chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered pharmacist (R.PH.) concerning a patient who on 01-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# and expiration not reported). On 03-APR-2011, two days later, the patient experienced redness at the injection site. The patient sought unspecified medical attention. No treatment was given for this adverse event. At the time of reporting the outcome of the patient was unknown. Additional information has been requested.
For the patient's second dose, she received undiluted pediatric Pfizer vaccine (0.2mL of undiluted vaccine). Patient's father contacted on the morning of 2/11/2022, when the incident was discovered. Inquired how the patient was feeling, he reported she "felt good" and she was "fine" after receiving her vaccination. He disclosed no concerns at this time. Patient's father was instructed to contact pharmacy with any future questions or concerns related to systemic side effects.
3rd day that she's feeling tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Apr2021, outcome "recovering", described as "3rd day that she's feeling tired".  Additional information: She got her first dose of the vaccine on Tuesday (30Mar2021) and scheduled for the 2nd dose on 20Apr2021. She said she's experiencing side effects and it's now the 3rd day that she's feeling tired. Also she said that she's feeling better now. She wants to know what are the preparations that she needs to do for her second dose if she feel any side effects again because she heard that the 2nd dose is more intense.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt experienced fever 100.4, muscle, joint weakness and pain,tongue and throat swollen and white coated, redness and tenderness below I.M. site. Decreased appetite. Symptoms began P.M. following injection. Pt feeling better on 6-5-7
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose number unknown, single (Lot number: 8025) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; ZOLOFT; VITAMIN D3.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the lack of efficacy  cannot be ruled out.
Expired vaccine administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  No treatment medications were provided.
Body aches for full 24 hours (string enough to not want to move or leave my bed) Headache Swollen lymp under left arm and breast Weakness/fatigue
Pt. developed pain in the weeks following the administration of of his second Moderna Bivalent Booster. Pt. stated that he then went in for blood work and was diagnosed with rheumatoid arthritis with no prior history of this disease.
Patient reported feeling sweaty and clammy while being observed after vaccine administration. Then he reported a headache and appeared pale. Patient vomited x1 and then reported feeling better after vomiting. Continued to monitor patient until he stated he felt well enough to leave.
Menveo /powder portoin reconstituted with another diluent; Menveo /powder portoin reconstituted with another diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA569A, expiry date unknown) for prophylaxis.   On 17th August 2021, the patient received Menveo. On 17th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, the patient had been given an incorrectly reconstituted dose of Menveo, powder portion reconstituted with another diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The only lot number available was that of the liquid portion AMXA569A. The reporter consented to follow up.
Pfizer vaccine administered after being in the freezer 11 days past the two-week standard time. Patient notified and given the option for an additional dose.
Symptoms: evening of , chills, fever 101 to 102.8, body aches all over, severe pain in my hands & feet & temp very cold, while my body torso , legs & arms were hot in temp at the same time the opposite for my hands feet & head.  Headaches, backaches trouble breathing regularly,  not able to lay , sit or stand comfortably for  2 days, then the third day just headaches & back, neck pain and still short of breath, using both inhalers since 4-26-21  Flovent & albuteral , which I haven?t used since February of this year.
rash on body; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL3246; Expiration Date: Apr2021), dose 1 via unspecified route of administration in the Left Arm on 26Jan2021 at 09:00 (at the age of 57 years old) as a 1ST DOSE, SINGLE DOSE for COVID-19 immunization (does not want to get covid, as reported) Pharmacy/Drug Store. The patient medical history was none. Patient did not have other Products. Patient was unable to provide the NDC or dose of Covid-19 vaccine given. No other vaccines given the same day or 4 weeks prior. Patient also never had a problem with vaccines in past. On Unspecified date in Feb2021 the patient experienced about 4-5 days later (On Feb2021) she developed a rash on her body and went to see the doctor. Was told to call and report this and gave the lot number. She guesses she can't get the next vaccine. Stated provider did not recommend her getting the second one. Since she was concerned about Covid she wanted to know if she can even take other shots again with this vaccine. It was reported that, Still has rash (date unspecified) but it is going away and almost gone. Event did not require a visit to Emergency Room but visited Physician Office. No relevant tests were performed. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Lot number: EH9889), in left arm, on 05Jan2021 as dose 2, single (Lot number: EL3214), in left arm and on 28Nov2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28May2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28May2022) Positive, notes: + COVID Ag test d8 post COVID. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: No other medication in 2 weeks. No Known allergies. Patient received Anti-viral treatment for COVID-19 with Paxlovid from 17May2022 to 21May2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events covid 19 , vaccination failure and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Vials were initially stored in refrigerator on 01-March-2022, and administered on 30-March-2022, which was expired on 19-March-2022; expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 01-March-2022, and administered on 30-March-2022, which was expired on 19-March-2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     Patient was never diagnosed or tested positive with COVID -19.  Patient does not have any known drug allergies.  Patient does not have any acute illness at the time of vaccination and up to one month before.     On 30-Mar-2022 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Mar-2022 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 01-March-2022, and administered on 30-March-2022, which was expired on 19-March-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 01-March-2022, and administered on 30-March-2022, which was expired on 19-March-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (expired vaccine used) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 01-March-2022, and administered on 30-March-2022, which was expired on 19-March-2022).    It was unknown whether the patient took any prescriptions, over-the-counter medications, dietary supplements or herbal medicines at the time of vaccination or at the time of adverse event It was reported that the vials were initially stored in refrigerator on 01-March-2022. The vails does not undergo any temperature excursion No treatment medication information was given.
Case number PHEH2012US006671 is an initial spontaneous report received from a physician on 20 Mar 2012. This case refers to an 11-year-old male patient. He was vaccinated with MENVEO vaccine (batch number: A10126) intramuscularly on 09 Mar 2012. On 10 Mar 2012, he developed fever, dizziness and vomited once. He was seen in the doctor's office on 12 Mar 2012. On examination he was found to have local swelling and erythema at the site of injection at the left deltoid. He had these symptoms over 2-3 days. He had recovered slowly on 13 Mar 2012. The causality was not reported. No other information was available.
4/10/2021 vaccination  4/11 or 4/12 at the latest, I started feeling a pain in my R calf. It was constant pain for a week and decided to go to the walk in clinic. Blood work which was high and they referred me to the ER and administered a sonogram.  *positive for blood clot Eloquence for 30 day starter pack. PCM is going to extend till July in which he will administer another sonogram.  *COVID +; 01/2021
Case number PHEH2015US003128, is an initial spontaneous report from a nurse received on 10 Feb 20155. This report refers to a 17 years old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly on 03 Feb 2015. It was reported that the vaccine which was given to the patient was frozen with excursions at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, at 0.8 Celsius for 36 minutes on 24 Jan 2015 and at 0.6 Celsius for 35 minutes on 31 Jan 2015. No adverse event reported following this medication error.
Received second dose of Pfizer at 10:30 AM.   12:30 PM  began to experience swelling and itching around the left eye.  Returned to clinic location and spoke to Dr.  volunteer on site.  RN spoke with client and client was given 25mg Benadryl PO at 1:40 PM. Client was in no distress. Took Medication, lives 5 minutes away, drove home.
Rapid heartbeat  Numbness in my neck and face Numbness in my lips, swelling in lips Numbness tip of tongue Chills, weakness, headache, blurred vision for a short time Took Benadryl on my own,  continued taking non drowsy Claritin 5 days after shot feeling better. Still have slight numbness in my lips and feeling weak
Left arm was sore, red, swollen day one and two of injection. Symptoms went away, and 7 days later left deltoid become hard, red, swollen,painful, and itchy. Symptoms are still persisting 3 days later.
Based on additional information received on 25 August 2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional (consumer) 11 August 2015. A female patient (age not reported), whose concomitant medications were not reported, had received an intramuscular first dose of ADACEL (batch number, expiry date site of administration not reported) on an unspecified date 2 weeks ago. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies (NKA) and illness at time of vaccination was coughing two weeks ago and the patient had a negative test for whooping cough. On an unspecified date, 1 week after the vaccination the patient still continued to cough/whooping cough. The patient required ER visit. The patient had another blood test which was found to be positive for whooping cough. Corrective treatments and laboratory investigations were not reported. Upon medical review, the case was considered as serious due to important medical event: whooping cough. At the time of this report, the event outcome was not recovered. Follow-up information received from a physician on 25 August 2015. A 61-year-old female patient had received a dose of Adacel vaccine on an unknown date. On 22 June 2015, laboratory investigations included pertussis toxin (PT) IgG: 11 IU/ml, PT IgA: less than 1 IU/ml, filamentous hemagglutinin antigen (FHA). Previous results included PT IgG: less than 1 IU/ml, PT IgA: less than 1 IU/ml, FHA IgG: 6 IU/ml and FHA IgA: less than 1 IU/ml. and on 03 aug 2015 reported IgG: 130 IU/ml (high) and FHA IgA: 65 IU/ml (high). It was reported that levels of antibodies recognizing pertussis toxin (PT) and filamentous hemagglutinin (FHA) were increased following the vaccination or natural exposure to Bordetella pertussis. This assay was not appropriate to assess the immunity to pertussis as the specific antibodies and antibody levels that correlate with protection were not well defined. Follow up information received from a physician on 18 September 2015. There was no additional information provided. Corrected report of the previous follow-up; It was reported that the patient had tracheobronchitis on an unspecified date which was manifested by a persistent cough. The patient was treated for tracheobronchitis. List of documents held by sender: none. Sender's Comments: Follow up received on 25 Jan 2015, dose not changes the assessment. As with any other vaccine, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE vaccination may not protect 100% of susceptible individuals. Aspects such as patient's immune status at the time of vaccination might interfere with the immune response to the vaccine. Blood test showed positive hence PERTUSSIS was confirmed. However patient's immune status, medical history, concomitant medication etc. is require to further assess this case.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 24-year-old patient who received MENVEO. In April 2017, the patient received MENVEO. On an unknown date, less than a month after receiving MENVEO, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to MENVEO. Additional details were provided as follows: Age at vaccination was not reported but could be 23 or 24 years. At the time of reporting, the patient was 24 years old. One month ago from the date of reporting, the patient received a dose of MENVEO and was still reporting pain and swelling at the injection site at the time of reporting. The pharmacist refused to provide further information.
Injection site pain, whole Body aches, headache for last 8 hours, hours of chills/shivering overnight, feel like I've been hit by a truck
Very tender and swollen lymph nodes on left side -- continued low energy - sore throat and cough when lying down.  (I know the lymph nodes are from the injection -- not sure about the rest of it.)  Not overly concerned -- just reporting so you have accurate data.
No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2023, 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 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant drug was reported.  On 10-Jun-2023, the vial was initially thawed.  No treatment drug was reported.   The case corresponds to 10th out of 30 patients who had received expired vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up received: Suspect details and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:
Patient reports that on 7-1-2018 after receiving injection 6-26-2018 that she started with intense itching and burning in her right breast area in the right upper half of breast. States it was red papular rash and within 2 days solid red. Did not have a fever but became more painful with aching pain. On July 8, 2018 she developed some swelling in the lymph nodes in the right axillary area. Today reports the pain has subsided, but is still tender. She did not seek any medical attention.
Patient received his 1st Covid 19 vaccine on 7-30-21, he had dizziness that started a few hours after vaccine.  The dizziness got worse over the following days and weeks with developing CP and palpitations with near syncope episodes. Saw Primary on 8-30 and referred to cardiologist.  Patient continued to have symptoms and saw Cardio on 9-17.  Diagnosis with dysautonomia after EKG, Echo in office was normal.  Orthostatic VS were abnormal.  Dr. started pt. on a treatment plan and patient wore event monitor. (sent back early d/t increasing symptoms).  One episode of tachycardia noted. Multiple ER visits d/t near syncope, CP/ Palpitations.  Continued symptoms with increased medications prescribed by cardiologist at a syncope clinic.
This spontaneous report as received from a pharmacist refers to a 70-year-old male patient with no drug reactions and no allergies. The patient's medical history an concurrent conditions were not reported. On 24-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M013156, expiration date 15-OCT-2017 in the arm (dose and route of administration were not reported) and, on the same date, he was vaccinated with a dose of FLUZONE in the same arm (lot number, expiration date, dose and route of administration were not reported). No concomitant medications were reported. On 24-SEP-2016, the patient developed redness which continued to spread out from the injection site for about 3 days and then it started to clear up on it's own. The pharmacist reported that the patient could not determine which injection site this reaction occurred at because both vaccines were administered in the same arm. There was no treatment given for injection site redness and the patient did not seek medical attention. The outcome of injection site redness was reported as recovered - the reporter stated that the redness was completely gone at the time of this report. The causality assessment was not provided. Additional information has been requested.
Left sided numbness, tingling and weakness immediately after vaccine. Some wax and waning persistent symptoms most localized to left arm/elbow several weeks later.
My son and I both had the J&J vaccine on March 6th and now have tested positive for Covid-19.  I have been ill for 10 days and still counting.  We don't have a lot of faith in the J&J vaccine, is there a possibility that we could get the same vaccine my wife received (Moderna), who tested negative despite having direct contact?  Wondering if it is safe to switch vaccines as it appears the J&J is not effective after six months.    Any guidance would be appreciated!
RASH STARTED AS DISCRETE RAISED LESIONS THAT COALESCED INTO LARGE RAISED WELTS.  PATIENT SELF TREATED WITH OTC BENADRYL, DID NOT SEEK MEDICAL ATTENTION LOCALLY.  RETURNED TO TRAVEL CLINIC AT 7 DAYS WITH A FEW LESIONS REMAINING BUT RESOLVING.