chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt had last vaccine 1/30/23. Greater than 6 month; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 30th January 2023).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: pt had last vaccine 1/30/23. Greater than 6 month). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16 August 2023 The patient had last vaccine on 30th Jan 2023, it was greater than 6 months. The reporter asked if they would need to restart the series over. Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
She has an itchy throat and soreness to her arm; She has an itchy throat and soreness to her arm; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history include exposure to COVID-19 (her son, who she is around a lot and gives her a kiss every morning tested positive for COVID) and concomitant medications were not reported. Patient reported that she received her first Covid vaccine dose yesterday (12Mar2021) and her son, who she was around a lot and gives her a kiss every morning tested positive for COVID. She reported that she has an itchy throat and soreness to her arm but no other symptoms at this time. She asked if she should go get tested for covid. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The patient presented initially with nontraumatic fall but then was subsequently found to have COVID pneumonia and hypotension which x-ray in the ED revealing right lung whiteout.  Patient was admitted to the ICU and patient had to be placed on high-flow oxygen along with p.r.n. BiPAP as well as multiple pressors including Levophed along with dobutamine for his known cardiomyopathy.  Patient was then placed on IV Decadron along with IV antibiotics.  On 01/06, patient continued to have significant opacification right lung so IR was consulted.  Chest tube was placed on 01/07 but CT of chest was done 1/13 which revealed complete obliteration right lower lobe.  IR placed another right-sided chest tube on 01/14 and patient's respiratory status slowly improved.  Patient has been weaned off pressors and was transferred on IV Zosyn.  Patient was seen by Nephrology after he developed acute kidney injury while on diuretics.  Unfortunately pt's respiratory status still deteriorated at the healthcare facility. Long discussion was made with the pt's family and decision was made for the patient's code status to be changed to comfort care measures.  Pt expired on 01/20/22 Acute hypoxemic and hypercarbic respiratory failure Acute COVID-19 pneumonia with sepsis Acute nosocomial pneumonia Acute bilateral pleural effusion R > L
Back pain/her back is currently hurting; This is a spontaneous report from a contactable consumer (patient) via a Pfizer- sponsored program 159558. A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 06Apr2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received her 1st dose of our COVID-19 vaccine on 06Apr2021 and scheduled to receive the 2nd dose on 27Apr2021 (exactly 21 days apart). She was asking how long it would be possible before she can take aspirin or Ibuprofen for her back pain. She mentioned that her back was currently hurting. Event outcome was unknown.  Information on the lot/batch number has been requested.
Misadministration of H1N1 vaccine. She was given the intranasal vaccine instead of intramuscular vaccine. No adverse reaction noted/reported.
I recently had a checkup and was discussing my reaction to my booster shot and was told I should report it.   On 02/05/2022 11:am at my local Pharmacy, I received my third Pfizer FJ6369 booster shot. As the day progressed (over 12 hours), the shot site was extra sore and developed a quarter sized hard bump. Then I went to bed at approximately 11:pm. Around 5:am on 02/06/2022 I awoke to extreme pain in both my hands, The middle fingers of both hands curled and cramped. As the morning progressed, I was able to finally move them. However, it left me with trigger fingers in both hands. Oddly, about 5 to 7 days later, the trigger finger in my right hand (none shot side) completely went away. And while it is improving (I sleep with a finger splint on left  hand) But, the left hand middle finger still has the trigger finger.
Narrative: 67 yo male with hx of HTN, alcoholism and gastritis received two doses of moderna vaccine on 02/14/2021 & 03/13/2021. Pt died on 08/14/2021 at their home. Death is not likely to vaccinations.
cold like symptoms; sore throat; coughing; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold like symptoms), OROPHARYNGEAL PAIN (sore throat) and COUGH (coughing) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LATANOPROST for an unknown indication.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced NASOPHARYNGITIS (cold like symptoms), OROPHARYNGEAL PAIN (sore throat) and COUGH (coughing). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold like symptoms), OROPHARYNGEAL PAIN (sore throat) and COUGH (coughing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Heart rate: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt presented at ER with temp 104.7/R  Hx seizure was evaluated and released. Tx Tylenol and Motrin, control fever. Fever and seizure happened 8 days after receiving MMR.
Pfizer COVID vaccine second dose administered 5 days early. No adverse effects were observed during 15 minute observation period. Followed up with patient today, 11/02/2021. Patient reported a mild headache, but no other symptoms.
Had a temperature of 100.1 F, pain in left deltoid, left deltoid area swelling, difficulty to lift her left arm.
On 4/13/01 it was reported that the left arm was red, hot, swollen and had hives. The symptoms started on 4/12/01 and started "getting worse". The pt was referred to PMD or ER for consult/evaluation. On 4/17/01 follow-up call provided that the pt was given anti-histamine and cortisone and had improved. MD states may be immune problem. Will not receive third dose.
Headache, Myalgia, CHILLS/INJECTION SITE SORENESS Narrative:
This is a spontaneous report from a contactable consumer, the patient. A 62-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration, administered in Arm Left on 21May2021 at 12:30 (Age at vaccination: 62 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's past medical history included high blood pressure. Allergy to Sulfa-based drug and possibly bee sting. Concomitant medications included Amlodipine, Losartan, Nadolol and Doxycycline Hyclate. The patient did not receive any vaccines within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 21May2021 (12- 18 hours of receiving the first dose), patient had genital herpes which were previously dormant (for years, maybe even a decade or more) but came back with the first dose of the vaccine. Patient's lifestyle habits had not changed so I could not attribute it to any other events. The patient did not receive any other treatment. Outcome of the event genital herpes was recovering.
Swollen lymph nodes in armpit area of same arm vaccination was administered causing soreness and tenderness.
Death Narrative: Patient received the first COVID-19 dose on 12/23. Afterwards, patient complained of localized pain on L deltoid area where the vaccine was administered; his temperature was 98.1 F. On 12/26-27, staff reported that patient appeared more fatigued than usual and was shivering on 12/27, which seized after blanket was given. On 12/28, patient presented with fever (Tmax 100.2 F) and acetaminophen was administered for alleviation of fever. ADR was reported for the fever on 12/29. Patient continued to decline and was placed back on hospice care on 12/29; on 12/30. the symptoms reported on nursing note include erythema and pain on whole L arm. Lidocaine was applied. Patient's family and provider mutually agreed not to administer the second dose of vaccine. He continued to decline and was started on end-of-life care around 1/4 and passed on 1/20 1417.
constant deep pulling pain since l week after the vaccine, no relief or improving with time.  If anything,  it is worse.
First 12 hours - normal with no effects. At 10:00 pm of day 1, chills and shivering began and continued until 10:00 am on day 2. I had fever of 99 to 100 from day 1 night until day 3 morning. Also on days 2 and 3 - headache and mild body ache. Injection site developed a hive-like rash, warm to the touch and swollen. Rash still remains on day 6. I also had itching on my waist at the site where I had a shingles outbreak the year before - no blisters. On days 2 and 3 I was not able to do normal activities due to severe fatigue, fever, and aching. Day 4 I did activities for 1/2 day and stopped due to fatigue. Day 5 was more normal, still resting. Day 6 much better.
Patient experienced chills the evening of vaccination. Felt weak. He was recovering from knee surgery 2 1/2 wks before. He mentioned the wound also felt more pain. Advised going to ER. Test showed he had infection in the blood, WBC increased also. Fever spiked to 103 2 days later. Red, swelling on injection site, also warmth to the touch. Pt. was admitted to hospital that nite.
Mother states that until 06/15/2003 site over right deltoid was swollen approximately size of a peach pit, tender and red. Today 06/16/03 noted to have circular area of erythema (mild) 43cm, mild swelling and warmth. No Hx of fever. from right deltoid to mid right upper extremity. Mild discomfort today.
Pimple like rash on leg and bottom. Also on abdomen. Resolved with treatment by 5/19/04.
Narrative: A 67yo male with PMH of Memory Loss, Depression, Shoulder Pain, Patellofemoral Stress Syndrome, Glaucoma, OSA, PTSD, Nuclear Sclerosis, Presbyopia, Low Back Pain, Knee pain He received Covid-19 vaccine first dose on February 21 PM and second dose on March 14, 2021 AM. On March 17, 2021 he was reported by the documenting attending physician with a historical ADR of Left Axillary Lymphadenopathy post the second Covid-19 vaccine in Lt arm.
Pain around injection site which went away after a few days. Headache, aches and chills lasting over a week. Decreased appetite. Tickle feeling in throat.
Pt developed a systemic reaction characterized by generalized edema, itching and possibly wheezing.
Moderna Bivalent dosing for adults in 0.5ml,  patient was given 0.25ml of the Moderna Bivalent booster vaccine
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Dec2022 at 14:30 as dose 5 (booster), single (Lot number: GJ3274) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Aug2022 at 14:30 as dose 4 (booster), single (Lot number: FP7139), 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's relevant medical history included: "hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIOTHYRONINE. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: antigen tested positive on day 13 prior antigen negative tests on day 9 and day 11; Negative, notes: antigen tested positive on day 13 prior antigen negative tests on day 9 and day 11; Negative, notes: antigen tested positive on day 13 prior antigen negative tests on day 9 and day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Adverse event: new symptoms on day 12; only sinus congestion and fatigue antigen tested positive on day 13 prior antigen negative tests on day 9 and day 11.
The patient called in and spoke with one of our triage nurses on 11-6-19 and was advised to be seen in Urgent Care.  She was seen in urgent care and was advised it looked like a vaccine reaction, and to continue to monitor.  She sent a message to us on 11-16-19, along with pictures of the wound, which was very concerning. She did see one of our providers on 11-18-19 and a wound was noted on her Left deltoid.  There was a resurfaced lesion black eschar, no drainage. It was tender to palpation, warm and there was about 1 cm erythema surrounding the wound. Irregular shaped wound measures 3.5 cm long by 2 cm at widest.  She was started on Kelflex and referred to wound care.  She presented to the Emergency Room on 11-19-19 where it was decided she will have outpatient debridement and will refer to Plastic Surgery.
Headache, body pain, chills, vomiting, diarrhea, mucsle pain joint pain
I had very high fever the first night, and high fever for the next five days, with headache and fatigue. I am approaching a month since the vaccine and I still have almost constant headache, fatigue, and fever between 99.3 and 99.5 (axillary).
This literature report concerns a series of 10 cases of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (1 of 10) concerns a 1-year-old male patient, who had a medical history of febrile seizures after mumps/measles/rubella. The patient died of sudden death, with no evidence of trauma, one day after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporter comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).
pt says she had normal flu like symptoms for the first 3 days.  On 3/22/2021 she developed a cough so went to a  pharmacy and got Claritin and cough medicine.  On 3/23/2021 she woke with rapid heart palpitations and fluttering in the left side of her chest.  Her face felt very hot and tingling.  She called J&J and cough medicine manf. and was told to contact her PCP.  Her PCP told her to go to an UC.  On 3/26/2021 she went to an UC.  They told her to go to an ER since they did not have an EKG machine.  She ended up not going and monitored it herself.  She felt like something wasnt right so on 4/5/2021 she went toHospital ER. She had an EKG, Blood work and Chest X- Ray.  All test were normal.  She was discharged to FU w/ Cardiologist and PCP.  She will be fitted for a heart monitor today 4/9/2021 and will see PCP on 4/13/2021.  she still has a heavy pressure feeling on her chest and has palpitations that will wake her up at night.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. No concomitant therapy was reported. On 19-MAY-2015 (also reported as "since 20-APR-2015"), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous vial (dose, lot#, expiration date and indication were not reported), which underwent supported temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was administered FLUCELVAX and it's for patients 4 years old and up. Patient was 2 years old and 10 months at time of administration. No adverse event. Patient has no complaints.
(L) shoulder pain onset after injection. Has continued 7 6 months. Developed adhesive capsulitis - steroid injection and now in PT.
Patient received vaccine IV; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 37-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th May 2022, the patient received Boostrix (intravenous) and Boostrix Pre-Filled Syringe Device. On 11th May 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route 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 Information: GSK Receipt Date: 11-MAY-2022 Reporter's Comments: The pharmacist reported that patient received a dose of Boostrix vaccine intravenously instead of intramuscularly. The reporter consented to follow up. Additional Supportive Information: The use of Boostrix vaccine intravenously instead of intramuscularly, which led to intramuscular formulation administered by other route.
Localized reaction in right deltoid, inflamed and hot to touch near injection site, afebrile and does not seem to bother him nor itch.
About an hour after receiving the vaccine patient experienced "tightness" in throat, no swelling present. Two hours after receiving vaccine patient experienced a "prickly sensation" and broke out in red bumps on back, arms, wrists, stomach, legs, and behind knees. Bumps were red in color at itchy. Patient took a dose of diphenhydramine and that helped throat tightness, but did not relieve rash. Patient bathed in Dawn Dish soap, which helped to calm the itch temporarily. Rash has not completely gone away, as of 3/17/21 patient still suffers from itchy bumps on legs.
Pt received flu and pneumo vaccine on 10/11/2005/ By 9pm that night clients left arm was extremely red and swollen past elbow. Wife indicated area looked overweight with folds hanging over. Swelling slowly resolving. Client indicates mild pain but no other symptoms.
notable pain at the injection site; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative. This 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the COVID vaccine on 23Dec2020, that evening he was having notable pain at the injection site. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
real achy all over; felt bad; felt like when he had COVID back in December 2020; pain in his neck and back; pain in his neck and back; fever got up to 101 but most of the time it was between 100-101 degrees; chills all night long; A spontaneous report was received from a consumer concerning a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events real achy all over, felt bad, felt like when he had covid back in December 2020, pain in his neck and back, fever got up to 101 but most of the time it was between 100-101 degrees, chills all night long.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 004M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) real achy all over, felt bad, felt like when he had covid back in December 2020, pain in his neck and back, fever got up to 101 but most of the time it was between 100-101 degrees, chills all night long.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 20 Feb 2021 the outcome of event(s), chills all night long was resolved. The outcome of event(s), real achy all over, felt bad, felt like when he had covid back in December 2020, pain in his neck and back, fever got up to 101 but most of the time it was between 100-101 degrees was unknown.
Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced TENDERNESS (Tenderness). On 16-Feb-2021, TENDERNESS (Tenderness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided no treatment medication were provided.
No adverse reaction.  Patient was given booster dose earlier than recommended per guidelines.  It had only been 4 months since the patient's second dose of her primary series.
At 10:30 pm,  just after I went to bed, I started shivering violently, though I did not feel sick or cold.  My hands were tremoring severely and my muscles were tight, though I wouldn?t say they were cramping. I tried deep breathing and relaxation with no improvement. After 40 minutes, I got out of bed, sat in a chair and drank hot tea. After another hour the tremors decreased significantly and I went back to bed and fell asleep.
Pt c/o metallic taste and tingling/itchy throat 3 mins after vaccination. Given Benadryl 25mg @ 10:20.  Pt stable and released from vaccination site.