chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates the patients were vaccinated with improperly stored VAQTA lot # L014068 and expiration date on 02-NOV-2017, lot # M036458 and expiration date on 02-MAR-2018 and lot # N014945, with expiration date on 31-AUG-2018, (dose and route of administration were not reported) for prophylaxis. The doses of VAQTA were exposed to a temperature excursion of 35 degrees Fahrenheit (°F) during a time frame of 1 hour and 15 minutes, which was detected by the data logger. There was no prior temperature excursion, no adverse events were reported and no product quality complaints were present. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA013506: US-009507513-1709USA013505.
Pt complained of nausea, prolonged sleeping (9-10 hours), headache, no vomiting, post vax. Pt has a large knot on right arm at injection site.
Began with sore arm, then sore throat (first like a rock I couldn't swallow - by 4pm aching pain and pains going into tongue, by 5 pm starting to feel lung congestion, then severe muscle aches by 6 with very sore upper and lower arm opposite the injection arm, then fever that went to 100.5 by 9 pm, fatigue, headache.  Took an ibuprofen and went to bed feeling very sick.  Next am still tired all day and some nausea.  Arm still very sore.  By Sunday sore arm and red splotches on upper.  Monday ok.
patient receiving 2 doses of the Moderna vaccine on the same day; A report was received from a physician concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced incorrect dose administered.   The patient's medical history and relevant concomitant medications were not reported.   On an unknown date the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient received a second dose of vaccine the same day.  No adverse events were observed. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, incorrect dose administered, was resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting that patient received two doses of vaccine on the same day without any associated adverse events.
tightness of chest which feels like bronchitis, achiness; tightness of chest which feels like bronchitis, achiness; tightness of chest which feels like bronchitis, achiness; feeling feverish; Disease recurrence; cold symptoms; This is a spontaneous report from a contactable consumer (patient) received via medical information team and a Pfizer Sponsored Program. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 30Mar2021 (at the age of 40-years-old) as dose 2, single for COVID-19 immunization. Medical history included asthma and bronchitis. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient experienced tightness of chest which feels like bronchitis, achiness, feeling feverish and cold symptoms on 30Mar2021. It was reported that patient knows that these are some of the side effects of the vaccine. It was asked can she take asthma medicine, or will it cause adverse reaction with the vaccine and can the doctor test her for COVID 19 even though she have had the vaccine already. Patient also asked that having a cold affects the effectiveness of the vaccine because she feels like she has symptoms of a cold and how dangerous is this for her since she has history of asthma. Outcome of events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Burning sensation from toes to head. Fever with pains through out entire body, like pins and needles poking at skin.  Extremely tiredness with nausea and soreness in all muscles. Lasted for 18 hours
Received MMR vaccine instead of the Varicella vaccine that was requested. MMR immunity was already up-to-date. Unknown adverse effects of giving extra vaccine at this time.
Experienced fever of 104 with severe muscle pain, extreme weakness, terrible headache, shivering, belly cramping and pain. Redness at injection site the size of half dollar with feverish hot to touch; dizziness with extreme stomach upset with neck gland discomfort and tightness in chest with a cough.
There was no adverse reaction. requested a VAERS report to be filed since the patient was 15.94 years of age and not 16.   Patient was in the presence of parent and has a history of asthma, and Pfizer vaccine was used since it is approved for 16 years of age.
The patient presented to the clinic with redness below the injection and swelling of the left upper extremity. The left arm (which was affected)measured 40.5cm and the right upper arm measured 36.5 in circumfrence. The patient complained of numbness and tingling down his left arm. The medial and ulnar surfaces were numb, per the patient. He did not complain of pain. Cap refill was less than 2 seconds. The patient had full range of motion. The injection site was slightly bruised.
Mother stated after pt received immunization on 10/9/03, later that night she noticed that her daughter began to stare upwards not making any eye contact.  Lasted about 6 minutes.
By 8/17/07 Arm turned very, very pink, hot approximately 4 inches down from the injection site. 8/20/07 Slightly pink, not as sore. Patient was advised to go to ER, use warm compresses. They encircled with marker and initially it increased a little but the next day felt better so did not go to ER (300 miles away).
Felt pain L upper arm on same day of vaccination. Next morning noted "knot" L upper arm, increased in size, became warm/hot and red and itchy. Treatment -> Medrol dose pack, diphenhydramine famotidine.
Arm is swollen; rash going down her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm is swollen) and VACCINATION SITE RASH (rash going down her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE SWELLING (Arm is swollen) and VACCINATION SITE RASH (rash going down her arm).   At the time of the report, VACCINATION SITE SWELLING (Arm is swollen) and VACCINATION SITE RASH (rash going down her arm) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.
I woke up at 2 in the morning from a deep sleep with verigo.   I held onto the bed as it spun.   Then I vomited.    20 minutes later it happened again.    Then I kept getting dizzy every 20 minutes.  I did not move until about 11 a.m.    I needed my husband to hold me up to get to the bathroom.  Every night ater that I was dizzy for a week.    If I layed down, I was dizzy.   standing or sitting I was fine.  I also had a fever and was very tired and nauseous the next day, but that was  normal.   The veritgo and dizziness is not.
Patient is a 33 y.o. male who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot EW0151 on 4/2/2021. The patient experienced the following reaction(s) during the immediate of observation: 9:23am Patient c/o feeling "faint" during observation period. Patient appeared diaphoretic and replying with one word answers. Patient wheelchaired to treatment area. Patient was treated/managed as follows:  9:28am Patient lying on mat with legs elevated. Ice pack provided and applied to to posterior neck. VS BP 106/76, HR 69, RR 20, O2 sat 97% on room air. Patient alert and oriented. Denies other symptoms. Water provided. Patient reports feeling better. Patient and conservatorship/uncle given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 9:38am VS BP 110/80, HR 75, RR 18, O2 sat 99% on room air. Patient reports symptoms resolved. 10am Patient escorted to car accompanied by conservatorship/uncle and RN.
15-year old patient received Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year old patient received Moderna vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year old patient received Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year old patient received Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Patient demographics-ethnicity updated, race information updated , pregnancy information updated
pt recv vax 12MAY97 & exp swelling of the feet & ankles, which progressed to swelling of the hands & face the next day 17MAY;no ER or MD visit was required to treat the event which resolved w/o tx over next 48hr;
Woke up at 4:00 AM with nerve pain followed by weakness in both legs. Difficulty walking: unsteady and shaky. Went to the emergency room immediately, and the neurologist claimed that it was most likely nerve inflammation.
sore arm; chills; swollen in my armpit/also had swelling in the lymph nodes; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (chills) and LYMPHADENOPATHY (swollen in my armpit/also had swelling in the lymph nodes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 012A21A and 028L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (chills) and LYMPHADENOPATHY (swollen in my armpit/also had swelling in the lymph nodes). In October 2021, PAIN IN EXTREMITY (sore arm), CHILLS (chills) and LYMPHADENOPATHY (swollen in my armpit/also had swelling in the lymph nodes) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.
Abnormal uterine and vaginal bleeding, unspecified. PFIZER Lot #'s EL9263, EN6200.
Starting Monday March 1st approximately 25 hrs after my injection I started feeling slightly nauseous , and had a loose stool, diarrhea, The following morning I had 2 of the same bowel movements. That continued for a week, until March 9. I would only go in the morning, not all day. The nausea went away after the first day. On Thursday of the week, I took a 1/2 pill of Imodium, On Friday I took another half pill, On the Saturday I took a whole pill. On the Sunday I took 1 pill in the morning and one in early evening. I called my Doctor on Monday March 8th to discuss, he suggested I continue taking Imodium, no more than 2 a day for the next 3-4 days, and to call if I was still experiencing the diarrhea after then. I took 2 pills on the Tuesday, then Wednesday I didn't have a bowel movement , and finall on the Wednesday March 10th I was back to normal... I am not sure if this was caused by vaccine or not, but felt like I should report it.
About approx 10 mins after vaccination, pt's mom called us over to alert us that her daughter was not feeling well. Pt said the injection site felt itchy & her head really hurt. I had her sit in a private area to take her blood pressure & ask her questions. After another 10 mins, she started feeling better. Also, pt did follow up several hours later. She didn't report any allergy reactions.
Patient developed a large bruise (hematoma) that diminished over time and was not painful.
Nausea from 12:15 am to 1:30 am, vomiting at 1:30 am
After receiving MENACTRA and Hep A injection. Pt c/o light headed, faint, nausea- Pale. Pt laid down - elevated feet - recovered - did fine.
Took the vaccine, got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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: Took the vaccine, got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   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: 16-MAR-2023 This case was reported by a patient wife via interactive digital media. The reporter reported that her husband received Shingles vaccine and experienced shingles. The reporter stated that every time he receive preventive pills and experience shingles. It was unknown if the reporter considered the vaccination failure and shingles to be related to Preventive pills.  This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Swollen painful red area around vaccination site Zyrtec  and cortisone creme Reaction lasted 2+ weeks
Patient presents to the facility today with complaints of left lower back/flank pain that radiates to the left abdomen x 3 days. Positive for decreased urine volume, difficulty urinating, dysuria and flank pain.
Decedent was in his usual state of health on a 4 month wellness check on 10/12/2017, at which time he received the ROTATEQ vaccination (among others). Decedent presented to pediatrician on 10/16/2017 for fussiness, irritability, and nausea. He continued to have nausea, vomiting, and diarrhea and his parents transported him to the hospital that evening. He arrived to the hospital in critical condition. He died shortly thereafter on 10/17/2017 at 0100 following an emergent bedside exploratory laparotomy that revealed diffuse intestinal necrosis without an identified cause.
Had a sore arm the first day of vaccination, but starting the morning after, I had low grade fever, body aches, chills which forced me to bed for the entire day with no help from taking TYLENOL.  The next day I still experience the same symptoms but less severe. Symptoms seem to have abated by next day, but still a very sore arm at injection site.
This medically confirmed spontaneous report (initial receipt 01-Sep-3015) concerns a 46-year-old male patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) at a dose of 0.5 ml, once for protection against seasonal influenza. No adverse reaction occurred after the administration. the outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA.
1 hr p/going to bed was whimpering; pt was limp & glazed eyes & wasn't responding well for 5 minutes; seen in hosp ER next day;
After the vaccine, my left arm was painful. Within 45 minutes after the vaccine, I started feeling numbness on my right arm from shoulder and up to neck. About two weeks ago, the feeling of numbness expanded all on my right side. My right hand, I'm having a difficult time holding a grip to anything. My doctor ordered ordered an MRI which indicated I had a small stroke. I am being referred to a neurologist. My doctor wants me to go to physical therapy maybe 3 times a week.
3-4 weeks after vaccine urgent care at Hospital diagnosed me with blood clots in left leg.
Onset with severe headache, nausea, diarrhea, vomiting, shortness of breath, difficulty concentrating from 4/3 -4/8.  Went to urgent Care on 4/8 where treated for severe dehydration and stomach aligment.  From 4/9 - 4/14 continued to suffer from same symptoms and then began to have heart taching, feeling as if there was a bubble in my chest.  Went back to Urgent Care on 4/14 and was again treated for dehydration.  Outcome is that no one knows why I have been feeling this way except for that it is a direct result of receiving the vaccine.
Fatigue; chills; headache; fever 100.5 F; This is a spontaneous report from a non-contactable consumer. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in left arm on 17Feb2021 at 01:00 (at the age of 54-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of COVID-19 (Lot Number: Unknown) as dose 1, single. No other vaccine in four weeks. No COVID prior vaccination. On 18Feb2021 at 04:00 AM, the patient experienced fatigue, chills, headache and fever 100.5 F. The patient underwent lab tests and procedures which included body temperature: 100.5. No COVID tested post vaccination. No treatment received. The outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 10:00 as dose 4 (booster), single (Lot number: Unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Known allergies: erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I have a recurrence of symptoms after testing negative for a week; (unspecified date) Positive, notes: COVID 19 Treatment; (03Jan2023) Positive, notes: Yesterday I tested positive again. Therapeutic measures were taken as a result of drug ineffective and covid-19 with Paxlovid from 24Dec2022 to 29Dec2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Inadvertently reconstituted with sterile water; Inadvertently reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a adult female patient who received Herpes zoster (Shingrix) (batch number xg7rf, expiry date 21st May 2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-FEB-2023 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received Shingrix vaccine which was inadvertently reconstituted with Merck sterile water diluent for mmr or varicella vaccine. The reporter did consent to follow up Additional supportive information: Shingrix reconstituted with Merck sterile water diluent for MMR or varicella instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Patient developed abdominal itching and rash 01 FEB. Rash is somewhat confluent perhaps slightly blanching somehwat lacy in nature and wide spread across the abdomen and the foreamrs on to the neck. PT does not have any rash on the face. Patient was ordered a urinalysis and prescribed atarax as needed for pruritis. Patient was informed to return to the clinic 02/09 for a follow up.
Rash starting on 7/16/05 covering belly, back, small amount on arms and legs; fever 7/14/05 only.
This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 2nd July 2018, the patient received the 2nd dose of SHINGRIX. On 2nd July 2018, less than a day after receiving SHINGRIX, the patient experienced headache. On 10th July 2018, the patient experienced rash, pruritus and erythematous rash. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the rash and pruritus were not recovered/not resolved and the outcome of the erythematous rash was unknown. It was unknown if the reporter considered the headache, rash, pruritus and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on right arm. The patient reported that he experienced a headache. The patient was unsure in the beginning because he had just gotten new eye glasses on 5th July 2018 and thought they were the cause. The patient soon realized that the glasses did not cause the headache and now believed the vaccine caused it. Around 10 July 2018, 8 days after receiving SHINGRIX, the patient noticed a rash on the inner bicep of the right arm and on the right side of the body. The rash looked like a small patch of little red bumps with itching. The patch of small bumps was about 5 inches in diameter and had not gotten any smaller. The itching has become more pronounced. The patient said that he had been using over the counter powder to help with the itching. Less than a month after receiving SHINGRIX, the patient still had trouble not sleeping well since the second dose. For tolerance of 1st dose of SHINGRIX, refer linked case US2018GSK128826.