chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health professional and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310464, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310559, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310708, 2020SA310768, 2020SA310769, 2020SA310770 and 2020SA277871 (same reporter).  This case involved a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (Product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
My menstrual period lasted from March 1st to March 21st, which is two weeks longer than usual.
A patient received half of a dose of Moderna COVID-19 Vaccine Bivalent instead of full dose by accident; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (A patient received half of a dose of Moderna COVID-19 Vaccine Bivalent instead of full dose by accident) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    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 ACCIDENTAL UNDERDOSE (A patient received half of a dose of Moderna COVID-19 Vaccine Bivalent instead of full dose by accident) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (A patient received half of a dose of Moderna COVID-19 Vaccine Bivalent instead of full dose by accident) 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 ACCIDENTAL UNDERDOSE (A patient received half of a dose of Moderna COVID-19 Vaccine Bivalent instead of full dose by accident).    No concomitant medications were reported.  No treatment information was reported.  It was stated that a patient received half of a dose of Moderna COVID-19 Vaccine and bivalent instead of full dose by accident. No patient identifiers or additional information on the case and also, and also reporter was running out of time would not submit a report but would let the colleagues know to report the AE later. It was unknown if patient experienced any AEs after the vaccine was given.   Reporter did not allow further contact
12 hours post injection- fever of 101.8, body aches, headache, fatigue. Lasted about 23 hours before fever was back to normal. Still have fatigue and weakness
Left arm numbness/weakness, nausea, fatigue, rapid heart rate. Symptoms resolved over night
felt a rush/felt out of it; increased heart rate; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a rush/felt out of it) and TACHYCARDIA (increased heart rate) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037AZ113) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FEELING ABNORMAL (felt a rush/felt out of it) and TACHYCARDIA (increased heart rate). On 24-Mar-2021, TACHYCARDIA (increased heart rate) had resolved. At the time of the report, FEELING ABNORMAL (felt a rush/felt out of it) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Heart rate: increased heart rate (High) Increased heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Significant swelling in left arm pit under the left arm where the injection was given on the outside of the left arm. There is a little soreness under the swelling, but not much.  Pain level 1-2 out of 10, where 10 would be intense pain. Injection received on 10/18/21.  Swelling appeared the morning of 10/20/21 and persists at the same amount on 10/21/21. I have taken no medication to reduce the swelling and pain is small, so no need for medicine for pain.  I had a little weariness and arm was sore at the injection site and those responses have cleared.  Clinic advised me to call back if swelling persists past 3 days from the injection date.
My arm is still sore. When I move my arm too high or behind my back I have muscle pain.  Makes me think that vaccine is sitting in my muscle. My arm should NOT be sore a month later!
pt. crying incolsably for 2 hours, temperature not taken, drooling but could swallow, Leg painful, refused to walk but not red and swollen, recovered spontaneously
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-MAR-2014, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, patient developed shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine (Vaccination failure). On or about 07-JAN-2015, the patient had physician office visit for treatment of shingles. The lawyer reported that as a direct and proximate result of the ZOSTAVAX vaccine, Patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses because of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. The reporter considered events to be related to ZOSTAVAX.
Swelling, feverish, redness all the way from the deltoid to the middle of the forearm. Was given Augmentin in the ER. Symptoms have lessened.
This spontaneous report as received from a physician via field employee refers to a male patient about 50 years old. On an unknown date the patient was vaccinated with ZOSTAVAX (dose not reported, one single shot). No concomitant medications were reported. On an unknown date the patient developed mild case of shingles. The outcome of the event was unknown. The patient sought medical attention - saw the doctor. It was not reported if the patient was given a treatment for the event. The relatedness between mild case of shingles and ZOSTAVAX was not reported. This report is linked with a case MARRS#1405USA008299 via same reporter link. Additional information has been requested.
Patient went to her doctor for her yearly well check-up. She was a healthy 14 year old who rarely was sick. She received the first dose of the HPV Vaccine on August 10, 2016. Within 24 hours of receiving the vaccine patient developed a headache that would not go away. At first we tried ADVIL, ALEVE and other over the counter medicine that in the past has worked for headaches she would get occasionally. This headache she had was a constant headache 24 hours a day. She woke up with it and went to bed with it. We brought her back to the doctors to help get treatment for these headaches. She was given a steroid pack at first, did nothing to relieve the pain. She was tested for Lyme disease which was negative. I asked the doctor if this could be a side affect of the HPV vaccine and was told no. Then we were sent to headache clinic. I asked again if this could be a vaccine injury and was told no again. We were immediately told at Clinic that she had chronic migraines and would begin taking medications until the right one was found. I told them patient never had a migraine before and now all of a sudden after that vaccine she develops chronic migraines. Didn't make sense to me but went along with their recommendations for patient to begin meds. This was in September. Her headaches at this time were 8-9 on a scale of 10. From September through December, patient was on 9-10 different medications, was given IV treatments twice, had 2 MRI's and nothing stopped the headaches. Then we were told this was all in patient's head and she needed to see a pain psychologist. She went to all of the visits and followed through with the psychologists recommendations and still the headaches persisted. In late December patient had about 33 shots of BOTOX in her head to help with the pain. Again, didn't help at all. At this point, we were completely frustrated and feeling hopeless. My daughter went from being very active every day, playing spots, hanging out with her friends to coming home from school; sleeping, getting up for dinner and going back to sleep. Sleeping was the only time she didn't have to deal with the pain. She was a completely different person than before she got this shot. Needless to say I never took her for the 2 and 3rd shots after experiencing what just one did to her. After yet another day of IV treatments in January at Clinic and getting a second opinion at another clinic I decided to take her to a Homeopathic Doctor. He has been able to give her supplements that have brought her head pain down to a manageable level at times but she is still suffering from headaches - some severe.
Caller read in news that people receiving moderna vaccine get skin problems; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced caller read in news that people receiving moderna vaccine get skin problems.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event, the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient experienced the event caller read in news that people receiving moderna vaccine get skin problems.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of events caller read in news that people receiving moderna vaccine get skin problems was unknown.
Moderna 3/5/21, 5/6/21. Positive on 4/3/22
I had a breakthrough case of Covid-19 with fever and chills took home test was positive for Covid called doctor and was prescribed PAXLOVID. Stayed home for 5 days until I tested negative.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient brings this action for personal injuries and damages suffered as a result of being inoculated with the ZOSTAVAX. The patient was inoculated with the ZOSTAVAX for the long-term prevention of shingles. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. In 2015, the patient was inoculated with the ZOSTAVAX at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. Later in 2015, the patient was treated by a physician, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
inadvertently administered a dose of Fluzone Quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F, with no reported adverse event; inadvertently administered a dose of Fluzone Quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F, with no reported adverse event; inadvertently administered a dose of Fluzone Quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F, with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 16 years old male patient who was inadvertently administered a dose of Fluzone quadrivalent (influenza quadrival a-b vaccine) prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f, with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) for Immunisation.  On 07-Feb-2023, the patient received a 0.5 ml dose of suspect influenza quadrival a-b vaccine prefilled syringe (lot UT7752MA expiry date: unknown) via intramuscular route in left deltoid with unknown strength for Immunization which was inadvertently administered, that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f, with no reported adverse event (accidental exposure to product) (poor quality product administered) (product storage error) on same day  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 24-JUL-2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed valacyclovir HCL (VALTREX) for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Vivid hallucinations. A face of someone trying to come through window; Face coming at her. Since realized was hallucinating went to sleep. In the morning was tired, achy. Has been taking EXCEDRIN, TYLENOL for headaches. Still not 100% has problems sleeping.
This spontaneous report was received from a consumer refers to himself as a male patient of unknown age. No concurrent condition, medical history or allergy/drug reactions were reported. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX injection (strength, dose, route and lot number or batch number unspecified) for prevention of shingles. No concomitant medication was reported. On an unknown date in 2015 (reported as 3rd time this year), the patient experienced shingles. On an unknown date, the patient sought unspecified medical attention. The outcome of shingles experienced three times by the patient was unknown. There were no product quality complaints (PQC) involved. The reporter did not provide the causality between the event and the suspect therapy. No further information was provided. Additional information has been requested.
FLUZONE QIV NP PFS, reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA054981 and 2023SA057733.  This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.  It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  Action taken: not applicable.  Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Vaccine given at incorrect interval for Moderna Covid19 series. Givem at 3 weeks instead of 4 weeks.
Patient had arm pain, redness, swelling x 3 weeks.  Supportive care only.
Other complications following immunization, not elsewhere classified, initial encounter on 2023-04-19.
Site: Pain at Injection Site-Medium, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Additional Details: Felt tired, and sick to stomach, then slumped over and convulsed about 10 min post-injection, was laid on her side, then paramedics arrived 15 min post-injection
shivering; Upset stomach; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shivering, upset stomach and tiredness. On an unknown date, the outcome of the shivering, upset stomach and tiredness were unknown.   It was unknown if the reporter considered the shivering, upset stomach and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose and experienced shivering, upset stomach and tiredness. The patient asked how many days the side effects would last.
Chest pain, went to ER.  Admitted to ICU with a heart attack, on 09/20/2004 under went a heart catheterization and balloon angioplasty to open up the coronary artery.  Troponin level was elevated.  D/c 'ed from the ICU two days later.