chrisvoncsefalvay/vaers-outcomes huggingface dataset:
step-dad got the shot and wabs very sick afterwards; Initial information regarding this unsolicited valid non-serious social media case received via a consumer and transmitted to Sanofi on 10-Dec-2020.  This case involved a male patient of an unknown age who got the shot vaccine INFLUENZA VACCINE and was very sick afterwards (Illness).  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route on an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the shot and was very sick afterwards (Illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was step-dad got the shot and wabs very sick afterwards. It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Hard lump at injection site and small red circle. Sore to touch.  Pregnancy delivery date is expected to be 3/9/2022
reported vague c/o "heavy feeling" in head 5 mins. post vaccination - denied any other symptoms whatsoever & stated, "I'm really fine, just wanted to let someone know.' does report anxiety R/T "all the hype being said in the media about the possible side effects of the vaccines.'   Drove off lot after total 25 mins. wait time.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018 14:30, the patient received the 2nd dose of SHINGRIX 50 mcg/mg. On 4th August 2018, 4 days after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms, fatigue, muscle disorder, chills, unable to walk, activities of daily living impaired and difficulty in standing. On an unknown date, the outcome of the muscle pain, influenza-like symptoms, fatigue, muscle disorder, chills, activities of daily living impaired and difficulty in standing were unchanged and the outcome of the unable to walk was unknown. It was unknown if the reporter considered the muscle pain, influenza-like symptoms, fatigue, muscle disorder, chills, unable to walk, activities of daily living impaired and difficulty in standing to be related to SHINGRIX. Additional details were provided as follows: The patient was administered in the left arm. The patient experienced muscle pain, loss of muscle control in legs, chills, shivering, and fatigue. The patient stated she was not able to do normal daily activities and the last couple days she had been in the bed. The patient was also having trouble sitting and standing while using the bathroom. Last three days from the date of reporting, the patient had been suffering with all kinds of adverse events. Due to the adverse reactions the patient visited her primary care doctor on 5th August 2018. Doctor mentioned to her that she was experiencing flu like symptoms and it was not related to the vaccine. The patient had three vials of blood drawn for blood test. Her white blood cell count was low, but her doctor mentioned it was nothing to be concerned about. The patient was still waiting on results of other vials of blood there were sent out for testing. No further details were provided.
Started with shortness of breath, increased heart rate, lightheadedness morning of May 2, called doctor Monday may, 36, went to Urgent Care.
Flushed, pale, diaphoretic, bradycardic. Epi administered and RRT called. Admitted to hospital with cardiac cath  - likely unrelated.
Pt. reports reaction started at 9:00 am on 06/22/17 he reported burning sensation and redness in his arm below the vaccine site that has not changed since the onset.
Next day after vaccination he was unable to stand up on his own.  Went to ER and was admitted to hospital.  Stayed 4 days.  Had a high fever.  CRP was elevated.  Back to normal after 5 or 6 days. Given an antibiotic. Every test available was taken and unable to find a cause.  Started improving by the next day and after 3 days did not have any symtoms.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 14-OCT-2012 11:31, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Friday afternoon ok I went to sleep about 11.00  p.m.. Next day did not wake up, my sister took me to the hospital, I was like that fot 3 days. I woke up I was 2 days more and then I was discgharge.  I am ok. now.
Rash all over body; itchy skin. Tx - over the counter allergy meds, creams, and Rx for prednisone to calm down reaction.
This spontaneous report as received from an Administrator, and refers to a 1 year old infant patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 01-JUN-2016, the patient was vaccinated with improperly stored dose of VARIVAX lot # L048468 (strength, dosing details, anatomical location were unknown). All the VARIVAX vaccines with lot # L048468, were moved to the backup freezer on 15-APR-2016 and moved back at the end of AUG-2016. This is one of the several reports reported by the same reporter. Additional information has been requested.
PT RECEIVED HER FIRST GARDASIL ON 7/16/2007.  WHILE PT WAS AT THE OFFICE HAD NO COMPLAINTS.  SHE HAD THE GARDASIL WHILE AWAY AT COLLEGE.  SHE RETURNED TO US LAST WEEK FOR FU AND REPORTED THAT AFTER BOTH 1ST & 2ND INJECTIONS SHE HAD HIVES AND THROAT SWELLING.
It was reported that a 21 y.o. male PT was given a Menomune A/C/Y/W-135 vax, administered SC in his left arm on 9/19/01. Immediately the PT had a small dime-size knot w/a bruised area come up in his arm. It was red and tender to touch, w/in 20 mins the area looked better and he stated he felt better.
I was seven weeks pregnant when I went to a confirmation appointment at the OBGYN on 12/20/2022. An ultrasound was performed, and there were indications that the fetus had never developed within the gestational sac; there was basically nothing there. I was told that it was possible that I was just behind schedule and that maybe the dates were off regarding the conception.  On 12/26/2022, I began to have light bleeding, but I continued going about my normal activities. On 12/27/2022, I began to experience physical weakness and faintness. On 12/28/2022, I began to have really heavy bleeding, which is inconsistent with a healthy pregnancy. It abated by the evening on 12/28/2022, but on the morning of 12/29/2022, the bleeding became heavy again. We decided that I should go to the hospital. At the hospital, an ultrasound was performed. It was clear that I had miscarried, but I had retained some fetal tissue. A few days later, I went to the OBGYN, and I was prescribed misoprostol, which was supposed to enable me to expel the remaining fetal tissue. However, it did not work. On 1/19/2023, I underwent a manual vacuum aspiration in the doctor's office. It was later confirmed that this had successfully removed the last of the fetal tissue. On 3/19/2023, I found out that I was pregnant again. I went to the OBGYN for a confirmation appointment on 4/6/2023; the doctor indicated that the pregnancy seems to be progressing normally. I have had food aversions and fatigue. I was given the due date of 11/24/2023.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) outcome was unknown and CHILLS (Chills) had resolved.            No concomitant medications were provided.  No treatment medications were reported.  Patient experienced fever and chills with the second dose.   This case was linked to MOD-2021-396168 (Patient Link).
PPROM at 35 weeks 3 days gestation. Treatment was expectant management, pregnancy continued without other adverse events until term. Birth was induced with Pitocin. Baby born vaginally at 37 weeks 1 day. Birth weight 6 lb 15 oz
Patient called me on Sunday reporting severe pain in her shoulder and neck and a rash that had developed near the injection site. She reported treating the pain with ibuprofen, acetaminophen, and hydrocodone. She was seen by her primary care physician the next day (Monday), who diagnosed the patient with an acute case of Shingles caused by her immune system being "preoccupied" with building immunity to the Hepatitis A vaccination.
Per pt, on 10/17/21 evening, developed itchiness on neck where she believed was from her necklace so removed necklace. The next morning itchiness and rash spread all over body. Pt took Benadryl with no improvement. She visited her provider and was given a Kenalog injection. Today, itchiness has lessened but still present and a follow-up with provider will take place.
Pt developed flushing/sweating and dizziness Vitals: 111/64, 65, 18, 98% -- > 132/66, 103, 18, 98% Pt given fluids and laid down for ~15mins. Pt verbalized feeling 100% better , ambulated without problems.  Pt stable and released from the vaccination site.
On 11/03/2021 I lost my sense of taste. On 11/4/2021 I got my taste buds back. I was able to taste a cough drop. I started having tears come out of my right eye that night. The next morning 11/5/2021 I drank milk and the milk spilled out of my mouth and my speech was slurred. I was rushed to the hospital and was diagnosed with Bells Palsy. They put me on two medications. They are Prednisone 20 mg and Cephalexin 500mg. I was prescribed a week's worth. I am talking better today 11/8/2021 but still experiencing bels palsy. I have never had this in my life.
On 4/27/2021 son began having a repeated crouping cough starting at 8:00am in the morning. Was feverish, appeared lethargic and tired and was displaying respiratory problems.
DTAP administered inadvertently instead of Tdap. No adverse reactions known at time report was prepared.
gen weakness & some nausea;seen in ER & had fluid replacement IV;no dx;resolved;exposed saliva & body fluids of a racoon over several month while taking care of it;no actual bite exposure;racoon tested positive for rabies & tx started;
Had soreness in left arm day 2 from administration.  5 days later started with widespread hives, rash.
Patient was given 2nd dose in series of Shingrix approximately 5 to 6 weeks after experiencing  a very mild case of shingles (4 dots on abdomen). Patien wanted to complete her 2nd dose in the 2 to 6 month window.  The first dose was 7/26/2019.  After her second dose a week later the patient began to experience severe itching over her body. Patient went to her physician where she was given a course of prednisone which helped her.  When she stopped Prednisone the itching came back and was given a 2nd course of Prednisone.  Dr. told patient she believes that the patien had an "acute allergic  reaction to the Shingrix vaccine.
Pt received flue vaccind at 4pm, at 4:10 developed chest pain/pressure, dizziness, nausea.  Was flushed, no SOB, given epinephrine, EMS notified, pt refused transport/ symptoms resolved. Advised to see MD. P 80, BP 150/98.
Information has been received from a physician concerning a 23 year old female with a history of blood clots, especially post operative (NOVEMBER 2005) who on 18-DEC-2008 was vaccinated with the third dose of GARDASIL (lot#, route and site of administration not reported). On 09-JUN-2009 the patient developed abdominal blood clots. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Additional information has been requested.
Initial misuse report received from a health care professional on 12 November 2013. An 11-year-old patient received DAPTACEL. (No information regarding patient was provided). No adverse report was reported. List of documents held by sender:  none
Because of the swelling patient went to her doctor's office/Shoulder is swollen; itchy on the inside; Burning on the inside/hands are burning on the inside; Shoulder is not moving; Hands are swollen/Fingers are swollen; patient is in so much pain; Numbness; Tingling; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Because of the swelling patient went to her doctor's office/Shoulder is swollen), PRURITUS (itchy on the inside), BURNING SENSATION (Burning on the inside/hands are burning on the inside), MUSCULOSKELETAL DISCOMFORT (Shoulder is not moving) and PERIPHERAL SWELLING (Hands are swollen/Fingers are swollen) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066K21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no history of allergies and medical history relating to adverse event and both acute and chronic similar past illnesses was reported as none.     On 06-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Because of the swelling patient went to her doctor's office/Shoulder is swollen), PRURITUS (itchy on the inside), BURNING SENSATION (Burning on the inside/hands are burning on the inside), MUSCULOSKELETAL DISCOMFORT (Shoulder is not moving), PERIPHERAL SWELLING (Hands are swollen/Fingers are swollen), PAIN (patient is in so much pain), HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling). The patient was treated with PARACETAMOL (TYLENOL) for Swelling, at an unspecified dose and frequency. At the time of the report, SWELLING (Because of the swelling patient went to her doctor's office/Shoulder is swollen), PRURITUS (itchy on the inside), BURNING SENSATION (Burning on the inside/hands are burning on the inside), MUSCULOSKELETAL DISCOMFORT (Shoulder is not moving), PERIPHERAL SWELLING (Hands are swollen/Fingers are swollen), PAIN (patient is in so much pain), HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.
severe chills; fever up to 101.7; severe body aches; joint pain (back, abdomen, hips); Pain and swelling at site injection; Pain and swelling at site injection; residual lower back pain; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0150, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 09:30 (age at vaccination: 55years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included glucose tolerance impaired and hypertension. Concomitant medication included losartan and metformin. Patient had no known allergies. Prior to vaccination, The patient was not tested positive for covid 19 and had not been tested post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications 2 weeks prior to the COVID vaccine. The patient previously took dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 12Mar2021 as dose 1, single (refrigeration issue - had to have 1st shot again on 19Mar) and dose 2 (Lot number: ER2613 / EN6205) via an unspecified route of administration, administered in Arm Left on 19Mar2021 at 09:30 AM and experienced pyrexia, chills and body aches continued for another 24 hrs (back pain) for COVID-19 immunization. On 09Apr2021 at 11:00 PM, the patient experienced severe chills started about 14 hours after shot, fever up to 101.7, severe body aches and joint pain (back, abdomen, hips). Fever subsided to low grade about 30 hours after shot continued for another 24 hours. Pain and swelling at site injection, still happening nearly 72 hours after shot. some residual lower back pain as well. fever is still about 1 degree higher than normal. No treatment received for the events. The patient underwent lab tests and procedures which included body temperature: 101.7 on an unspecified date in Apr2021 fever up to 101.7. The outcome of the event pyrexia, vaccination site pain and vaccination site swelling was not recovered and other events were recovering.   No follow-up attempts are needed. No further information is expected.
Fever 103-104 x 5 days, irritable, transient rash x 1 days, emesis x 3;
Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.   No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided The vaccines were stored in freezer , they take out one to two vials and placed in fridge each day as needed.
This spontaneous report was received from a medical assistant refers to an unspecified patients of unknown age. On an unknown date from 28-JUL-2016 to 03-OCT-2016, the patients were vaccinated with improperly stored ROTATEQ lot # L013204, expiry date 28-JAN-2017, # L020861, expiry date 25-JAN-2017, # M014318, expiry date 30-SEP-2017 for 66 hours, previous excursion 10 centigrade for 10 hours, Time 0.89 centigrade. No adverse effects were reported. This is one of the several cases reported from the same reporter. Additional information has been requested.
Swollen and tender lymph nodes under armpit of injected arm. Large red rash on arm where injection took place.
1st dose Sept2021 and 2nd dose Jan2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received in September 2021).   In January 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. In January 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: The patient was late for her 2nd dose of Twinrix. First dose was received in September 2021 and second dose was received in January 2022, which led to lengthening of vaccination schedule. The reporter consented to follow up. No additional information available from RPH since she did not have their profiles available. This case had been linked to US2022047723, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022047723:Same reporter.
12/08/21 presents to ED for "tachycardia" " lethargic with generalized weakness". PMHx of "CAD s/p CABG, HFpEF (EF 55% 10/9/21), AFib, HTN, HLD, OSA on CPAP"
Red patch on arm about 2 inches in diameter. It is warm and a tiny bit itchy. Does hurt or burn ans it is not swollen or raised.
Golf ball sized lump under left armpit (lymph nodes), appeared within 24 hours of vaccine. No treatment. Swelling slowly decreasing. Lack of menstrual cycle.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose route and frequency unknown. On 21-SEP-2011 the patient was vaccinated with an improperly stored dose of VARIVAX lot #: 669601/0138AA dose number 2. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
a female patient received a dose of Fluzone Quadrivalent 0.5 mL prefilled syringe via subcutaneous route rather than intramuscular route/No AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient (age unknown) who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringe via subcutaneous route rather than intramuscular route lot number and expiry date not reported via subcutaneous route in unknown administration site on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient did not receive any other concomitant vaccines.   It was an actual medication error due to inappropriate route of vaccination.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Approximately 4 hours post influenza vaccine developed persistent cough (lasting 3 hours), oral mucosal edema, sudden itchy eyes. Subsequently this patient described "near anaphylaxis with respiratory involvement and angioedema".
Extreme nausea, generalized malaise, and vomiting. Treatments given where 1 L of normal saline, 4 Mg Zofran IM, and 8 Mg of dexamethasone IV slow push.
by late wed pm pt had welts all over, red spots, swollen face, fever of 101 degrees F, tired, threw up. Wed thru Mon pt had bad cough & extreme tiredness. Family refuses 3rd dose.