chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doesn't know how much of the medication patient received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number TP2N2, expiry date 10th February 2023) for prophylaxis.   On 8th September 2021, the patient received Shingrix. On 8th September 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The pharmacist reported that, he administered Shingrix and the needle was defective and either the medication started coming back out or was not going in.  The pharmacist did not know how much of the medication, if any, the patient received, which led to incomplete dose administered. The reporter consented to follow up via email.
Lymph node swelling in right shoulder/clavicle area. Rash around swelling on right shoulder. Skin tingling upper shoulder area. Headache noted on December 20, 2021, which was relieved with Ibuprofen.
Client called clinic on 2/20/18 and 2/26/18 regarding symptoms she began experiencing after receiving these two vaccines. The symptoms included: racing heartbeat, difficulty catching her breath, numbness and tingling to both lower extremities, frequent headaches, generalized fatigue, nausea, and stiff and achy shoulder muscles.
Complained of alcohol taste in mouth and difficulty swallowing. Per ED report also had mild angioedema. Solumedrol and Benadryl administerd IV. Admitted to inpatient unit.
After vac administered pt slumped forward in chair, I sat him upright, head went back, skin pale, cyanotic, apnic. All extrems et head had rhythmic jerking all lasting 10 sec. Pt then was responsive but somewhat lethargic. No further sz activity noted but remained pale. Pt to lying position at school nurse remained with child. B/P 84/42. Mother called advised to see PCP.
Client reports as of 10-10-07 that a rash along the hair line, front, sides and back began approximately 1 month after receiving the Zostavax vaccine.  Reports that rash itches without pain.  Rash comes and goes.  Denies any new hair products, foods, meds.  Rash is sparse over forehead, pale red in color.  Some areas have fine, small scabs d/t scratching.  Client unable to identify with anything other than this vaccine.  CDC has been called as of the above date.
fatigue, muscle aches, joint aches, appetite loss, body cramps. Currently on medication hold.
HCP thought it could be related to COPD; did not have a menstrual cycle until the first week of August; flu like symptoms for days; sore arm for days; shortness of breath; cycle it was like a blood bath; Bacterial lung infection; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA BACTERIAL (Bacterial lung infection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced PNEUMONIA BACTERIAL (Bacterial lung infection) (seriousness criterion medically significant), HEAVY MENSTRUAL BLEEDING (cycle it was like a blood bath) and DYSPNOEA (shortness of breath). On an unknown date, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (HCP thought it could be related to COPD), AMENORRHOEA (did not have a menstrual cycle until the first week of August), INFLUENZA LIKE ILLNESS (flu like symptoms for days) and PAIN IN EXTREMITY (sore arm for days). At the time of the report, PNEUMONIA BACTERIAL (Bacterial lung infection), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (HCP thought it could be related to COPD), AMENORRHOEA (did not have a menstrual cycle until the first week of August), HEAVY MENSTRUAL BLEEDING (cycle it was like a blood bath), INFLUENZA LIKE ILLNESS (flu like symptoms for days), PAIN IN EXTREMITY (sore arm for days) and DYSPNOEA (shortness of breath) outcome was unknown.            Concomitant product usage included pain medicines . Treatment details were not provided.  Company's comment: This is an spontaneous case concerning a 52 year-old, female patient with no significant clinical history who experienced the unexpected serious event of PNEUMONIA BACTERIAL and other non-serious events. The event approximately 3 months after the second dose of Spikevax The rechallenge is not applicable" as the events occurred after the second dose and no details were provided about the first dose The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-353032 (Patient Link).; Sender's Comments: This is an spontaneous case concerning a 52 year-old, female patient with no significant clinical history who experienced the unexpected serious event of PNEUMONIA BACTERIAL and other non-serious events. The event approximately 3 months after the second dose of Spikevax The rechallenge is not applicable" as the events occurred after the second dose and no details were provided about the first dose The benefit-risk relationship of Spikevax is not affected by this report.
Two days after the injection on Wednesday, red spots began to appear on the neck from Friday. From the evening it began to spread to the chest and legs. Saturday got worse, so itching in my neck and chest. The eyes were swollen and the double eyelid disappeared. On Sunday, my eyes were swollen and pus started to form from the red spots. On Monday, I couldn't go to work because my eyes were so swollen, and my skin became dry and itchy.
Two weeks after second Pfizer vac, I developed bradycardia about 40 bpm, myalgia in my right arm(opposite of vac), . The bradycardia then became tachy and has not resolved as to date. Only trigger was the vaccine
blisters under breasts red & raised 330PM Friday;lt arm felt paralyzed-weak, black & blue by evening-hot to touch-3" x 6", chills;painful on saturday;took DPH;
Client c/o arms/abdomen itching 10 mins after flu shot. BENADRYL 50 mg IM (R) deltoid @ 11:50 am No rash No difficulty breathing No difficulty swallowing B/P 134/70 AP=76 R=18
Narrative:  96yo male patient passed away on 10/15/2021 at hospital. Pt had HTN, CRI, Spinal stenosis s/p multiple surgeries and chronic back pain. Pt's problem list: Spinal stenosis of lumbar region (SCT 18Macular Degeneration (ICD-9-CM 362.50) Osteoarthrosis, unspecified whether geneBenign essential hypertension (SCT 1201005) Hyperlipidemia (SCT 55822004) Pt had received covid vaccines on 2/8/21 & 3/1/21. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
diagnosed with Bell's palsy 13 days following her first Pfizer vaccine; This is a spontaneous report from a contactable physician. A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with Bell's palsy 13 days following her first Pfizer vaccine. The patient is reluctant to receive her second dose on schedule. She has had no improvement with steroids and valacyclovir. The event was assessed as serious (medically significant). Therapeutic measures were taken as a result of diagnosed with bell's palsy 13 days following her first pfizer vaccine (facial paralysis). The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship and known drug safety profile, a causal association between BNT162B2 and the reported Bell's palsy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Information has been received from a nurse referring to an unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot#, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Arm hurts really bad; Feeling sick; Nausea; Low grade temperature; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts really bad), MALAISE (Feeling sick), NAUSEA (Nausea), PYREXIA (Low grade temperature) and HEADACHE (Bad headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts really bad), MALAISE (Feeling sick), NAUSEA (Nausea), PYREXIA (Low grade temperature) and HEADACHE (Bad headache). At the time of the report, PAIN IN EXTREMITY (Arm hurts really bad), MALAISE (Feeling sick), NAUSEA (Nausea), PYREXIA (Low grade temperature) and HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-118000 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional Information received and Patient Demographics updated.Dose 1 Batch number was added
Large hive- 24 X 10 cm on afflicted arm consistent with injection site.
On January 7th, 2021 few minutes after the first injection, I became dizzy and had heart palpitations and hyperhidrosis. I was about to start my shift for work and notified a coworker. I sat down for a few moments until the symptoms resolved. For the remainder of the month, I noticed that my back pain especially in the area of my lipomas had worsened. On January 28, 2021 I received my second vaccine and  by the 3rd of February my back pain was so severe that it was hard to climb stairs. I remember this now because looking back through my calendar that is the time that my husband and I took a mini vacation to go South to  see if a warmer climate may help. Shortly after that I noticed the ill-feeling that I had experienced for a week or two for a few years was now a daily experience and that I had more lipomas, mainly in my back. I had surgery to remove 4 lipomas in my back in May 2021. After that, beginning around August or September of 2021, the malaise and pain were an every day experience and then I noticed lipomas everywhere from neck to feet. It was so bad that I had to end my career. I stopped working in January 2022 and was awarded Disability in July 2022. I often asked if it could be from the vaccine but because it was so new, nobody knew. After reading about others with an Immune Response to the vaccine, I am convinced that mine is also from that. Dercum's Disease is my new diagnosis.
815PM to ER red rash-diffused raised to face trunk extremities;wheels noted to be both thighs raised area to site;rash subsided @ 1115PM & left home;mom called 1PM; temp & stated rash returned
Patient presented to the ED on 4/6/21 with nausea/vomiting. Patient presented to the ED on 4/13/21 and was subsequently hospitalized.
Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022; No Adverse event; Received expired Monovalent vaccine after 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent vaccine after 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent vaccine after 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022).    Concomitant Medication use information was not provided by reporter.  It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 days beyond use date 22-Sep-2022.  There were unbroken cartons. Vial size for 6 months to 5 years was 2.5 ml. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient was given vaccine after BUD date. The vial did not undergo any temperature excursions.  Treatment Medication use information was not provided by reporter.
vaccine given at 1532, symptoms started about 1545, client started coughing, said she felt funny, felt faint, pale, skin to touch was very cold, she said she was cold, BP 182/94, Resp 28, O2 99% on room air, HR 64, she was short of breath, was not tracking, would stare off looking at the ceiling, at 1552 0.5mg Epinephrine was given IM, EMS was called at 1553, EMS arrived at 1558, no relief in with the Epi, left via ambulance at 1605
Vaccine given at 4:30pm 10/17 at 8:30 pm felt short of breath, chest tightness and used inhaler. 10:30 to 11:00 pm began shivering Temp 101 oral and continued til 4am when temp broke. Had a severly debilitating headache. On 18th was ill all day with malaise, headache, and muscle aches which lasted 2 days.
I had pierced my ear on march 7th,  with no swelling or tenderness at all. On the morning of the 19th I woke in extreme pain. My entire ear was swollen, red, hot, it literally felt like I was being stabbed. I have several piercings nothing like this has ever happened before. I had to return to my piercer and have it removed professionally. My ear was so swollen the stud had embedded into my lobe and was suctioned in. I couldn't even find the top.  I'm just grateful it didn't have to be cut out.  Terrible side affect and one that should be mentioned BEFORE you get the shot!
Patient reports 2 hours after the vaccine was administered experiencing redness in her face which lasted about 2 hours. She also experiences swelling of her lips and itchy sensation in the roof of her mouth, both of these symptoms lasted about 2 days. All symptoms eventually resolved without long term damage.
c/o sore throat, aches, fever 100.8 for over a wk; Seen by MD 7NOV91; MD ordered ATB; as of 15NOV91 pt improved but not quite over it;
Health department gave 16 year old the Moderna 18+ vaccine; A spontaneous report was received from a 16-years-old female healthcare facility staff member who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, product administered to patient of inappropriate age.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an undisclosed date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and experienced product administered to patient of inappropriate age.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event, product administered to patient of inappropriate age, was considered resolved.; Reporter's Comments: This report refers to a case of 16- year-old female patient who experienced non-serious unexpected event of health department gave 16-year-old the Moderna 18+ vaccine (product administered to patient of inappropriate age) for mRNA-1273, lot # unknown, Exp date-unknown. There were no reported AEs associated with this case of health department gave 16-year-old the Moderna 18+ vaccine.
dose 1 given 4JAN93; Pneumonia dx 29JAN93; dose 2 given 12FEB93 febrile synd fever, URI
Admit for hyperkalemia due to missed dialysis. Also tested positive for COVID but did not require increase supplemental O2, was treated with steroids, zinc, singulair. Discharged home.
Breakthrough case on 5/15/22.  V Safe reported and received a phone call asking me to fill this out
No known adverse effects.; A 53 year old patient received a dose of PROQUAD; This spontaneous report has been received from a medical assistant concerning a 53-year-old patient of unknown gender. The patient's current conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.   On 18-FEB-2020, the 53-year-old patient was vaccinated with a dose of  Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, recombinant Human albumin (rHA) (PROQUAD) (product administered to patient of inappropriate age), 1 dosage form for prophylaxis  (lot number S0172393, has been verified to be a valid, expiration date reported as 01-DEC-2020,  but upon internal validation, it was established as 01-DEC-2021) (concentration, frequency of vaccination scheme, route and anatomical location of vaccination were not reported).  No known adverse effects were reported.
Pain, swelling and itching on and around the vaccine spot 1 week after vaccination. Pain radiating to neck, shoulder, and upper back. Swollen spot it warm to the touch.
This spontaneous report was received from a certificated medical assistant and refers to patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 31-AUG-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L038503, expiration date 18-DEC-2017 (dose, frequency, route of administration were not reported). The patient's concomitant therapy was not reported. The administered dose of vaccine was exposed to a temperature of 12.2 degree Celsius, for 1 hour 49 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
His wife feels like she had been beaten up for 3 days after having the Moderna vaccine/his wife had reactions which we typically hear about; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (His wife feels like she had been beaten up for 3 days after having the Moderna vaccine/his wife had reactions which we typically hear about) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (His wife feels like she had been beaten up for 3 days after having the Moderna vaccine/his wife had reactions which we typically hear about). At the time of the report, IMMUNISATION REACTION (His wife feels like she had been beaten up for 3 days after having the Moderna vaccine/his wife had reactions which we typically hear about) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. It was reported that patient had reactions and felt like was beaten up for 3 days after having vaccine.  Treatment medications were not provided.   Reporter did not allow further contact
Cerebellar IPH with IVE requiring intervention (failed angiogram, then craniotomy with clipping) Dural arteriovenous fistula
COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Pt felt a pop when needle injected then noticed afterwards the site was high up on the deltoid near the shoulder. More painful than his first 2 moderna shots. I noticed the bandaid about an inch higher than it should be. 2 hours later he said his left upper arm hurt "like a broken bone would hurt". He took a motrin before dinner and again before bed. He is now sleeping.
Injection site became sore on 7-16-17. On 07/17/17 pt's complained of redness, swelling and itching in arm where both Meningococcal vaccines were given. 8 cm x 5 cm area. Pt. was instructed to use BENADRYL at first of week but it didn't seem to help. Pt treated on 7/21/17 for cellulitis. Started on cephalexin 500 mg one cap every 12 hours and a MEDROL (Pak) 4 mg dosepak. Instructed to monitor for increasing infection including warmth, redness, swelling, fever or pus. Follow up if no improvement or worsening symptoms.
Shingle like rash/pain from top right center of forehead to above the right eye with pustules lasting over 10 days.
Fever started 1/1/03. Now on 1/2/03, bumps on whole body. Seen by doctor diagnosed as chicken pox. No known exposure.
Patient received their COVID vaccine on 4/7/21. Recently admitted for COVID (3/24/21 - 4/2/21) discharged on room air, doing well. Returned 4/17/2021 with acute onset and persistent right sided chest pain.
PATIENT CAME INTO THE PHARMACY TO GET THE COVID PEDIATRIC BOOSTER DOSE AND THE PEDIATRIC VIAL WASN'T DILUTED BEFORE DRAWING UP THE 0.2 ML DOSE. PATIENT RECEIVED AN UNDILUTED 0.2ML COVID PEDIATRIC DOSE INSTEAD OF THE DILUTED CONCENTRATION. PATIENT RECEIVED HIGHER CONCENTRATION THAN RECOMMENDED
swelling, itchy spots: , itchy knot on hip, itchy spots: under breasts, ears, and palms-- swollen lips