chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm and that the shot on the right side was worse; flu-like symptoms; Chills ever since the shot/not like goosebumps chills like internal chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm and that the shot on the right side was worse), CHILLS (Chills ever since the shot/not like goosebumps chills like internal chills) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006821A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARIPRAZINE HYDROCHLORIDE (VRAYLAR) for Depression, VILAZODONE HYDROCHLORIDE (VIIBRYD) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (Chills ever since the shot/not like goosebumps chills like internal chills). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm and that the shot on the right side was worse) and INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, VACCINATION SITE PAIN (Sore arm and that the shot on the right side was worse), CHILLS (Chills ever since the shot/not like goosebumps chills like internal chills) and INFLUENZA LIKE ILLNESS (flu-like symptoms) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-238880 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up information received on 21 Jul 2021,contains event information-no new information - Patient reported that she was still experiencing the same side effects 138 days later after her 2nd dose. On 21-Jul-2021: Follow-up information received on 21 Jul 2021,contains no new information - Patient saw her Doctor. On 21-Jul-2021: Follow-up information received on 21 Jul 2021,contains physician details added. On 27-Jul-2021: Follow Up Information received on 27 Jul 2021, chills not recovered, met doctor twice
This spontaneous report as received from a physician refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 18-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Woke up around 2am with chills (no fever) and lower abdominal cramps. This lasted on and off until Sunday, March 14th when I woke up at 9am. Throughout Saturday, I experienced hip flexor and quadriceps pain in addition to chills (no fever). At the time of the vaccine, I was 33+6 days pregnant. No medication was taken so that fetal movement could be detected (10 movements in 2 hours). Normal fetal movement was detected on Friday and all days following injection. No pregnancy concerns so I did not call my OB office.
Starting April 20th and still continuing i have had irregular periods. They use to be like clock work now they come every 2 weeks are much heavier.
injection site bled; arms is swollen; Arm is painful; Arm is red; Arm is tender; not injected properly into muscle; A spontaneous report was received from a healthcare professional who was also a 63 year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the vaccine was not injected properly into muscle / incorrect route of product administration, and experienced injection site bleeding / vaccination site haemorrhage, arm was swollen / peripheral swelling, arm was painful / painful extremity, arm was red / erythema, and arm was tender / tenderness.  The patient's medical history was not provided.  Concomitant medication included metformin, tamoxifen, Synthroid, spironolactone, Protonic, vitamin D, and magnesium.  On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  On an 12Feb2021, the patient received the second of the planned doses of mRNA-1273 (lot number 041L20A) for prophylaxis of COVID-19 infection.  On 12Feb2021, the patient experienced injection site bleeding, arm swollen, painful, hot, and tender.  No treatment was reported.  Action taken with the mRNA-1273 was not reported.  The outcome of the event, not injected properly into muscle, was resolved on 12 Feb 2021. The outcome of the events, injection site bleeding, arm was swollen, arm was painful, arm was red, and arm was tender, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a consumer concerning his 22 year old female friend with no pertinent medical history, drug reactions or allergies, who on 03-JUN-2008 was vaccinated with the first dose of GARDASIL, 0.5 ml, IM.  There was no concomitant medication.  It was reported that "the night after the vaccination," (04-JUN-2008), his friend developed "dizziness", nausea, headaches, migraine headaches, fatigue, 30 second periods of vision loss and loss of appetite.  She had visited different hospitals in the area and had been admitted" a few times."  The hospitalizations were for unknown periods of stay.  The patient had unspecified bloodwork, magnetic resonance imaging (MRI), electroencephalography (EEG), electrocardiogram (EKG), magnetic resonance angiography (MRA) and "basically anything you can test for."  There were no specifics in reference to the testing provided, and no results were reported.  The patient is reportedly recovering.  The patient will not be continuing the series.  Additional information has been requested.
About an hour after vaccination, She started itching on thigh and then the itching spread to the torso and bilateral upper and lower extremities. No rash, No hives. She self medicated with Benadryl and the itching resolved by that night.
Fever, body aches, chills and large local reaction. On 1/19/2012 experienced nausea and vomiting and visited Emergency Department where she was informed symptoms possibly related to vaccine vs flu like illness. 1/21/2012 informed our office of symptoms and related increasing large local reaction "size of a grapefruit" with streak going down to elbow on dorsal aspect of arm, vaccine was administered IM Left Deltoid. Encouraged ice and Tylenol, and if swelling increases return to ER. Office visit scheduled for tomorrow to assess further.
Swelling and bleeding at administration site that led to ER visit over that weekend (per pt's company HR)
ON MARCH 16, 2022 STARTED EXPERIENCING A RED RASH COVERING MY UPPER CHEST, NECK AND FACE, WHICH DEVELOPED WELTS, AND EDEMA OF THE NECK, FACE, AND THROAT. SKIN WAS VERY HOT TO TOUCH AND BURNING SENSATION. POST VACCINE INFLAMMATROY SYNDROME
This case was reported by a nurse via sales rep and described the occurrence of blister in a female patient who received SHINGRIX for prophylaxis. On 21st June 2018, the patient received the 2nd dose of SHINGRIX. On 23rd June 2018, 2 days after receiving SHINGRIX, the patient experienced blister. On an unknown date, the outcome of the blister was recovering/resolving. It was unknown if the reporter considered the blister to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Thursday, the patient received the SHINGRIX vaccine. The patient noticed on Saturday 23rd June 2018, 3 small blisters vessels on her ankle. The patient did not have pain, fever or chills. The patient had a follow up visit on 25th June 2018 with the provider and that was when she reported her blisters to the provider. However, the blisters on the day of reporting had improved. The nurse agreed for follow-up contact.
I developed a herpes sore on my top lip 2 weeks post injection for both doses. Treated topically at home with OTC Abreva cream, resolved about 1 week later.  I also experienced oral discomfort on my hard palate and tongue about 24-48 following both injections. It was similar to a chemo side effect but not as severe, tenderness, kind of raw/burning sensation. Resolved on its own after several days
The entire next day, I was tired and every part of my body ached. I spent the day in bed and the following day I felt much better. No other symptoms.
Patient was due for Dtap, HIB, IPV. she was given the DTAP and IPV portion of the of the pentacel vaccine. it was not mixed with the HIB powder.
started with diarrhea the night of receiving the vaccination. It wasn't until the next morning that I cycled through the rest of the symptoms. The fever and headaches are the only symptoms that extended to 3 days after the vaccine
The spot where I got the shot remains tender. But the biggest issue has been my throat. Around the area where my vocal cords feel inflamed and while not in constant pain, I've been having terrible swallowing issues, especially with solid foods. Sometimes I need to drink water to push the food to pass through.
feel unwell; developed shingles; This is a spontaneous report from a contactable consumer (patient's wife).   A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 23Apr2021 (Batch/Lot Number: ER8735) as 2nd dose, single (at the age of 38 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, at the age of 38 years old for COVID-19 immunisation.  The patient experienced Pfizer covid 19 vaccine on 23Apr2021. he started to feel unwell Sunday into Monday and was formally diagnosed with shingles yesterday (27Apr2021). Treatment for adverse event: Reporter stated, "They just provide valacyclovir, that's the antiviral an the other one is, shingles can cause like nerve pain, Gabapentin. It's 1gram tablet and the tablet has to be taken by mouth three times a day for week. It's 100mg one capsule by mouth 3 times daily for the 30 dosages". The outcome of shingles was not recovered and other event was unknown.   No follow-up attempts are possible. No further information is expected.
Patient reported rash/hives by phone about 4 hours after IM injection of 0.5ml FLUVIRIN. Instructed to take 25mg diphenhydramine and go to minor medical clinic for further evaluation.
This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 10:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unspecified indication, from an unknown date and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 10Feb2021 at 11:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 04Mar2021, the following morning after vaccination, the patient experienced running nose that lasted all day. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event running nose was resolved on 04Mar2021.   No follow-up attempts are needed. No further information is expected.
The day after receiving vaccine, patient developed fever, nausea/vomiting, severe pain at injection site, inability to move affected shoulder, and  red rash on his elbow, which is not the site of innoculation.
Redness around thigh (7inx4in), warm to the touch Treatment; epsom salt bath, Bentonite Clay, Glutathione cream
nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) 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 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced NAUSEA (nauseous). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of UNK dosage form. At the time of the report, NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
first dose of Shingrix on Feb 25th, 2021 and the second shot (June 24th, 2021).; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 26th February 2019).   On 24th June 2021, the patient received the 2nd dose of Shingles vaccine. On 24th June 2021, unknown after receiving Shingles vaccine, 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.  Additional details were provided as follows: The health care professional reported that, the patient received 2nd dose of Shingrix 2 years later, which led to lengthening of vaccination schedule. The reporter did not consent to follow up. There was discrepancy in vaccination dates reported in narrative and in structured field of source document.
sore throat, nausea and diarrhea for 24hs; sore throat, nausea and diarrhea for 24hs; sore throat, nausea and diarrhea for 24hs; Within 15min of the injection patient developed itchiness on her right hand; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (sore throat, nausea and diarrhea for 24hs), OROPHARYNGEAL PAIN (sore throat, nausea and diarrhea for 24hs), PRURITUS (Within 15min of the injection patient developed itchiness on her right hand) and NAUSEA (sore throat, nausea and diarrhea for 24hs) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01da21a) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal disorder NOS (The patient used Ondansetron to treat symptoms for her stomach problems.). Concomitant products included INSULIN, COLECALCIFEROL (VIT D [COLECALCIFEROL]), SIMVASTATIN, GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Mar-2021, the patient experienced PRURITUS (Within 15min of the injection patient developed itchiness on her right hand). On 06-Mar-2021, the patient experienced DIARRHOEA (sore throat, nausea and diarrhea for 24hs), OROPHARYNGEAL PAIN (sore throat, nausea and diarrhea for 24hs) and NAUSEA (sore throat, nausea and diarrhea for 24hs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ONDANSETRON at an unspecified dose and frequency. On 05-Mar-2021, PRURITUS (Within 15min of the injection patient developed itchiness on her right hand) had resolved. On 07-Mar-2021, DIARRHOEA (sore throat, nausea and diarrhea for 24hs), OROPHARYNGEAL PAIN (sore throat, nausea and diarrhea for 24hs) and NAUSEA (sore throat, nausea and diarrhea for 24hs) had resolved.
My child was very fussy with a runny nose for two days then she was very unresponsive on the third.  On the fourth day she stopped breathing.  The on call physicians only advice for treatment was baby tylenol.  11/18 Death certificate states COD as severe hypoxic ischemic injury w/cardiac arrest & complex cyanotic heart disease as contributing factors. 11/13/07 Reviewed hospital medical records which also included birth records. Admitted 5/29-5/30/2007 s/p cardiopulmonary arrest at home.  Seen initially in outlying ER & transferred for higher level of care s/p resuscitation, intubation & interosseus dopamine drip.  IV & a-line established & placed on ventilator.  Transfused PRBCs & FFP.  Acidotic, hypoglycemic & hypocalcemic on admit.  Tx w/antibiotics.  EEG showed very low voltage activity.  Extubated & patient expired quickly w/parents in attendance.
I mistakenly thought the vaccine expired 24hrs after opening, not 12 hrs. Vaccine was opened at 4:55pm on November 15, 2022. I gave vaccine on November 16, 2022 at 9am. After back up vaccine coordinator called and spoke with employee, it was made clear that there is no harm no foul to the patient, she does not need an additional booster at this time.
Pt called to report chills, muscle cramps, joint pain, headache and upset stomach on 2/24/2021. Pt took Tylenol for symptoms. Reported on 2/25/2021 that she had not fever today, but still had cold sweats, muscle cramps and her hands were swollen. She is seeing per primary provider for an annual check-up today and will make them aware.
Bloating; stomach pain and abdominal pain; diarrhea; . This case was reported by a consumer via call center representative and described the occurrence of bloating in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a day after receiving Shingrix, the patient experienced bloating, abdominal pain and diarrhea. On an unknown date, the outcome of the bloating, abdominal pain and diarrhea were recovered/resolved.   It was unknown if the reporter considered the bloating, abdominal pain and diarrhea to be related to Shingrix.  Additional details provided as follow: This case was reported by the patient. The patient took second dose of shingrix on 10th March 2021. The patient experienced abdominal pain, stomach ache, diarrhea and bloating after getting second dose of shingrix at night on the same day. The reported events were resolved. No further information was provided
Patient did receive the 1st shot in the left arm and experienced little fatigue the next day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Patient did receive the 1st shot in the left arm and experienced little fatigue the next day) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Patient did receive the 1st shot in the left arm and experienced little fatigue the next day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Patient did receive the 1st shot in the left arm and experienced little fatigue the next day) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.    This case was linked to MOD-2021-055252 (Patient Link).
deep erythema, swelling, pain, elbow to shoulder rt side, nausea/diarrhea;
about 2hrs p/vax pt started an unconsolable prolonged crying that lasted @ least 3-4hrs;pt also had an elevated temp 103 & would not eat;pt would also hold breath; pt given APAP drops
Patient presented to the ED on 3/21/2021. Patient also presented to the ED on 3/28/2021 and was subsequently hospitalized. Both incidents were within 6 weeks of COVID vaccination.
Tired, weak, fever ranging from 100 to 102 for 24 hours. 3 days later still tired, weak, but no fever.
Tingling in head, light headedness.  Stated she is scared.  Anxious.  V/S  122/56, HR 72, O2 99%.
Nurse administered vaccination at 1355, patient put her own bandaids on and seemed fine. She then got off table and sat in chair, sister was then put on table for vaccinations. Sister was given her vaccinations, at that time patient had fallen off chair and was on the floor. Nurse picked picked patient up and put her on the exam table and checked for breathing. Patient was breathing, nurse then called for assistance, patient was rigid throughout her body for about 1-3 minutes. Given ice pack and juice, after examination from physician. Patient recovered and left office approximately 1 hour later.
None per group home. 3 Hep A's given (inadvertently) Misadministration rather than any adverse event.
PT RECEIVED MODERNA #1  3/17/2021.   SHE BEGAN TO EXPERIENCE LEG CRAMPS ON THE LEFT 4/12/2021.  SHE RECEIVED MODERNA #2 4/14/2021 SHE WAS DIAGNOSED WITH LEFT LEG DVT 4/19/2021 AND STARTED ON XARELTO. SHE WAS ADMITTED 5/3/2021 AND DIAGNOSED WITH PULMONARY EMBOLI SHE HAS SEEN HEMATOLOGY DR. 5/5/2021 MANY LABS ARE PENDING
Aches from top of my head to toes, headache,  fever,  swollen lymph nodes under right arm.
Fever, violent chills, sweating, joint pain, back pain, nausea, arm pain, numbness in left fingers, left shoulder pain, soreness,(left shoulder), sleeplessness, frequent urination with little to no urine, rash (spread across neck collar region, up and down entire spine, and under pectorals).
She got her vaccine, had no reaction.  The next morning she had a real red rash down her arm.   She was having symptoms of a stroke earlier that morning.  Her husband took her to hospital  and did a  CT scan and an MRI and she had a brain stem stroke and was transferred to hospital by ambulance.  She was discharged after 3 days.   She is showing signs of improvement and her neurologist expects her to recovery 100%.  Her therapist felt that she would regain it within a year.   They treated her rash with a Benadryl shot and has recovered from the rash aspects of the vaccine.