chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (MI)and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves 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, form: prefilled syringe) via an unknown route in unknown administration site for prophylactic vaccination on 05-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 (latency: same day).  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. No thermometer was in packaging and product was cold when they received it.  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.
patient report back to the pharmacy after 10 to 15 minutes from getting the vaccine complaining  about feeling warm, difficulty in breathing and shakiness , diphenhydramine 25 mg liquid was given to the patient and she waited in the pharmacy  for at least a hour until she felt better, patient was advised to pick up benadryl before she leaves home
For her previous vaccinations she had prolonged reactions to the vaccines.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (For her previous vaccinations she had prolonged reactions to the vaccines.) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     It was unknown if patient had relevant medical history or conditions, allergy, concomitant diseases and risk factor.     On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (For her previous vaccinations she had prolonged reactions to the vaccines.). At the time of the report, IMMUNISATION REACTION (For her previous vaccinations she had prolonged reactions to the vaccines.) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       It was unknown if the patient receives any other vaccine in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-748669 (E2B Linked Report). This case was linked to MOD-2023-748669 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748669:other vaccines
Spike in BP; Spike in heart rate; Lighted; This is a spontaneous report received from a contactable consumer (patient). A 63-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP8727), via an unspecified route on 19Mar2021 at 10:15 (at age of 63-years old) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included thyroid, high cholesterol. The patient had no known allergies. The patient concomitant medications included levothyroxine with dose 125mcg and Atorvastatin with dose 20mg from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route on 26Feb2021 (at age of 63-years old) as dose 1, single for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 12:00, the patient experienced spike in BP, spike in heart rate and lighted. The patient received treatment IV fluids for events. The event resulted in emergency room visit The reporter assessed the case as non-serious. The outcome of the events was recovering.
Pruritic lesions on truck, became generalized between 14-17 days post-vaccination lesions consitant with erythema multiforme
uncontrollable shaking beginning 24hrs p/shots;checked by neurologists & given MRI-no MS detected;given Ativan to control shaking;gradually wearing off;weakness in knees &blurred vision during episode & dizziness which is now resolved;
He devloped febrile seizure following day after he received influenzae shot. Child was taken to ER, blood work and physical exam were normal. Child was sent home. Medical records state atelectacis, cold, rhinnitis. msv
no period prior to vaccine , post menopausal x 5 years.; right ovarian cyst; heavy bleeding daily( still to this day)/Menorrhagia; joint pain; hair loss; first dose:05Mar2021; second dose: 05Mar2021; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in left arm on 05Mar2021 (Batch/Lot Number: EN6206) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in left arm on 05Mar2021 (Batch/Lot Number: ER8727) as DOSE 2, SINGLE for covid-19 immunisation at Hospital. No other vaccine in four weeks. No other medications in two weeks. The patient did not have covid prior vaccination. No known allergies nor other medical history. The patient's concomitant medications were not reported. On 05Apr2021, the patient experienced menorrhagia, heavy bleeding daily (still to this day), no period prior to vaccine, post menopausal x 5 years. joint pain, hair loss, right ovarian cyst. Surgery for endometrial ablation and cystectomy scheduled for Sep2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The treatment for events included ultrasound, biopsy, surgery scheduled. The covid tested post vaccination included Nasal Swab on 29Jul2021 with negative result. The patient was not recovered form the events, outcome of 'first dose:05Mar2021; second dose: 05Mar2021' was unknown.  Follow-up attempts are completed. No further information is expected.
He has his wife both tested positive.; he has really sick; head ache; coughing and having blood come up/I see some blood in some phlegm; coughing sometimes; I am just distraught/My mind is so scattered right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GJ5342) 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's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "He has his wife both tested positive."; MALAISE (non-serious), outcome "unknown", described as "he has really sick"; HEADACHE (non-serious), outcome "unknown", described as "head ache"; HAEMOPTYSIS (non-serious), outcome "unknown", described as "coughing and having blood come up/I see some blood in some phlegm"; COUGH (non-serious), outcome "unknown", described as "coughing sometimes"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I am just distraught/My mind is so scattered right now". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course: The reporter is a Male consumer who stated that he has had 3 shots and went to get his 4th shot on Thursday and was feeling fine. He stated he wore his mask everywhere and hasn't had any family gatherings. On Friday night he began to feel sick and on Saturday he stated he has really sick and had a headache and a bad time. He has been coughing and having blood come up. On Sunday, he stated it was a little bit better and he tested at home for Covid. He has his wife both tested positive. When enquired about the email address, the patient said that he count not think of it. his mind was so scattered. he really did not know what to think, he was just distraught."  Conclusion of Previously Completed Investigation: The complaint for pfizer-biontech covid-19 vaccine was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GJ5342. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (Site name-withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
This spontaneous report as received from a registered nurse refers to a 3 months old patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with liquid PEDVAXHIB (lot #: J016185, expiry date: 02-OCT-2015, dose and route of administration were not reported) that was exposed to temperatures out of range (multiple excursion over a 24 hour period totaling 5 hours below 36F, including three cycles below 28F, have occurred on unspecified date, reported as prior to the morning 23-JUN-2014) that were not supported by Merck's stability data. No adverse effects have been reported. This is one of several linked reports received from the same reporter.  Additional information has been requested.
Patient/parent disclosed 2 previous vaccines, but not a 3rd. Our system said she was due for booster. Queried database, and no immediate response, so administered booster. After administration, database responded with information indicating that she had already gotten her booster in 12/2021. Is not eligible for 2nd booster, but received it at this visit.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 11:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 11:39 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 49.71 for dose administered on 28-Feb-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 degrees Fahrenheit at 09:00 AM and 26 degrees Fahrenheit at 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Bell?s Palsy with severe headache & severe dizziness for more than 2 months.Dizziness was so severe that even lying down in bed & turning from side to side ,I got dizzy. This is 6 months since it occurred & my full eye blinking has not return & slight facial droop & decrease sensation on the affected side of face still present.
Information has been received from a pharmacist concerning a female patient "in her early 20's" who "in early 2008" was vaccinated with 3 doses of GARDASIL (lot number not reported). The patient received her doses from another facility. About one year after dose 3 was administered, in 2009, the patient began to experience myalgia and tiredness. Unspecified medical contact was sought. The patient did have lab work done but the pharmacist doesn't know which ones. At the time of the report, the patient had not recovered. The Pharmacist contacted during telephone follow-up could no supply the following information patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of even and recovery status. The Pharmacist was waiting to speak with the doctor regarding these patients. This is one of several reports from the same source. Additional information has been requested.
Inflammation and redness at the injection site which increased in size (from about the size of a quarter to about four inches across) and also spread down and around the arm.  This was accompanied by itching and was not relieved by using Benadryl Cream.
asthma exacerbation, sob, pt used own albuterol inhaler x 6 within 1 hr, transferred to ED
First got J&J shot in April 2021. Recently got Pfizer booster on 2/15/22. Last night my hand started burning after washing. I noticed they were red like eczema. Small red dots below the skin surface. Right arm only. Very mild but when I sometimes wash hands or use lotion it gets irritated. Opposite arm of injection. Mild. I also saw 2 big red dots on my ankles. One of each leg. No pain or irritation. Looks like a big bug bite without the bump in middle or any itchiness. Hard to tell if it's from the cold or just dry skin. But I've never had a rash on entire back of hand before. Since I did just get the booster I wanted to report it. I have photos.
pt recv vax 12DEC97 & 2 days p/vax exp a non-raised, splotchy rash on the palms, soles of feet & all over the body;this was characterized as a mild allerg rxn;Annual follow-up dated 10/30/00 provided no additional data.
I experienced fever, chills, muscle pain, joint pain, nausea, diarrhea, fatigue , light headed
Injection was placed in my upper left arm. Around the injection site my arm is hot, red, the skin is raised in the red area, and the skin in this area is very itchy. This area is about the size of my palm. It started 2 days after the injection and has not gone away yes (5 days later).
Blood clots from COVID Vaccine/Can you please repeat the product name; Eliquis; This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received unknown number dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced blood clots from covid vaccine. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
NAUSEOUS; TOOK UNREFRIGERATED COURSE OF VIVOTIF; This spontaneous case (PVX2019-883) was received from a caregiver on 15-Apr-2019. It describes a female consumer who felt nauseous, after the administration of Vivotif (lot no: 3003242 and expiry date: Nov 2019) for typhoid prophylaxis. The consumer also "took unrefrigerated course of Vivotif".  Case report: The consumer took all four doses of Vivotif before she realized it should be kept refrigerated. It had also made her nauseous. She stated that she was not sure of the exact date of the nausea, but she estimated that it started after the first dose, and it resolved about two to three days after the last dose. She did not eat any unhygienic food or water intake.  The consumer had no medical history.  The consumer was not taking any concomitant or treatment medication   Action taken with Vivotif with respect to the event nauseous was dosage maintained while with the event "took unrefrigerated course of Vivotif" was not applicable.  The clinical outcome of the event nauseous was resolved while with the event "took unrefrigerated course of Vivotif" was unknown.  Company's Comment: In this case, it was reported that the consumer felt nauseous following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, nausea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.The causality of the event "took unrefrigerated course of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer felt nauseous following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, nausea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.The causality of the event "took unrefrigerated course of Vivotif" was considered as not applicable.
Numbness, tingling, and pain to entire left side of body starting from toes and working upward.
ARM HIT WITH BAT; DROP DEAD FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On an unspecified date, the subject experienced arm hit with bat, drop dead fatigue, and nausea. The action taken with covid-19 vaccine was not applicable. The outcome of the drop dead fatigue, nausea and arm hit with bat was not reported. This report was non-serious.
Patient experienced headaches and facial twitching starting the day after vaccination. She spoke to her doctor and attributes reaction to interaction with RESTASIS eye drops & eye condition.
Side Effects post COVID-19 jab: Some immediately, some took several weeks, some took 4-6 weeks: ? Brain fog, word finding & name finding difficulty ? Decreased strength & stamina ? Erectile dysfunction x2 months ? Extreme fatigue (worsens with work & activity) ? Headaches ? Limb jerks, twitching, spasms ? Muscle pain throughout body ? Pain and/or pressure in and/or behind left eye ? Testicle/scrotal pain ? Weakness, numbness, pain, & tingling in legs & arms & face (predominantly left side); generalized clumsiness, dropping things accidently out of hands, difficulty writing fast, difficulty walking, clumsy gait, heavy feeling limbs, left leg buckles & gives out, left foot drop ? Worsening tinnitus ? fast drum beat in left ear (felt & heard) that can last for hours to days ? dry eyes, blurry vision, eye haze & sensitivity to sunlight ? dry mouth, throat, nose, skin ? sinus issues ? difficulty swallowing (especially dry food & bread)
Father noted red face x 4 days.  Low grade fever x 2 days. Runny nose.  Behavioral changes...more defiant and much more energetic.  Sleeping more and eating more than normal.
Sore arm; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 17Apr2021 as a dose 1, single for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 08May2021 as a dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore arm after his covax which he received on 17Apr2021 and 08May2021. He had heard on the news about the booster and asked when it would be available, he was informed that it has not been approved by the FDA yet and was provided with PMI phone number to see if they have further information on the booster. Medical questions were addressed by the program and forwarded/referred to medical information. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Nosebleeds  Very heavy menstrual cycle that?s still ongoing and my normal cycle just finished a week prior. Red hives all over front and back of my upper body. Severe fatigue  Nausea  Diarrhea  Malaise Loss of  appetite  Low grade fever  Dehydration  Headaches