Patient received one dose of PNEUMOVAX 23 on 9/19/2022 and was accidently given a dose again of PNEUMOVAX 23 o; This spontaneous report was received from a registered nurse and refers to a 89 year old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 19-SEP-2022, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and on 27-SEP-2022, he accidentally received another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U027357, expiration date: 25-MAR-2023), 0.5 mL (route of administration, anatomical location not provided) for prophylaxis (extra dose administered). No additional adverse event was reported.     This is one of 2 cases reported by the same reporter.
Asthma flare up, fever, fatigue, heart palpitations, new mental health issues including suicidal thoughts.
her knee went out/the pain was so bad; This is a spontaneous report from a contactable nurse (patient, self-reported). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 03Mar2021, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received the first dose of the vaccine and then her knee went out on an unspecified date in Mar2021, and she had a steroid injection today on 09Mar2021 because the pain was so bad, and she couldn't take it anymore. The steroid shot was received this morning. She wanted to know if it was okay to get this with the vaccine. She wanted to know if that will interfere with the covid vaccine. She stated she was scheduled for the second dose on 24Mar2021. Outcome of the events were unknown.  No follow-up attempts are possible; information about Lot/Batch number cannot be obtained.
Altered level of consciousness and agitation. Symptoms cont for approx 3 hrs after hosp admission. 6 mos after vax, pt seen multiple times for recurrent abdominal pain and thrombocytopenia.
Left upper arm with about 4cm light erythematous area which is tight and mildly tender to touch.
Pfizer-BioNTech COVID-19 Vaccine EUA Woke up with severe pain in my joints, very tired, all over body aches, migraine and the chills for 2 days and sore/red/hard/hot/raised injection site.  On third day the chills went away and  I was feverish, but still had all the other symptoms.  This lasted  one more day.  I still have the sore/red/hard/raised injection site, but the other symptoms finally went away.
the swelling on his eye; the swelling on his lip; a bit of a allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (the swelling on his eye), LIP SWELLING (the swelling on his lip) and ALLERGY TO VACCINE (a bit of a allergic reaction) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012a21a and 031l20a) for COVID-19 vaccination.     Concomitant products included MOMETASONE FUROATE (ASMANEX) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced EYE SWELLING (the swelling on his eye), LIP SWELLING (the swelling on his lip) and ALLERGY TO VACCINE (a bit of a allergic reaction). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE SWELLING (the swelling on his eye), LIP SWELLING (the swelling on his lip) and ALLERGY TO VACCINE (a bit of a allergic reaction) outcome was unknown.
Developed arm soreness, headache, and right eye swelling with eczema a few hours after 2nd dose. Had whole body aches and chills throughout the night. Woke up with swollen, red, itchy face. Had fatigue and dizziness throughout next day. Side effect subsided within 24 hours. 6 days post 2nd shot, developed face swelling, redness and itch. Woke up the morning of 7 days post 2nd shot with extremely swollen eyes, cheeks and lips that were red and burned. Went to ER and received 3 IV drugs, including Benadryl, took 3d of oral prednisone and also a topical steroid prescribed by dermatologist. Swelling and redness subsided within 48hrs but flared again 14d post 2nd shot.  This flare was mild compared to d7, is limited to mild swelling of lips, redness and itch of lips and eyelids and is being treated with topical steroids.
Patient received booster dose of Pfizer and about a minute after complained of feeling thirsty. Patient had been seated but moved from seat to another seat near the water fountain. I brought the patient some water and stayed with her and her friend. I verified with the patient that she had no issues with the previous shots which she did not. Patient also stated she ate lunch around 1pm and was not aware of any low sugar issues. Patient stated she was not aware of any blood pressure issues. I asked patient if she would like a cold towel which she said yes she would. I went and got a cold pak from the pharmacy and activated it. I placed it in a few hand towels and held it to the patients forehead. After about 5 minutes, the patient stated she felt good enough to go home. Called patient about 20 minutes later and she informed me that she was in the store shopping and feeling fine. She thanked me for the care and concern.
temperature excursion of pentacel vaccine as temperature reached to negative -40f degrees for 8 hours and 25 minutes with no reported adverse event; patient received pentacel post-temperature excursion with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA137908, 2023SA138048 and 2023SA136956.  This case involves an unknown age male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] post-temperature excursion with temperature reached to negative -40F degrees for 8 hours and 25 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included Rototec.  On 18-Apr-2023, the patient received a 0.5 ml dose (frequency: once) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) (lot: UJ753ABA; expiry date: 16-Sep-2023; strength: standard) via intramuscular route in the left thigh for Immunization.  On 18-Apr-2023 the temperature excursion of pentacel reached to negative -40F degrees for 8 hours and 25 minutes with no reported adverse event (product storage error) (unknown latency) and patient received pentacel post-temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  It was reported, "Human Error: UNKNOWN Does extended stability data cover the excursion? No PRODUCT UNOPENED Caller wanted to know if products were given to a patient would they need to call and revaccinate. The caller reported that since the excursion 3-patients received doses of the vaccines; that 2-of the 3-patients received both DAPTACEL and ACTHIB post excursion; and 1-patient received PENTACEL post excursion."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Parent deliberately wrote date of birth incorrectly to ensure child would receive 2nd dose of vaccine. This led to an underage child receiving the Moderna vaccine.
4 mini strokes since 05/10, 3 severe n/v episodes since then, 4-5 vision disturbances that doctors think might be migraine, which she has not history of, since then , all new to patient and not explained by anything.  don't know the cause of the mini strokes and possible emboli in the brain
PATIENT COMPLAINED OF SHORTNESS OF BREATH. PATIENT REFUSED AMBULANCE AND SAID SHE WAS GOING TO USE INHALER THEN GO HOME AND TAKE A BREATHING TREATMENT. PATIENT INSTRUCTED TO GOTO EMERGENCY DEPARTMENT IF SYMPTOMS PERSIST OR GET WORSE.
Patient called and report that she has swelling on face, rash on her arm,vision problems and diarrhea.
Little tired; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little tired) and HEADACHE (Slight headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Allergy: Vaccines (every 2 weeks which she did not take for 1 month before Moderna vaccine).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Little tired) and HEADACHE (Slight headache). At the time of the report, FATIGUE (Little tired) and HEADACHE (Slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: negative (Negative) No antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported. Treatment information were not provided.   This case was linked to MOD-2021-034236 (E2B Linked Report).; Sender's Comments:  MOD-2021-034236:Same reporter