chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received undiluted PEDS dose of .3 mL instead of Pfizer 12 + vaccine pt reports slight headache only
Two patients were given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients were given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 046H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 24-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients were given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients were given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge) 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 Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Two patients were given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge).    Information about previous COVID-19 vaccination doses included Moderna doses on 29-Apr-2021 and 21-May-2021.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Two patients were given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge. The vaccinator accidentally used the punctured vial on the following day. The HCP was advised by her rep to call Moderna to make sure that the patients can be revaccinated. She wants to know if the patients need to be revaccinated. She has not contacted the patients yet, so she doesn't know if they experienced any adverse reactions. Bivalent dose administered >12 hours post puncture, vial size was unknown, date the vial was initially stored in the refrigerator reported as 17-Jan-2023 which was the date they received the thawed vaccine. The bag said "today's date is 13-Jan-2023" and "Best use by date is 12-Feb-2023". Date and time vial was first punctured was 23-Jan-2023 at around 1 PM. Date and time of administration of vaccine reported as 24-Jan-2023 at around 10 AM and 10:30 AM. Vial was stored inside the fridge post puncture. The vial had not undergone any temperature excursions. The vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) only to draw doses.   This case was linked to US-MODERNATX, INC.-MOD-2023-705040 (Linked Report).  This case was linked to MOD-2023-705161 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705040:Second patient case
Immediately post vaccination pt had dizziness and a syncopal event.  Pt reported buzzing in his ears.  Vitals: 15:20 (supine) 127/59, 68, 12, 100% -- > 15:30 (sitting) 112/55, 78, 12, 100% Pt given water and s/s resolved.  Advised pt to request next vaccination in the supine position.  Pt stable and released from the vaccination site.
rash/hives, itchiness, throat/lunch itchiness, cough, draining within 6 hours, still persistant, taking benadryl Q6h
Abd. pain, vomiting & diarrhea 1 wk prior to immun. which resolved - had 3yo PE received PREVNAR 13 & FLUMIST - nl exam 24 hours later dev rash diaper area, legs with leg pain & limping - Seen in ER 24 hours later dx with HSP (Henoch Schonlein purpura) - OV next day confirmed HSP nl BP (-) UA no limp no abd pain (10-11-10) F/u OV 10-18-10 HSP sx improving (-) UA nl BP no tx.
Pt c/o dizziness, sweating, inc resp rate immediately p/administration of 1cc of Plague vax; Pt was given Chlo-Amine tabs & Epi;
Patient stated she experienced extreme redness and tenderness surrounding the vaccination site.  She was using a cream on the site and it has since gone down but since she was filling her prescription she wanted to show it to the Pharmacist on duty.
pt exp extreme tiredness-lost voice, pounding h/a, stuffed up head & sinus-no voice x 4 days;
Received first vaccine 9:24 am.  Went to observation area and  was able to stand to schedule for second vaccine (less than 5 minutes after receiving vaccine and then went and sat down.   About 10 minutes after vaccine given, patient became pretty dizzy.  Was placed in a wheelchair for safety.  BP 163/79 with HR 114.   Started to improve in dizziness.  Repeat BP 155/78 and HR 110 10 minutes later. Patient did eat breakfast and had 2 cups of caffeinated coffee this AM (usual amount).  Patient recovered with no interventions.
Pfizer-BioNTech COVID-10 Vaccine EUA.  Patient experienced diaphoresis, lightheadedness, and paleness. His first set of VS included BP 87/41, P 73. Patient stated this has happened a few times in the past when he gets shots. Certirizine 10mg PO administered at 1245. Patient denied SOB, trouble breathing or swallowing, and symptoms of anaphylaxis. Before leaving clinic, VS included BP 121/62, P 60, O2 100%. Patient felt comfortable with no additional or worsening symptoms upon leaving clinic.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Negative, notes: I tested negative on the last day of my medication 26May; (30May2022) Positive, notes: I started feeling like I had a cold and I tested positive on 30May. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The patient not received other medication in 2 weeks. The patient received anti viral treatment on 21May2022 and stop on 26May2022 for treatment of COVID-19. She tested negative on the last day of my medication 26May, she started feeling like she had a cold on 30May2022 12:00 PM and she tested positive on 30May2022. She had no any known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
ADMINISTRATION ERROR: vaccine dose administered to a person too young to meet EUA requirements.  16yo female received Janssen COVID19 vaccine, but the vaccine is currently only approved for patients age 18+.  Error identified by patient's parents.  Currently patient has not reported any serious ADEs, but is self-reporting fever, chills, and body ache.
cleared her blackout from the trauma of getting kidnapped; caught Covid again after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (cleared her blackout from the trauma of getting kidnapped) and COVID-19 (caught Covid again after getting the 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 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 THERAPEUTIC RESPONSE UNEXPECTED (cleared her blackout from the trauma of getting kidnapped) and COVID-19 (caught Covid again after getting the vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (cleared her blackout from the trauma of getting kidnapped) and COVID-19 (caught Covid again after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.  This is a spontaneous case concerning  a  patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious event of therapeutic response and Covid-19 as an additional event. The events occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious event of therapeutic response and Covid-19 as an additional event. The events occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
J&J leaked out of the needle - definitely did not administer the full dosage in the right arm - so i readministered another shot in the opposite arm (left); pt was fine with it
Covid Positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid Positive) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid Positive). At the time of the report, COVID-19 (Covid Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Relevant concomitant medications were not reported.  It was reported that patient got COVID-19 positive after double dose of Moderna COVID-19 Vaccine.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a female patient of an unknown age with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of the 2 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a female patient of an unknown age with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of the 2 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Intermittent upper torso pains mostly focused in the chest and heart area. Hypersensitivity affecting emotions.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2012. In Jan-2012, expired FLUMIST was administered to the patient. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. On 20-AUG-2014, 2 patients were vaccinated with a dose of LIQUIPD PEDVAXHIB (lot number, expiration date, dose and route were not reported) that was improperly stored at 48F for 39 minutes. No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Started with chills and fever, progressed into body aches and joint pain in knees and ankles, continued with 102.5 degree fever and exhaustion over the course of 2 days. Third day was severe dehydration and exhuastion. Pain continues in legs, knees, hips, feet and ankles.
Ongoing numb like, tingling, ache in arm/hand. Feel cold more often than before.  Swelling in axillary lymph nodes and surrounding areas. Increased edema. Increase joint pain.
pt exp erythema, induration, inflammation, & swelling @ inject site p/flu vax;
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the unspecified amount of clients were vaccinated with improperly stored ROTATEQ (lot# and expiration date not provided) (dose not reported), orally by default. No adverse effects were reported. This is one several reports received from the same reporter. Additional information has been requested.
The morning of Feb 24th a cold sore on top lip on the right side. I have a standing prescription for acyclovir that I use for previous cold sores so I contacted my OB via phone to confirm I can use it because I am pregnant. She confirmed it was okay to use. I am due August 16, 2022. The cold sore is still there, but today is my last day.
About 12 hours AFTER receiving my second dose, I've had a non-stop fever that continued for about 24 hours, with temperatures ranging between 99.8 and 102 degrees. I haven't had a fever for more than a year, and I haven't felt that bad in a long while. There was a little headache as well, which has continued into the third day (which is today), but I do not have the fever anymore. I have had used 5 Tylenol in about 30 hours, and not sure if I will need one for the current headache. Also, the second dose left the pain in my arm for much longer compared to the first, but that was nothing compared to the problem with the non-stop fever, which is the adverse effect I am mostly concerned about.
This spontaneous report as received from a pharmacist refers to a 72 year old female patient. The patient had a previous history of cold sores. The patient had no drug allergy. On 11-JUL-2013 the patient was vaccinated with ZOSTAVAX lot # H022152, exp. 18-MAR-2013. There was no concomitant medication. On 11-JUL-2013, The patient received ZOSTAVAX in the morning and then developed cold sore later in the same day. No lab test was done. The outcome of cold sore was reported as not recovered/not resolved. The patient contacted pharmacist for medical attention. Additional information has been requested.
Started with absent seizures within one week of shots.  Then 4/16/19 first Grand Mal, resulting in Epilepsy diagnosis.
This case was reported by a nurse via sales rep and described the occurrence of difficulty breathing in an unspecified number of the patients who received MENVEO for prophylaxis. Co-suspect products included ROCEPHIN for an unknown indication. On an unknown date, the patient received MENVEO at an unknown dose and ROCEPHIN at an unknown dose and frequency. On an unknown date, unknown after receiving MENVEO, the patient experienced difficulty breathing, numbness in fingers, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the difficulty breathing, numbness in fingers, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the difficulty breathing and numbness in fingers to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that MENVEO liquid component was inadvertently mixed with ROCEPHIN and administered to an unknown number of patients for an unknown period of time, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was a vaccine administration error. The MENVEO liquid component was mixed with rocephin instead of mixing ROCEPHIN with diluent. After receiving vaccination, the unspecified number of the patients experienced some numbness in fingers and difficulty breathing. It was unknown if the reporter considered the difficulty breathing and numbness in fingers to be related to ROCEPHIN. No additional details were available.
Patient started experiencing shivering around 4 pm, a fever of 105 degrees farenheit at around 6 pm, and feeling of pressure going from his legs to the feet.
Woke at 1;00am with severe aches, weakness and dizzy. Fainted and vomited.  Could not stand up independently to get to bathroom.    *This is in addition to becoming flushed right after shot and also getting sinus headache, congestion and cough within hour of vaccine.   Severe chills and aches started at 6:00pm 2/15/21 but the event at 1;00 am 2/16/21 was extreme.  Felt somewhat better in morning so did not call doctor.  Aches gone later on 2/16.   Mild-moderate Cough and sinus congestion and some weakness/fatigue remained  through today 2/20/21 - (much better this evening).
Information has been received from a consumer concerning her 4 year old grandson who developed a fever and a rash after the reporter was vaccinated on 11/26/06 with a 0.65ml dose of varicella zoster vaccine. The reporter, who has no allergies, a history of pancreas cancer, and was on no concomitant medication, indicated that on the date of her vaccination, she saw her grandson later in the afternoon as well as several days after. On 10/28/06 her grandson woke up with a fever and as of 10/31/06 he developed a rash on his face and front and back above the waist. A product complaint was not involved. Additional information has been requested.
sensitive to light; fever of 102.9 F; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (sensitive to light), PYREXIA (fever of 102.9 F) and HEADACHE (bad headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PHOTOPHOBIA (sensitive to light), PYREXIA (fever of 102.9 F) and HEADACHE (bad headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, q6h and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK, q6h. At the time of the report, PHOTOPHOBIA (sensitive to light), PYREXIA (fever of 102.9 F) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 (Inconclusive) 100.1.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received Motrin and Tylenol every six hour but it did not help.   This case was linked to MOD-2021-027714 (Patient Link).
Injection site numb; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 17-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPOESTHESIA (Injection site numb) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HYPOESTHESIA (Injection site numb). At the time of the report, INJECTION SITE HYPOESTHESIA (Injection site numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter.  No Treatment medications were provided by the reporter. For mRNA-1273 (COVID 19 Vaccine Moderna) (unknown), the reporter did not provide any causality assessments.
Within 3 hours of vax, the baby became very lethargic, was staring off in space, did not respond well to mother, had a fever of 100.6 and was admitted to the hospital. Baby was dehydrated and had a WBC count that was elevated. A follow up report received 12/20/2001 adds: 10/18/01: "Pt had lethargy and decreased responsiveness beginning shortly after receiving immunizations. Pt was admitted to the hospital the same day apparently for dehydration, but this is not clear. The dehydration and increased WBCs suggest the child had an intercurrent illness, and the lethargy and decreased responsiveness were unrelated to vaccines given. Continue routine childhood immunization schedule."
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX temperature excursion and two patients of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot# J008652 exp. Date: 10-JUL-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
7AUg92 pt recvd Engerix-B & 13AUG92 reported that immed felt pain from site of inject to wrist, pain in armpit & upper back, arms feels heavy;