chrisvoncsefalvay/vaers-outcomes huggingface dataset:
last one nearly killed me and I'll never take another or advise anyone too; Initial information received on 17-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional via Digital Media.  This case involves a patient of unknown gender and age who experienced last one nearly killed me and i'll never take another or advise anyone too while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (dose, route, strength, formulation, batch lot number and expiry date: unknown) via unknown route in unknown administration site for Influenza.   On an unknown date, the patient developed a serious event last one nearly killed me and i'll never take another or advise anyone too (near death experience) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant and life-threatening.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (near death experience).  At time of reporting, the outcome was Unknown for the event near death experience.; Sender's Comments: Sanofi Company Comment dated 23-Feb-2022: This case involves a patient of unknown gender and age who experienced last one nearly killed me and i'll never take another or advise anyone too (near death experience) while receiving vaccine influenza vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, therapy details, any family history of cancer and any relevant medical history of patient, any concurrent conditions and type of cancer and indication of the drug precludes comprehensive case assessment.
Received the second shot 7 weeks after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second shot 7 weeks after the first shot) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second shot 7 weeks after the first shot). On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second shot 7 weeks after the first shot) had resolved.       Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was not provided.   Reporter did not allow further contact
Fever with peak of 103.9 degrees Sunday evening (7/25/10).  PMH significant for PENTACEL, pneumococcal, and rotavirus vaccinations 7/20/10 (Tues). MOTRIN dosed regularly from shots until Sat. due to hx. of fever with 4 m.o. vacc - -pneumococcal, DTAP, HIB, IPV given (at previous doctor).
pt recv vax & 7 to 10 days post vax pt devel pharyngitis & neutropenia & was hosp;tx w/IV ATB & did well;@ time of report pt had been d/c from hosp;
Pt state a rash appeared on her left forearm about a week after the first dose. She said it lasted only a few hours.
Patient should have gotten a PNEUMOVAX 23 vaccination but received PREVNAR 13 in error. Patient did not experience any adverse effect but will need to still receive a PNEUMOVAX 23 vaccination.
Patient reported that after she completed her 15 min observation in the clinic she left an around 10 min later she stated that she began to feel her throat swelling and tingling feeling. patient referred to the feeling as if she had gone to the dentist and had lidocaine administered. Patient reported that she didn't have trouble breathing. Her lips didn't feel normal for around 24 hours.
Employee told me this morning that she is having pain in the left shoulder which radiates to her upper chest. This pain is similar to the same complaint she had after receiving her first injection of Hep B Vaccine. She saw her private doctor after she had these complaints and was told that she had bursitis in her right shoulder. I gave her injection yesterday in her left deltoid.
2 days after shot had 4-5 inch area of redness & warmth & hard knot developed. Now 10 days later redness is gone but 1/2 inch hard knot under the skin remains.
12 hrs after dose - rigors, fever, body aches - symptoms lasted 48 hours 72 hrs after dose - headache, stiff neck, pain/swelling/redness/hard to the touch at injection site - ?covid arm?
Jansen Covid 19 Vaccine Immediately after receiving vaccine, I experienced blurred vision,  and dizziness. My lips were semi-numb. The day following the vaccine I was extremely tired, and had a mild fever on and off for approximately 36 hours. Since receiving the vaccine, I have experienced a relentless headache, increased bruising, joint pain, tiredness, and what I have been describing as a floating sensation. None of the symptoms have left me unable to perform daily responsibilities, but the strange headache accompanied by the dizzy, floating sensation has been odd, and I thought it was worth mentioning. Today is the first day I have woken up without the strange headache, and tiredness since receiving the vaccine.
Pt recvd 2nd dose of vax 14AUG92 & on 17AUG92 pt devel faint & transient rash; also c/o  pain & a dec ROM in rt hip; could barely walk; also sl t99.8; lab eval revealed 10,700 WPC per cu mm & ESR 12mm/hr; xray of joint was nl;  dx tenoso
pulmonary embolus; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Oct2021 (Lot number: FH8028) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies.  Concomitant medication(s) included: INFLUENZA VACCINE INACT SAG 4V (SEQIRUS FLUCELVAX; Lot number: 308523) taken for immunisation, administration date 01Nov2021. Vaccination history included: BNT162B2 (Dose 1; Lot number: EL1284 in the right arm), administration date: 29Dec2020, when the patient was 64 years old, for COVID-19 immunization; BNT162B2 (Dose 2; Lot number: EL3302 in the right arm), administration date: 19Jan2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, medically significant, life threatening) with onset 08Nov2021, outcome "recovered", described as "pulmonary embolus". The patient was hospitalized for pulmonary embolism (hospitalization duration: 3 day(s)). The event "pulmonary embolus" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) negative. Therapeutic measures were taken as a result of pulmonary embolism, which included heparin and then apixaban (ELIQUIS).; Sender's Comments: Based on the available information in the case, the causal association between the event pulmonary embolism and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Chills, fever, weakness, dizziness, nausea, couldn't sleep, too cold.
Cellulitis with lymphangitic spread from vaccinia vaccination site to left axilla; Tequin 400mg x 5d.
Fussy, sleepy (not wanting to wake up), loss of appetite (missed feeding), fever (lasted 2 hrs. but had given infant Tylenol), glassy eyed (not focusing on anything, not alert). All systems, excluding fussiness and loss of appetite lasted until 1/28/11 at 5:30 PM.
1st Dose- 03Sep2021 and 2nd Dose-20Sep2021; Foggy Headed; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 20Sep2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "RHEUMATOID ARTHRITIS" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; VITAMIN C [ASCORBIC ACID]; TYLENOL ARTHRITIS; IBUPROFEN; TIZANIDINE HCL; LORATADIN; OMEPRAZOLE; LIOTHYRONINE SODIUM; LEVOTHYROXINE; METHOTREXATE; VITAMIN D3. Past drug history included: Morphine sulfate, reaction(s): "ALLERGIES: MORPHINE SULFATE". Vaccination history included: Bnt162b2 (Dose 1), administration date: 03Sep2021, when the patient was 46 years old, for Covid-19 Immunization, reaction(s): "Foggy headed". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Sep2021, outcome "unknown", described as "1st Dose- 03Sep2021 and 2nd Dose-20Sep2021"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Foggy Headed".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
3 large loose stools, vomited several times, inconsolable crying lasting longer than 3hr;
24hr p/vax pt broke out in a rash & hives w/itching & small blisters on the face, neck back legs & arms; seen by MD 1 wk later; told mom that rash was rxn to MMR D/T allergy to eggs;
Bumps on her stomach the first day of the shot then several day later on her back, face, legs, pubic area. They look like hives. Bumps red and itchy. child was very irritable. Just a note they gave me paperwork for the HPV shot also. But I decline for my 15 year old daughter.
Developed fever, chills, arm pain, redness, swelling and mild numbness of Rt arm. Dx cellulitis and placed on BACTRIM DS. Came in office 8/23/10 and mild tenderness present.
This spontaneous report was received from a nurse refers to a two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 07-FEB-2014 the patients were vaccinated with MMR II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
I was post menopausal - 16 months without a period, then got a period the day after my 1st vaccination. The day after my second dose I started another extremely heavy period. The worst I had in years which included many painful clots.
Information was received on 28-JUN-2017 from a registered nurse who reported that a 12 year old 11 month female patient received VAQTA (lot# M039055, expiration 22-JUL-2018) adult dose of 1.0 ml booster dose in right deltoid on 28-JUN-2017 at medical office, as a second series of shots, with the first shot of VAQTA administered in April 2010 as a 0.5 ml dose for prevention of hepatitis A. The nurse stated that the patient did not have any concomitant medications, laboratory data, and relevant medical history. As of 28-JUN-2017, the outcome of the patient receiving 1.0 ml adult dose of VAQTA is unknown. Additional information has been requested.
My daughter took the GARDASIL shot in August 2012. She got sick with a virus which set off a reaction to the shot. She got very sick in December 2012 and my daughter had pain in all her joints and could not move. She has been sick for 2 and a half years. She can't walk and has recently had another relapse that has left her neck unstable. She has been in 4 hospitals.
pneumonia; got Covid-19 after vaccinated; A spontaneous report was received from a consumer concerning a female patient of 69 year old, who was administered moderna's COVID-19 vaccine and tested positive for covid-19 and Experienced pneumonia.  The patients medical history was not provided. No relevant concomitant medications were reported.  On 06-JAN-2021, prior to the onset of events, the Patient received their first of two planned dose of Mrna-1273(Lot number: 012L20A) intramuscularly. On 11-JAN-2021,five days after receiving vaccine, the patient tested positive for covid-19 and had pneumonia. Patient  was admitted in the hospital for five days of a ten day intravenous therapy and recently got home. Patient has one treatment left. Doctor said wait 90 days to get the second shot . Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events was not reported.; Reporter's Comments: This case concerns a 69-year-old female hospitalized with serious unexpected events of COVID-19 and COVID-19 pneumonia. Event onset 6 days after the first dose of mRNA-1273. Treated with 10 days of IV therapy. Very limited information regarding the events has been provided at this time.  Further information has been requested. Based on the current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Redness and swelling of left arm noted 2/6/19 and was increasing in redness and itchy-applied ice pack. Non tender swelling and redness left arm extending from just below the shoulder to above elbow encircling left arm.
Pt school nurse called and stated that where pt received her flu shot yesterday there is an oblong red area that is about 2" long and 1 1/4" wide. Stated that the area is red and slightly warm. Using warm compresses and monitor the area.
Left arm red and swollen opn no limitation of movement DTAP- IM, LD, IPV- SC, LA given 3-11-04 in Left arm. Treatment Keflex 250/5 1 tsp orally three times a day for 7 days.
Patient reported swollen eyes, warm, redness, and very itchy at injection site. The redness spread to above elbow area. Redness and swelling decreased over the course of 5 days.
Client was scheduled to get second dose of Pfizer Covid-19 on 02/19/21.  Received call from family stating that client suffered a stroke on 02/18/21 and was admitted to hospital.
Pt received Pfizer bivalent, after 10 minutes states that she is having tingling sensation in her right deltoids that irradiated to her hand. VS -68, 135/75, 98%.  around 12:45 pm pt states that tingling sensation is improving, but she is experiencing pain in her right arm 4/10.  12:53 pm pt states that she was feeling better. ED precautions given, pt verbalized understanding. Pt was discharged home.
I have started to have occasional, and unusual spotting/bleeding; I have started to have occasional, and unusual spotting/bleeding; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female consumer reported for herself that. A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 12:00 PM as (At the age of 50-years) dose 2, single for covid-19 immunisation. Medical history included contraception from an unknown date and unknown if ongoing. Concomitant medication included medroxyprogesterone acetate (DEPO PROVERA) taken for contraception, start and stop date were not reported. No known allergies ware reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Mar2021 09:00 AM as dose 1, single for covid-19 immunisation. The patient experienced i have started to have occasional, and unusual spotting/bleeding (intermenstrual bleeding and vaginal haemorrhage) on 29Mar2021. Patient did not receive any tenement for events. The outcome of events was not recovered.  Information about lot/batch number has been requested.
BLOOD CLOTS; WATER RETAINAGE; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unknown date the patient reported that "Thanks for almost killing me. Blood clots, water retainage, ultrasound, prescription drugs for all the side effects from your vaccine. But I still think vaccines are good". Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and water retainage was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220203871-covid-19 vaccine ad26.cov2.s-Blood clots.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Itching face, scalp and back; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy dates unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had itching face, scalp and back. The outcome of the events, 'itching face, scalp and back', was unknown.  Information on lot/batch number has been requested.
Japanese Enceph #1 given on 02/22/2005-localized pain at site Japanese Encephalitis #2 given 03/01/2005, 36 hours later she developed angioedema of lips, gums, tongue and continued for 4 days. No urticaria, no resp. distress, cough, or wheezing.
huge bright red welt below injection site on side of bicep; Area below injection site is warm; lump below injection site; Area below injection site is sore; low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (huge bright red welt below injection site on side of bicep), VACCINATION SITE WARMTH (Area below injection site is warm), VACCINATION SITE INDURATION (lump below injection site), PYREXIA (low-grade fever) and MYALGIA (Area below injection site is sore) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 003C21A) for COVID-19 vaccination.     No medical history for the patient was reported.  Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for Bronchial disorder.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (low-grade fever). On 30-Apr-2021, the patient experienced ERYTHEMA (huge bright red welt below injection site on side of bicep), VACCINATION SITE WARMTH (Area below injection site is warm), VACCINATION SITE INDURATION (lump below injection site) and MYALGIA (Area below injection site is sore). On 02-Apr-2021, PYREXIA (low-grade fever) had resolved. At the time of the report, ERYTHEMA (huge bright red welt below injection site on side of bicep), VACCINATION SITE WARMTH (Area below injection site is warm), VACCINATION SITE INDURATION (lump below injection site) and MYALGIA (Area below injection site is sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment include Tylenol on 30Apr2021, ice to area on 30Apr2021, warm compress to area on 01May2021 - 02May2021.  Concomitant medication include vitamin supplement.   This case was linked to MOD-2021-102021 (Patient Link).
Wheezing, hives, slight fever, injection site redness, pain. Patient better without medical attention.
Information has been received from a physician concerning a 7 year old female with a history of chronic benign Granulocytopenia at childhood and asthma, who on 17Jul1998 was vaccinated once with a 0.5ml SC dose of varicella virus vaccine live. There was no concomitant medication. It was indicated that the chronic benign granulocytopenia causes a low WBC count, and that the pt's WBC count was still low. In Feb 2005 (also reported as 26Jan05), the pt developed a severe case of chickenpox. The pt was hospitalized for 2 weeks and had 4 surgeries. The pt had developed necrotizing fascitis and had a problem with her foot. It was reported that the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a physician indicated that on 26Jan05 the pt developed chickenpox lesions. She presented to the physician's office on 27Jan05 and was diagnosed with breakthrough. On 31Jan05, she presented to the hospital, febrile with chickenpox, and was not looking toxic. She was then noted to have a 104 degree fever, increased soreness in her right leg, foot pain, foot itching, and 2 gray spots on her toe. She was then transferred to another hospital on 01Feb05 for immediate incision and drainage of her right leg. She had an incision and drainage again on 02Feb05, 03Feb05 and 07Feb05. It was noted to be a deep tissue infection for the fascia with no necrosis. She was also noted to receive hyperbaric treatment during hospitalization. She was treated with antibiotics. The discharge diagnosis on 14Feb05 included: cellulitis with deep tissue necrosis, chickenpox, and chronic benign granulocytopenia at childhood. At the time of the call, the pt was noted to be recovered. Her sites were well healed and she was active. No product quality complaint was involved. Chickenpox and cellulitis with deep tissue necrosis were considered to be immediately life threatening and other important medical events. Additional information has been requested.
Information has been received from a nursing supervisor concerning a male in his middle 50's who on approximately 15-APR-2009, two to three weeks ago, was vaccinated with a "standard dose" of PNEUMOVAX. Subsequently, a few days after receiving PNEUMOVAX, the patient noticed that his skin around the injection site was peeling off. The patient sought unspecified medical attention from a physician. It was unspecified if lab studies were performed. At the time of the report, the patient's status was unknown. Additional information has been requested.