chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; Headache; Sore arm; This is a spontaneous report received from a contactable consumer (Patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0170), via an unspecified route of administration, administered in the left arm on 16Apr2021 09:30 (at the age of 65 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. No family Medical History Relevant to AE. No other vaccines were given within 4 weeks. No additional vaccines administered on same date of the pfizer suspect. No PQC was present. No investigation assessment was reported. No vaccine administered at private facility. On 16Apr2021, the patient experienced rash, headache, sore arm. Events has not resulted in physician room visit and emergency room visit. The caller stated she had minimal side effects with the first dose Pfizer COVID 19 Vaccine. When the caller received the first dose Pfizer COVID 19 Vaccine it was wonderful and the caller did not feel a thing. Description of complaint reports after receiving first dose Pfizer COVID 19 Vaccine the caller never had a problem with the left arm and the caller felt like she did not get the Pfizer COVID Vaccine. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0182), via an unknown route of administration, administered in Arm Left on 07May2021 09:30 (at the age of 65-years-old) as dose 1, single for COVID-19 immunisation. When patient received the second dose Pfizer COVID 19 Vaccine. The caller clarified her arm was sore with both doses Pfizer COVID 19 Vaccine. After second dose it was jabbed in the arm and felt like an immediate burning sensation and it just felt really unusual. The caller felt relaxed when she received the first dose Pfizer COVID 19 Vaccine and felt relaxed with the second dose Pfizer COVID 19 Vaccine but all of a sudden it was like the caller arm was jabbed and felt this burning sensation when receiving the second. Others who have gotten the Pfizer COVID 19 Vaccine have said they never felt this like the caller did. The caller was hesitant to have another booster. The caller just needs to have this resolved. The caller used her left arm to receive the Pfizer COVID 19 Vaccines and does not want to get in the right arm. The caller was just a little traumatized. The clinical outcome of the events rash, sore arm was reported as unknown and headache was reported as recovered on Apr2021 (lasted four or 5 days).   Follow-Up (13Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100978816 same patient, different dose vaccine and different event.
I started to notice on Tuesday, January 19th, that there was a red bump on my arm. It looked more like a mosquito bite to me and was not bigger than a quarter. It didn?t feel itchy but I thought nothing of it. I noticed when I got home it was twice as big but I still felt no pain. It appeared that my arm was also swollen. The following day on Wednesday, it has grown in size again covering my arm, maybe the size of four quarters. Throughout the day it felt a bit hot, especially when I touched it. It did not feel itchy and I didn?t feel any pain. I felt a bit tired this day so I?m not sure if it was because of it. The redness has gone down today (Friday, January 22nd) however the mark is still big and in the shape of a square now. The outer part of the mark is more red and raised up, like it has a red border.
My husband received the first injection on Feb 3, 2021 he developed a cough afterwards, cough would come and go.   He was scheduled to receive 2nd dose on March 11 and I was concerned about having a cough at the time of 2nd vaccine.  He went to walk-in clinic and got a covid test was negative, he said his exam was normal, they gave him prescription of Benzonatate 100mg he took one and it did not help so he never took any more.  On March 5 while working in the yard he collapsed, paramedics arrived and he was in cardiac arrest, they started CPR,  they used AED was in vfib, he was taken to Hospital then transferred to second hospital.  I was told he had blood clots in both lungs, one in his leg, and possible clots in the mesenteric area of abdomen.  His heart stopped due to the blood clots in his lungs.   He remains in the hospital in the Intermediate Coronary Care Unit.  He has not yet gained full consciousness.
HCP reports that a patient received a dose from an expired Moderna vial.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP reports that a patient received a dose from an expired Moderna vial.) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A and 076C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received 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 an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP reports that a patient received a dose from an expired Moderna vial.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP reports that a patient received a dose from an expired Moderna vial.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.
Pt went to walk away from getting flu vaccination. She said her arm was hurting, we looked and she had a large knot on her arm where the vaccine was given.  We held ice and I observed her for one and one-half hours.  She did not exhibit any signs of an allegic reaction.  We have been using the pharmaject when giving flu shots this year.  I believe that it was the device that may have bruised her arm. We also let her medical doctor know of the reaction.
w/in 2 hrs post vax pt began crying & stiffening legs-constant screaming x 5 hrs; had redness & swelling @ site of lt leg; mom talked to MD nurse but did not take pt into office; pt given APAP;
ONSET OF RASH SAME DAY AS INOC. NO TREATMENT WAS GIVEN. RECOVERED 28-DEC-90. RASH REAPPEARED 01-FEB-90 WITH NO ADDITIONAL DOSE GIVEN.
NUMBNESS RIGHT SIDE OF FACE, NASAL PASSAGE, GUMS, UPPER + LOWER LIP, ROOF OF MOUTH, CHEEK, EYE LID, MOUTH + TONGUE ELCERS ON THE BELLS PALSY SPECTRUM. MRI + CAT SCAN WHERE NEGATIVE.  DIAGNOISED BY ACUPUNCTURIST. ALSO RECEIVING HIGH DOSES OF VITAMIN C + GLUTOHIONE
Patient had topical reaction to right arm. Patient also had hives around her mouth. Hives have disappeared, arm is still very swollen and red.
THE PATIENT STATED SHE FELT LIKE SHE WAS HAVING AN ALLERGIC REACTION TO THE VACCINE. HER SKIN APPRARAL FLUSDED AND SHE FELT DIZZY.
Skin rashes all over the body; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old non pregnant (including at time of vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), at the age of 39-years-old via an unspecified route of administration administered in Arm Left on 22Mar2021 10:30 (Batch/Lot Number: EN6207) as DOSE 1, SINGLE for COVID-19 immunization. No medical history and concomitant medications. On 26Mar2021 21:00 (as reported), the patient experienced skin rashes all over the body after 5 days of taking the first dose of vaccination. It was stated that the rashes were getting worst every day. Then, the primary care physician prescribed steroid and BENADRYL. The event resulted to doctor or other healthcare professional office/clinic visit. The patient then been to urgent care where they administered IV steroids (dexamethasone sodium phosphate), IV BENADRYL and famotidine. The patient was not patient diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. Outcome of the event was not recovered.
Pt received FLUMIST nasal spray Tues 10/20/09. C/o abd pain & vomiting Thursday 10/22/09 also after eye brows swollen. Pt woke Friday 10/23/09 with top lip swollen.
patient noticed arm tingling after injection, then "loopiness" a few hours afterwards, mental confusion, vertigo, nauseousness. A week later she noticed underarm swelling, then 2 weeks layer had a fever and sweating.
Arm swollen red itchy hot to the touch around area of the injection but only appeared one week after the injection
On Thursday 3/18 around 5:00 I started feeling tired, went to bed early woke up Friday with my eyes burning, the skin around my eyes was red, creapy, and was burning and itching. It was mainly my eyes, but my face felt puffy. My torso felt hot from inside. My throat felt swollen towards the top. By Friday night it was getting worse so I took Benadryl and sat with ice packs on my eyes, and put hydrocortisone around my eyes and eyelids. I continued that til Tuesday when it finally subsided. I did take pictures of my face, and  I contacted my doctor to ask about the second shot. They advised against it, so I?ve cancelled my appointment. I might try the J & J shot in a few months.
One minute after receiving her second Shingrix vaccine, patient started to feel light headed and dizziness. This did not occur with the first dose of the Shingrix vaccine. Patient sat down for about 35 minutes (drank water and had a candy bar)and after which she felt better enough to get up and walk she walked and was feeling "back to normal" before I had her leave and go home. Patient was accompanied by husband. I followed up with her later on in the day after she left and she was feeling normal. No further action was needed. She said as a child this would happen to her when she would get a vaccine.
Still itchy and feeling allergic after resolution of rash after booster; Feels itchy and allergic from it; Eyes watering after resolution of rash after booster; Rash on lips and jaw, arms, and part of the inner leg 2 weeks after booster; Rash on lips and jaw; This spontaneous case was reported by a consumer and describes the occurrence of CHEILITIS (Rash on lips and jaw), RASH PRURITIC (Still itchy and feeling allergic after resolution of rash after booster), DERMATITIS ALLERGIC (Feels itchy and allergic from it), LACRIMATION INCREASED (Eyes watering after resolution of rash after booster) and RASH (Rash on lips and jaw, arms, and part of the inner leg 2 weeks after booster) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 040A21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced CHEILITIS (Rash on lips and jaw) and RASH (Rash on lips and jaw, arms, and part of the inner leg 2 weeks after booster). On an unknown date, the patient experienced RASH PRURITIC (Still itchy and feeling allergic after resolution of rash after booster), DERMATITIS ALLERGIC (Feels itchy and allergic from it) and LACRIMATION INCREASED (Eyes watering after resolution of rash after booster). At the time of the report, CHEILITIS (Rash on lips and jaw) and RASH (Rash on lips and jaw, arms, and part of the inner leg 2 weeks after booster) had resolved, RASH PRURITIC (Still itchy and feeling allergic after resolution of rash after booster) and DERMATITIS ALLERGIC (Feels itchy and allergic from it) had not resolved and LACRIMATION INCREASED (Eyes watering after resolution of rash after booster) outcome was unknown.            Patient reported that the batch number for booster dose as 077C21B or 077621B.  Concomitant medications details were not reported by the reporter.  Treatment details included antihistamine and steroid.   This case was linked to MOD-2021-416039, MOD-2021-416040 (Patient Link).
Sore muscles and joints, sleepy - common, have had with earlier Covid vaccinations I didn't run a temperature, but the 1st 3 night I woke up shortly after falling asleep in a cold sweat.
This spontaneous report as received from a medical assistant refers to a 18 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 06-DEC-2016, the patient was vaccinated with a dose of improperly stored VAQTA with lot number M027879 and expiration date of 24-JAN-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
COVID-19 virus test positive (swab test); COVID-19 virus test positive (swab test); bad allergies; feeling not so good; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 15Jan2021/16Jan2021 the patient started feeling not so good, she had bad allergies. She went to an urgent care and they did a COVID-19 virus test (swab test) and she tested positive.  The information on the lot/batch number has been requested.
By 4 pm, the body aches turned into a high fever and went to the emergency room at 8 pm with a fever of 105.5. I was given 2 bags of cold saline IV and it dropped to 101 and they released me.   Janssen COVID-19 Vaccine EUA
Administered PEDIARIX instead of INFANRIX; Pediarix was a 4th dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number n7hl3, expiry date 15-APR-2024) for prophylaxis.   Previously administered products included Pediarix (First dose received in 9 weeks of age.), Pediarix (Second dose received at the age of 18 th week) and Pediarix (Third dose received in 7 months of age.).   On 19-MAY-2023, the patient received the 4th dose of Pediarix. On 19-MAY-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Administered PEDIARIX instead of INFANRIX) and extra dose administered (Verbatim: Pediarix was a 4th dose.). The outcome of the wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-MAY-2023 The reporter reported that the patient received Pediarix instead of Infanrix accidently. The reporter did consent to follow up. The reporter reported that the patient accidently received Pediarix vaccine instead of Infanrix, which lead to wrong vaccine administered. The patient received 4th dose of pediarix which led to extra dose administered.
Acute illness 2 weeks, post vax, with rapidly progressive motor weakness peaking at 4-6 weeks and now recovering. Appears to be fairly classic, acute mild LGB syndrome. Pt had no other illnesses and temporal relationship to flu vaccine; makes this dx highly likely. First I've seen since 1977. Not fully recovered as yet.
Information has been received from a 65 year old female with environmental allergies who in October or November 2007, was vaccinated with a 0.65 mL dose of ZOSTAVAX (lot number, injection site and route not reported). Concomitant therapy included heart medication, thyroid and simvastatin (MSD). In approximately October 2007, also reported as 2 weeks after the vaccination, the patient experienced a case of shingles. The patient This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a 65 year old female with environmental allergies who in October or November 2007, was vaccinated with a 0.65 mL dose of ZOSTAVAX (Oka/Merck) (lot number, injection site and route not reported). Concomitant therapy included heart medication, thyroid and simvastatin (MSD). In approximately October 2007, also reported as 2 weeks after the vaccination, the patient experienced a case of shingles. The patient has had 5 cases of the shingles since receiving the vaccine. The patient developed a lot of blisters underneath her arms. The patient would be seeing a neurologist to determine why the shingles kept reoccurring. Two weeks ago, the patient recovered from shingles. Additional information is not expected.
Information has been received from a Licensed Practical Nurse concerning a female consumer who on 05-MAR-2008 was to be vaccinated with her second dose of varicella virus vaccine live (MSD), but was inadvertently vaccinated with zoster vaccine live (Oka/Merck) instead. The patient was administered her first dose of varicella virus vaccine live (MSD) on 09-AUG-1996. The LPN stated the zoster vaccine live (Oka/Merck) vial was placed in the varicella virus vaccine live (MSD) box by mistake and the nurse did not notice it because varicella virus vaccine live (MSD) and zoster vaccine live (Oka/Merck) vials look similar. No adverse experience was related to this event. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. Follow-up information form LPN indicated she was unable to provide patient information, and she said it was "honest mistake."
Began feeling tight in my stomach late evening Jan 13.  Took one dose of Miralax Jan 14 @ 4am (assuming pains were constipation).  Vomited twice (Jan 14 @ 5 am; Jan 14 @ 8:pm).  Slightly elevated temp (99F), slight pain at injection site, chills.  Feel much better after 2nd emetic event.
I fainted Approximately at 5;30 am while was in the restroom , 18 hours after I received the second dose. Symptoms started with nausea then vomiting , fatigue, fever and chills, I was unconscious for 5 minutes, my jaws were completely locked and my tongue was rolled back to my throat keeping from breathing my family was next to me who was able to open my jaws and keep my tongue out to open my air ways. I was taken to the emergency room by an ambulance there it was decided that it was my bodies reaction to the vaccine.
Had a heartattack  8weeks ago; This spontaneous case was reported by an other health care professional and describes the occurrence of MYOCARDIAL INFARCTION (Had a heartattack  8weeks ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Had a heartattack  8weeks ago) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Had a heartattack  8weeks ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient had a heart attack 8weeks ago.  Patient got booster dose on 14 Jan 2022.  Treatment information was not provided.  Company comment:  This case concerns a patient with no medical history reported who experienced serious unexpected AESI of myocardial infarction, that occurred unspecified time after the 2nd dose of the mRNA-1273.  The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient with no medical history reported who experienced serious unexpected AESI of myocardial infarction, that occurred unspecified time after the 2nd dose of the mRNA-1273.  The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
fever; chills; This is a spontaneous report from a non-contactable pharmacist (the patient). A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 13:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation at Workplace clinic. The patient has no medical history. The patient was not allergic to any drugs, food and other products. The patient's concomitant medications were not reported. The patient not received any other vaccines in four weeks prior to COVID-19 vaccination. The patient was not diagnosed with COVID prior vaccination. The patient has not been tested for COVID post vaccination. On 27Feb2021 16:00, the patient experienced fever, chills. It was reported that, in the afternoon on 27Feb2021, 4 days after receiving the Pfizer/BioNTech COVID-19 vaccine, the patient started to experience chills followed by fever. The patient took 2 Advil around 19:30 and the chills and fever subsided. After going to sleep on 27Feb2021, the patient woke up in the middle of the night again with fever and chills. Again the patient took two Advil and the fever and chills subsided. On 28Feb2021, the patient had a low grade fever all day with mild chills, but he did not feel the need to take any additional Advil. At the time of reporting, the fever and chills were completely gone and seems like he has fully recovered. The outcome of events fever and chills was recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
5.5cm X 10cm area to left arm with induration and redness. Mild limitation of ROM. History of fever.
PAINFUL , RED (5"X 6") AREA ON ARM, HOT TO TOUCH  STARTED THE DAYOF  VACCINE, BUT GOT WORSE THE DAY AFTER VACCINE (SHE CAME BACK TO PHARMACY 2 DAYS AFTER VACCINE)