chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intramuscular influenza vaccination; Necrotizing fasciitis; This spontaneous case was received on 10-Nov-2023 from other non-health professional (reference number SEQW23-04188) and concerned a male patient of unreported age.  The patient's medical history and concomitant medications were not reported. The patient's historical procedures included dyalisis.  On 22-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (Influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date, following the vaccination, as reported, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced necrotizing fasciitis.   On 23-Oct-2022, a year and a day later, as reported, the patient purportedly died from intramuscular influenza vaccination as allegedly determined by the Coroner. The further information about the autopsy was not provided.  The reporter assessed the event of 'vaccination adverse reaction' to be related to Flucelvax Quadrivalent.  This case was assessed as serious due to the fatal outcome. Additionally, the event of necrotizing fasciitis was considered to be medically significant by a Physician.  Company comment: A patient was vaccinated with the suspect product Flucelvax Quadrivalent. An unspecified time after vaccination the patient experienced necrotizing fasciitis. A year and a day later, as reported, the patient purportedly died from intramuscular influenza vaccination. Autopsy report was not provided. Cause of death was not specified. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Due to limited information provided and unclear temporal relationship causality for the events immunisation reaction and necrotising fasciitis is unassessable.; Sender's Comments: A patient was vaccinated with the suspect product Flucelvax Quadrivalent. An unspecified time after vaccination the patient experienced necrotizing fasciitis. A year and a day later, as reported, the patient purportedly died from intramuscular influenza vaccination. Autopsy report was not provided. Cause of death was not specified. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Due to limited information provided and unclear temporal relationship causality for the events immunisation reaction and necrotising fasciitis is unassessable.; Reported Cause(s) of Death: Intramuscular influenza vaccination
Chronic sinus condition began that could never be remedied. Constant mucus buildup. No prior history of mucus, allergy or sinus issues prior to vaccine. Antibiotics were unsuccessful long term. Sinus surgery performed In 10/22. Mucus still builds up, even after surgery.  Strong immune response to the next vaccine given in 2018 (Gardasil)- significantly swollen  lymphatic glands. No doctor ever connected the dots but I have researched and have learned the truth.  Doctors aren't trained to treat the root cause of anything. This vaccine impacted the quality of life for my son.
Mom called states received vaccines 1-14-14. 2 days after vaccination he developed rash to bilateral legs. (+) itching (+) redness. Rash covers legs completely. Decreased itching now but increased rash.
Devel fever to 104F 9 days following below immun; Was examined on 10th day & found to have rt OM; Has not been back for f/u;
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 18-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The PROQUAD was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) lot # M034763, expiration date 22-APR-2019. The temperature excursion was of 6°F to 14°F, during 120 hours 30 minutes. However, a previous temperature excursion of 47 °F to 50°F for 35 minutes was also reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from  the same reporter.; Sender's Comments:  US-009507513-1801USA003525: US-009507513-1712USA013991: US-009507513-1801USA003527: US-009507513-1801USA003520: US-009507513-1801USA003524: US-009507513-1801USA003523: US-009507513-1801USA003522: US-009507513-1801USA003521: US-009507513-1801USA003612:
Received vaccine mid AM. Later that day arm became sore and lasted about 3 days. About 3 days after shot developed redness around site - warm, itchy. Grew to size of small orange. Stabilizing now but very itchy - MD recommended BENADRYL q 6 hours (12/22/14) to see MD if does not start to recede.
Vaccine given late morning.  Pt. had an appointment with the clinic at 1:20  to check on getting a new scooter. His family picked him up to take him and while riding in the truck he slumped over and was unresponsive.  Family took him to Hospital where his heart doctor is located, and he was not able to be revived.
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 2 November 2007 the subject received unspecified dose of Flulaval in an unknown arm.  Immediately after vaccination with Flulaval, the subject experienced an injection site reaction.  On 4 November 2007, the event was resolved.  Follow-up information was received on 11 December 2007 via a healthcare professional, who reported that the subject immediately developed a lump and redness at the injection site following vaccination of Flulaval.  The reporter stated that the events were resolved in two days with no further problems.
Swelling and pain in the left arm pit and peck muscle. Causing pain in the chest and difficulty breathing due to pain.
Injection site became swollen, red, and hot to the touch. This developed within a few hours of injection. Redness was present in a large area approximately 4inx4in.
I had same symptoms as when I had strain COVID19 in 4/2020; but with vaccine I had more pronounced/higher fevers and worse fatigue/myalgias/myositis. fever to 103.5 lasted until 9/14 when defervesced with RTC tylenol.   chills lasted until 9/15 nausea and vomiting/anorexia lasted until 9/14 treated with zofran myalgias/myositis lasted until 9/17-18 treated with RTC tylenol headache lasted until 9/15 and resolved with tylenol fatigue lasted until 9/15
A non-serious spontaneous report of product left at room temperature for 20 days was received from a Consumer or other non health professional concerning an adult female. The spouse had purchased FLUMIST over the counter and was not advised or counseled to refrigerate. The spouse did not read the packaging and stored at room temperature. The FLUMIST was left at room temperature for 20 days and then administered on 10-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
About a week after the first COVID shot, I developed a rash on my neck. It was just one spot but I noticed it getting bigger and rounder. It did not itch or cause any discomfort so I just left it alone. About two weeks later, I noticed I was getting more little spots?they kind of looked like bug bites. I went to urgent care about the big one on my neck as it was kind of looking like ringworm?the NP said it looked like ringworm or excema. She prescribed me Oxiconazole for ringworm. The same day I saw her I got my 2nd COVID shot and began applying the antifungal cream that night. It?s been about a week since that last shot and the antifungal cream is not working?kind of making things worse. The rash may or may not be a side effect from the shot but I am just informing you.
Per pt., approx 20 min after injection, developed sudden headache with pain 8/10, neck pain, and redness/itchiness/swelling at injection site. Arrived at school nurse office at 12:30. Reported that her fingers were swelling. Fingers were not visibly swollen, and her rings were freely movable around fingers.  BP 130/80, HR 90, 98% RA. Ice pack applied. Pt reported her daily meds (see above) and that she had not taken her daily anti-anxiety medication. Pt requested 2 cups water. Pt agreed to administration of 25mg Diphenhydramine po. Stated that it seemed to be helping. Denied "feeling like I am having anaphlaxis, I know how that feels." Reported arm/headache feeling better. continued: At 12:45, Pt ambulated  from Elementary School Nurse office to highschool nurse office for further observation. School nurse was familiar with pts baseline, and noted she looked different. PHN noted that patient was now diaphoretic and arm swelling seemed more pronounced. Pt agreed to have EMTs called, after being encouraged by 3 nurses. At 1pm, BP 152/90, HR 90, O2 sat went from 95% RA to 87% RA while awaiting ambulance. Pt remained talkative and sitting upright throughout. Denied shortness of breath or difficulty breathing.  Erythema marked with pen and did spread beyond pen border while awaiting transport. Pt transported to ER via Ambulance around 1:20pm.
Pt given extra doses of each of the above vaccines by mistake. Pt left clinic with no s/s of AE.
increase was observed in the sperm count; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPERM CONCENTRATION INCREASED (non-serious), outcome "unknown", described as "increase was observed in the sperm count". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter reported that the Embryologist, who gave information about the results of the study published open in Jul2021 and conducted in the Department of Urology at the University said, According to this study, sperm analyzes of volunteers were performed before and after vaccination with Pfizer-BioNTech, one of the mRNA vaccines approved for use by the Food and Drug Institute and applied in country, and with Moderna vaccines administered in various countries and the local , both vaccine groups were tested. An increase was observed in the sperm count, quantity and movement of the volunteers.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
developed a red non-raised rash on one side of vaccination site, occurred 15 post vaccine, and resolved 1/2 hour later
Chills; sweats; fever 100.5; headache; stuffy nose; body aches; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246) intramuscularly administered in left arm on 05Feb2021 12:00 pm (24-year-old at vaccination) at a single dose for COVID-19 immunization. Medical history included COVID-19. No known allergies. The patient was not pregnant. Facility type Vaccine was at hospital. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced chills, sweats, fever 100.5, headache, stuffy nose, body aches; with start date on 06Feb2021 03:00 am. No treatment received for events. The outcome of events was unknown. No COVID tested post vaccination.  Follow-up attempts completed. No further information expected.
Headache the day of 1st dose and two days after. By the third day post 1st dose, I started having swollen lymph nodes in bilateral armpits and outer bilateral breasts. This has continued since the third day post 1st dose, however my lymph nodes became more swollen on Monday, August 16th, with lateral and superior bilateral breast tenderness.
Information has been received from a physician concerning a male child who was vaccinated with Hep-B vaccine recombinant (yeast) and subsequently, the pt "experienced a seizure the day following the vaccination" and was hospitalized. The seizure was disabling and immediately life-threatening. Upon internal review, the seizure was determined to be an "Other Medical Event". Additional information has been requested.
Lump in armpit, swelling of face, mouth and neck. Was instructed to go to ER after taking Benadryl with no relief.
Patient complained via telephone on 08/30/2001, of a "large local reaction". The patient was advised to treat with an ice pack. The patient went to the ER on 09/02/2001 and was diagnosed with cellulitis. Augmentin was prescribed.
Eyes swollen after receiving the Moderna Covid-19 vaccine; The left side of the bottom lip felt like it had been burned and is still swollen and to touch it, it burns; Half of her right eyelid was swollen and was real red, described as its being a reddish purple color.; Had kind of an itchy, burning feeling of the right eyelid; Itchy eye; This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (the left side of the bottom lip felt like it had been burned and is still swollen and to touch it, it burns), SWELLING OF EYELID (Half of her right eyelid was swollen and was real red, described as its being a reddish purple color.), EYE IRRITATION (had kind of an itchy, burning feeling of the right eyelid), EYE PRURITUS (Itchy eye) and EYE SWELLING (Eyes swollen after receiving the Moderna Covid-19 vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blisters (Occasional fever blisters). Concomitant products included LISINOPRIL for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced SWELLING OF EYELID (Half of her right eyelid was swollen and was real red, described as its being a reddish purple color.), EYE IRRITATION (had kind of an itchy, burning feeling of the right eyelid) and EYE PRURITUS (Itchy eye). On 30-May-2021, the patient experienced LIP SWELLING (the left side of the bottom lip felt like it had been burned and is still swollen and to touch it, it burns). On an unknown date, the patient experienced EYE SWELLING (Eyes swollen after receiving the Moderna Covid-19 vaccine). The patient was treated with LYSINE ongoing since an unknown date for Swollen lips and Burning lips, at a dose of 1 dosage form. On 30-May-2021, SWELLING OF EYELID (Half of her right eyelid was swollen and was real red, described as its being a reddish purple color.) and EYE IRRITATION (had kind of an itchy, burning feeling of the right eyelid) had resolved. At the time of the report, LIP SWELLING (the left side of the bottom lip felt like it had been burned and is still swollen and to touch it, it burns) had not resolved, EYE PRURITUS (Itchy eye) had resolved and EYE SWELLING (Eyes swollen after receiving the Moderna Covid-19 vaccine) outcome was unknown.            Concomitant medication Cholesterol medicine and Acid Reflux medicine was reported by the patient.  Action taken with mRNA-1273 in response to the events was not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: New event added in the event tab.
Typical reaction of fever and severe achiness throughout my body. Then the chills started. Probably felt achier than ever before from this Moderna vaccine. The different thing this time was that I had bad problems controlling my urine. I had to get up at least once an hour to urinate throughout the night. Never had this happen before. By morning, that reaction stopped and I began to feel much better. No problem since.
10 days after vaccine administration patient developed left lower quadrant pain and back pain which quickly progressed to bilateral flaccid paralysis of lower extremities. MRI shows acute demyelinating myelitis vs transverse myelitis.
Debilitating fatigue, muscle weakness, muscle shaking, pressure and ringing in ears, vertigo, dizziness, nausea, increased heart rate, increased orthostatic intolerance, exercise intolerance, headache, cognitive impairment
9/1/09 - Left arm red, hot, tender no increase in size on 9/2/09.  Rx: ORAPRED, BENADRYL, cool compresses.  Rev 9/3/09 - Resolving local Rxn .
Information has been received from a nurse concerning her 4.5 year old grandson with celiac disease who was vaccinated with Varivax. In April 2006, the patient experienced a mild to moderate breakthrough chicken pox. Unspecified medical attention was sought. At the time of this report the patient had not recovered. No product quality complaint was involved. Follow up information indicated that no additional information was available. No additional information is expected.
devel diarrhea/vomiting 6MAR96 about 3-4PM;7MAR96 had t103 ax;saw MD 8MAR96 entered hosp x3 days w/dehydration;mild toxic appearance w/irritability;WBC indicative of viral infect;mild cough;impressions BOM;dx BOM-fever-r/o sepsis;
Immediately after, arm was sore for 2 days, 8 days later a rash appeared that was hard, warm and raised. It's 24 days after the shot and you can still see where the rash was. It is no longer hard, warm or raised but you can still see it.
Nauseated, aches, fever of 104.5, mouth sores, debilitating headache, neck and shoulder pain, sharp shooting pains throughout body, fatigue, dizziness. High fever lasted for 24 hours. Other symptoms lasted 5 days.
1/11 2:00AM - Awoke with chills & shivering, headache, sinus drainage with a lump at the back of my throat and a fever of 101.1. Extreme fatigue - no energy. Fever gradually went down and was normal by evening. 1/12 All symptoms were gone and I was back to normal.
Pt came in complaining of right arm swelling and feeling sore after receiving vaccine on Friday 3/21/2014. Given a prescription for Benadryl and Clindamycin with return appointment for 3/26/2014.
Saturday nigh I started with some hives on the side of my stomach. I took Zyrtec and it calmed me down, but Sunday morning when I woke up my whole body and back was covered with rash. I had to go to the emergency room because my lips were also numb. They gave me several medications in the veins and also serum, they sent me home with oral medications
Booster; Migraine; pain in left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and a sales representative. The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 10:00 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose: Date administered: 19Jan2021, Lot/NDC/Expiry: Unknown, Caller did not have CDC vaccine record card with him at time of the call., Dose: Unknown strength/volume/dose injection to he thinks the right arm at 12:00.), administration date: 19Jan2021, for covid 19 immunization; Bnt162b2 (Second dose: Date administered: 09Feb2021, Lot/NDC/Expiry: Unknown, Caller did not have CDC vaccine record card with him at time of the call., Dose: Unknown strength/volume/dose injection to he thinks the right arm at 13:30), administration date: 09Feb2021, for covid 19 immunization.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 10Dec2021, outcome "recovered" (10Dec2021), described as "pain in left arm"; MIGRAINE (non-serious) with onset 11Dec2021, outcome "not recovered", described as "Migraine". Therapeutic measures were taken as a result of migraine.  Additional information: Normal pain in left arm: Recovered completely from this event within about 12 hours of onset. Migraine headaches: Onset time initially reported as about 36 hours after administration of booster dose; but later clarified as in the morning when he woke up, exact time unknown. At time of onset, he described waking up with migraine headaches, major migraine headaches. He thought initially that this event would be transient, but it's a week later and still persistent. During the day event is manageable, it doesn't bug him as much; but in bed, the migraine headaches seem to be at their worst in the mornings when he first wakes up, like when he gets up to go to the bathroom. Migraine headaches: Onset time initially reported as about 36 hours after administration of booster dose; but later clarified as in the morning when he woke up, exact time unknown. At time of onset, he described waking up with migraine headaches, major migraine headaches. He thought initially that this event would be transient, but it's a week later and still persistent. During the day event is manageable, it doesn't bug him as much; but in bed, the migraine headaches seem to be at their worst in the mornings when he first wakes up, like when he gets up to go to the bathroom.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt recvd vax 28DEC92 & 4JAN93 devel a red mark from wrist to elbow & exp some heat in the area;
This spontaneous report was received from a medical assistant, concerning to a 2 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 04-AUG-2017 at 9:00, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # M038717 for prophylaxis (Dose, strength, frequency and expiration date were not reported). No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA006123.
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates since 12-MAY-2015, multiple unspecified patients were vaccinated with unspecified doses of improperly stored GARDASIL (lot # K001500, expiry date 06-NOV-2016; lot # K003520, expiry date 20-NOV-2016; lot # K006124, expiry date 02-FEB-2017) (dosage, strength and route were not reported). At the time of the report, there was no adverse effects reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Initial and follow-up information has been received from a nurse practitioner concerning a 15 year old white female with no medical history and no drug allergies, who, on an unspecified date was vaccinated with a dose of GARDASIL. There was no concomitant medication. There were no illnesses at the time of the vaccination. On 02-OCT-2007, the patient developed hives. The patient was seen by her physician. No laboratory diagnostics were performed. the patient recovered on 04-OCT-2007. Additional information has been requested.
Pfizer Bivalent COVID-19 vaccine given as second dose of primary series as opposed to the monovalent vaccine. No side effects reported by patient next day.