chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Did not follow up for the second dose on time; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (first dose received in November 2022).   On 18-APR-2023, the patient received the 2nd dose of Twinrix. On 18-APR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Did not follow up for the second dose on time). The outcome of the drug dose administration interval too long was 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: 19-Apr-2023 The pharmacist stated that the patient was calling from home and did not have access to patient information at this time. The pharmacist did not have initials, date of birth, or any additional information available at the time of call.  The pharmacist consents to follow up but stated might not have any further information she could provide to safety. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
High Blood pressure; dose 1 and dose 2 on 07Jun2021; dose 1 and dose 2 on 07Jun2021; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 07Jun2021 09:00 (Lot Number: EW0177) (at the age of 48 years old) as single, and dose 2 via an unspecified route of administration, administered in Arm Right on 07Jun2021 (Lot Number: EW0198) (at the age of 48 years old) as single, both for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications patient received with in two weeks of COVID vaccine. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient previously took tylenol with codeine and experienced drug allergy. The patient experienced high blood pressure on 10Jul2021, dose 1 and dose 2 on 07jun2021. Adverse event high blood pressure resulted in emergency room/department urgent care visit. No treatment given for the event high blood pressure. Patient did not tested for COVID post vaccination. Outcome of the event high blood pressure was recovering.
I was extremely stiff to where I couldn't move, cold sweat, panic attack and started my menstrual cycle, chills.
Patient received a dose of Janssen and then received a dose of Moderna. 1st dose of Janssen on 3/22/21 and 2nd dose of Moderna on 5/7/21.
2nd Moderna shot received approx 10:10 am Saturday 2/27. Mild soreness at injection site during the day, some mild aches all over. Sunday 2:00 am experienced chills and mild fever 99 degrees.  Sunday am 8:00 experienced severe headache, moderate fatigue, mild pain at injection site, body aches all over.  No fever.. Took 2 Tylenol with no affect.  4 hrs later took 2 Alleve which diminished headache.  Still had moderate fatigue.  Monday 3/1 only experiencing mild soreness at injection site, and mild fatigue. No other symptoms.
aproximately six days following the first shot, tremors or shakes uncontrolled on upper torso and right arm,  time last between a few minutes to over an hour repeats. back of  neck area gets tight, sweating and chills still by September 25, 2021
Patient said that injection site was red later in the day on the same day as the injection.  Two days later the patient said the injection site continued to be red but now became swollen and started itching.  The patient came to speak with the pharmacy manager on 7/8/10.  At that time the pharmacist could not see a red or swollen injection site.
Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.; No Adverse Event; HCP stated they accidentally administered 2 doses beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses beyond use date), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.) and NO ADVERSE EVENT (No Adverse Event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7647B) for COVID-19 prophylaxis.    Co-suspect products included non-company products CBA 1205 for an unknown indication and INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    It was reported that patient relevant medical history/conditions, allergy, concomitant diseases and risk factor were unknown.    On 06-Aug-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient received dose of CBA 1205 (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 06-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses beyond use date), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses beyond use date) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.).    Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023. Vial size was reported as 2.5 ml. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-736294 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736294:Patient 1
Headache, Sedation, Myalgia, Fever, UrticariaPruritus, NauseaVomiting, chills and fatigue. pain, redness, and swelling at the  injection site Narrative:
About 3 hrs. after the flu shot, I started coughing and wheezing and experienced trouble breathing. I couldn't sit down because it was harder to breathe. The difficulty in breathing lasted about 6 hrs. I called the pharmacist and she suggested cough medicine and TYLENOL. I developed a headache about 7 hrs after the flu shot and also felt very tired and weak. The next day the breathing was better and the headache and tired and weak feeling persisted. It took about 4 days to feel better.
Body aches; fatigue; sore throat; chills; This is a spontaneous report from a contactable nurse who reported for herself. A 44-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL9261) at her right arm 08:30 AM on 17Jan2021 for Covid-19 immunization. The patient received her first shot (lot number EL0140) at right arm 08:30AM on 27Dec2020. The patient had a medical history included asthma, anxiety, hyperlipidemia. Patient had no known allergies. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), duloxetine, salbutamol (ALBUTEROL), rosuvastatin calcium (CRESTOR), and montelukast sodium (SINGULAIR). 06:30 PM on 17Jan2021, the patient experienced body aches, fatigue, sore throat, and chills. No treatment was received for the events. The outcome of the events was not resolved at the time of reporting. Patient had no COVID prior vaccination and had not COVID tested post vaccination.
Soreness at injection site for 3 days. Nausea for 3 hours.
17 days after patient received MMR, varicella vaccine, HiB, and PCV7, she was seen in this office with severe bruising. A platelet count was done with a result of 5000. She was hospitalized and received intravenous immunoglobulin. Followup platelt count was 42000. Platelt count on 12/4/06 was 324000, and on 12/22 was 334000. 12/28/06-Hem Onc consultation report received and reviewed DX: Isolated thrombocytopenia on CBC consistent with ITP.  RX with IVIG.
swollen lymph nodes; chills; This case was reported by a consumer via call center representative and described the occurrence of inguinal lymph nodes enlarged in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced inguinal lymph nodes enlarged and chills. On an unknown date, the outcome of the inguinal lymph nodes enlarged and chills were unknown.   It was unknown if the reporter considered the inguinal lymph nodes enlarged and chills to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. More than 3 weeks ago from the date of reporting, the patient received Shingrix. The patient had swollen lymph nodes in groin and chills. The reporter was not sure if these were side effects of vaccine or something else and wanted to confirm the same.
fever 3JUN 107 temp-hosp;MD could not say yes or not to vax rnx;
4/8 Extreme lowers abdominal pain began 4/10 Admitted to Emergency Room at St Joseph?s Hospital  North 4/10 Diagnosed with a 3cm hemmoragic ovarian cyst. 4/23 new ovarian cysts development   NO PRIOR OVARIAN CYSTS  TO THIS EVENT
Systemic: Fainting / Unresponsive-Mild, Additional Details: i administered pfizer vaccine to patient and after 5 minutes she experienced syncope and we had to call an ambulance for the patient.  The NP within the store helped the patient as well by checking blood sugar, blood pressure and o2.
It was reported that a pt rec'd Menomune A/C/Y/W-135, lot #UB229AA, on 9/18/02. After 14 minutes, the pt experienced a vagal response, felt hot and faint, and had to lie down. Blood pressure was 100/60, with apical pulse of 68 and respiration's 18 per minute. 26 minutes after injection, the pt's blood pressure was 102/58, pulse 64, respiration's 20. 45 minutes after vaccination, her blood pressure was 98/62, pulse 68, respiration's 20. The pt was afebrile. Within the hr, the pt reported feeling better and sat up wanting to leave, but her blood pressure was still low (100/60). She was instructed to follow up at the health dept with any further problems. Pt verbalized understanding and ambulated out without distress. It was not reported whether the pt recovered.
2 days p/vax pt devel rash @ inj site described as a bumpy area;seen by MD who dx erythema mult & allerg dermatitis & prescribed 2.5% hydrocortisone cream;1wk later rash had extended to the crotch area & half way down leg & blisters;
Patient given 1st GARDASIL injection. 3 hours later patient developed pruritic rash on back and torso.
Headache, every day, whole day; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2022, the patient received the 1st dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: GSK receipt date: 23-OCT-2022 Reporter's comment:  This case was reported by a consumer via interactive digital media. The patient reported that the he/she got 1st shot of Shingrix last Tuesday and since the he/she had headache every day, whole day. Additional Supportive Information:  Follow up would not possible, as no contact details were available.
Burning pain @ Lt Deltoid muscle area especially when sleeping the turn to that side.  Warm compresses since vaccinated , but no improvement. Deltoid exercises as directed by PCP BUT NO IMPROVEMENT.
Reddened raised patchy areas on (R) thigh in areas where injections were given - one area size of open hand at one point warm to touch, red, skin taught. KEFLEX given to cover possible cellulitis.
Myalgia, Fever, redness & swelling left arm, eye pain Narrative:
chills, sweats, fever, nausea, general malaize   72 hours later, injection site redness, starting at the injection site and going southwest down the arm in an irregular shape, 4.5 inches long and 2.5 inches wide
exacerbation of chronic graft versus host disease; This is a literature report, Program ID: (005851) for the following literature source(s): "Chronic graft-versus-host disease exacerbation after SARS-CoV-2 vaccination", Bone-Marrow-Transplant, 2022; Vol:57(3), pgs:502-503.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single), for COVID-19 immunisation. The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown", described as "exacerbation of chronic graft versus host disease".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient
Very heavy period and longer by 6 days than usualt; Very heavy period and longer by 6 days than usualt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Aug2021 (Lot number: EW0198) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN CALCIUM. Vaccination history included: Bnt162b2 (dose number: 1, lot number: EW0179, vaccine location: Left arm), administration date: 16Jul2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), OLIGOMENORRHOEA (non-serious) all with onset 04Sep2021, outcome "recovered" (2021) and all described as "Very heavy period and longer by 6 days than usualt". Therapeutic measures were not taken as a result of heavy menstrual bleeding, oligomenorrhoea.  Additional information: Patient received COVID-19 vaccine in pharmacy or drug store for administration. The Patient did not receive other vaccines within four weeks prior to the COVID-19 vaccine. Patient received Atrovastatin 20 mg as medication/vaccine in two weeks. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected. The lot number for bnt162b2 was not provided and will be requested during follow up.
Client came to clinic 06/16/2008 for Varicella vaccine 3:30pm. Administered in R arm SQ. Pt. Phoned Health Department 06/18/2008 9:15am stating she was now out of town and her arm had a blistered rash with a knot the size of her fist.  (Pt. stated she noticed 06/17/2008 @ 11:30pm after a 4 hour walk that site was red and itching with a slight knot). Instructed client to seek medical attention if condition worsened and she could take OTC Benadryl for reaction. (Client stated she has previously had chickenpox--needed titer for proof of disease for school--had decided to received vaccine)
Information has been received from a 60 year old female patient with hypertension and hyperlipidaemia and a history of open heart surgery in past, ulcerative colitis (but was currently in remission) and shingles in 2007 who on 22-JUN-2010 was vaccinated IM with ZOSTAVAX (Merck) into her left deltoid. Concomitant therapy included high blood pressure medicine and high cholesterol medicine. On 24-JUN-2010 the patient developed sensitivity and a bump in location of previous zoster outbreak on, which had progressed to light rash, and more bumps. The patient had not seen her physician yet. At the time of report, the patient had not recovered. Additional information has been requested.
12 hrs after injection...unable to move arm more than 12 inches from my side.  Pain on moving arm.  Three weeks later able to move arm somewhat higher but still painful.  Pain on sleeping also.
Was being monitored x 30 minutes after vaccination. Approximately 15 minutes after administration, eyes began to get heavy and swell. "My heart was racing." Wheelchair to ED. They could not get IV access. Throat was dry. They got an IV and gave Benadryl. "My throat starting swelling and I could not swallow." "I was panting and my heart was beating out of my chest." The ED staff administered epinephrine pen via IM injection. Anaphylaxis resolved and she was monitored x 4 hours in ED. Sent home on prednisone and fomatidine.
This spontaneous report was received from a pharmacist refers to an currently 84 years old female patient. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified), route, dose and location unspecified. The pharmacist reported that the patient who received ZOSTAVAX subsequently developed shingles. At the time of report, the outcome of the shingles was unknown. Additional information has been requested.
"Pt had the shingles vaccination on the 13th. Last night she noticed her lymph nodes on her L neck feel swollen. She has been feeling body aches and tenderness in her lymph node."
increase discomfort in both my biceps arms; notice an immediate reduction in this discomfort that I have for many years in both of my arms and it is still to say now It's much better than that was; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration in Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history includes: quite severe pain in upper arm muscles taking the biceps, they were also very weak and discomfort in both of arms. Concomitant medications were not reported. The patient actually had a very positive experience from the vaccine and not a negative. Further mentioned, had a positive reaction to the vaccine and the improvement of some condition that patient previously have, after having the second dose of the vaccine. For couple of days, there was increase discomfort in both biceps arm. When those symptoms went after second to third day, patient notice an immediate reduction in this discomfort that patient have for many years in both of arms and now it's much better than it was and put it down to a positive side effect of the vaccine. Consumer added, "It's not a co-incident, it's definitely the vaccine that did that for me so I just want to let you know in case your research and people interested." Outcome of events was reported as recovering.  Information on the lot/batch number has been requested.
pt rcvd vax; pt devel systemic reaction; erythema; pruritus; myalgia; pain neck; stiffness; tachycardia; rash; asthenia/fatigue; pain, fever;
after the 1st shot I began itching different places on my body. Sometimes it was just a scratch and it was gone and sometimes it didn't go away for awhile. Then 2 weeks later I got the second dose and the itching really kicked in. again sometimes its been a scratch and it's  gone and then sometimes it was relentless and wouldn't go away to the point of scratching it raw. Some of the times it wouldn't subside little bumps would arise on my skin. there are some nights that I can't even go to sleep due to the itching. I didn't make the connection at first until I seen that 1 of the adverse effects was itching.
No reaction noted at time of  vaccination. Client walked out of  exam room & left with her gmother. Gmother called back a few minutes  later to say the client had fainted in the  car. Advised her to call 911 if pt not responsive.  Pt was "coming around"  when EMS arrived Gma states pt. was  dazed and quiet for total of approximately 10 minutes. EMS did not transport pt. Pt was  feeling fine & acting normally on 7/29/20,  per grandmother.