chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increased heart rate 152 beat per min; Body aches; Fever of 102.7; Nausea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heart rate 152 beat per min), MYALGIA (Body aches), PYREXIA (Fever of 102.7), NAUSEA (Nausea) and CHILLS (Chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O25J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Increased heart rate 152 beat per min), MYALGIA (Body aches), PYREXIA (Fever of 102.7), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with ONDANSETRON for Myalgia, at a dose of 8 mg. At the time of the report, HEART RATE INCREASED (Increased heart rate 152 beat per min), MYALGIA (Body aches), PYREXIA (Fever of 102.7), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.7 (High) 102.7. On an unknown date, Heart rate: 152 (High) 152 beat per min.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
blisters behind ear, back of head, neck and chest; 2 by 3 inch red streak down left arm/red streak below injection site; pain to elbow, hand and forearm; elbowpain; shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles to face and cornea when she was 4 years old and again at 27 years). Previously administered products included Zostavax (received Zostavax at age 60).   On 10th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th May 2022, 1 days after receiving Shingrix, the patient experienced erythema of extremities. In May 2022, the patient experienced shingles, pain in arm and pain in elbow. On 17th May 2022, the patient experienced blister. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles, erythema of extremities and pain in elbow were unknown and the outcome of the pain in arm and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles, erythema of extremities, pain in arm, blister and pain in elbow to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comments: The reporter was the patient and also a nurse. The patient received first dose of Shingrix into left deltoid. A day and a half later patient developed a two by three inch red streak down her left arm. The red streak started below the injection site. Last week patient had pain to her left elbow, hand and forearm. On the day of reporting  patient had blisters behind her left ear, back of head, left side of neck and left side of chest. The patient saw her doctor on the day of reporting and was diagnosed with shingles and prescribed Acyclovir.  The doctor told her Shingrix caused the shingles outbreak. The reporter did not know batch number or expiration date. The reporter consented to follow up.
patients 2nd dose given too early on day 10 instead of day 21, no treatment patient contacted per CDC dose does not need to be repeated.
Left ear hearing ?loss? ? like clogged hearing when on an airplane. Severe Tinnitus, ringing and buzzing.
SUSPECTED COVID-19 INFECTION; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A) dose was not reported, 1 total, administered on 19-JUN-2021 on left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 26-AUG-2021 for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered  (Dose number in series 2). No concomitant medications were reported.  On 01-JAN-2022 or 02-JAN-2022 (2-3 days ago), the patient's symptoms started. The patient had symptoms of fever, cold and pain in the body. On 03-JAN-2022, the patient tested COVID positive using a lab test antigen test (suspected covid-19 infection) (Dose number in series 2). On 03-JAN-2022, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
27OCT96 pt was seen @ ER w/gen contractions lasting <1sec;of which had about 10 episodes in a 30min period;
Pt reported that she started having adverse effects starting the morning after receiving the flu shot (10/28). She started having changes in her vision and needed to blink multiple times to focus. That day she went to pick up her meds from her regular pharmacy and then went to choir practice. She was still having vision issues and then developed a headache, for which she took Tylenol to help with the pain, and then went home. When she was home her eyes started to dart side to side. She notes that she slept well that night but the following day had felt worse. On the morning of 10/29 she still had trouble with focusing and then felt unsteady. On 10/30 she said that she was feeling a little worse. She still had trouble with her eyes darting and her balance was getting worse, however she also had vomited once in the day. On 10/31 she stated that she couldn?t focus completely, had bad balance and had to stagger to throw out her trash. When she came back inside her house her eyes were still darting and felt like she was going to fall so she sat down and called the EMTs. They came about 5 minutes after her call and took her vitals, which were fine, and then they took her to Hospital. While at the ER, a chest x-ray, EKG and MRI of her head and neck were done, however she was not told of the results. The hospital also ran a urinalysis on the patient, which she states had tested positive for bacteria. A Rhomberg test and Epley test were administered in which she had trouble balancing and was leaning to the right. Due to this she spent the night at the hospital for observation and was given Zofran, but this had no good response for her. On 11/1 the patient was discharged to rehabilitation where she stayed for 11 days to work on her balance. The patient states that the nystagmus had slowly started to resolve and her balance had slowly gotten better during this time, however it is not completely back to normal. On 11/13 she was discharged to her primary doctor, who she saw on the Monday following her discharge. Since then the patient had home visits with physical therapy, who helped her with exercises to help her balance and to help her walk with a walker and then a cane. The patient has recently been able to visit the site for these appointments and her last appointment will be next week. Pt has appointment with Dr. on 1/30/20.
swelling of face, hard to breathe, crying 12 hrs p/shot; stopped walking for 4 months;
Myalgia, Fever, Sore throat, Stuffy Nose, Fatigue, Injection site soreness Narrative:
Pt states date of vaccine admin experienced generalized discomfort at site. Redness at site but not noticed until that evening, then noted heat at site then too. No limit to limb movt or ROM (inj to (L) tricep area). No improvement in s/s since. Denies need for further tx when offered.
Flaccid activity lower extremities began 2MAY91 ended w/in 6 hrs, "could not walk", paralized, crying & cranky, runny nose;
Patient states that on 1/8 he had low grade fever (99.8) and fatigue and he slept all day On 1/9/22 he woke up with a "baseball" sized swelling in his (L) armpit. He went to ER @ MC and was diagnosed with a superficial blood clot. Restarted on Eliquis. Inst'd to apply warm compresses up to 4x/day. States that swelling is "about the same" this morning.
The second dose of Moderna vaccine was given prior to the 28th day.  The first one was given on 3/25/21 and the second given on 4/14/2021.  Ongoing investigation to determine how this occurred and how to prevent it from happening in the future.
1/11 vaccination 1/18 I woke up I was talking to my cousin I noticed like I had a Charlie horse in my mouth. My jaw was tightening on one side. I immediately talked to my siblings and they said to take ibuprofen up to 800 mg daily. Those symptoms lasted for less then a week.  'lock jaw syndrome'
5in x 3 in red bullseye that was hot to touch, red and swollen for 2 days.  Slowly resolving after 2nd day, not hot, only red and swollen.
Pt recvd vax & 9 days later exp chest congestion, malaise, weakness & elevated liver function tests;
Got Shingles, Shots don't always work/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (Had as a kid).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that after received Shingles vaccine he/she experienced shingles a bad case of them. The patient stated that shots always not works. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Information has been received from a Licensed Practical Nurse concerning an approximately 15 month old male patient, who on an unspecified date was vaccinated with a dose of MMR II (Lot # not reported). The nurse reported that the patient might have developed autism after receiving MMR II. The nurse reported that the patient developed the autism around 15 months of age and the patient's mother had suspected MMR II. The nurse indicated that the patient's mother reported that the patient was doing much better. The patient was identified as currently being 7 years of age. The nurse had only spoken with the patient's mother on the phone. The patient sought medical attention, contact office. At the time of the report the patient was recovering. Upon internal review autism was considered to be other important medical event. Additional information has been requested.
2" diameter rash at injection site. Little itching, warm to touch. No temp. No flu symptoms. Improvement by 10/9.
She received the Prevnar 13 after the recommendation was changed.   I tried to contact her to explain that since she received the Prevnar 13 vaccination the recommendation is she receive a second dose in the series of the Pneumovax 23.    At he time she received this vaccine the recommendation the Prevnar 20.
Injection Friday.  No issues Friday, Saturday, or Sunday other than slight pain at the injection site and slight body aches on Sunday.  Monday morning at approximately 0230 i woke up to what i can only describe as lightning pains in my legs.  It was a very intense pain shooting from my upper thighs to my knees and slightly bending around to the top of my calves on the outside of the leg.  Monday all day i did not feel well.  Had a dull pain in center of chest, and my left arm from the shoulder blade to the elbow had what i can only describe as a slight warm sensation.  I was also very "foggy" and light headed.  On Tuesday the pain in my chest worsened.  My left arm kept going numb (and still does today 04.21.2021), my jaw hurt, i was light headed and again very foggy.  On Wednesday it was the same thing and I called the VA and they told me to come to the ER for evaluation.
Itchy skin shortly after injection; aware of Hives 2 hours after vaccine received. No respiratory symptoms. Self medicated with BENADRYL.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 17-NOV-2009, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 15-MAR-2016, the patient was treated by a healthcare provider for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 05-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 804 hours, the lowest recorded temperature was 20F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Short term reaction to second vaccine caused flu-like symptoms. Severe headache, body aches, chills, starting about 12 hours post vaccination and continuing for about 36 hours. Chills add it hard to get warm, and felt like I had little circulation to extremities. I noticed that my hands and feet also fell asleep more easily and I continued to get pins and needles sensations after sitting or lying still with my weight on them.  Starting 10 days later, I began to experience areas of complete numbness on the tops and sides of my feet, much more severe on the right side. It feels like my skin has been injected with anesthetic, and it does not go away with movement or stimulation. It seems to be spreading up over my ankle bone and up the back of my leg. I also have twinges and a tingling sensation running up the back of my right leg into my hip on the right side.
my arm was sore with all the shots; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (my arm was sore with all the shots) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     Patient did not had other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient had never tested for diagnosed with COVID. Patient had no history of COVID-19 infection and myocarditis/pericarditis. Patient had a huge list of allergies.  Concurrent medical conditions included Drug allergy (anti-inflammatory drugs), Food allergy (green pepper allergy), Food allergy (garlic allergy), Milk protein allergy (milk products allergy), Food allergy (raw onions allergy), Spice allergy (spicy food allergy), Arthritis (50 years ago and still ongoing, recent change in status was worsened.), Asthma (20 years ago and still ongoing, recent change in status was worsened.), Neck pain (5 years ago and still ongoing, recent change in status was worsened.) and Heartbeats irregular (20 years ago and still ongoing, recent change in status was stable.). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, DULOXETINE, FAMOTIDINE (PEPCID [FAMOTIDINE]), ATORVASTATIN, TRAZODONE and LOSARTAN for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (my arm was sore with all the shots). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (my arm was sore with all the shots) outcome was unknown. Patient had a sore arm with all shots of the Moderna vaccine.   This case was linked to MOD-2022-565146, MOD-2022-564313, MOD-2022-565145 (Patient Link).
Twitching coming from the muscle the shot was given. It started three days after the shot and has been going on for two days.
No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 09-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T041685 has been verified to be valid, expiration date reported and established as 10-DEC-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
Difficulty swallowing and dizzy began quickly.  Nurse stayed with me. Gave me juice. Brought me to a back room to lay down. Checked and monitored vitals all were good.  It has been hours since my shot and I still have difficulty swallowing, my face feels hot.
Information has been received from a physician concerning a 20 year old female who is July 2008, was vaccinated with the first dose of GARDASIL (lot# 660555/ 0279X) and on 27-SEP-2008 was vaccinated with the second dose of GARDASIL (lot# 661044/0548X). On 29-Sep-2008 the patient began to feel unwell with fever of 101.3 F. She later developed nausea, passed out and vomited once or twice. The patient sought medical attention, in office. At the time of reporting the patient was recovering. Additional information has been requested.
13 hours after vaccination developed severe arm tenderness at injection site, aches and chills.  These lasted about 12 hours.  Aches and exhaustion continued another 6 hours.
soreness in his arm; 2nd dose not receivd yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Influenza vaccine for prophylaxis.   On 19-OCT-2021, the patient received the 1st dose of Shingrix (left arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 19-OCT-2023, the patient received the 1st dose of Influenza vaccine. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm (Verbatim: soreness in his arm) and incomplete course of vaccination (Verbatim: 2nd dose not receivd yet). The outcome of the pain in arm was resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date: 10-NOV-2023 The patent mentioned that he had his first dose of the Shringrix vaccine in October 19th of 2021 and never received the 2nd dose. The patient had no lot number or expiry date, or route of administration to provide. The patient stated he probably received the 1st dose of Shingrix in his left arm, but was not sure. The patient also reported that he was pretty sure he received a flu shot (unknown product) at the same time. The patient reported that he had soreness in his arm for a few days after receiving Shingrix. No further information provided about this event. The patient stated that he left the country and was unable to schedule a second dose. The patient enquired that as a very healthy 65 year old, was it recommended to start over and get two shots and was there a significant risk in simply getting a booster now or alternatively was there a significant risk in getting two more now. The consent to follow up with Healthcare professional was obtained, however the patient did not had a primary care physician, and was not able to provide any Healthcare professional information. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
pt vax hepta B. 24hrs aft vax pt devel n/ chills, flushing, malaise, and felt feverish.  recovered in 3-4 days
Patient developed hives the afternoon she received COVID vaccine.  She had a telemedicine visit with this provider on 4/7/2021.  She was prescribed Medrol dose pack, was taking Benadryl, and famotidine was added.  She developed tongue and facial swelling later in the day, and went to hospital  for treatment.  Provider does not have above vaccine information as vaccine was not given at facility