chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 4/10/21 to Urgent Care.  Found blood clots in my lungs and Pneumonia,   Clots removed at Hospital on 4/11/21.  Hospitalized until 4/13/21. Treatment - blood thinners (enoxaparin, heprin and steroids),  azithromycin, Advair disk, albuterol,  Spiriva, Symbicort Outcome:  Still trouble breathing, slow moving and sore from the incesion.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Oct2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Breakthrough COVID-19 case, death. Vital records cause of death: CARDIOPULMONARY FAILURE, FAILURE TO THRIVE, END STAGE DEMENTIA. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: COVID-19
For approximately 8 hours the peripheral portion only (at the hairline) of my face felt tight like a mud mask. The sensation went away on it's own with no treatment.
Our 2-year-old son has begun to repeat his words when speaking at the beginning of sentences. It is somewhat like a stutter except it is the whole word and not just the initial sound. I know that may not seem like such a big deal since he is only two but this child has been forming sentences since October '09 (1 year, 9 months in age) and has not exhibited any trouble with his speech. I haven't read anything about this being a possible side effect but there is a direct correlation between his receiving the Hep A vaccine and his compulsion to repeat the first word in his sentences. What do I do? Will this go away? It's been 2 weeks and he's still doing it. Should he get the follow-up dose? Has anyone else had this problem? Please help.
flu like symptoms; more distress; This case was reported by a consumer via and described the occurrence of influenza-like symptoms in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of emotional distress (1st dose received on an unknown date, refer case US2020248583).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms and emotional distress. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms and emotional distress were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and emotional distress to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The age at vaccination was not reported but could be 65 or 66 years. In 2019, the patient received 2nd dose of Shingrix in the left arm and on the same day, he experienced flu like symptoms and was more distress. The patient stated that this feeling lasted for two days and then fully resolved. No additional information was reported. The reporter consented to follow-up to HCP. This is 1 of 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248580:same reporter (sister´s in law case) US-GLAXOSMITHKLINE-US2020248574:same reporter US-GLAXOSMITHKLINE-US2020248569:same reporter US-GLAXOSMITHKLINE-US2020248583:Same reporter
Got shot, still got shingles/suspected vaccination failure; Shingles of eye; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot, still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles of eye) (serious criteria GSK medically significant) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was not reported and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and still experienced shingles of the eye. The patient stated that it was very painful and still have the pain. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Swollen tongue; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (Swollen tongue). At the time of the report, SWOLLEN TONGUE (Swollen tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  No relevant Lab Data was provided.  No relevant medical history was provided.   This case was linked to MOD-2021-252824 (Patient Link).
Menstrual cycle earlier; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jul2021 (at the age of 35-years-old) as a single dose and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Aug2021, the patient had menstrual cycle 7 days earlier than usual. The patient always had 35 days cycles and at the time of the report, it was 28 days cycle. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event menstrual cycle earlier was unknown at the time of this report.   The lot numbers for BNT162b2, were not provided and will be requested during follow up.
Patient reported several bruises up and down left and right forearm the day after receving the vaccine.
SORE THAT WON'T HEAL IN THE AREA THAT THE VACCINE WAS GIVEN, SHE HAS TRIED CORTISONE CREAM AND ANTIBIOTIC OINTMENT
4wk p/vax pt devel intussusception (colocolic intussusception)
Arm was really sore; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was really sore) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia (For a long time but had not been bothered by it in several years). Concomitant products included METFORMIN for Diabetes, ATENOLOL, LISINOPRIL, MONTELUKAST SODIUM (SINGULAIR), ALPRAZOLAM (XANAX), ACETYLSALICYLIC ACID (BABY ASPIRIN), DULOXETINE and VITAMIN D NOS for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was really sore) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm was really sore) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were provided. The patient received both doses of the Moderna COVID-19 Vaccine on it's right arm (it's not entirely sure), patient takes Blood pressure pill (on nap time), Baton for the hair and nails and Acidol for the stomach to put good bacteria in your system as concomitant.   This case was linked to MOD-2021-276528 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received: Added medical history (fibromyalgia) On 08-Sep-2021: Follow up received and contains concomitant details
Anthrax immunization, dose #5. Shoulder pain for 3 months with limited ROM. Pain and rash at the site. Complete recovery per visit in Aug, 2009. Discussed with agency Support Center. Given exemption.
20 y/o male calls Call Center with c/o skin rash approximately 10 days after receipt of SPV, AVA, & Typhoid vaccines.
Patient mentioned he was not feeling well due to having pain in his one arm (right arm) and Migraine.
redness extending from vaccination site (left deltoid muscle), measuring 4 cm wide and 10 cm long;  not hot or tender, has lightened slightly over days, and the location has continued towards elbow and medially. no itching, pain
Tinnitus with insomnia - flushed all ear wax, eliminated caffeine and alcohol  consumption.
Admit for bilat pna. Fully vaccinated. Tested positive after admit and dx with COVID pna. Treated with steroids, O2, remdesivir, vit-c, vit-d, zinc. Eventually improved to RA and was discharged home.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 15-MAY-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L029073, with expiration date 19-APR-2017, for prophylaxis (administration route was not reported). No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Temp 102, fussy, crying, drowsy, difficult breathing, heart rate fast. Nurse used a large amount of vaccine, did not recommend child return for second dose of flu vaccine.
Hives later that evening, did not respond to BENADRYL.  Hair loss began shortly after. The patient states she lost eye brow hair as well as almost all hair on her scalp, stated she is almost bald.
TDAP ADMINISTERED AT APPROX. 8:30AM PT. IMMEDIATELY WENT LIMP AND UNRESPONSIVE AND WAS PLACED IN FLOOR IN TRENDELENBURG POSITION. INITIAL B.P. 120/90 PULSE THREADY SKIN COLD AND CLAMMY WITH NO RESPONSE FROM PT. RECHECK B.P. 118/88, MONITORED FOR APPROX. 10 MIN.PT. ASSESSED BY FNP, PERRL O2 STARTED BY MASK AT 2L/MIN B.P. 110/55 PULSE 68 CALLED EMS. EMS ARRIVED ON SCENE AT 08:57 O2 SAT 98% BP 108/62 BS 100 TRANSPORTED BY AMBULANCE TO ER
Patient called stating his arm was aching/sore/stiff, and he had a rash develop on his chest 48 hours after administration. His concern was the vaccine may have been administered too high on his arm, but I was unable to confirm this as he called on the phone.
I lost my voice and had a sore throat. I had a fever with some chills and a slight headache, some nausea.
Information has been received from a physician concerning an 18 year old female who was vaccinated with GARDASIL. The patient had a negative pap smear test on 22-JUN-2007 and  negative HPV test. Patient then received the first dose of GARDASIL vaccine on 18-DEC-2006 and second dose on 28-FEB-2007 and the third dose on 19-JUN-2007. Patient had a negative pap smear and positive high risk HPV on 19-SEP-2008. On 10-FEB-2009 the patient had a low grade squamous cell HPV high risk positive. Lot #'s were not available. The patient sought medical attention by physician. At the time of the report the patient's status was unknown. Follow-up information has been received from a pediatrician concerning the patient she reported as having negative pap smears/negative HPV tests until after receiving the third dose of GARDASIL. Subsequent to the third dose, the patient had positive results. The pediatrician did not know which HPV strain was detected. The patient received her doses on 18-DEC-2006 (lot # 653938/0954U), 28-FEB-2007 (lot # 654702/0011U) and 19-JUN-2007 (lot # 657868/0523U). No other vaccines were given at the time of the GARDASIL vaccine. The outcome of the patient was unknown. The patient was referred to gynecology. No further information is available. This is one of several reports received from the same source.
12-36 hours after administration consistent fever with tmax 102.6, also with headache,  myalgias, chills, and significant fatigue. Beyond 36 hours fatigue and occasional myalgias, headaches persisted.
Case number PHEH2014US025024, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 73-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 26 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursions began on 16 Oct 2014 and the temperature was between 46 6o 49 degree F during the excursion. No adverse event reported following this medication error.
Myalgia, CoughWheeze, Diarrhea, NauseaVomiting, Tachycardia, Aggravated her known cardiac arrhythmia Narrative: Also c/o posterior left shoulder pain going to anterior chest.
Information has been received from a physician concerning a male who on 26-AUG-2008 was vaccinated with the first dose of MMR II. Suspect therapy included VARIVAX (MSD). Concomitant therapy included HAVRIX. By time the patient returned home he had developed "hives" on his arms and legs. Medical attention was sought by calling the physician's office. The patient was referred to an allergist. There were no diagnostic or laboratory tests performed. No product quality complaint involved. Additional information has been requested.
I had the moderna booster shot and the flu shot at the same time one in each arm and 21 days later I had an infusion of Remicade. I believe all of these meds together caused my current situation. I am off balance and have fallen 3 separate times since receiving them, I can hardly walk and both my hands are numb. I feel very unstable on my feet, my gait is almost as if I have cerebral palsy or something. I fell again today trying to get into my chiropractors office.  I'm scared, I go for an MRI on Nov. 23rd. I thought I should say something as I had none of these symptoms prior to getting all of these shots/infusions.
got the shot. now have the flu; Initial information regarding an unsolicited valid social media non-serious case received from via consumer/non-hcp on 26-Dec-2022.  This case involves an unknown age and unknown gender patient who experienced got the shot. now have the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route, administration site) for prophylactic vaccination.  On an unknown onset and latency after getting the shot, the patient has a flu (influenza).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event influenza.
3 vaccines administered 2/14/14 - Rash occurred on trunk and neck - progressing to both arms and Rash - resolved without medical intervention by 2/19/14. Rash described by pt as Flat, no itching or burning sensation. Called back after trip on 3/3/14 - reports he has completely recovered without medical intervention.
This spontaneous report as received from a pharmacist refers to a 75 year old female patient with drug reactions/allergies to aminoglycosides, macrolides, ketolides, oxycodone and potassium. On 03-JUL-2015, she received a dose of PREVENAR 13. On 02-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 injection, lot # M005287, expiration date: 08-OCT-2017, intramuscularly in the right arm (exact dose was not reported). On 02-SEP-2016 (also reported as "on 03-SEP-2016"), the patient experienced swollen injection site on her right arm. The pharmacist requested a lot check which was time sensitive. The outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
First Dose: Feels Lousy/Second Dose: Feels Lousy; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Mar2021 (Lot number: ER8733) at the age of 63 years as dose 1, single and administered in arm right, administration date 18Apr2021 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM taken for anxiety (ongoing). The following information was reported: MALAISE (non-serious) with onset 29Mar2021, outcome "recovered" (19Apr2021), described as "First Dose: Feels Lousy/Second Dose: Feels Lousy".  Additional information: Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination): Thyroid Cancer, Anxiety, Undiagnosed autoimmune stuff going on, thyroid, skin condition, connective tissue. Concomitant medication included Thyroid Replacement taken for thyroid cancer. Date of start of drug: 28Mar2021. Batch/lot number: FG3527. First Dose: Feels Lousy. Date of start of reaction/event: 29Mar2021. Date of end of reaction/event: 29Mar2021. Outcome: Recovered. Second Dose: Feels Lousy. Date of start of reaction/event: 19Apr2021. Date of end of reaction/event: 19Apr2021.Outcome: Recovered. Relatedness of drug to reaction(s)/event(s): Reaction assessed: First Dose: Feels Lousy. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related. Relatedness of drug to reaction(s)/event(s): Reaction assessed: Second Dose: Feels Lousy. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related. Relevant Tests: None. Investigation assessment: No.  No follow-up attempts are possible. No further information is expected.
nausea, urticarial rash; 21FEB92 f/u returned stating several cases of local reactions; ceased using this lot; have no record of any pts w/above sx;
Mother reported on 7-2-12 that patient had a seizure 11 days after receiving 1st/GARDASIL vaccine. She was previously seen on 1/25/12 in the local ER for syncope & seizure & has seen a neurologist.
Patient complained of left sided partial numbness/paralysis that started about 1 hour after she had the vaccine and that lasted for about 1 hour and self resolved to normalcy.
Pt recvd vax & &JUl92 was fatigued & tongue was hot & burning; has not been seen by MD; sx on going as of 10JUL92;
Difficulty breathing and wheezing. Severe chills. Lasting approx 1 hour.
This is a spontaneous report received from a contactable  consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the (3rd booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# 30155BA), on Sep 27, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), single dose, for COVID-19 immunization. The  patient experienced diplopia, visual impairment, reduced visual acuity, all with onset Sep 2021, with outcome of unknown. In summary: After receiving the booster vaccine, patient experienced an adverse event or adverse reaction of having double vision, vision problem/eye problem ("deteriorated terribly"); eye disorder (20/20 vision in each eye but together have a problem), onset Sep 2021, with outcome of unknown. Patient also experienced a confusional state ("my head isn't right"), loss of personal independence in daily activities (haven't been able to go out) and impaired driving ability (haven't been able to drive), onset Sep 2021, with outcome of unknown. All events evaluated at a physician office visit. Relevant laboratory tests and procedures available in the appropriate section. Additional information: Patient mentioned after receiving the booster vaccine, she had an adverse event or adverse reaction. She is having double vision/vision problem. She went to the doctor to remedy the symptoms. She had the vaccination equally apart like she was supposed to - all three Pfizer shots. No follow-up attempts possible. No further information expected.
VACCINATED WITH TdAP AND MENACTRA-APPROXIMATELY 2 MINUTES AFTER ADMINISTRATION, CLIENT BECAME DIZZY, PALE. HEAD WAS PLACED BELOW THE LEVEL OF HEART, PULSE 66, AMMONIA INHALANT PROVIDED.  WATER, ORANGE SODA, PEANUT BUTTER CRACKERS PROVIDED.  PLACED IN RECUMBANT POSITION WITH FEET UP. BP MONITORED FREQUENTLY.  MD ASSESSED CLIENT AND FOUND HIM TO BE STABLE AND WAS ESCORTED TO CAR BY FATHER AND NURSE.
Patient was given Pediatric dose of Pfizer instead of adult dose of Pfizer. Patient attended previous event of COVID 19 clinic and received the correct first dose of adult Pfizer.
Site of PNEUMOVAX was raised and itching but not red. Pt is doing much better on 9/26/11. PCP treated with BACTRIM DS and Rifampin. ER doctor treated with Prednisone and PEPCID.