chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back pain; Joint pain; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included ongoing back problems. The patient's concomitant medications were not reported. The patient experienced back pain and joint pain on an unspecified date. Outcome of events was unknown.    Information on the lot/batch number has been requested.
3hr p/vax pt started to cry incessantly for approx 11hr;mom stated that pt awakened 3AM 19JUL97 & had inc fever 106.6;also irritable;gave APAP w/Ibuprofen & was better that morning 19JUL97;no more extreme fussiness since the incessant cryin
Started Tuesday evening with light headed, dizziness, headache, in the early morning hours pt said she felt as if her right side was going numb & asked to go to the hospital. Later in the afternoon she got worse along with bad chest pain & stomach & started vomitting
No date or time onset for adverse reaction. Under-dose possible second dose was given. Vaccination error.
Immediately after providing the second vaccine which was the Fluarix Quad the patient fainted. They just slide down in the chair. They regained consciousness within a few seconds.
pt recvd vax 21APR93 & following vax pt exp sore arm, h/a, & vomiting; pt recovered; No further details were provided;
Pressure headaches; Eye pressure pain; Eye pressure pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An 81 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer", start date: 2020, stop date: Nov2020, notes: cancer free since November of 2020.; "Chemotherapy", start date: 2020 (unspecified if ongoing); "Radiation", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEAD DISCOMFORT (non-serious), outcome "unknown", described as "Pressure headaches"; OCULAR DISCOMFORT (non-serious), EYE PAIN (non-serious), outcome "unknown" and all described as "Eye pressure pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8/13/18 awoke 8/13/18 with complaints temp 99.6 and neck pain. No other complaints following administration of N/V - Advised not typical 4D following immunization to F/U with MD to be seen same day. 8/27/18 - LM for parent to call for F/U. 8/30/18 - mother stated - Patient ended up with body aches also - all symptoms lasted 4D and resolved with ADVIL.
Pt c/o "I have to take deep breaths in order to breathe" 14 mins after receiving the first dose of the vaccine. She denied any other symptoms or past med hx. She was assessed and monitored by NP, EMT, and paramedic. BP - 115/80, HR - 75, O2 sat - 97% on R.
About 2-3 days after receiving the shingles vaccine, I experienced some symptoms similar to a low grade flu. I was tired, weak and had aches for approximately two weeks.  I did not have any symptoms of respiratory congestion, cough or stuffy, runny nose. Two weeks prior to the shingles vaccine I had a flu vaccination.  No adverse symptoms to the flu vaccination.
Patient received vaccine at College of Pharmacy/College of Nursing Flu shot clinic event. The event was under the protocol of the Hospital flu vaccination project. Vaccine administered by pharmacy student on 10/24/08 - about 1 PM. About a week later, the patient talked to me about the symptoms. These are his exact words:  "I had a slight ache around the injection site for a few days but the symptoms really started to bother me about 5-6 days after the shot. it seems to have gotten a little better but over the last two days I haven't had any improvement. I just have a constant dull ache in my shoulder basically all the time. I feel like it might be nerve related but I also have muscle soreness so I don't know." This was received by me 11-7-08, after I asked for permission to release his name and condition. This was actually the second case that had been described to me - so I thought it was time for a VAERS - the side effects somewhat different than  the usual "sore arm". I suggested patient see his doctor or student health.
A patient received the 2nd booster from a vial that had been open for more than 12 hours.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received the 2nd booster from a vial that had been open for more than 12 hours.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received the 2nd booster from a vial that had been open for more than 12 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received the 2nd booster from a vial that had been open for more than 12 hours.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. The vial was initially stored in the refrigerator 2May 2022, the vial was first punctured 3 may 2022 at 11:00 am and at time of administration of vaccine was 4 may 2022, around 9 am. The vial stored post puncture was in Room temperature. Vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8 to 25 degree Celsius 46° to 77°F) was for 22 hours. No Adverse event were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: Follow-up received contain no significant information
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L015460 with expiration date 20-JUL-2017, lot # M002268 with expiration date 20-SEP-2017 and lot # reported as M022924 with expiration date 24-JAN-2018; dose and route were not reported). The vaccines were stored in 50.3F for 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Admitted to ICU with high fever protracted vomiting. Found to have MRSA peritonitis. PD cath removed and pt placed on HD, tolerating well.   11/20/09 Medical records received for DOS 10/8-10/28. Final DX; MRSA peritonitis/sepsis/bacteremia associated with peritoneal dialysis  C/O fever and chills. Vomiting, abd pain, Hypotension, anorexia, weakness. Peritoneal catheter infection. Cloudy fluid. +MRSA cx.
t/c from nany of client who states noted pt limping on lt leg & @ sit eof bioject reddness p/20hr of vax;no fever occured & pain limping resolved that afternoon of 20MAY96;
This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter made a general statement regarding adverse events seen with Bexsero and stated she regularly sees a sore arm following a patient receiving a dose of Bexsero. The reporter denied consent to follow up.
This patient is the spouse of a patient who received smallpox immunization. She presented with lesion on her right elbow. This lesion was sent for viral culture/PCR and came back positive for vaccinia. She was given dx of accidental inoculation with vaccinia virus.
Dizziness; Sleep excessive; Depressed Mood; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HYPERSOMNIA (Sleep excessive), DEPRESSED MOOD (Depressed Mood) and HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced DIZZINESS (Dizziness), HYPERSOMNIA (Sleep excessive), DEPRESSED MOOD (Depressed Mood) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), HYPERSOMNIA (Sleep excessive), DEPRESSED MOOD (Depressed Mood) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.
Parent called on 9-27-16 to report that on 9-23-16 patient started having diarrhea. He ran a low temp (101.0F) for the first two days, then a "small bumpy rash" appeared, starting on his head and face then descending to torso and linear. Rash was not itchy. Mom administered TYLENOL for the temp. The diarrhea continued throughout though he never vomited and was able to continue fluids. Mom took to ER for the diarrhea on 9-27-16. F/U call update from mom says ER Doc said rash not due to vaccines and as long as he was taking fluids to take him home. Symptoms disappeared by 9/29/2016.
Severe pain up and down left arm, sometimes moving into shoulderblades and back. Severe pain when moving arm in any direction. Pain wakes me when I move while sleeping.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm from the first two doses) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination. No Medical History information was reported.On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm from the first two doses). At the time of the report, PAIN IN EXTREMITY (sore arm from the first two doses) outcome was unknown. Concomitant medications were not provided.Treatment information was not provided. This case was linked to MOD-2021-400075, MOD-2021-400085, MOD-2021-400025, MOD-2021-400075 (Patient Link).
Inability to "recall how to walk" and needed standby assistance; followed by onset of significant edema (more than pitting 2) of legs/feet; significant elevation in blood pressure, drop in oxygen saturation; required emergency hospitalization in cardiac unit for acute heart failure
Vial was punctured and used beyond the 12 hour; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was punctured and used beyond the 12 hour) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was punctured and used beyond the 12 hour). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was punctured and used beyond the 12 hour) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Tinnitus-Severe, Systemic: Vomiting-Severe, Additional Details: EMS was called. EMS arrived on scene in under 5 minutes. BP was too low for EMS to get a clear reading. He may have lost consciousness briefly. He was much better and talking when they left to take him to the hospital. Still very dazed and confused. Spoke with family member later in the day and he was able to go home the same day.
Patient received vaccine (FLUARIX quadrivalent) in left deltoid and in less than 5 minutes, developed hives to forehead, chest and arm. Became itchy and developed swelling and redness at injection site. Treated with 0.3 ml epinephrine which began to resolve symptoms. Pt transported to Urgent Care for MD follow up. Had previously had flu vaccine each year without incident.
Menomune administered on 7/1/03. Pt developed area of redness and tenderness by 7/2/03. Area firm and warm, but not indurated. Already on Augmentin 875 BID for infected cyst behind right ear, which was begun on 7/1/03. Pt applying ice and taking 600-800 mg ibuprofen. Area 4 cm in circumference.
Information has been received from a health professional concerning an 11 year old white male, with no medical history and no allergies, who on 9/18/95 was vaccinated with 1, 0.5ml SC dose in the left arm of varicella virus vaccine live (lot # 608588/0415B). Concomitant vaccine administered on the same day included a dose in the right arm of MMR (lot # 615324/0620B). There was no illness at the time of vaccination and no adverse events following prior vaccination. On 10/10/05, the patient presented with a vesicular rash of about 40 lesions. The patient was being treated with over the counter diphenhydramine hydrochloride. At the time of the report, the patient was recovering. The patient was to follow up with a nurse practitioner. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that on 10/9/05, the patient was afebrile and a rash started with 30-40 scattered papules and vesicles. Treatment included diphenhydramine hydrochloride and avena. It was reported that the patient recovered. Additional information is not expected.
Pt reports hives, swollen arm and allergic reaction post vaccination. Reported 28 days after vaccination.
After both doses of the Moderna vaccine, about 2-3 minutes post-injection, I noticed a metallic taste in my mouth for about 2 seconds.  The taste was there just long enough for me to notice the metallic taste and then it was gone.  I had no other adverse reactions to the vaccine.  I did have the muscle aches and fatigue that been documented as common side effects post-vaccination but those eased after about 36 hours. I searched online for "metallic taste" but was unable to find any information as to whether this is an expected side effect, hence my reporting it now.
patient received doses from an expire vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received doses from an expire vial) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperglycemia since 31-May-2018, Hypercholesterolemia since 31-May-2018 and Hypertension since 11-Jun-2009.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received doses from an expire vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received doses from an expire vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has a current condition og Benign hyperstension. Patient had no known allergies. Concomitant medication and treatment drug were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant Follow-up added as case change from invalid to valid, patients demographics added and all current condition added. Action taken updated from unknown to not applicable.
Developed pain redness and swelling at injection site. Increased in size to about 8 inches circular, Warm to touch.
nausea and headache on and off; nausea and headache on and off; nagging headache; Increased Morning blood pressure 147 to 150mmHg; nausea; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (nausea), HEADACHE (nagging headache), NAUSEA (nausea and headache on and off) and HEADACHE (nausea and headache on and off) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (oesophageal).    The patient's past medical history included Aortic aneurysm enlargement and Liver transplant (post liver transplant 15yrs ago medications used during liver transplant- cyclosporine 125mg daily Ursidiol). Concurrent medical conditions included Hypertension (Drugs for HBP-Metoprolol, Losartan,,Amlodipine taking). Concomitant products included METOPROLOL, LOSARTAN and AMLODIPINE for Hypertension, CYCLOSPORINE and URSODIOL for Liver transplant.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) (unknown route) at an unspecified dose. On 08-Jan-2021, the patient experienced NAUSEA (nausea). On 09-Jan-2021, the patient experienced HEADACHE (nagging headache). On 10-Jan-2021, the patient experienced NAUSEA (nausea and headache on and off) and HEADACHE (nausea and headache on and off). At the time of the report, NAUSEA (nausea), HEADACHE (nagging headache), NAUSEA (nausea and headache on and off) and HEADACHE (nausea and headache on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Several hours after dose was given patient began with chills ,fever, extreme aches and pains.  Patient was able to rest the remainder of the day.  I told her husband that she could be given extra strength tylenol and continue with fluids
Pt. came to our office (we are PCP) due to concern about discoloration and dry skin at site of zoster vaccine.
Brain fog approximately one hour post vaccine. Approximately 4 hours after the vaccine, chills started, approximately one hour after chills (5PM) temperature began to rise. After taking temperature, it was 103.8 degrees Fahrenheit. Took tylenol to attempt to lower temperature, however it did not minimize temperature significantly. In addition to the fever, the onset of intense migraine and severe dizziness occured. Took a second dose of tylenol and the temperature did not reduce- and raised to 104.9 degrees fahrenheit. I was unable to sleep the night the vaccine was administered as my head was throbbing and spinning so intensely. I may have had an increased  heart rate- which likely prevented my body from being able to settle, despite other side effects. I also had loss of appetite due to fever, and was able to eat normally until approximately 2 days after the vaccine. The fever broke approximately 24 hours later, however fatigue set in afterwards and lasted through the following week (felt mostly normal the Thursday after receiving the shot 3/18/2021).
Patient started to have slight pain about 10 minutes after the injection prior to leaving the pharmacy.  Daughter called on Monday saying that the Sunday after the injection, she had a large area (2x3 inches) come up at the site and it was very painful.  She said it was very warm to the touch and the area stayed that way for a few days before contacting the pharmacy.  The area had started to get smaller with yellowing around the base of the red perimeter.  Patient had been placing cold packs on the area to help with swelling and redness.  Daughter contacted pharmacy on Thursday and advised to take Tylenol for the pain and try Benadryl for a few doses to help with any allergic reaction symptoms.  She was advised to take her to the doctor if it didn't subside but that with the yellowing of the skin, it may be a bruising under the skin from the injection.  Patient was called on March 5 and area was no longer red and swollen and the size was down to a pinpoint area.  Patient voiced no other complaints.
Left work early because  Chills, sweating Fever, Headache, Muscle and body aches, Fatigue, Shortness of breath, Fast heartbeat, Blood pressure 150/86/98 at 4:10pm on April 11.  Cyclobenzaprine 10mg at 5pm and slept under multiple blankets because I was cold and sweating.  Woke up the next day fine just a sore arm.
BODY ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered on 12-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, fever and body aches was not reported. This report was non-serious.
I felt ill with a runny nose, fatigue, I did throw up once. Mostly achiness. COVID-19 test was positive. Most symptoms lasted 4-5 days but fatigue lasted quite a while.