chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had extreme chills ,chills went all the way to the bone; After the second dose I was sick as a dog for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (After the second dose I was sick as a dog for 2 days) and CHILLS (Had extreme chills ,chills went all the way to the bone) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (After the second dose I was sick as a dog for 2 days) and CHILLS (Had extreme chills ,chills went all the way to the bone). At the time of the report, ILLNESS (After the second dose I was sick as a dog for 2 days) had resolved and CHILLS (Had extreme chills ,chills went all the way to the bone) outcome was unknown.            Relevant concomitant medications were not provided.  Patient was sick for 2 days. Patient was informed to take the 3rd dose.  Treatment medication was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Reporter did not allow further contact
Pt received Dtap, Polio and MMR today in child health clinic between 2-4PM. Mom stated child began to have whelps with redness and itching and eyes began to swell around 10PM. Tx with Zyrtec and Ospred d/t. MD confirmation of allergic urticaria lively to vaccination.
At 9:00 PM started with rash (hives).  Very itchy.  Some difficulty breathing, relieved with Albuterol inhaler.  Took Benadryl at 9:30 AM with effect.  Patient reports some discomfort in right arm.  Advised to take Zyrtec if symptoms persist.  Hives on right arm.
No Adverse Event; Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients) and NO ADVERSE EVENT (No Adverse Event) in an 8-month-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients).    No concomitant medications were provided. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Vaccine information reported. On 28-Feb-2023: Follow up received contains no new information. On 28-Feb-2023: Patient demographics reported and vaccine details reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 1
Fever to 103, down to 99.9 by next day.  Chills, fatigue.
administered an expired dose of Daptacel (expired on 21-Jun-2023) with no repported adverse event; Initial information was received on 26-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 years old and unknown gender patient who experienced administered an expired dose of daptacel (diphtheria-15/tetanus/5 ac pertussis vaccine) (expired on 21-jun-2023) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Jun-2023, the patient received a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (Suspension for injection) (lot C5893AA, expiry date : 21-Jun-2023) (strength unknown) via unknown route in unknown administration site for Immunization.  On 26-Jun-2023 the patient developed a non-serious event of administered an expired dose of daptacel (expired on 21-jun-2023) with no reported adverse event (expired product administered) (latency : same day) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken with DIPHTHERIA, TETANUS and acellular pertussis vaccine (Daptacel) was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired dose of daptacel (expired on 21-jun-2023) with no repported adverse event.  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.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "NASH" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: Sulfa, Eryromycin. Concomitant medication(s) included: LEVOTHYROXINE, start date: Jun2019; LOSARTIN, start date: Apr2018. Past drug history included: Keflex, reaction(s): "known allergies: Keflex", notes: known allergies: Keflex; Erythromycin, reaction(s): "known allergies: Eryromycin", notes: known allergies: Eryromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other vaccine and medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 26Aug2023 till 30 Aug2023  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 physician concerning a 14 year old male who on 07-DEC-1996 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported). On 03-MAY-2000, the patient was vaccinated with as second dose of MMR II (route, site, dose and lot number not reported). On 01-DEC-2009 the patient experienced mumps. (thought the date diagnosed was reported as 31-DEC-2009). The patient was afebrile. The outcome for mumps was not reported. Follow up information was received from a physician who reported that the patient was 14 year old who on 20-JAN-2010, experienced mumps. ON 21-JAN-2010, the patient was diagnosed with swollen left cheek and left parotitis. It was unknown if patient had orchitis. The patient had no other symptoms. The first work was performed on 21-JAN-2010 and the results were: IgM: <1:10; IgG: 5.32 and serum amylase: 189. The patient was diagnosed with mumps on 21-JAN-2010. This is one of several reports from the same source. No further information is available.
pain on her feet; pain mostly on her knee; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on her feet) and ARTHRALGIA (pain mostly on her knee) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 immunisation.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Aspirin Allergy).   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain on her feet). 28-Mar-2021, the patient experienced ARTHRALGIA (pain mostly on her knee). In May 2021, PAIN IN EXTREMITY (pain on her feet) and ARTHRALGIA (pain mostly on her knee) had resolved with sequelae.            Concomitant medications were not provided Treatment information was not provided. Patient Reported that she was Recovered with residual effects (Knee Pain). Patient had experienced similar event in the past (Light knee pain) but it was not that painful. Her knees hurt when she walked.   This case was linked to US-MODERNATX, INC.-MOD-2021-035726 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received: Added Patient Demographics, Medical History, Vaccine Information (site), Event outcome (Recovered/Resolved with Sequelae).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-035726: 2nd dose.
Left arm rash. 24hrs of injection Steroid cream, benadryl, Claritin unable to resolve rash Oral steroids prescription by MD day 6
shingles rash; rash; This case was reported by a physician via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced shingles rash three days after administration. The reporter was not sure if it was 1st or 2nd dose for patient. No further information reported. The reporter consented to follow up. This case has been linked with case US2021094202, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094202:same reporter
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. The patient has no pertinent medical history or concurrent medications. Patient has no known drug reactions/allergies. On 06-JAN-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, Lot # K009874 expiration date on 19-MAR-2016, 0.5 ml, intramuscular. Co-suspect therapies or concomitant medications were not provided. It was reported that patient contacted pharmacist on 08-JAN-2015 stating that she was experiencing redness, soreness and itching at injection. The pharmacist advised patient to take TYLENOL for the soreness and at an unspecified time later, patient took BENADRYL. Pharmacist stated that patient was recovered on 10-JAN-2015 from adverse events. The relatedness between the events and suspect therpay was not provided. Additional information has been requested.
IT WAS A VERY BUSY DAY ON A MONDAY AND I WAS GIVING MANY VACCINES. I HAD GIVEN 2 MODERNA SHOTS BACK TO BACK AND I THOUGHT THAT THIS WAS ALSO MODERNA BUT IT WAS SUPPOSED TO BE THE 2ND DOSE OF PFIZER.  I REALIZED IT AFTER I GAVE IT WHEN I WAS ABOUT TO GIVE THE CORRECT 2ND DOSE OF PFIZER TO HER MOM. MOMWAS NERVOUS AND A LITTLE UPSET.   I IMMEDIATELY APOLOGIZED AND DOUBLE CHECKED WITH THE OTHER RPh ON DUTY TO CONFIRM THAT THEY'RE BOTH INTERCHANGEABLE AND IT'S THE SAME FORMULATION.   MOM FELT BETTER AFTER HEARING THAT IT WAS OKAND NO HARM WOULD BE DONE TO HER DAUGHTER.  I APOLOGIZED AGAIN AND SHE WAS FINE AFTER THAT.
my head is looking terrible; This is a spontaneous report from a non-contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that AstraZeneca patient doctor gave AstraZeneca Vaccine a month ago. Then it was successful. Numbness and pressure on the left side of my head. Second Vaccine Biontech, there was no problem in it. But patient head was looking terrible. The patient afraid of thrombosis. Outcome of event was unknown.  Follow-up attempts were completed. No further information was expected.
5hrs post vax flu like sxs, chills, sick feeling, aching (went to bed) better later in day
This spontaneous report as received from a physician refers to a 20 year old patient. The patient pertinent medical history was not reported. On 09-JUN-20114 the patient was inadvertently vaccinated with pediatric dose of RECOMBIVAX HB. Concomitant medications were not reported. The physician also stated that the dose given on 09-JUN-2014 would be the patient's fourth dose of RECOMBIVAX HB. The physician stated that the patient had the complete series "as an infant" but that the patient's school was requiring a second series to be administered. No information on titers was reported. No adverse effects reported. The outcome of received pediatric dose and dose given on 09-JUN-2014 would be patient's fourth dose of RECOMBIVAX HB was unknown. Additional information is not expected.
Patient reports that approximately 15 days he attended his primary doctor because he did not feel well and received a diagnosis from Guillain-Barré.
Patient came into pharmacy, a day after getting her 2nd Covid shot.. she woke up with hives on her right side leg and left side lower arm..she stated when she touches them it feels like a bruise.  She stated it has not gotten worse through out the day. Recommended taking Benadryl and if it gets any worse to go to urgent care/hospital. Told to follow up with doctor in the morning, but if gets worse to contact doctor right away or go to urgent care/hospital
p/vax pt devel high fever 103 & had a sz;pt was taken to hosp ER & then transferred to another hosp for observation & tests;febrile sz;
Breakthrough case: I developed symptoms from COVID 19 on 09/24/2021. My symptoms included congestion, difficulty breathing, a painful sinus headache, cough, and I had a fever up to 102.
This spontaneous report was received from a pharmacist refers to a 71 year old male patient. On 01-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J004310. Expiry: 30-JUL-2014). The patient also received a dose of FLUZONE (unspecified manufacturer). The vaccines were delivered into separate anatomical sites, one in each arm. On approximately 03-OCT-2013, on the unspecified arm, which was used to administer ZOSTAVAX the patient experienced redness and a lump at the injection site. The patient came into the pharmacy today, 23-OCT-2013 and there was still a red mark at the injection site for the ZOSTAVAX and now there was redness on the other arm where the FLUZONE was administered. No treatment was given. No medical attention was sought. Pharmacist also stated that there was no itchiness or warmth at the injection sites. The outcome of lump at the injection site was unknown. The outcome of redness at the injection site was not recovered. Additional information is not expected.
patient woke up following morning after vaccine  with lips and face swelling.  she went to urgent care and got Benadryl and Prednisone prescribed and felt relief after a few days.  she is feeling ok now.
Information has been received from a female patient who "about a year ago" in approximately 2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). Patient was administered ZOSTAVAX (Merck) for the herpes zoster relief, after already having shingles and shingles kept coming back. The patient did not seek medical attention. No further information is available.
cortisone shot 2 days after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (cortisone shot 2 days after vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced VACCINATION COMPLICATION (cortisone shot 2 days after vaccine). At the time of the report, VACCINATION COMPLICATION (cortisone shot 2 days after vaccine) outcome was unknown. Not Provided    Concomitant medication was not provided. The caller did not have enough information to indicate what the cortisone shot was given for.   Reporter did not allow further contact
Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a healthcare provider. This case is linked to case 2018SA299777 same reporter. This case involves 87 years old patient who received vaccine FLUZONE HIGH DOSE (batch number, expiry date, dose, route and site of administration were not reported) on 26-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Expired vaccine used. It was reported that give a high dose flu vaccine on September 26, 2018 and it was discovered during charting that the shots were from 2017-2018 flu season. It was unknown if any adverse event was occurred. 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 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. Documents held by sender: none.
I contracted COVID-19 and had typical symptoms of fatigue, fever, chills, and body aches, but I also experienced dizziness. This all lasted for about two days with the exception of the dizziness which lasted a few months. I eventually went to the urgent care clinic on 3/29/22 where the doctor sent me to a physical therapist who instructed me on some exercises which improved the dizziness in just one day.
1 of 4 pts who exp an inject site rxn & fever following vax; pt was seen in office; tx included APAP & cold compresses;
The Pt presents with swelling of her lips 20 minutes following injection of 1 dose Janssen vaccine to the left deltoid. The Pt states that she has had anaphylaxis in the past to Macrobid, Sulfa, Amoxicillin. She has an Epipen at home but states that she has never had to use it because her symptoms develop slowly. In the past she has driven herself to the ER where she has received breathing treatments and observation. Pt denies swelling of the eyes, tongue, throat tightness, difficulty swallowing, itching of the skin, SOB, CP, nausea or vomiting. She also denies dizziness, lightheadedness, or vision changes. The Pt also has a Hx of meningioma and SVT s/p ablation.   Suspicion for anaphylaxis high due to lip swelling, wheezing, and previous episodes of delayed onset anaphylaxis. Pt drove herself today so IM injection of diphenhydramine was delayed. Upon recheck Pt?s wheezing was unchanged and lip swelling had not progressed further. Due to past episodes of SVT and no progression of current symptoms, epinephrine was on stand by but not administered. Care was transferred to EMS.  Care was transferred to EMS and Pt was transported to the hospital.
Hospitalization for acute psychosis/toxic metabolic encephalopathy on dates 7/22/2023-7/24/2023. Treated with no COVID-19 medications.
Described anemia (NOS) in a 59-year-old female who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccinee and has not been verified by a [hysician or other health care professional. Reportedly, the vaccinee was allergic to ampicillin, and dextropropropoxcyphene (Darvocet). Vaccinee had anemia (NOS) at times.  The follow up states the vaccinee had lactose intolerance beginning in 1999. The vaccinee reported that she received her first left deltoid dose of LYMErix on 4/28/99. Three days later she felt fatigued. Reportedly, on 5/28/99, the vaccinee received her second left deltoid dose of LYMErix. She reported that, on 6/6/99, she experienced a drop in red blood cell and hematocrit counts. Her fatigue continued. Reportedly, on 8/9/99 and 8/10/99, repeat lab tests showed continued decrease in red blood cells, white blood cells, and hematocrit. The vaccinee stated that a diagnosis of anemia was made "because I had low RBC, WBC, and HCT counts. Her "B12" was normal, reportedly. She stated that she underwent three occult blood tests, esophagogastroduodenoscopy, and colonoscopy. These tests were reportedly normal. Reportedly, on 9/2/99, lab tests were repeated: WBC was normal, and RBC and HCT were "almost normal." Reportedly, on 10/25/99, WBC, RBC and HCT were all "dropping." No treatment was given. Reportedly, 4/13/00, all lab values were normal. On 1/20/02, the reporting physician stated that on 8/10/99, the vaccinee reported fatigue to  him. Lab analyses performed in August 1999 showed HCT 30%, WBC 3300/cumm, and platelet count of 141,000/cumm. Reporting physician stated htat the fatigue was moderate in intensity and was possibly related to LYMErix. Reportedly on 4/28/00, the vaccinee received her third left deltoid dose of LYMErix. oN 8/23/00, her WBC was "low," and her RBC and HCT were normal. In February 2001, all labs were reportedly normal. As of 9/5/01, the vaccinee's symptoms had resolved.
Pupils dilated (photo available).  Started immediately while at vaccination site, did not notice until we got home and were looking at vaccine photos.  Did not resolve for 48 hours.  (note - 5 year old brother - same reaction but resolved quicker - will make separate report)