chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. An adult female patient of an unspecified age (more than 18 year) and ethnicity received TRUMENBA (Lot: M95612; Exp.: 30Jul2017) IM 0.5 ml single dose in left arm on 19Aug2016 09:30am for immunization (Meningococcal infection prophylaxis). Relevant medical history and concomitant medications were unknown. No other vaccines were administered on the same date. No other vaccinations within 4 weeks prior the date of vaccination.  On 21Aug2016, the patient had a localized reaction, the patient experienced a small knot. Patient got redness on the arm at the site of the injection. It was not a rash, was not itchy or swollen, her mother said it was gone within 2 days. Patient did not even notice the redness. She had on shirt with no sleeves and the mom noticed the redness.  The redness was pretty extensive. No hurt and itch were reported. The event did not require an emergency room or physician visit. Clinical outcome of the events was recovered. The reporter stated that the patient did provide to him/her information regarding the reported adverse events with the use of the suspect. The reporter considered there was  a reasonable possibility that the event is related to suspect product. The reporter was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts are completed. No further information is expected. Follow-up (11Oct2016): New information reported from a contactable pharmacist included: suspect details; reporter informed regarding the adverse events; no other vaccines administered with suspect; events onset date and outcome; course of events; reporter event causality assessment; reporter further contactability.
angular cheilitis; tongue inflammation; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (lot number and expiry date was not reported) as dose 1, single and dose 2 via an unspecified route of administration on 29Apr2021 (lot number and expiry date was not reported) as dose 2, single for COVID-19 immunization. Medical history included allergy to gluten on an unknown date. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient underwent an RT PCR nasal swab COVID test with an unknown result. It was reported that on an unknown date in 2021, two weeks plus one day after each vaccination, the patient developed angular cheilitis and tongue inflammation. After the first vaccination, the symptoms resolved within a few days. After the second vaccination, the symptoms wax and wane but have not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Joint pain. Bilat. upper extremity weakness, achiness all over (muscle). 9/15/09 T 101-102 degrees F, tightness in throat. 9/16 MD visit decreased joint pain, increased lack of dexterity esp side rec'd injection, left side. Advised by MD to take ibuprofen.
Patient came into store to show a high immunization administration and c/o pain in shoulder due to vaccine from prior day. Patient sees a regular shoulder MD due to a previous hx of frozen shoulder X2.  Administration site was approx. 1 finger width below should joint, high in the deltoid.  Discussed use of ibuprofen/ice and check in with regular shoulder MD if continued pain. No visible increased swelling or redness at site. I had to look very closely to see needle pin hole from Admin site. Pt stated that immunizer kept telling him to  relax his arm. Notified PRIVATE 4/7 of event (immunizer is rotating student with current training and certification). Discussed event with immunizer and without stating patient name, she was able to remember the interaction and stated that the patient was wearing a tight shirt and had to hold the shirt up with the other arm in order to provide immunization and had difficultly relaxing arm.  Reviewed regular administration technique and discussed the necessity to have a patient remove a shirt if restricting the view of their full arm.
My first period after my second vaccination was extremely heavy and full of clots. I normally have heavy menstrual flows, but this was heavier than usual. My second period after the vaccination was also heavy and full of clots, but not as much as the first. By the third period after the shot, I no longer had clots, but the flow was still heavier than it was before the vaccination. To this day, I continue to have heavier menstrual flows. Also, since the vaccination, the timing of my periods has been irregular. Whereas before the vaccination the timing was regular, my periods have been 7-10 days late or early since the vaccination. However, it now seems that my periods are trying to resume their pre-vaccination timing. Not only that, but before the vaccination, my periods were normally 5 days long, but they are now 7 days long.
mom noted a rash covering pt entire body;rash is macular & does not appear to be bother child;no fever;pt taking fluids approx & is acting appropriately;MD advised pt had had a cold for 2+- wk;
Felt hot; temp not measured; local reaction rt thigh; screaming episode (high pitched abnormal cry or screaming lasting > 3 hrs;
Patient developed motor tics about 8 hrs after giving first dose of hepatitis B and polio. Opening/closing of mouth, eye blinking. Symptoms have continued for the last 5 days.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 83-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 18-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805444 was crossed linked to original cases 201804863 due to same reporter.
This spontaneous report was received from a registered nurse referring to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (strength and dose were not provided) reported lot # L019997 and expiration date 02-DEC-2015, that were improperly storaged. No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested. Lot number L019997 has been verified to be a valid number for PROQUAD (Merck).
This spontaneous report as received from a health professional (medical assistant) refers to unspecified number of patients of unknown demographics. Pertinent medical history, concurrent conditions and drug reactions/ allergies of the patients were unspecified. Reporting medical assistant stated that on an unknown date, an unspecified number of doses of GARDASIL (lot # K006960, expiry date: 19-FEB-2017; lot # K008931; expiry date: 04-MAR-2017) and/or ROTATEQ (lot # K015816, expiry date: 29-MAY-2016; lot # K005273, expiry date: 23-FEB-2016) were administered to these patients. Concomitant medications were not reported. No adverse experiences were reported. This is one of the two reports received from the same source (MARRS # 1506USA012861). Additional information has been requested.
patient states right arm is red, swollen, hot to touch, and raised since she has received the vaccine. no signs of improvement with ice and ibuprofen.
patient receiving only the liquid portion of PENTACEL, did not receive the lyophilized powder portion with no reported adverse event; Initial information received on 04-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 6 months old male patient who received only the liquid portion of pentacel, did not receive the lyophilized powder portion with no reported adverse event, after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination.  On 04-Jun-2022, the patient received a dose number 1 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE ( lot LUJ660AAA and expiration date: 25-Feb-2023) at a dose of 0.5ml once via unknown route in unknown administration site for immunization.  On 04-Jun-2022 (latency: same day),the patient received only the liquid portion of pentacel, did not receive the lyophilized powder portion with no reported adverse event (Single component of a two-component product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Low fever 101.3 for two days, chills, some body aches, sore throat, headache
pt recv vax & devel 30 vesicular lesions in various stages of devel, on wrist, lt flank & 2 lesion on rt palm;all of the lesions were grouped;pt had no coexisting conditions;3/18/98 PCR analysis of VZV DNA revealed an inadequate specimen;
medication error,  patient was supposed to  get second dose  for the Moderna and  instead he received the Pfizer vaccine
Body ache; Diarrhea; Cannot stay awake; Heavy cough; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), DIARRHOEA (Diarrhea), INSOMNIA (Cannot stay awake), COUGH (Heavy cough) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache), DIARRHOEA (Diarrhea), INSOMNIA (Cannot stay awake), COUGH (Heavy cough) and HEADACHE (Headache). At the time of the report, PAIN (Body ache), DIARRHOEA (Diarrhea), INSOMNIA (Cannot stay awake), COUGH (Heavy cough) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Extreme cold, fatigue, nausea, vomiting,  muscle pain, joint pain
Approx 8 pm 3-24-07 felt nausea, joint pain entire body, emesis x 2, temp 100.8 flu like s/s - con't Tue 3-25-07 morn Went to her PCP. Given PO Benadryl s/s resolved 3-25-07 by evening. PCP DX allergy to chicken protein.
This spontaneous report as received from a registered nurse via company representative refers to a female patient of unknown age. Information regarding drug reactions or allergies and medical history was not reported. On 04-FEB-2015 the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot#, expiration date were not reported). Concomitant therapies were not reported. In approximately February 2015 (reported as: "now") the patient was experiencing severe sinus infection. There was treatment with MEDROL dose pack given for the event. The outcome of severe sinus infection was reported as not recovered/not resolved. The patient sought medical attention by seeing a doctor. The relatedness between the therapy with ZOSTAVAX and the event was not reported. Additional information has been requested.
Three cycles post vaccine were all abnormal.  Shorter cycles, with spotting In between and lighter. Third cycle was multiple days late and I had horrible night sweats and it was extremely heavy.
Patient complained of being dizzy after given vaccine on 1-19-15-continued with dizziness on and off x 4d. Also headaches on and off. Also injection site (R) arm red.
Chills probably grade 2; This case was reported by a pharmacist via sales rep and described the occurrence of chills in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided but the patient was in 50s. The patient had experienced chills for about 24 hours after receiving Shingrix. The patient did not experienced any other adverse effect. It was unknown if the reporter consented to follow-up.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose number unknown, 0.3ml single (Lot number: ER8736) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: With the Pfizer COVID-19 Vaccine she was administered on 21Apr2021 she reported sore arm, but that did not last terribly long; event start date and stop date unknown other than event lasted for about a week and she recovered completely.
Bad break out all over his body and breathing started to worsen. Was instructed to increase his at home oxygen. Also started a detox bath.
My son spiked a fever. He completely started staring blankly at a wall after his first nap after the vaccines. It was not his normal. He would cry out in pain whimpering for almost three weeks after the vaccines, when he never did that before. His thighs were swollen for a few days and he acted very different. My son normally is a happy baby and he regressed and was quiet, wouldn't make any eye contact and was miserable. His body broke out in tiny red dots that went away after a few days.
Fever, Chills, Lymph Node swelling, Body ache, Joint Pain, Loss of Smell / Taste, Extreme Headache, Fatigue, Nausea. Pretty much felt like I was hit by a bus for 24+ hours. Pain at injection site for 48+ hours.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-AUG-2012, the patient was vaccinated at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. The patient was treated at urgent care for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles (date not reported). The patient was prescribed gabapentin for the management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. This corrected report. Case opened to add reporter information. Additional information has been requested.
Patient returned feeling lightheaded and sweaty. Started to faint, gave 1 EPIPEN injection, laid patient on floor. Call paramedics. Patient taken to hospital. Talked to ER doctor.
This spontaneous report as received from a registered nurse refers to a 50 years old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, dose, frequency and route unspecified). On an unknown date the patient experienced injection site irritation after receiving the vaccine. No lab diagnostics study was performed. The outcome of the event was reported as recovering/resolving. Additional information has been requested.
Appx 3 hours after vaccine, woke from nap with chills and had temperature of 103 F.  Called family practice physician and asked if it would be ok to take aspirin.  Was told to take tylenol instead of aspirin
Vasovagal reflex Numbness of the lips Tachycardia Aluminum flavor
tested positive for covid yesterday; tested positive for covid yesterday; fever 99.6/ felt hot; throat scratchy; continues to have cold like symptoms; decreased blood cell count; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: (060820).  A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LETROZOLE; LUPRON. The following information was reported: PYREXIA (non-serious) with onset 02May2022, outcome "recovering", described as "fever 99.6/ felt hot"; THROAT IRRITATION (non-serious) with onset 02May2022, outcome "recovering", described as "throat scratchy"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022, outcome "unknown" and all described as "tested positive for covid yesterday"; NASOPHARYNGITIS (non-serious) with onset 2022, outcome "not recovered", described as "continues to have cold like symptoms"; FULL BLOOD COUNT ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "decreased blood cell count". The patient underwent the following laboratory tests and procedures: Pyrexia: (02May2022) 99.6; SARS-CoV-2 test: (05May2022) Positive; White blood cell count decreased: (unspecified date) Decreased, notes: decreased blood cell counts. Therapeutic measures were taken as a result of drug ineffective, covid-19, pyrexia. Clinical course: Patient took dose:100 mg capsule daily for 21 days and off 7 days with daily Letrozole and Lupron. patient reports since start of therapy: starting on lowered dose of 100 mg daily for 14 days (20Apr2022, approximate) after being on hold for decreased blood cell counts. after start of therapy, on 02May2022 had fever 99.6, felt hot, throat scratchy. 03May2022, evening started feeling better, fever decreased- Tylenol. Tested positive for covid yesterday, and was advised by md to go on hold 05May2022. was prescribed covid medication (unknown) to take for 5 days then will retest. continues to have cold like symptoms. Patient stated she was vaccinated and boosted for covid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Amendment: This follow-up report is being submitted to amend previously reported information: report type updated to spontaneous.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information.
Pt reports no immediate problems, shortly after receiving injection, however on following morning she woke up with intense itching and red macular rash on arms, abdomen, back and legs. She went to PMD and Dr thinks it was allergic reaction to Hepatitis vaccine and he gave her a shot of cortisone and a prescription for Prednisone 60mg daily x 7days. Pt also reports that greater than one week ago she had poison sumac which was treated with topical ointment.
I had a fever of 102 the night of the vaccine. I took ibuprofen 800 mill. and fever came down to 101. The fever continued until the evening of the next day. I felt aches and pain all over my body . My glands in my neck were swollen hard to swallow.
Extended hives covering almost all upper and lower thoracic areas. Strong itch and burning sensations. After informing the doctor, he prescribed Zyrtec. The hives continue to manifest every day since their first burst on Dec 10. Even when taking Zyrtec daily, the hives manifest through the body, even though they are not as itchy as before. If I miss Zyrtec one day, then they come with high itching and burning.
could hardly walk; feel this is killing them; pains and it was bothering; knee was bothering them too; something started bothering them terribly/m lot of pain/really bothering them/so much pain on their back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (something started bothering them terribly/m lot of pain/really bothering them/so much pain on their back), GAIT DISTURBANCE (could hardly walk), FEELING ABNORMAL (feel this is killing them), PAIN (pains and it was bothering) and ARTHRALGIA (knee was bothering them too) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Oct-2021 at 12:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced BACK PAIN (something started bothering them terribly/m lot of pain/really bothering them/so much pain on their back). On 02-Nov-2021, the patient experienced GAIT DISTURBANCE (could hardly walk), FEELING ABNORMAL (feel this is killing them), PAIN (pains and it was bothering) and ARTHRALGIA (knee was bothering them too). At the time of the report, BACK PAIN (something started bothering them terribly/m lot of pain/really bothering them/so much pain on their back), GAIT DISTURBANCE (could hardly walk), FEELING ABNORMAL (feel this is killing them), PAIN (pains and it was bothering) and ARTHRALGIA (knee was bothering them too) had not resolved.            No Concomitant medications were provided by the reporter. No Treatment information was reported. They tried to put ice on it but it did not helped There. Patient recalled that after the second Moderna vaccine they were going through therapy for an injection on the knee, and for 3 days they had pains and it was bothering them too, so much they had to skip therapy for a few days.   This case was linked to MOD-2021-373473 (Patient Link).
01/17/22 presents to EC ED for "worsening fatigue, loss of appetite and dehydration". PMHx of "IgG lambda multiple myeloma (diagnosed 2/2020 via BMB ~50% plasma cells) and Alzheimer's dementia"