chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Miscarriage.  The fetus was absolutely fine, (e.g., good heart beat & etc) until the H1N1 shot.  Surgery was required; D & C.
Initial unsolicited report received from a consumer on 17 Aug 2016. This case involves a 64-year female patient who was vaccinated with a dose of TDAP (batch number, expiry date, dose, dose in series, route and site of administration were not reported) and a first dose of ADACEL (batch number: U5467AC, expiry date: 08 Oct 2018, dose and route of administration was not reported) in the left arm on 06 Aug 2016. It was reported that the patient did not have any problems in the past with regular Tetanus vaccine. Patient's Illness at time of vaccination was not reported. The patient had a heart attack at the end of April 2016 and almost died twice. Patient had a history of hypertension, Irritable Bowel Syndrome with Diarrhea, and Fibromyalgia in the past. Patient's concomitant medications were not reported. On 06 Aug 2016, same day following the vaccination, the patient had to clear the throat, feeling like there is something in the throat/ feeling as if something is stuck in the throat, getting cramps in all of the muscles, It was worse in the hands and fingers, but also in the feet/toes. The patient was having some cramps in the arms and legs as well/ Patient had severe muscle cramps in arms, hands, legs and feet, can't rub the cramp out, and just doesn't feel right in general. The patient thought that she had heartburn and was concerned about the ADACEL affecting her heart muscle. Lab data and corrective treatment was not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
11/11/21 presents to local ED for "generalized body aches".  PMHx "Chronic AFib no AC, history of septic right TKA on chronic prophylactic Doxycycline, Liver Cirrhosis"
Pt. is developing hives. Started after shot at home - some have resolved but pt. stated hives are on her back now.
I stood up after the vaccine and I was walking around the store and I had to sit down in the middle of an aisle because I got so dizzy, like the world was spinning and I couldn't see straight. For the rest of the day, I felt yucky and it lasted for 1 1/2- 2 hours and I had positional vertigo. The next morning I had a headache and body aches and I took some Aleve and I was fine by the time I went to bed that night. I also had a sore arm.
Fever; Head pressure; The shakes; Eyes were hot; Right arm and shoulder soreness; Head cold; Swollen and puffy eyes; Swollen and puffy eyes; Right arm and shoulder soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head pressure), NERVOUSNESS (The shakes), ABNORMAL SENSATION IN EYE (Eyes were hot), PAIN IN EXTREMITY (Right arm and shoulder soreness) and NASOPHARYNGITIS (Head cold) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included PROPRANOLOL for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEAD DISCOMFORT (Head pressure), NERVOUSNESS (The shakes), ABNORMAL SENSATION IN EYE (Eyes were hot), PAIN IN EXTREMITY (Right arm and shoulder soreness), NASOPHARYNGITIS (Head cold), PERIORBITAL SWELLING (Swollen and puffy eyes), EYE SWELLING (Swollen and puffy eyes) and ARTHRALGIA (Right arm and shoulder soreness). On 11-Mar-2021, the patient experienced PYREXIA (Fever). On 11-Mar-2021, NERVOUSNESS (The shakes) and ABNORMAL SENSATION IN EYE (Eyes were hot) had resolved. At the time of the report, HEAD DISCOMFORT (Head pressure), PAIN IN EXTREMITY (Right arm and shoulder soreness), NASOPHARYNGITIS (Head cold), PERIORBITAL SWELLING (Swollen and puffy eyes), EYE SWELLING (Swollen and puffy eyes), ARTHRALGIA (Right arm and shoulder soreness) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 101.4 (High) 101.4.     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 treatment information was provided.
"Felt sick for a day or two after dose #2; chills; Slight fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("Felt sick for a day or two after dose #2), CHILLS (chills), PYREXIA (Slight fever) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis in 2020. Concomitant products included RISEDRONATE SODIUM (ACTONEL), ECHINACEA PURPUREA, FISH OIL, MULTIVITAMINS [VITAMINS NOS], CALCIUM, COLECALCIFEROL (CALCIUM WITH D3) and CYANOCOBALAMIN (B12-VITAMIIN) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (Slight fever) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION COMPLICATION ("Felt sick for a day or two after dose #2). The patient was treated with PARACETAMOL (TYLENOL EXTRA-STRENGTH) (oral) for Headache and Slight fever, at an unspecified dose and frequency. On 14-Mar-2021, CHILLS (chills), PYREXIA (Slight fever) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION COMPLICATION ("Felt sick for a day or two after dose #2) outcome was unknown. Not Provided          This case was linked to MOD-2021-020677 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: added patient medical history , added concomitant and treatment medications, updated events outcome; Sender's Comments:  MOD-2021-020677:1st dose case
Pins and needles in fingeres and toes after first shot in March then after 2nd shot in June 2018 was noticing stumbling then woke up one morning all crippled and 2 days after being crippled legs gave out and has to learn to walk and write all over again.  been a 3 yr battle and still not recovered.
Terrible Itching; This is a spontaneous report from a contactable consumer (Neighbour of patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number and Expiration Date was not reported), via an unspecified route of administration on 16Mar2021, as 2nd dose, single for COVID-19 immunization. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date, as 1st dose, single for COVID-19 immunization. No reaction on previous exposure to drug. The patient medical history and concomitant medications were not reported.  She received 2nd dose of vaccine on 16Mar2021 and had terrible itching. No more information reporter share. Once confirm was it Moderna vaccine. She said sorry It was not Moderna covid vaccine but Pfizer vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Swelling at injection site. Some redness with itching. Sx seen after post injection: no tx - suggested ice pack and hydrocortisone cream.
Increased swelling and fluid retention, around the area of the upper arm, then spread down the arm, down the back and chest, turning bright red and hot.  Caused fever and walking with right side lower than left.  Arm and right side looked at least three to four times the size of the left arm and back.
Long lasting headache, migraine, vertigo, nauseous, unable to concentrate, brain fog, insomnia, stiff neck, head sinus. Has been ongoing for 2 weeks
allergic reaction; whole body hives including soles of feet and scalp; This case was reported by a nurse via sales rep and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction and hives. On an unknown date, the outcome of the allergic reaction and hives were unknown.   It was unknown if the reporter considered the allergic reaction and hives to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination not applicable. The field representative received an email from the RN. Stated the following: Patient has prior history of allergic reaction to the prior shingles vaccine There were no additional details provided in the call. It was unknown if the reporter considered the allergic reaction and hives to be related to Shingles vaccine.
COUGH,RUNNY NOSE,LOSS OF TASTE AND SMELL,SORE THROAT,MUSCLE ACHES,FEVER,HEADACHE,FATIGUE
Redness & swelling at site of injection 13x14 cm - seen at urgent care 12/30/07.  Rx-written PO Atavax.
There was not actually an adverse event but this dose was given after the recommended beyond use date of 31 days under refrigeration. Our company has been in contact w Pfizer and have their approval not to be concerned. Under old guidelines the dose expired 4 hours previous but now no issues according to Pfizer.
Beginning 10/08 , this patient had unbearable foot and ankle swelling, with pain. He was unable to walk, knee pain, swelling, fever, hives, and a headache. (Significantly worse than any symptoms of Lyme disease prior to vaccination). 60 day follow up states residual symptoms are welts, rash, joint pain and fatigue.
Employee became dizzy at time of check out from observation area. Employee was taken to ED for evaluation.
Not be taking 2nd shot; Body aches; Headache; Light headed; Weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), ASTHENIA (Weak), PRODUCT DOSE OMISSION ISSUE (Not be taking 2nd shot), MYALGIA (Body aches) and HEADACHE (Headache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (Light headed), ASTHENIA (Weak), MYALGIA (Body aches) and HEADACHE (Headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not be taking 2nd shot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Light headed), ASTHENIA (Weak), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Not be taking 2nd shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication list was not provided.  Action taken with mRNA-1273 in response to the event was withdrawn.
After the first dose my left armpit was very sore but not swollen and I wasn't able to lay on my left side. Sometimes it would be sore after a full day at work but other than that it would only be sore if I moved my arm around or laid down on that side. It continued to be sore the entire 3 weeks until the second dose. After the second dose I had a slight fever, muscle aches and fatigue but the pain in my armpit has gotten significantly worse to the point that just lowering my arm or having clothing touching the spot sometimes is very painful.
Extreme nausea and stomach bloating resulting in both vomiting and liquid stool over the next 18 hours.
I didn't know what was going on I was traveling and I thought it was based off the area. I was feeling okay until the 16 and it was an outdoor party. I went but didn't really want to go I was feeling weird had a sore throat and tightness in my throat with congestion and a runny nose. I thought it was based off the weather. On the 19 and 20th I just didn't feel right. Wednesday the 21 I walked to my son's house to walk his dogs and then I received the Vsafe checking asking if I was okay and I thought maybe I should take a test I did and it was positive. My son came home for the December holiday, went and took a test and his was positive as well. On the 23 of December, I called my doctor and was told that I was out of the window. I was told to get the sinus wash and MUCINEX and they both caused more issues than helping. I have been isolated in my hotel. I am planning on leaving today but I have decided to wait another 7 days before I fly out. I tested yesterday and I was positive still. I did get all my other shots.
Pt taken to ER 04/08, 04/09 and 04/10 with rash and urticaria  involving entire body accompanied by low grade fever.
headache; chills; fever; muscle soreness; injection site soreness; This is a spontaneous report from a non-contactable consumer (wife). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported. On 14Jan2021 19:00, the patient had headache, chills, fever, muscle soreness and injection site soreness. Outcome was unknown. Information on batch number has been requested.
The BIVALENT covid vaccine was ordered and meant to be administered.  However the regular covid vaccine was administered in error.
Within 4 hours of vaccine patient developed some redness and itch to the site.   The redness and itch became much worse 9 days after the vaccination.  Additionally, the site was very warm and tender.  Patient was treated for a local allergic reaction and possible infection.  Medrol and Bactrim were prescribed
Patient checked in 10/14/2022 requesting bivalent Pfizer vaccine. Medical Assistant took out the monovalent Pfizer vaccine from the fridge and doctor did not visually inspect the vial and administered the vaccine. No adverse side effects reported.
Tested NAAT positive for COVID 11/18/21 after being fully vaccinated.
The mother, who is a healthcare professional, reported that the patient received Prevnar and Recombivax-HB (Merck) on 11/10/00. That evening she developed redness, swelling, and inflammation that presented as a "big ball" at the injection site. Touching the site caused the child to cry. She was treated with cold compresses and acetaminophen. On 11/11/00, the redness resolved. As of 11/13/00, the "big ball" was still present.
Nausea, ringing in ears, fatigue, muscle and joint aches, fever, headache, chills
A report received from a health care professional on 06Nov02 concerning a male vaccinee of less than 4 years old who was inadvertently administered 0.25ml Fluvirin on 25Oct02. On 25Oct02 the vaccinee who was less than 4 years old was administered 0.25 ml Fluvirin IM. No adverse event was reported in relation to the incident.  There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200705.
Pt given 0.5mL instead of 0.25mL as booster dose
Fever 100.7; chills; headache; nausea; injection site pain redness & swelling; injection site pain redness & swelling; injection site pain redness & swelling; exhaustion; This is a spontaneous report from a contactable 65 reporting for herself. A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6201/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 11:00 (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Hashimoto's hypothyroidism. The patient has allergies to halibut and sea kelp. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via an unspecified route of administration, on 22Jan2021 at 03:30 PM (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID), rosuvistatin, acetylsalicylic acid (ASPIRIN), probiotic, and vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 at 23:00, the patient experienced fever 100.7, chills, headache, nausea, injection site pain redness and swelling, and exhaustion. The events did not require hospitalization. The outcome of the events fever 100.7, chills, headache, nausea, injection site pain redness and swelling, and exhaustion was recovering. Since the vaccination, the patient had not been tested for COVID-19.
sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: sore arm). The outcome of the pain in arm was resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine five years ago and the only thing he/she had was a sore arm for a day. The follow up would not possible as no contact details were available.
Initial unsolicited report received from a consumer on 30-Sep-2016. This case was linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188849, 2016SA188850, 2016SA188851. This case involves a patient of (age, sex unknown), who was vaccinated with FLU SHOT (batch number, dose, expiry date, site of administration, route of administration unknown) on an unknown date. Medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced flu like symptoms; according to the patient it was reported that- "the only time I ever got a flu shot is the only time I ever had the flu/ thought I was going to die". Laboratory investigations and corrective treatment were not reported. The outcome for the events was not reported. List of documents held by sender: none.
Pt reported to me on 3/5/19 that several hours after her vaccination that she had swelling in her mouth and lips. In addition, she had itching on her body. She reported she took Benadryl and her symptoms resolved in about 24 hours.
redness, swelling, tenderness rt thigh;tx cool compresses, APAP & DPH;
Information has been received from a pharmacist concerning a 63 year old female consumer who on 13-MAY-2008 was vaccinated SQ with 0.65ml of zoster vaccine live (Oka/Merck) (lot # 659411/0293X). Subsequently, the next day the patient developed redness at the injection site that was about 3-4 inches in diameter, and also warm to touch. Unspecified medical attention was sought. It was unspecified if lab studies were performed. The patient took over the counter diphenhydramine HCl (BENADRYL) and naproxen sodium (ALEVE). No other symptoms were noted. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report previously submitted on 6/24/2008. Information has been received from a pharmacist concerning a 63 year old female with sensitivity to neomycin who on 13-May-2008 was vaccinated subcutaneously with a 0.65 ml first dose of ZOSTAVAX (Merck) (Lot # 6659411/0293X). The next day the patient developed redness at the injection site that was about 3-4 inches in diameter, and also warm to touch which was continued 3 days post vaccination. No other symptoms were noted. The patient took a couple of doses of over the counter BENADRYL and ALEVE. On 16-MAY-2008, the patient was referred to the physician for evaluation. The physician prescribed DORICEF 500g twice a day for 5 days "just in case". On 19-MAY 2008, the patient recovered from the events. There was no product quality complaint involved. Additional information is not expected.
I got my first round of the Pfizer vaccine on 1/14/21. On 1/27/21 I woke up feverish, with chills, body aches, diaherra and intense nausea. I went to Urgent Care on 1/28/21 and was tested for Covid, Influenza (A and B) and strep, all 4 tests came back negative/ not detected. I was told I had a viral infection and to be off work for 7 per symptoms. All of my symptoms worsened extremely over the next week. I went to Hospital on 2/2/21 after 3 days of no sleep, intense pain aches, headaches, and severe vomiting.  They also gave me another Covid test that came back negative. The ER physician informed me that he thought my symptoms were too late to be considered an adverse reaction to the Pfizer vaccine.
Patient received vaccine 03/08/2021 which was on her menses. Two weeks later the patient developed heavy bleeding which was unusual for this patient, she has never had mid cycle bleeding. Patient found out she was pregnant the middle of April, and then she had miscarriage at the end of April at home.
After receiving Td vaccine, patient's arm became very swollen, patient experienced arm pain and minor fever. Patient's was seen at the ER for the arm swelling. The reaction resolved within couple of days.
show RPh 2 inch red circle, itchy and a little sore on 10/25. Gave BENADRYL cream and she will see her MD Thursday.
4 days after receiving vaccine , I broke out in hives (raised itchy rash all over my body). I cannot rule out if this was due to a new soap product that I started using on Jan 19th or because of vaccine or other environmental factor. I have been treating the rash with Benadryl and cortisone 10 cream purchased OTC.