chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 patients vaccinated from vials stored in freezer no DDL temp monitoring; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer no DDL temp monitoring) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer no DDL temp monitoring). At the time of the report, PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer no DDL temp monitoring) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information were given.  Reporter stated the pharmacy hasn't been using a data digital logger to monitor the freezer temperatures that the Moderna COVID-19 vaccine is stored in. The HCP reported 6 patients have received vaccination since February 2022 from these potentially affected vials that were originally stored in the freezer with no DDL monitoring. It was reported that to their knowledge, there has been no temperature excursion and the temperatures of the freezer remained consistently within range. They keep a written temperature log. It was reported that there is no current and previous temperature excursion. The storage condition at the time was frozen storage. The lot numbers supposedly affected were 022J21A, 083J21A, and 059M21A. Maximum or minimum temperatures were not recorded but only morning and evening temperatures were recorded. The excursion in question was from 8 Feb 2022 to 20 May 2022 and affected only 6 patients within that time frame. The vials were moved to the refrigerator to be thawed for vaccinations on 8 Feb 2022, 21 Feb 2022, 31 Mar 2022, 2 May 2022, and 20 May 2022.  No treatment information were given.
Patient sat in post-vaccine observation area. Within 10 minutes post-vaccine, patient felt "head was swelling" and passed out for a few seconds and regained consciousness. Witnessed with RN staff and Doctor.  Patient recalled waking up with pain in nose due to ammonia salt use. Vitals obtained by RN and EMT. Patient given apple juice and observed until condition improved. Patient reported he ate a sandwich prior to coming in for vaccine, but did not drink water during the day. States such an event never occurred before. Adverse event did not require transport to hospital. Patient went home with mother. Called patient on 1/24/2 stating he is feeling better
This is a spontaneous report from non-contactable consumer based on the information received by Pfizer from Regulatory Authority. (Manufacturer Report Number: 2021_012780).  A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number was not reported) via an unspecified route of administration in Apr2021 (age at the time of vaccination was 63 years) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization and tolvaptan (JINARC) started on 07Mar2021 at 45 mg and 15 mg polycystic kidney disease (congenital cystic kidney disease). The patient current conditions included autosomal dominant polycystic kidney disease (congenital cystic kidney disease). The patient's concomitant medications and laboratory data were not reported. On an unspecified date in Apr2021, the patient had experienced dry eyes after vaccine. No action was taken with Jinarc in response to the event dry eyes. The outcome of the event dry eyes was unknown at the time of this report.  Reporter assessment: The event dry eyes was assessed as non-serious, and its causality with respect to Jinarc and Pfizer COVID-19 vaccine was unknown.  Regulatory Authority causality assessment: This was a male patient who experienced the event of dry eyes (Dry eye) on an unspecified date in the month of April after initiation of treatment with Jinarc at 45 mg and 15 mg, once a day for autosomal dominant polycystic kidney disease (ADPKD) from 07Mar2021. The event had been assessed as non-serious. The presence of other concomitant drug also presented as a confounding factor, but the causal rote of suspect drug could not been excluded. Moreover, in view of temporal relationship and established safety profile of the drug the event has been assessed as related to the suspect drug.   Health authority comment: Not applicable   No follow-up attempts were possible, information about lot/batch could not be obtained.
Patient describes having a deep muscle pain in her right arm immediately after receiving the H1N1 vaccination.
My eye lid over my right eye was swollen, my left arm was swollen, itchy and had a rash  at the injection site. I was treated with antibiotics.
This spontaneous case reported by a consumer, describes the occurrence of illness (she got sick with the second dose/really sick) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the 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; 1 dosage form. On an unknown date, patient experienced illness (she got sick with the second dose/really sick). At the time of the report, illness (she got sick with the second dose/really sick) outcome: unknown. No concomitant medication or treatment information provided. Most recent follow-up information incorporated: On Sep 2, 2021: Follow-up received contained patient identifier.
cellulitis; fallen; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 27Feb2021 (Lot:EN6198, expiry:30Jun2021) as a single dose for covid-19 immunisation; and potassium, via an unspecified route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included ongoing non-ischemic cardiomyopathy. Concomitant medications included atenolol taken for cardiomyopathy, magnesium (MAGNESIUM) taken for an unspecified indication, and furosemide, potassium chloride (LASIX + K) taken for an unspecified indication. The patient was diagnosed cellulitis and was prescribed with cortisone and antibiotics, she was taking 2 antibiotics, named one as Bactrim and unable to name second one, possibly Cefaxin. She was prescribed with prednisone now. She was wondering if the prednisone would interact with the vaccine. Patient had blood work and everything was normal, including new blood tests yesterday. Went off a particular medication, had been on a high dose of Magnesium because she was taking Lasix and Potassium so this test was checking all of that. She hasn't heard back regarding the test yet but is not anticipating any problems. Patient wanted to know if she should take an antibody test to determine if she already gained immunity then she could take her prednisone. It was also reported that about 5 or 6 days before her second shot, which was this past Saturday, she went to her orthopedic doctor and got 2 shots of Cortisone, 1 in each shoulder. Patient had fallen a week before her doctor thought there was a hairline fracture not picked up on the first X-ray. Stated she was supposed to start prednisone and was reading the pamphlet. Patient wanted to know if this would interfere and if taking steroids after the vaccine will interfere with the efficacy of the vaccine. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
injection site was swollen; headache; chills; nausea; arm was sore for a few days; muscle pain; weakness; fever; This is a spontaneous report from a contactable nurse.  A 27-year-old female patient received receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EH9899, intramuscular, in the left arm from 16Dec2020 17:45 at SINGLE DOSE for COVID-19 immunization.  Medical history included asthma, Hypothyroid, HSV (Herpes simplex virus) and Penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant. Concomitant medication included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA).  On 17Dec2020 10:00, it was reported that the injection site was swollen for about a week. Her arm was sore for a few days and had muscle pain and weakness which also started on 17Dec2020 at 10:00. She also had headache, fever, chills, and nausea 17Dec2020 10:00. The outcome of events was reported as recovered. No treatment was received/ required due to events.  No follow-up attempts possible. No further information expected. Information on the batch/lot number has been obtained.
Warm, firm swollen area to increase right thigh where DTaP was given two days before.
Caller discovered a red lump and swelling next to the injection site.; Caller discovered a red lump and swelling next to the injection site.; Caller discovered a red lump and swelling next to the injection site.; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 12Feb2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient received 2nd dose yesterday. Patient discovered a red lump and swelling next to the injection site. Patient asked is that a reason for a concern. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Caller stated he received the bivalent Moderna COVID19 vaccine 7 times in the time; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Caller stated he received the bivalent Moderna COVID19 vaccine 7 times in the time) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Kidney transplant. Concurrent medical conditions included Immunocompromised.    On an unknown date, 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 an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Caller stated he received the bivalent Moderna COVID19 vaccine 7 times in the time) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Caller stated he received the bivalent Moderna COVID19 vaccine 7 times in the time) 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 EXTRA DOSE ADMINISTERED (Caller stated he received the bivalent Moderna COVID19 vaccine 7 times in the time).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that patient responded well to the majority of vaccines in the past. No treatment information was provided.   Reporter did not allow further contact
pt recvd vax 2OCT92 930AM & felt cold, aching, fever ?, w/perspiration by 2OCT92 @ 430 no sycope; APAP was taken & pt felt better by 3OCT92;
administering Infanrix but the vial just cracked in her hands; vial just cracked in her hands; administering Infanrix but the vial just cracked in her hands/cracked vial of Infanrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of occupational exposure while administering product in a patient who received DTPa (Infanrix) (batch number 253J4, expiry date 07-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced occupational exposure while administering product (Verbatim: administering Infanrix but the vial just cracked in her hands), exposure via skin contact (Verbatim: vial just cracked in her hands) and pharmaceutical product complaint (Verbatim: administering Infanrix but the vial just cracked in her hands/cracked vial of Infanrix).  The outcome of the occupational exposure while administering product, exposure via skin contact and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 06-SEP-2023  The reporter reported via call to medical information department that a nurse was administering Infanrix, but the vial just cracked in her hands. The GSK Sales Representative had pictures of this vial. The reporter consented to follow up. The reporter reported that nurse was administering Infanrix, but the vial just cracked in her hands, which led to occupational exposure while administering product and exposure via skin contact.
Fever, myalgias, urticaria, trunk and extremity skin rash persisting over 4 days time. Sought express-care telemedicine visit for fever/headache on 5/26, sought ED care on 2/57 regarding urticarial reaction to trunk and scalp,  fever, myalgias and arthralgias. Lab tests including CBC, BMP, LFTs, UA, magnesium, stat-K, blood cultures, troponin, and CXR obtained notable for mild hyperglycemia and hypokalemia. Again sought ED care on 5/29 for pruritic urticarial lesions on b/l inner thighs, myalgias, and edema to these sites - no labs obtained, treated with famotidine, tylenol, and cetirizine with improvement.
Right arm was black and blue about the size of a quarter; Right arm pain; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DISCOLOURATION (Right arm was black and blue about the size of a quarter) and VACCINATION SITE PAIN (Right arm pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced VACCINATION SITE PAIN (Right arm pain). On 12-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Right arm was black and blue about the size of a quarter). At the time of the report, VACCINATION SITE DISCOLOURATION (Right arm was black and blue about the size of a quarter) outcome was unknown and VACCINATION SITE PAIN (Right arm pain) had not 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.   Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: aBased 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.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 3:36 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Storage condition at the time of the excursion: frozen storage. Excursion duration was reported to be 1 month. Treatment information was not provided.   This case was linked to MOD-2021-402935 (Patient Link).
Information has been received from a physician concerning an 80 year old male who on approximately 14-FEB-2008 was vaccinated with zoster vaccine live (Oka/Merck). The physician reported that "the patient received zoster vaccine live (Oka/Merck) at a pharmacy around 2/14/2008, (the pharmacy information was unspecified by the reporter), and that the patient had broke out in hives about 24 hours after receiving zoster vaccine live (Oka/Merck). The physician reported that the patient come into the office on 2/19/2008 which was five days after receiving zoster vaccine live (Oka/Merck) with hives still on his body." The patients status was unknown at the time of reporting. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Severe fatigue, soreness at injection site, chills without fever All symptoms started about 9:30 am March 10th. Chills left around 12:00 pm on March 11th and fatigue left around 5:00 pm March 11th.
As soon as the vaccine was injected, I started feeling unwell.  I felt like I was in a fog, and within 30 minutes, I felt like I had the flu.  I felt some dizziness, and later in the evening, I thought my heart was racing a little.  For almost a week, I would feel fine, and then I wouldn't feel well.  It would come in waves.  I had some nausea, fatigue, muscle/joint pain, headache, and some dizziness.  My second dose is scheduled for 5/12/2021.  I am concerned about taking the second dose.  I do have some sensitivity to medications.
COVID arm immediately after vaccination; a red COVID arm immediately after vaccination; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (COVID arm immediately after vaccination) and VACCINATION SITE ERYTHEMA (a red COVID arm immediately after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm immediately after vaccination) and VACCINATION SITE ERYTHEMA (a red COVID arm immediately after vaccination). At the time of the report, VACCINATION SITE REACTION (COVID arm immediately after vaccination) and VACCINATION SITE ERYTHEMA (a red COVID arm immediately after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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.
Information has been received from a physician concerning his 37 month old white grand daughter student who on 21Feb02 at twelve months of age was vaccinated SC in the right arm with a dose of varicella virus vaccine live (lot 639488/0572L). Concomitant vaccination on 21Feb02 included a SC dose in the left arm of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (639527/1083L). On 04Apr04, the pt developed breakthrough pox. Six varicella lesions appeared on the body. The pt saw a pediatrician while on vacation. No treatment was given. There was no increase in the number of lesions and they disappeared in a few days. It was noted that the pt recovered. A product quality complaint was not involved. Additional information is not expected.
feel terrible; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel terrible) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PREGABALIN (LYRICA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and PREGABALIN (LYRICA) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feel terrible). At the time of the report, FEELING ABNORMAL (feel terrible) outcome was unknown.        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.   No concomitant medications were reported.  No treatment medications were reported.