chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My left torso and thigh down to my knee including groin area has pins and needles and numb; My left torso and thigh down to myknee including groin area has pinsand needles and numb; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 26Feb2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issue. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination.  On 15Mar2021, the patient's left torso and thigh down to his knee including groin area had pins and needles and numbness. No therapeutic measures were taken as a result of event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events left torso and thigh down to his knee including groin area had pins and needles and numbness was not recovered at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in unspecified location in 2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation.
Pt received varivax and MMR on 4/28/00; On 5/9/00 he had onset of fever and morbilliform rash.
Systemic: Nausea-Mild, Systemic: Vomiting-Medium, Additional Details: Pt was uneasy about needles and vomited about 2 minutes after administration. Pt also had some mild nausea. Pt was monitored for 30-45 minutes before leaving pharmacy when she felt normal and fine.
This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient of an unspecified ethnicity started to receive PREVNAR 13 via an unspecified route of administration, from an unspecified date (on Monday), single dose; and PNEUMOVAX 23 via an unspecified route of administration, on "17Jul" at unknown dose and frequency, both given for immunization. Relevant medical history and concomitant medications not reported. It was reported that the patient was in the hospital on "17Jul" and was given pneumococcal vaccine polysacch 23V. On an unknown date, the patient was feeling sleepy. Outcome of the event was unknown.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about patient's concomitant medications, concurrent conditions and medical history was not reported. On an unknown date the patient was vaccinated with a dose of improperly stored (temperature: 58 F and time frame: 2 hours)ROTATEQ (dose not reported, lot # L020865 with expiration date 09-FEB-2017) orally. It was reported that there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician and a practice manager via two company representatives referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 21-DEC-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot # L010598, expiration date 06-AUG-2016, route unknown). This specified lot number vaccine was exposed to temperature excursion fourteen times. The total cumulative excursion time (hour) and lowest recorded temperature (Fahrenheit degree) for each time were as below: (216, 29.3); (144, 34.2); (24, 33.6); (24, 33.4); (52, 33.1); (72, 32.9); (144, 32.4); (100, 34.5); (28, 30); (24, 34.3); (48, 34.9); (36, 31.1); (104, 29.1); (24, 34.8). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
First 3 days sore arm, muscle cramps and joint pain for the past 4 days. Rash all over body started 2 days after vaccine . Today is day 4 and still itching . Itching and redness all over extremities with small bumps . Stomach cramps and nausea for the past 2 days. Overall feeling exhausted  and aching.
severe stiffness in back, upper shoulders, neck  and legs, weekness in thighs, fatigue.  given a course of Steroids for stiffness  which improved symptoms.  Saw a rheumatologist and after blood work determined to have ANCA positive vasculitis.  will repeat blood tests to see if it improves.
Presented with Vfib cardiac arrest 4 days after second dose of COVID vaccine. Cardiac arrest 9/12 around 0500.  In vfib per EMS, defibrillated, amio, multiple rounds of CPR/ACLS. Did achieve ROSC. Limited echo in ED EF 5-10%. Hypothermia protocol. Due to presentation, there was some concern of possible myocarditis related to the recent COVID vaccine. Was treated with IVIG and methylpred x 2 days. Initially on Norepinephrine, dobutamine, and amiodarone infusions. Has been weaned off all and successfully extubated.
First four days had the typical sore arm.  On the 5th morning woke up with tenderness in the lymph node area  by the clavicle? on injection side. On  6th day the node is tender and swollen and again on 7th day-tender and feels like a marble in that triangle area on shoulder.  It's not anything I can't "tough out" but thought I should mention it. Also, had the injection on this side because I still have all my lymph nodes on the left-as opposed to the right side, which has only 2 left .
general soreness in my arm; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (general soreness in my arm), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.    On 25-Jan-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 IN EXTREMITY (general soreness in my arm), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (general soreness in my arm), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had episodes of chills and a fever, the fever would break, then it came back. This occurred 3 times with the first dose of the vaccine. The patient also had ageneral soreness in her arm and a headache. She would consider this nothing unusual.   This case was linked to MOD-2021-378077, MOD-2021-378066, MOD-2021-378077 (Patient Link).
Situation:               Name of Reactive drug/vaccine: Pfizer COVID vaccine               Time of Immunization Administration: 1330   Time of Reaction: 1340   Subjective symptoms reported by patient:  C/O being "light headed"   Objective symptoms/nursing assessment: Color normal for skin type, no SOB,  BP 120/78 HR 76  PO2  97                  Immediate nursing interventions: Gave orange juice  Observed x 30 minutes    Was the Emergency Protocol for Anaphylaxis Initiated?  no   Patient response to interventions and additional details:   Patient states no longer feels lightheaded.   Left ambulatory @ 1400 with instructions to hydrate
Patient returned to the pharmacy this morning after getting her vaccination yesterday afternoon, her arm is swollen, red, hard, and painful; it looks like the patient may be having an allergic reaction.  I suggested she see her primary care provider to be sure there is no possibility of cellulitis as she is going on vacation in a couple of days. She stated that she started feeling an 'itchy, burning sensation' in her arm immediately after the vaccination. She also stated she had had a problem in the past with a tetanus (she believes) vaccine about 10 years ago.
Redness & swelling at the site.  Cool compresses Motrin for pain & to monitor area to make sure it doesn't get bigger.
I took my Emgality injection the same day that I got the first of the two Shingrix injections.  My Emgality stopped working and it took 9 months and more than monthly injections of Emgality before I got significant headache relief again.
Pain in left arm (injection site)  is so severe that patient cannot lift arm above 45 degrees and cannot drive.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 04Mar2021 as dose 2, single (Lot number: EN6198), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 301485A), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: other medical history: Hypertension; "hyperlipidemia" (unspecified if ongoing), notes: other medical history: hyperlipidemia; "Benign Prostatic Hypertrophy" (unspecified if ongoing), notes: other medical history: Benign Prostatic Hypertrophy. Concomitant medication(s) included: LISINOPRIL; ROSUVASTATIN GLENMARK; TAMSULOSIN AUROBINDO; FINASTERIDE ACCORD. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 21Jul2022, Treatment stop date: 26Jul2022, Lot number = GC4800, Indication: Treatment of COVID-19
New patient came to clinic to establish care with Aunt.  No vaccine records presented when intake was done.  Later during the visit-mother arrived with vaccine and records.  CMA placed all records on RN desk. (RN was with another patient).  When RN saw vaccine records she entered all vaccines in chart.  Per vaccine records patient was to receive an MMR.   The RN did not see the records that reflected that the child had received 2  MMR's.   Pediatrician informed immediately upon realization of error.   Child returned to clinic 3/08/22.  Aunt stated child did not have any adverse effects and was feeling well.
Patient complained of nausea after receiving the vaccine. As a result, patient started vomiting consistently, and stated she hadn't eaten. Patient was given a snack, 40mg of famotidine, water and sprite. Vitals signs were good. B/P 122/76. Pulse 97%,Oxygen 97  and temp. 96.8. Patient was  EMS, arrived and transported to the hospital of choice.
Excessive vomiting, unable to keep down food since 0600 on 5/31. Sometimes able to keep down breastmilk.  Extremely loose and frequent diarrhea. Very watery.
About 2 weeks post vaccination-lump appeared at or around site of injection No fever-just cranky. At this visit (5/15/02) also had right AOM . The lesion looks like one varicella. No other lesion seen
On Saturday (3/26/22), patient stated she experienced tenderness near the injection site, fever, chills and body aches. By Monday, she felt pain upon raising her arm and it was painful to touch, hard and warm. So she made a visit with her physician and was diagnosed with cellulitis and prescribed her cephalexin. Patient stopped by the pharmacy on Thursday evening (3/31/22) to report and show me her rash that developed below the injection site.
Patient returned to pharmacy 9-10-12 with a hard, red, hot to the touch, reaction at the injection site.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 12-DEC-2009, a healthcare provider at a physician's office administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2011, the patient was treated by a physician/MD at a physician's surgical office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
The first 4 were associated with a left axillary enlarged lymph node that developed within a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 72 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose: covid-19, Product name and manufacturer lot number: Pfizer EN6201, Date: 11Feb2021, Healthcare professional or clinic site: (withheld)), administration date: 11Feb2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "The first 4 were associated with a left axillary enlarged lymph node that developed within a few days"; BNT162b2 (2nd dose: covid-19, Product name and manufacturer lot number: Pfizer EN6201, Date: 04Mar2021, Healthcare professional or clinic site: (withheld)), administration date: 04Mar2021, when the patient was 71-year-old, for Covid-19 immunization, reaction(s): "The first 4 were associated with a left axillary enlarged lymph node that developed within a few days". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "The first 4 were associated with a left axillary enlarged lymph node that developed within a few days".  Additional information: All of the injections were in the left deltoid and all were provided by in (City name and State name withheld). The first 4 were associated with a left axillary enlarged lymph node that developed within a few days and caused no problems and which resolved within several weeks.
I have Friends that got the shingles shot 11 of them now have shingles/suspected vaccination failure; I have Friends that got the shingles shot 11 of them now have shingles; 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: I have Friends that got the shingles shot 11 of them now have shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient got shingles shot and now he/she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This was 1 of 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104617:same reporter US-GSK-US2023AMR104619:same reporter
a patient received an expired RECOMBIVAX; This spontaneous report as received from a nurse referring to a 15 years old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.     On 21-DEC-2020, the patient was vaccinated with expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (dose # 2; 1 dosage form; lot # R001529, expiration date 07-NOV-2020, route was not provided) for prophylaxis. No further information was available. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R001529; expirationdate: 07-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Erythema multiforme day 7 after vaccine. Pt also had fire ant bite 2days prior to EM. Pt with congestion and Upper respiratory infection today (03/24/2005)
Fell down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Fell down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical History not reported.     On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FALL (Fell down) (seriousness criterion hospitalization). At the time of the report, FALL (Fell down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She was due for second dose today. She fell and was now is in the hospital.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccination error occurred because the administrator of the vaccines did not notice that the EMR records and the stated vaccine registry did not match. The EMR record indicated that the patient received the third dose of PEDIARIX (DTaP-IPV-Hep B) XX-XX-2011 at 6 months of age and the state vaccine registry did not . The patient did not need DTaP-IPV-Hep B at the visit, but one was administered. In actuality the patient received a 4th dose of PEDIARIX 2 1/2 months after the third dose which did not allow for the 6 month or more interval required between the #3 dose of PEDIARIX and the #4 DTaP. Administered at a XXXX product: PEDIARIX, GlaxoSmithKline Dose: 0.5 mL report done in the training of another nurse.
Light headed and very dizzy. I had came back to work. I got severely tired. I went home to bed. For the next 2 days I was weak, headache, light headed, dizzy, couldn't concentrate. Nausated. I had covid in November 2020 and it was some of the symptoms I had then.  I am very worried about the second shot
Client reported waking up Thursday 10/17/19 vomited 1 time and left arm was swollen above the elbow to the injection site. Arm was red and warm to touch and she felt week and not good. Friday the arm was still swollen & she was still week so went to FNP at medical office they gave her a breathing treatment and and told her she was dehydrated and had fever of 102 so advised her to the ER at the ER Patient states they took her blood and told her all her labs were ok and sent her home. No meds given per pt repot. On Saturday she was feeling better and the swelling had went down a little and has continued to go down each day until It was completely gone on Tuesday the 22nd.
Chills; Fever; Nausea; Fatigue; Extreme muscle pain all over body; Extreme joint pain all over to include hands; Severe headache.; This is a spontaneous report from a non-contactable other healthcare professional (patient). This is the second of two reports. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0151) via an unspecified route of administration in the right arm on 06Apr2021 at 13:30 (at the age of 38-years-old and non-pregnant at the time of vaccination) as DOSE 2, SINGLE for COVID-19 immunisation. The medical history included asthma. The patient had known allergies included tree nut allergy. Concomitant medications included ascorbic acid (VITAMIN C), vitamin D (VITAMIN D NOS), melatonin, ibuprofen and paracetamol (TYLENOL). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6204) via an unspecified route of administration in the right arm in Mar2021 at 13:30 (at the age of 38-years-old) as DOSE 1, SINGLE for COVID-19 immunisation and experienced soreness at the injection site. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After the 2nd dose of the Pfizer Vaccine, on 07Apr2021 at 01:30, approximately 12 hours after the injection the patient experienced chills, fever, nausea, fatigue, extreme muscle pain all over body, extreme joint pain all over to include hands, and severe headache. The aforementioned effects lasted about 36 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The outcome of the events was recovered on 08Apr2021 at 13:30.   No follow-up attempts are possible. No further information was expected.
Vaccines 7/15/03. 7/16/03: Phone report left upper arm with redness and warm to the touch, afebrile. 7/17/03: Seen in office-left arm 7.5 x 4.5 cm red, firm lesion, reaction to DTaP? Ice arm, call back if symptoms persist.