chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They got very sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, after receiving second dose they got very sick. The detail of how they got sick was not reported not provide name, demographic information or any other information regarding the incident because it happened long time ago.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063860:Same country, Same product
Patient started shopping in the store before the 15 minute waiting period was up after receiving her vaccine. She came back shortly after and sat in her chair, complaining of dizziness and spots in her vision. She thought she was going to pass out. She was given water and offered food, which she declined. She told me to watch her and check on her in a few minutes, which I did. She said she thought she was going to pass out and her speech was not clear. Since she was getting worse, I called a technician out to help keep her steady and called 911. During the time it took for them to get there, she started shaking slightly and told me she thought she might vomit. She never ended up fainting or throwing up. The paramedics arrived and they took over. She refused the ambulance and had a friend pick her up shortly after, once she was feeling better. She was thankful for our help.
This is a spontaneous report from a contactable consumer (parent) from a Pfizer sponsored program. A female patient of an unspecified age received TRUMENBA, Lot number and expiration date was not reported, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced running a low fever of 99.3 degree Fahrenheit and diarrhea. According to the consumer the patient received the vaccine in school. The outcome of the events was unknown. Information on the lot number has been requested.
At 12:24PM, patient received his first dose of Pfizer vaccine, alert and oriented X4, denies any allergies, pain or shortness of breath. No known medical condition but has history of fainting or passing out.  At 12:27PM, 3 minutes after receiving the vaccine, per patient?s verbalization, he felt nauseous, warm and lightheaded while seated at the observation area then lost his consciousness. Patient was assisted to the floor and regained his consciousness immediately. Assessment done. Patient is alert and oriented X4. Denies any pain, able to move all extremities without difficulty. Vital signs were taken: BP: 140/82, HR:70bpm, RR:19cpm, O2 Saturation at 97% room air. He denies any pain, shortness of breath or itching.  Noted sweating but denies dizziness. Patient claimed he had not taken his breakfast before coming for his vaccination. At 12:28PM EMS was called. 12:35PM, vital signs were taken, BP: 132/73, HR: 64bpm; RR:18cpm; O2 Saturation: 98% at room air. Resident is alert and oriented. At 12:39PM, EMS arrived, vital signs: 132/74, HR: 68bpm; RR:20cpm, O2 Saturation: 97% at room air. Assessment done, patient was asked if he wants to be brought to the hospital. Patient verbalized, he feels better and will just go home. Patient reported no dizziness or difficulty breathing. 12:50PM, patient went home ambulatory without complaints, accompanied by brother-in-law.
Pt's daughter called to report patient was feeling nauseated and slightly dizzy.  These are side effects listed in the literature.
Phone call received at 3:45 from mom stated son's head was shaking back and forth and hands twitching and jerking upon getting him out of car seat. She had given him Tylenol at 2PM. DTaP is only immunization. She read about that could have this side effect. Advised to go to ER and call pediatrician. Drs office closed today. Went to ER immediately after . Was observed x 15-20 min and sent home. Appointment with pediatrician 12/11/04. Mom refused lab work. Reaction thought to be possible seizure from temperature spiking.
LOT FC3184 was my 2nd pfizer shot. the day after i was very tired, could not get out of bed and body joint pain all over body. It was painful to have the sheets on top of me while asleep. This minimized over the next few days. during the next 2 weeks, I struggled to stay awake during the work weeks and constantly taking over the counter pain relievers to reduce the body joint pains but unsuccessful.  Starting September 24 to now I have been suffering random joint pains, pins and needles from my fingers down to my toes, I feel I have bugs crawling on me with itching from my legs and back to my arms, I feel dizzy at times and get very fatigued and tired, my hands legs and feet get spasms or twitching and shaking, I feel overall weak and feels like my vision gets cloudy. Since September 24th it has not changed or has not gotten any better.
an 8 month old patient received a first dose of Moderna Bivalent COVID-19 vaccine from a vial with a dark pink cap; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (an 8 month old patient received a first dose of Moderna Bivalent COVID-19 vaccine from a vial with a dark pink cap) and NO ADVERSE EVENT (No adverse event) in an 8-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 WRONG PRODUCT ADMINISTERED (an 8 month old patient received a first dose of Moderna Bivalent COVID-19 vaccine from a vial with a dark pink cap) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (an 8 month old patient received a first dose of Moderna Bivalent COVID-19 vaccine from a vial with a dark pink cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (an 8 month old patient received a first dose of Moderna Bivalent COVID-19 vaccine from a vial with a dark pink cap).    Concomitant medication not reported.  Treatment medication not reported.
A report has been received from a Health Professional concerning a 42 year old, female subject, who had been receiving FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced developed a headache in the right frontal portion of the head the day after receiving FLUMIST QUADRIVALENT which started on 17-OCT-2014. The patient recovered from the event of developed a headache in the right frontal portion of the head the day after receiving FLUMIST QUADRIVALENT on an  unspecified date. The report was considered to be non-serious.
A dose discrepancy between the signed consent and the charting on patients Moderna booster. The signed paper work is noted that they received a booster shot which is a half dose, but the documentation in chart states they received a regular full dose. Can not guarantee or verify what dose was received but it is possible that instead of a half dose booster a full dose was received. No adverse effects or side effects were noted.
Severe bodily redness starting from neck to lower extremity; hot to the touch. Difficulty swallowing. Fever.
had covid 10-12-2020 and had vaccine 1-20-2021; deceased 2-16-2021  after having colon cancer with mets to lung and pneumonia and copd exacerbation apparently had been admitted to the Hospital 2/2021
Pruritis starting approx. 2 days ago (1/26/21). After showering this morning, spouse noted redness surrounding injection site. Spouse called RN, and RN observed red, warm, indurated area measuring 8 x 6.5 cm in a square shape surrounding vaccination site on L deltoid.
Complaints of profuse sweating and elevated glucose levels. Reported a fasting blood sugar level of 250 this morning, but denies being a diabetic.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 3:15 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 77.81. Concomitant products were not provided. On 03-Nov-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Covid arm?redness, swelling, hot, firm to the touch, from injection site to elbow
This is a 65 yo F who presents to our facility with concern of myalgias. Symptoms present and worsening over past few days. Unsure of any sick contacts however pt works in a grocery store as chef. Pt also notes diarrhea which she attributes to eggnog a few days ago. Additionally, pt work up with fever this morning with tmax 100.2. She has not taken anything for symptoms. She is vaccinated for COVID however has not received booster as she had a reaction to second vaccine which was lymphadenopathy. She has no other complaints at this time. On examination, patient nontoxic. Chest and lungs are CTA. Afebrile. Await workup. EKG without significant ST or T wave changes.      1158 Covid-19 Result(!): Detected  1203 Pt covid positive. Admitting to HA at this time. Husband at bedside now states he has also been having symptoms of headache and fatigue. Await remainder of workup.  1600 Troponin negative ×2. Patient able to ambulate without evidence of hypoxia. At this time she is stable for discharge. Advised to follow up with primary care physician after quarantine. Return precautions discussed. Pulse ox provided. All questions answered. Patient agreeable to plan.
pt recvd vax & had high fever for 2-3 days, difficulty breathing (wouldn't take bottle), high pitched crying for 5 days; hands & feet were cold;
Hives and redness on chest and neck with a little on my back.  It started on 1/2/2021 and ended on 1/5/2021.  I took Benadryl that night, and was much better the next day.  On January 4, 2021 after taking a hot bath, I had a red feverish area around the injection site that measured about 6"X2".  It was much better the next morning.  I could barely see slight red area.
felt sick; Irritable; with second dose had aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick), IRRITABILITY (Irritable) and MYALGIA (with second dose had aches) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included GABAPENTIN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MALAISE (felt sick), IRRITABILITY (Irritable) and MYALGIA (with second dose had aches). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (felt sick), IRRITABILITY (Irritable) and MYALGIA (with second dose had aches) had not resolved.            This case was linked to MOD-2021-377149, MOD-2021-377159 (Patient Link).
The last two nights I have gone to bed with itchy legs on and around my ankles, shins, knees, wrists, and elbows. The itch has been so severe and uncontrollable I wake up in the night and cannot go back to sleep.
Pain in lower back; Pain in waist; Pain in shoulder blade to neck jaw and right shoulder; Can not turn neck; Scalp above your right ear is sensitive; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain in lower back), PAIN (Pain in waist), ARTHRALGIA (Pain in shoulder blade to neck jaw and right shoulder), MUSCULOSKELETAL DISCOMFORT (Can not turn neck) and SKIN IRRITATION (Scalp above your right ear is sensitive) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Pain in lower back), PAIN (Pain in waist), ARTHRALGIA (Pain in shoulder blade to neck jaw and right shoulder), MUSCULOSKELETAL DISCOMFORT (Can not turn neck) and SKIN IRRITATION (Scalp above your right ear is sensitive). At the time of the report, BACK PAIN (Pain in lower back), PAIN (Pain in waist), ARTHRALGIA (Pain in shoulder blade to neck jaw and right shoulder), MUSCULOSKELETAL DISCOMFORT (Can not turn neck) and SKIN IRRITATION (Scalp above your right ear is sensitive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
I sustained a fever of 102-103 and I took Tylenol. I had fever, chills, and headaches and muscle aches. Symptoms resolved in 7 days.
Red mark near injection site; mild soreness in arm near injection site; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6208; Expiration date were not reported), via unspecified route of administration in the left arm on 13Mar2021 06:15 PM (at the age of 35-years-old) as first dose, single dose for COVID-19 immunisation. The patient has no relevant medical history. The patient has no concomitant medications. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 14Mar2021 07:00 AM, the patient experienced red mark near injection site and mild soreness in arm near injection site. No treatment was taken for the events. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
patient was given vaccine that had been refrigerated for 7 days (outside window of storage per the EUA)
We recently took a trip out of town and attended the theater. I wore a mask for the entire trip, but others were not always masked. We returned home on 09/24/2022. On 09/25/2022 at 05:00PM my throat began to hurt, and my husband was also not feeling well. We both tested negative on at home COVID-19 tests. The next day, 09/26/2022, we tested again, and the results were positive. I called my doctor who prescribed us each PAXLOVID which we began taking that same day. My symptoms have not begun to improve yet. I'm still experiencing sore throat, fever, aches and pains, lethargy, stuffy nose, respiratory wheezing in my chest, and diarrhea.
Pt states month after 2nd dose chest tightness, sweating, fatigued. Since then no breath, low energy.  Feels like his heart is pounding out of his chest. Doctors ordered stress test, Ekg 04/28/2021. Extreme mental state stress.
Warm sensation over whole body, most notable was the fact my eyes felt "hot". Occasionally my vision would blur. The sensation lasted roughly an hour (10p to 11p). The symptoms began approximately 3 hours after shot. I did not seek medical treatment and there were no notable affects the next day.
chills/shivering; Tired; Achy Joints; Achy Muscle Pain; Chills; arm was sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (2 years ago). Concurrent medical conditions included nerve pain (had shingles 2 years ago and still had pinched nerve pain in the center of his back from that event).   On 11-OCT-2023, the patient received the 2nd dose of Shingrix (left arm). On 11-OCT-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm was sore). On 12-OCT-2023, the patient experienced shivering (Verbatim: chills/shivering), tiredness (Verbatim: Tired), joint pain (Verbatim: Achy Joints), muscle pain (Verbatim: Achy Muscle Pain) and chills (Verbatim: Chills). The outcome of the pain in arm, shivering, tiredness, joint pain, muscle pain and chills were not resolved.   It was unknown if the reporter considered the pain in arm, shivering, tiredness, joint pain, muscle pain and chills to be related to Shingrix.     It was unknown if the company considered the pain in arm, shivering, tiredness, joint pain, muscle pain and chills to be related to Shingrix.  Additional Information: GSK Receipt Date: 12-OCT-2023 The reporter was a patient that received his 2nd dose of Shingrix yesterday (from the reporting day), and reported that his arm was sore yesterday and was still sore today (on the day of reporting). The patient also reported this morning (on the day of reporting) 1 day after vaccination, he had chills, achy muscle pain, achy joints, was tired and shivering. The patient did not had any information about lot, expiry, or route of administration. The reporter consented to follow up.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. In or about 2008, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, vaccination site, lot # and expiry date were not specified) administered by a healthcare provider for the long-term prevention of herpes zoster or shingles. On an unknown date, the pt was treated at a physician's office for shingles or herpes zoster. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, he had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. The outcome of the event was not recovered. The event of shingles or herpes zoster was considered to be related to zoster vaccine live (ZOSTAVAX).
Information has been received from a physician concerning a female who on 25-MAY-2007 was vaccinated with the second dose of GARDASIL (Lot #657736/0389U). Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). On 25-MAY-2007 the patient fainted after receiving the vaccination. The patient recovered that day and plans to receive the third injection of the vaccine. Medical attention was sought. Additional information has been requested.
This spontaneous report as received from a Doctor of pharmacy refers to a 65 years old female patient. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) SC on approximately 15-SEP-2012, "2-3 days ago". No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that after receiving the ZOSTAVAX in September 2012, the patient experienced extreme swelling in her entire arm and no feeling in her forearm. The patient went to the emergency room. At the time of the report, the patient's outcome was unknown. Additional information has been requested.