chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after receiving the PNEUMOVAX 23 vaccine she experience chills and slight fever for a day or two; after receiving the PNEUMOVAX 23  vaccine she experience chills and slight fever for a day or two; This spontaneous report was received from a female consumer of unknow age referring to herself. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 14-NOV-2020 (reported as last Monday),  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) as prophylaxis (concentration, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).     On 14-NOV-2020, the patient experienced chills and slight fever (pyrexia) for a day or two.  The patient recovered from the events on an unspecified date in November 2020.  The causality assessment between the suspect product and the aforementioned events was not provided.
joint pain; feels like bursitis; became painful and weak; became painful and weak; This is a spontaneous report received from a contactable consumer or other non hcp via a Regulatory Authority. A 59-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: #R8727), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 09:00 (at the age 97-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included fibromyalgia, glucose tolerance impaired, limb injury (Had a previous injury there decades ago) from an unknown date. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, has the patient been did not tested for COVID-19. The patient experienced joint pain, feels like bursitis, became painful and weak, became painful and weak on 10Apr2021. It was reported that "General joint pain and a few days later in left arm (shot arm) at deltoid feels like bursitis) became painful and weak. Had a previous injury there decades ago. After second shot overall joint pain increased and left arm got worse (second shot in right arm) Sacroiliac became very inflamed and painful (site of other old injury) Then right deltoid pain (feels like bursitis) Still battling mild to severe pain over a month after second shot. Some daily vertigo moments but dissipating". Outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
IGG was greater than 4000, other one positive, greater than 160; Hives; rash; I believe it to be Shingles.; night itching; This case was reported by a consumer and described the occurrence of hives in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 13th August 2021, the patient received Shingrix and Tdap Vaccine. On 18th August 2021, 5 days after receiving Shingrix and Tdap Vaccine, the patient experienced hives, rash, shingles and pruritus. On 7th October 2021, the patient experienced immunoglobulin g increased. The patient was treated with allergy medication {nos} (Claritin (Allergy Medication Nos)), famotidine (Pepcid Ac), fexofenadine hydrochloride (Allegra), hydroxyzine, mometasone (Mometasone Cream), methylprednisolone (Medrol Dose Pack), benadryl (nos) (Benadryl) and prednisone burst packs. On an unknown date, the outcome of the hives, rash, shingles and pruritus were recovering/resolving and the outcome of the immunoglobulin g increased was unknown.   It was unknown if the reporter considered the hives, rash, shingles, pruritus and immunoglobulin g increased to be related to Shingrix and Tdap Vaccine.  Additional details were provided as follows: The reporter was the patient. The patient required urgent care for hives, rash, shingles after vaccination with Shingrix and Tdap Vaccine. The patient prescribed with Prednisone Burst, Medrol dose pack and was instructed to take Claritin. The patient instructed to continue taking Claritin and Pepcid AC in the morning and Benadryl in the evening. The patient belived it to be shingles. On 16th September 2021, the dermatologist prescribed 15 days of Prednisone, and continued with Claritin and Pepcid AC. She also prescribed Hyrdroxyzine for the night itching and mometasone cream. This regimen seemed to have calmed it down tremendously. On 7th October 2021, the patient was off Prednisone and felt the hives or rash beginning again. The Allergest instructed to take Allegra & Pepcid AC in the morning, Clartin and Hydroxyzine in the evening, which helped. The patient had some blood tests and according to the results, immunoglobulin g was greater than 4,000, other one positive, greater than 160. The Allergist recommended not to take the 2nd shot unless they could do a patch test with the 2nd shot. The patient asked was there a way to have a sample sent to Allergist so that he could perform a patch test or did recommend not to take the 2nd shot.
lump apple sized at injectio site-feel bad for a week, not this time, lethargic
Limited range of motion (eg. cannot comb her hair); Extreme soreness at the arm where it was administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Extreme soreness at the arm where it was administered) and INJECTED LIMB MOBILITY DECREASED (Limited range of motion (eg. cannot comb her hair)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PAIN (Extreme soreness at the arm where it was administered). On 21-Feb-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Limited range of motion (eg. cannot comb her hair)). At the time of the report, VACCINATION SITE PAIN (Extreme soreness at the arm where it was administered) outcome was unknown and INJECTED LIMB MOBILITY DECREASED (Limited range of motion (eg. cannot comb her hair)) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
no adverse event; one dose of Moderna Bivalent vaccine was administered beyond 12 hrs post punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (one dose of Moderna Bivalent vaccine was administered beyond 12 hrs post punctured) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (one dose of Moderna Bivalent vaccine was administered beyond 12 hrs post punctured). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (one dose of Moderna Bivalent vaccine was administered beyond 12 hrs post punctured) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (one dose of Moderna Bivalent vaccine was administered beyond 12 hrs post punctured).    Concomitant medication not reported. Treatment medication not reported.
Shoulder blade pain. Did not notify provider until 11/4/16. She states the shot burst her bursa sac. Provider could see the bruise where the shot was given and it was not close to the bursa. No pain at the injection site only in her back.
The person developed some numbness to the left cheek of the face. We watched the individual and held her for additional 30 minutes and then she states she had tightness in her chest. She was seen in the ED. No other symptoms developed at this time. She was given pepcid and benadryl in the ED. She was told she had a mild anxiety attack but she states the medications did help.
C/O vomiting/diarrehea approx. 4 hours after receiving flu shot.  Fever, aches, same evening. Fever, vomiting resolved 11-02-03 evening. Imodium AD controlling diarrhea, still some aches.
I had a ringing on my left ear and I'm still experiencing it 7 days after it started. This began two hours after the vaccine. I was told my doctor that if the ringing continued to contact an ENT, I saw one this week, and they performed an MRI to check if there were any issues. They didn't notice anything and applied an ear steroid injection. They didn't give me an oral injection, so that it wouldn't interfere with my vaccine.
pt recv vax 30SEP96 & pt exp swelling in breast area & the entire arm where pt recv vax;
haven't felt like herself; dizziness/lightheadedness; stomach started to turn/nausea; no ambition; stomach pain; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that she haven't felt like herself. She woke up in the morning and felt good but by 2pm, she experienced dizziness/lightheadedness, stomach started to turn/nausea, no ambition and stomach pain. She took a pain pill and sat down for a couple of hours and then the stomach pain resolved. She wanted to know if these were all normal and if she should get the second dose given the side effects that she experienced. The outcome of the event stomach pain was recovered on an unspecified date while unknown for the other events.  Information on the batch/lot number has been requested.
no adverse effects reported; improperly stored dose of vaccine was administered to the patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 30-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R024144, expiration date: 23-AUG-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA004595: US-009507513-1905USA011854: US-009507513-1905USA011855: US-009507513-1905USA011856: US-009507513-1905USA011857: US-009507513-1905USA011858: US-009507513-1905USA011859: US-009507513-1905USA011861:
This spontaneous report as received from a consumer refers to her 78 year old husband with high blood pressure, depression, gout, allergy to "caines" and prednisone. On 16-MAY-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # not reported) subcutaneously. The consumer reported that on 13-JAN-2014, the patient had a routine blood done and the patient's platelet count decreased. The patient had follow up tests performed and the results showed the patient's blood platelet counts continuing to decrease. The patient did not receive treatment for the adverse event. At the time of the report, the patient's outcome was unknown. Additional information is not expected as the reporter did not wish further contact.
Pt developed a warm, red and swollen wheal (3"-5") around site of DTAP injection. Pt complained of pain at site. Signs appeared on 8/1/01.
undiluted vial of the Pfizer BioNtech covid 19 vaccine was drawn up and given to a patient in a single dose/ received a whole vial of contents that were undiluted; undiluted vial of the Pfizer BioNtech covid 19 vaccine was drawn up and given to a patient in a single dose/ received a whole vial of contents that were undiluted; This is a spontaneous report from a contactable pharmacist. A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8735; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration on 07Jun2021 09:00 (at the age of 36-year-old) as 2nd dose, 0.3 ml single dose for COVID-19 immunization. The patient medical history was none (Patient History: No). The patient's concomitant medications were none reported (Other Products: No). The patient previously received first dose of BNT162B2 (Lot Number: ER8734; Expiration Date: 31Jul2021) on 17May2021 for COVID-19 immunization. Pharmacist reported that an entire undiluted vial of the Pfizer BioNtech covid 19 vaccine was drawn up and given to a patient in a single dose (07Jun2021 at 09:00). Patient was informed of incident and monitored for 30 minutes. States when he got here this morning, one of his partners had administered an undiluted vial of contents to a patient without knowing he had to dilute it. Pharmacist stated he was calling to see if there was any further insight or anything else they need to do. Pharmacist states he had already done a VAERS report and an incident report on the end. Pharmacist clarified the patient received a whole vial of contents that were undiluted. Pharmacist states it had previously been unopened. Pharmacist stated this occurred today at 09:00 a.m. Treatment was none, states he seemed okay, and they kept him in the lobby. States it was his second dose in the series. Pharmacist again confirmed that patient was given 0.3mL of the undiluted vaccine out of the vial, and not the full 0.45mL. Just a single dose of undiluted vaccine. The patient was monitored and told to call if any adverse events developed. He was relaxed and calm during the monitoring and did not have any reaction. There was no investigation assessment. The outcome of events was unknown.; Sender's Comments: Based on the narrative information provided the events Overdose and Product preparation issue are related to BNT162B2 (COVID-19 mRNA VACCINE).
On 9/29/99, the pt presented to a physician with cellulitis around area of injection site. Treatment with steroids was initiated and was followed by resolution of symptoms. No further information is available.
Complained of feeling weird/ tingly.  No sense of pain to pinch.  Dulled responses. Acting  without inhibition- wanted to pour water all over self, sleep face down in the grass, fly a plane.  Acting inebriated or drugged.
Redness, slight swelling and firmness around vaccination site, itchy , about 3? in diameter.  Treating with Benadryl tablets and corticosteroid cream.
My symptoms, I had a scratchy throat, a couple days later I felt like my spine had a fever, my body hurt so bad and I had a cough.
High fever (101.5), extreme body aches, lower back and hip pain, sciatica, chills, dizzy
Moderna COVID-19 Vaccine EUA.  Chills, Fever, Aching Joints, Aching Muscles, Runny Nose & Eyes, Shortness of Breath
I had a chills and fever of 102.  Coughing and runny nose. I had a bad headache. I went to the ER and they just told me to take over the counter medicine to relive fever and symptoms. They to me to rest and to drink lots of fluids. Fever went away after 2 days but still had cough really bad. I still have it at time with shortness of breath.
PATIENT REPORTED THAT DURING THE FIRST 15 MINUTES POST-VACCINATION SHE HAD TYPICAL SIDE EFFECTS (SORNESS AND REDNESS AT THE INJECTION SITE). SHE REPORTS THAT APPROXIMATELY 2 HOURS POST-VACCINATION HER ENTIRE TONGUE TURNED WHITE AND THAT IT IS STILL DISCOLORED 2 DAYS POST-VACCINATION. SHE ALSO REPORTS THAT SHE IS UNABLE TO TASTE MOST FOODS/DRINKS UNLESS THEY ARE SWEET.  AT THIS TIME, I RECOMMENDED A WATCH AND WAIT APPROACH AND THAT SHE REPORT THIS TO HER PHYSICIAN. SHE DOES NOT RECALL HAVING COVID AT ANY POINT IN TIME.
31-year-old gentleman with history of no known chronic medical problems who presented with acute chest pain. Lab evaluation revealed significantly elevated troponin EKG revealed ST elevations reciprocal ST depressions. Echo findings show LV dysfunction with an EF between 35 to 40%. with the most likely cause of  non-ischemic cardiomyopathy, specifically noted Takotsubo CM  (stress induced) although he did receive his second dose of mRNA vaccine 2 days prior to the event.
Pt received Shingrx on Saturday, May 27 2023 at 3 pm.  Patient started having dry heaves at 4 am on 5-28-23.  Difficult breathing, fatigue and had difficult standing on her own. Family then attended the patient with assistance on getting oxygen and laying with her to calm her down.  She did get calmed but passed away at approximately 8:30 am on that same day.  No ambulance or dr's were  involved.   Not sure if Shingrix was involved, but we are reporting at this time.
It was my third COVID-19 shot. After each one my environmental allergies became very bad for a couple weeks. After the third shot they were awful for two months. Things I was never allergic to before I was allergic to. For example, red wine. It instantly made my throat itchy and I needed to take Benadryl. I was horribly sick for 3 days after trying to drink one glass. I had to take lots of medicine to control my allergies during that time and then suddenly it was fine about two months later.
Patient admitted to the hospital for COVID 19. Reporting per Janssen COVID vaccine EUA.
Following tetanus shot after leaving center, donor experienced chills, sore throat, dizziness, and congestion through next day.
Injection site pain; This is a spontaneous report received from a contactable nurse. The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), intramuscular, administered in arm left, administration date 27Dec2020 14:00 (Lot number: EH9899) at the age of 27 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Birth control" (unspecified if ongoing). Concomitant medication(s) included: JUNEL FE taken for contraception, start date: 2012 (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Dec2020 03:00, outcome "recovered" (28Dec2020 15:00), described as "Injection site pain". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: The patient provided information regarding the reported adverse event with the use of the product. The patient considered that the Pfizer product had a causal effect to the adverse event. The only reaction to the first shot was injection site pain for about 12 hours.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122919 Same patient and product; different events and dose
Mom states the pt had a high pitched cry, unconsolable for four hours and she was controlled temporarily with breast feeding. She was brought to the ER for evaluation, no fever, no vomiting, no diarrhea, no URI, and appetite's fine. She was diagnosed as "fussy baby-no fever."
30 minutes after receiving flu vaccine she had a local reaction as well as throat swelling, palpitations, and difficulty breathing.
Painful vesicular rash on trunk, right side, 4 weeks. Rapid onset of symptomatic wet macular degeneration, 2 days after vaccine. Noted visual field low - not present before. Recurrence of painful vesicular rash (R) trunk (March 2015).
Pt became very fussy with a fever of 102F and was crying constantly in the office. The fever started early AM. She was hospitalized to r/o sepsis.
Administered expired vaccine outside of 12 hour window/ realized the vial had expired in the 12 hour window; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine outside of 12 hour window/ realized the vial had expired in the 12 hour window) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-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 EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine outside of 12 hour window/ realized the vial had expired in the 12 hour window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine outside of 12 hour window/ realized the vial had expired in the 12 hour window) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment drugs were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received on 29-JUN-2021, Contains Non-significant information. Degree of the Primary Reporter: Pharm D.
This case was reported by a healthcare professional and described the occurrence of swelling in a 64-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject's medical history included local reaction to intravenous dyes and local reaction to bee sting. Previous and/or concurrent vaccination included yellow fever vaccines (non-gsk); Sanofi; unknown; unknown given on 15 July 2010. On 15 July 2010 the subject received 1st dose of TWINRIX (1 ml, unknown route, left arm) as part of the accelerated dosing regimen. On 16 July 2010, 1 day after vaccination with TWINRIX, the subject experienced swelling, hives under arm and itching under arm. On 17 July 2010, the events were resolved. After the next vaccination with TWINRIX the events recurred. On 22 July 2010 the subject received 2nd dose of TWINRIX (1 ml, unknown route, left arm). On 23 July 2010, 1 day after vaccination with TWINRIX, the subject experienced swelling, hives under arm and itching under arm. On 25 July 2010, the events were resolved. The healthcare professional considered the events were related to vaccination with TWINRIX. The subject did not inform the healthcare professional of the adverse events experienced following the 1st dose of TWINRIX. He received the 2nd dose and the reactions were more exaggerated and lasted a little longer. The reporter did not know whether the reaction was systemic or localized. The reporter had initially thought that the yellow fever vaccine could be a co-suspect vaccination. However, they now believe that TWINRIX was the cause because the events recurred after the 2nd dose and were worse. Follow up information was received on 16 August 2010. It was reported that the 2nd dose of TWINRIX was given intramuscularly. It was noted that the accelerated dosing schedule of TWINRIX was postponed while waiting for primary care physician recommendation.