chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; This is a spontaneous report from a non-contactable consumer (patient) from the Pfizer-sponsored program via Regulatory Authority Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash, no other side effects, but she also reportedly gets rashes from other vaccines and wanted to ask about it. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
High Fever 104-105; Vomiting; Aches; Weakness; Lightheaded; Nausea; Fatigue; Injection site extremely sore.
Patient developed rash, 2-3 mm papules on face, (B) arms, trunk & back w/in minutes of receiving influenza vaccine. BENADRYL 25mg PO x 1 given. Rash then resolved. No respiratory distress, no n/v, no swelling or edema.
no adverse reaction.     Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
The patient (employee) came back to the pharmacy and said that it was mainly her upper left arm that had gone numb.  She also said that the feeling seemed to be coming back.  Her ob-gyn was contacted who had told her to get the vaccination (she is 5 months pregnant).  He saw no need for her to go to emergency room but told her to go if she got dizzy or faint.  Her vaccination was done under a standing order from Dr.
shingles; Interchange of vaccine products; This spontaneous case was reported by a nurse and describes the occurrence of HERPES ZOSTER (shingles) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information and treatment information was provided by reporter.  Follow up : Reporter states that the shingles reaction  is believed to be  from the Pfizer vaccine and not the Moderna.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Co-suspect Pfizer Covid-19 vaccine was added.
developed red, round area 93" x 5") below inject site; tx applied cold compresses;
The  1ST dose of Pediatric Pfizer (5-11 years) was given to patient on 10/03/2022. The information that we perceived at the time was: expiration date 10/31/2022 (based on manufactured date 10/2021), and beyond use date was 10 weeks from fridge date (fridge date was 08/22/2022, BUD is 10/31/2022). The information to recall was received on 10/12/2022 and the product was isolated on the date of.
The patient reported chest congestion and productive cough about 2 weeks after receiving the vaccine, had 3 emergency rooms visits since
headache; Sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration on 12Jan2021 (at the age of 68-year-old) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included prednisone taken for an unspecified indication from 08Feb2021 to 15Feb2021. The patient experienced headache and sore arm on 12Jan2021. The reporter stated that Just a headache for 24hrs after 1st vaccine dose 12Jan2021 sore arm. The outcome of the events was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
First: hip pain, right neck soreness. First days: Back and hip pain, Upper leg  pain and aches, Tightness around my knees.  Bilateral. Subsequent days and weeks: All of the above, but not always all at once.  Sometimes with increased intensity.  Sometimes with less intensity.  Sometimes accompanied by fleeting pain in different areas of my back, legs, and knees.  Some neck pain. Dr. discontinued Simvastin on April 18th.  Prescribed Cyclobenzaprine to take at bedtime to facilitate ability to sleep.
Patient was administered 4 doses of Prevnar vaccine between 4/8/02 and 1/31/03. Unfortunately, he acquired a severe streptococcal pneumonia with empyema (serotype 19). He was hospitalized for 3 weeks. Required artificial ventilation and chest tube placement. Disease acquired 2/8/05; vaccine failure. 3/24/05-Reviewed d/c summary and the principal diagnosis was listed as respiratory failure/pneumonia. Secondary diagnoses were listed as empyema in lungs, acute renal failure, sepsis, and narcotic withdrawal (due to prolonged use of Fentanyl patches).  Four days prior to admission, he went to the emergency room with a temperature of 103. He had significant cough, congestion and some emesis typically following his cough. He had decreased urine output over the two days prior to admission, decreased appetite and was very fussy and tired. Mom had recently had the flu.
Started feeling dizzy after vaccination; throat feeling like closing; coudnt swallow well; difficulty speaking; anxious; afraid; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Started feeling dizzy after vaccination), OROPHARYNGEAL DISCOMFORT (throat feeling like closing), DYSPHAGIA (coudnt swallow well), DYSARTHRIA (difficulty speaking) and ANXIETY (anxious) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 025J20-2A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis (Anaphylaxis to avocados). Concurrent medical conditions included Fruit allergy (Anaphylaxis to avocados).   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced DIZZINESS (Started feeling dizzy after vaccination), OROPHARYNGEAL DISCOMFORT (throat feeling like closing), DYSPHAGIA (coudnt swallow well), DYSARTHRIA (difficulty speaking), ANXIETY (anxious) and FEAR (afraid). The patient was treated with EPINEPHRINE (intramuscular) on 28-Jan-2021 at a dose of Epinephrine 0.3mg x 2 and DIPHENHYDRAMINE (intramuscular) at a dose of 50 mg. On 28-Jan-2021, DIZZINESS (Started feeling dizzy after vaccination), OROPHARYNGEAL DISCOMFORT (throat feeling like closing), DYSPHAGIA (coudnt swallow well), ANXIETY (anxious) and FEAR (afraid) had resolved. At the time of the report, DYSARTHRIA (difficulty speaking) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Blood pressure measurement: normal (normal) BP was normal. On 28-Jan-2021, Oxygen saturation: normal (normal) spo2 normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DIZZINESS (Started feeling dizzy after vaccination), OROPHARYNGEAL DISCOMFORT (throat feeling like closing), DYSPHAGIA (coudnt swallow well), DYSARTHRIA (difficulty speaking), ANXIETY (anxious) and FEAR (afraid) to be possibly related.    Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: No specific follow-up information recorded.
Patient received ADACEL and AFLURIA vaccines on 10/6. She developed a bruise like AE, that was about 5x5 inches large. Was very sore for about 3 days. No fever, and she was feeling a lot better when I saw her.
Body aches, malaise, abdominal pain and anorexia starting 1 day after hospitalization. Hospitalized 10/3/22 through 10/6/22. Patient did well in the hospital. GI was consulted.  His right upper quadrant discomfort subsided.  He complained of foul-smelling stools that smelled like "burnt motor oil".  He denied vomiting, fevers, diarrhea or chills.  He noted that his urine was darker than normal but improved.
lt deltoid w/large erythematous, urticarial lesion approx 2" for center; mildly tender full ROM @ lt shoulder, OP clear neg, no uvula swelling; localized react to DTP given DPH;
shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; Chills; Fatigue; Shingles; This is a spontaneous report from a contactable consumer.A 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 14:30 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation.  Medical history included Mitral valve prolapse, thyroid surgery, sleep apnoea. The patient's concomitant medications were not reported.  On February 26th she got her first dose of the  vaccine, and she is scheduled to get the second April 8th. She says on March 8th she was diagnosed with shingles. Her shingles rash she really didn't have long, it has almost faded now, it is almost nothing as far as scabs. She says she still has the burning, itching, and pain, but today it is not so bad. She says she sometimes has chills, which is one of the things that goes along with it, and fatigue. She says her concern was about this too, because even though the rash is gone she still has symptoms, does this mean her shingles are still active. She says she asked her pharmacist and they said it could still be active. her first dose of the vaccine was given in the afternoon, probably 02:30PM. She says she was diagnoses with shingles on March 8th after a visual diagnosis. Pfizer COVID-19 vaccine NDC/EXP: Not provided on handwritten vaccine card. AE Treatment:  Caller says for the shingles her doctor hasn't said anything, she did get a prescription which she took, of 3 tablets a day for a week, so 21 tablets. She says she was also prescribed an ointment that she was putting on. She says that the tablets were Valacyclovir 1 gram, and she took one tablet by mouth three times daily for 7 days. She says this medication was dispensed in a pharmacy bottle from pharmacy, NDC/LOT/EXP were not provided on pharmacy label. Caller says the ointment was Triamcinolone Acetonide ointment USP 0.025%, which was applied usually before bed around 10:00PM-10:30PM. She says the label on that says apply externally to affected area twice daily for 15 days, but she applied it only once a day. Caller says that the EXP on the tube is little, it is July 2022, LOT: Unknown, unable to see on the tube. NDC: Caller says this is very, very little, she needs her magnifying glass, it looks like it is 45802-054-35. She says that the NDC is almost not on there, it is so little. Outcome of  shingles, rash,burning, itching, and pain was recovering, of  chills and fatigue was unknown.Therapeutic measures were taken as a result of shingles.  No follow-up attempts possible. No further information expected.
Ten hours post vaccine Fever as high as 102.6, rigors, headache, body aches, nausea and vomiting  which lasted 36 hours. Completely resolved at 48 hours.
Well child care including immunizations given 08/19/2005 between 11AM and 12 Noon.  The infant was sleeping on Mother in parent's bed on 08/21/2005 - Infant brest fed - Mother woke at 2 AM to find baby face down in pool of vomit on her chest.  EMS to ER- resuscitation attempted, pronounced dead 08/21/2005 04:45. Received medical records from ER which reveal patient in full arrest on arrival & unable to be resuscitated.  Received Autopsy Report which reveals COD as suffocation & manner of death as accidental.
Moderna COVID vaccine #3 given 9/8/21, lot # 045C21A; pt had a positive COVID test on 4/18/22 while staying at Nursing Home; 4/24/22 pt sent to hospital due to being found unresponsive; CXR showed COVID pneumonia; CT of the brain showed chronic subdural; in acute renal failure; admitted; post acute respiratory failure; O2 supplementation; pt made comfort care only; septic shock; pt passed away in the hospital
The patient received a vaccine that underwent a temperature excursion; No adverse event; The patient received a vaccine that underwent a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (The patient received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The patient received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The patient received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (The patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (The patient received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (The patient received a vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (The patient received a vaccine that underwent a temperature excursion).    No concomitant medication was reported by reporter.  The patient weight was reported as 33 (units not specified).  The patient received first dose and second dose on LQ (not specified).  Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 07-Aug-2022 and was picked up by state review of the temperature data logger two weeks later after the excursion. Total 38 patients had received these. One refrigerated vial was with lot number AS1412B and expiration date was on 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3 hours and 5 minutes. Vial was moved from refrigerator on 08-Aug-2022. Those were administered and discarded. Proposed desired used by date was 18-Aug-2022. Storage condition at the time of the excursion was reported as refrigerated.  The patient side effects were reported as none.  No treatment medication was reported by reporter.
Initial and follow-up information had been received from a physician for the Pregnant Registry for VARIVAX (Merck) concerning a 16 year old female patient with a history of 0 pregnancies and 0 live births who on 08-AUG-2008 was vaccinated subcutaneoulsy with a 0.5ml dose of VARIVAX (Merck) (Lot # 659953/0329X) on the same day the patient was vaccinated with a dose of GARDASIL (lot # 660387/1967U). Concomitant therapy included prenatal vitamins (unspecified), INFANRIX (lot #AC52B027AA), MENACTRA (lot # U2665AA), influenza virus vaccine (unspecified) (lot # U2828AA), and TYLENOL. Subsequently, the patient became pregnant (LMP 27-JUL-2008 and EDD 03-MAY-2009), and on 04-MAY-2009, delivered a normal, healthy male baby weighing 38.95 grams. There were complications during the pregnancy as excessive weight, gestational hypertension and protracted labor required vacuum assist. It was reported that pre-natal blood work had normal results, a pre-natal ultrasound on 30-DEC-2008 showed no abnormalities, and a serum alpha-fetoprotein test (MSAFP) on 04-FEB-2008 was normal. No adverse effects reported. Additional information is not expected.
Warm to the touch; Swollen; Again with arm sore; Sore arm; A spontaneous report (United States) was received from a consumer concerning a 65-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/ vaccination site pain, swollen/ vaccination site swelling and warm to the touch/ vaccination site warmth.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 25 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 030L20A) for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced sore arm during 2 to 3 days. On 1 Feb 2021, the patient started again with arm sore, swollen and warm to the touch.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, sore arm was resolved on 29 Jan 2021. The outcome of the events again arm sore, swollen and warm to the touch was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a nurse practitioner concerning a 66 year old female with a history of chickenpox, AODM, HTN, HLP, and insomnia and drug reactions/allergies to NKDA, who on 26-JUN-2007 was vaccinated SC in the left side with a 0.64 mL dose of ZOSTAVAX (lot number: 657764/0584U).  On 16-OCT-2007 the patient developed a shingles rash after receiving the vaccine.  She experienced intense burning in the right thoracic area.  There was an impression post herpetic neuralgia T7 dermatome.  The patient's maximum temperature was 97.8 and pain was 9.  There was no presence of rash.  There was no recent exposure to chickenpox or shingles.  There was no photo taken.  The patient was being treated with pregabalin (LYRICA), lidocaine (LIDODERM PATCH) and unspecified steroids.  The patient had not fully recovered at the time.  No further information was provided.  There was no product quality complaint.  Additional information has been requested.
pt recv vax;HA,cough,low back pain swelling/pain of "big toes";c/o chills;fever,myalgia,pain neck;ankles swollen/painful;sneeze;MD felt serum sickness vs mycoplasmal infect w/meningitis,arthritis,?Lyme disease;in er,dx of meningitis;
Pt vaccinated with DTP/OPV child presented for well child exam 20Aug90. Only concerns noted were precipitous weight gain & intermittant regurgitation of Prosobee.
Red hot bump at site of injection. Fussy/tired. Gave Tylenol. The next day temp of 101.4 rectal continued fussy/tired with loss of app. The next two days. All other symptoms have gone except hard knot at injection site still present today.
Received H1N1 0.5 ml (2nd dose) on 12/28/09. Onset fever (101.9) on 12/30/09 nasal congestion. Hx head drop spells x 1 on 1/3/10 and 2 spells 1/4 am. During EEG at neurology on 1/8/10 had spells and EEG findings c/w seizures. Started on KEPPRA. Prior hx febrile sz 8/15/07 and unprovoked sz 4/28/09. MRI & EEG on 7/09 wnl.
WITHIN 5 MIN AFTER RECEIVING PEDIATRIC COVID-19 MODERNA VACCINE, PATIENT DEVELOPED SEVERAL RASH-LIKE RED SPOTS ON BOTH LOWER ARMS, BUT NOT AT THE INJECTION SITE. PATIENT SAID HIS BREATHING WAS FINE, AND NO ITCHINESS WHERE THE SPOTS WERE. MOM WAS ADVISED TO GIVE PATIENT BENADRYL WHEN GET HOME.   I SPOKE TO MOM ON THE PHONE AROUND 4PM--SHE SAID HER DAD GAVE PATIENT 2.5ML BENADRYL AND PATIENT IS DOING FINE.
Severe Nausea as well as a sore arm was persistent for 3 days following the injection.  In addition, a rash appeared on the left side of my back and left thigh.
On Oct 6 2016 I went to Dr office for a Dog Bite that happened on Sept 29 2016. I started cephalexin 500mg on Sept 29 2016 I had the meds from previous took them 3 times a day for 7 days. On Oct 6 I went to Dr office because my leg hurt and was still swollen. Dr look at the wound and said he was giving me a shot and some more antibiotics. Nurse came in gave me two shots one on the upper left arm which was the tetanus shot. And one in the buttocks (ROCEPHIN) on right side. The tetanus injection hurt while injecting it. The next morning my upper arm hurt so bad like a deep bruise that lasted about 2 weeks. Then time wise is unknown but one morning I woke up not able to lift my left arm, that lasted about a week till I found the right antiflammatory drug. My relief came within an hour of taking CURAMED 750mg Healthy inflammation response after the arm incident my leg was still hurting went back to Dr he ordered a Doppler nothing showed up. Went back to Dr he ordered a vein specialist that Dr didn't find anything. In the  mist of all this I would go to the ER and urgent care. They couldn't help either. The urgent care gave me another round of antibiotics this time BACTRIM. So here we are a year later and I'm still hurting and I developed a lung infection, a skin infection on arms only. This is the third time I'm going.
1.  COLD SORES:  I developed a bad cold sore within a couple weeks of the first (1/10/21) vaccine.  Within 2 weeks of my second CoVid vaccination (2/7/21), I developed another cold sore.  ***I have not have a cold sore in over 20 ++ years***  2.  CHALAZION:  I have never had a chalazion in my life.  A  week after the first vaccination I got one on my low right eyelid.  Three weeks after the second vaccination, I developed one on my left lower eyelid.  So strange.  Neither of these are life threatening but so strange to have developed these conditions.  I was taking PenVK for a tooth issue between the two vaccinations. Not sure if
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The vaccine (oka-merck) PROQUAD (lot# J001054, expiration date 28-JUL-2014, route not reported) was accidently placed in the refrigerator on Friday, 24-MAY-2013, at noon, where it remained for the next 100 hours at 4-5 degree Centigrade (C). The reporter stated that when (oka-merck) PROQUAD was unpacked from the shipper, the person who stored the PROQUAD saw the "A" on the carton and thought it was hepatitis a vaccine. This confusion was the reason the (oka-merck) PROQUAD was stored in the refrigerator. None of the doses of (oka-merck) PROQUAD were administered to any patients for whom hepatitis a vaccine was intended; therefore no adverse event (AE). No patients were effected by this product confusion. No Product Quality Complaint (PQC) identified. Additional information has been requested.