chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Haven't felt right since this shot. Was ill with muscle pain and low fever for nearly a week after. It's now been nearly 2 months and I have had very strange nerve pain throughout my body. They are sharp, burning pain. They occur out of nowhere. They will follow a nerve wherever they occur: my scalp, arms, legs, across the trunk of my body, groin, hands, face, etc. VERY WEIRD and uncomfortable. They vary in intensity. And, I've never had anything like this before the SHINGRIX shot. Also, there was swelling and a rash at the injection site that lasted for 2 weeks. Much longer than any reaction I've had before (usually from a flu shot which can last 5-6 days). I am still experiencing sharp pain at the injection site ...nearly 2 months later. The fever varied but was not over 100. Fever was recurring over a full week after the injection. The reaction has been severe enough, and not getting any better, that I am now afraid of taking the 2nd shot - and I am not a person who is adverse to immunizations or queasy about shots.
Rash at site of MMR. DTAP - 1cm erythema. Maculo-papular rash on lower extremeties (B). Min on trunk. No resp or ENT sysmptoms.
Severe swelling; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "Severe swelling". It was unknown if therapeutic measures were taken as a result of swelling.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Pain right upper shoulder to upper arm just above elbow since 1430 today.  Given shingles injection at 1300 today same arm; bandaid noted to right shoulder.  Pain worse with movement.  Took Ibuprofen 800 mg at 1530 with no relief.  She was given oral Decadron in the ED. Patient is encouraged to take prednisone daily to help with inflammation.  Norco for severe pain.  Should not drive or drink alcohol with this.  Ice to the affected area 20 minutes 3-4 times daily.  Gentle massage and range of motion as tolerated.  If symptoms not improving recommend she follow-up with orthopedics.  Return here with any new or worsening symptoms including redness or fevers.
Pt reported muscle pain and cramps that come and go every once in a while duration of 15 minutes. Event started after second dose of Moderna and continued thereafter.
Fever, chills, night sweats, fatigue 5 p.m. next day after injection
Expired doses administered to 13 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. It was unknown if the patient experienced any symptoms.  No treatment medication was provided.
PAIN IN THE NECK; BACK PAIN; TROUBLE IN RAISING HER ARM; DAILY LIVING ACTIVITY AFFECTED; SWELLING ON THE LEFT ARM; SWELLING ON THE LEFT SHOULDER; REDNESS ON THE LEFT SHOULDER AND ARM; PAIN IN LEFT SHOULDER; PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included egg allergy, antibiotic medication allergy, non smoker, and abstains from alcohol. The patient was not pregnant at the time of report. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031 and expiry: 26/MAY/2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, the subject experienced pain in the neck. On 22-MAR-2021, the subject experienced back pain. On 22-MAR-2021, the subject experienced trouble in raising her arm. On 22-MAR-2021, the subject experienced daily living activity affected. On 22-MAR-2021, the subject experienced swelling on the left arm. On 22-MAR-2021, the subject experienced swelling on the left shoulder. On 22-MAR-2021, the subject experienced redness on the left shoulder and arm. On 22-MAR-2021, the subject experienced pain in left shoulder. On 22-MAR-2021, the subject experienced pain in left arm. On APR-2021, Laboratory data included: Clot blood (NR: not provided) Negative. Treatment medications (dates unspecified) included: codeine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling on the left arm, swelling on the left shoulder, and redness on the left shoulder and arm on MAY-2021, was recovering from pain in left arm, pain in left shoulder, pain in the neck, and back pain, and the outcome of daily living activity affected and trouble in raising her arm was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
This spontaneous report as received from a other health professional  refers to a patient of unknown age and gender. On 01-AUG-2017,  the patient was inadvertently vaccinated with an expired dose of M-M-R II, human serum albumin (HSA), lot number M001200, expiration date 28-AUG-2016, for prophylaxis. No adverse effects were reported.
Massive headache pain. Taking the maximum amount of Aleve each day. Nauseated and no appetite.  Force myself to eat and feel bloated and gastrointestinal pain. Constopation. Sore throat. Drinking herbal tea to soothe my throat and additional water and clear broth. I have had a flu shot for years and never had a reaction. This is so severe I am not sure I will ever get another one again.
developed A-fib after booster; This is a spontaneous report received from contactable reporter(s) (Physician).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number (booster), single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer- Unknown, Dose 1), for COVID-19 immunization; Covid-19 vaccine (Manufacturer- Unknown, Dose 2), for COVID-19 immunization.  The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "developed A-fib after booster".  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
arms hurt worse; every muscle aches; This is a spontaneous report from a contactable consumer (patient's mother).   A 30-year-old patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 28Apr2021 (at the age of 30-year-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunisation and experienced arm hurt, head feels swooshy and ears were clogged up. On an unspecified date in 2021, after receiving second dose, patient experienced arms hurt worse and every muscle aches. it was reported that Caller proceeded to share AE information regarding herself, her son, and her girlfriend. She said her "son's arm hurt, of course, and it was really weird. A day or two later her son said my head feels swooshy and his ears were clogged up. We thought it was water in his ears. Her girlfriend experienced the same thing".  After the second dose, she reported that "our arms hurt worse". Her son told her "every muscle aches". He went on a walk with a friend and "felt 100% better". Caller shared she was told by the vaccine nurse to "overly hydrate herself. I got body armor and drank one before and one after. I took a couple doses of Tylenol and felt better". Caller also shared that she doesn't drive because she has narcolepsy. Son is male, 30 years. Girlfriend is female, age not asked. Response received as Spoke from the attached FAQ document: The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone. (2)The Centers for Disease Control and Prevention (CDC) states that information about the characteristics of these variants is rapidly emerging. Scientists are working to learn more about how easily they spread, whether they could cause more severe illness, and whether currently authorized vaccines will protect people against them: This variant was first detected in Mar2021. It was initially identified in Dec2020. So far, studies suggest that the current authorized vaccines work on the circulating variants. Scientists will continue to study these and other variants. Outcome of the events were unknown.  Information about Lot/batch number has been requested.
Pt. states that after receiving the 3rd dose of Phizer 01/18/2022, started experiencing symptoms that evening of (Right) arm Lymphnoid swelling, headache, and chills (Lasting 24hrs). No noted Primary visit/communications.
Exagerates Local reaction with erythema, induration Also arthralgia, fever. symptoms of Fever, arthralgia resulted 11/5. Arm pain much better and still improving 11/8/07
unconscious on the floor; seizure; This is a spontaneous report from a contactable other HCP (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 07Jan2021 09:00 (Batch/Lot Number: EL3249), dose 2 on 03Feb2021 09:00 (Batch/Lot Number: EL9261); both intramuscular, administered in Arm Left as single dose for covid-19 immunisation. Medical history included Graves Disease from 1997, type II diabetic, allergy to gadolineum. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin; sitagliptin phosphate (JANUVIA); sertraline hydrochloride (ZOLOFT); levothyroxine; magnesium; calcium; colecalciferol (VIT D3); curcuma longa (TURMERIC); atorvastatin calcium (LIPITOR); lisinopril. On the morning of 28Jan2021, the patient's grandson found her unconscious on the floor. She had a seizure and spent 3 days in the hospital. On 11Apr2021 during the night she had another seizure and spent 3 more days in the hospital. After 2nd seizure and hospital stay, the patient was put on anti-seizure medication. The patient underwent lab tests and procedures which included Nasal Swab (Covid test): negative on 02Jul2021. The patient recovered from the events. The case was serious as resulted in hospitalization.; Sender's Comments:  Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events unconsciousness and seizure cannot be excluded but also consider patient medical history of graves and DM2 as a contributory role. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
2 inch red, warm, itchy, painful rash like spot grew to 5 inches in diameter, started 4 AM Saturday 2/1/14. Treated with Cephalexin from CC. Rash went back down to 2 inches.
Started feeling feverish and chills. Fever continued to reach 102.6 until about 6:00am the next day. Migraine followed, along with some slight nausea, keeping me bedridden until about 2:00pm
Strong muscle cramps/spasms in stomach and upper abdomen, primarily on left side. Mild nausea
Fever of 103.3, chills, shakes, body pain, headache that lasted three days. On the 12th of april, itching over all of body. Doctor treated with Hydroxyzine.
he had a sore arm for a couple of days after the first Pfizer Covid 19 injection.; This is a spontaneous report from a contactable consumer (other non-HCP) who reported for friend. A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration, on an unspecified date (age at the time of vaccination was 62-year-old) as a single dose for COVID-19 immunization. Medical history included chronic ankle pain from a boating accident in Aug2010. Concomitant medication included Oxycodone. The patient had no known allergies. The patient had no other vaccines in 4 weeks. The patient was not tested for COVID prior to vaccination but was tested for COVID post the vaccination. On 07Apr2021, the patient experienced he had a sore arm for a couple of days after the first Pfizer COVID 19 injection. No treatment was received for the event. The patient underwent lab and medical procedure of SARS-CoV-2 test on an unspecified date, with negative result. The clinical outcome of the event was recovered on an unspecified date.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
This spontaneous report as received from a health worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (route, dose and lot # were unknown). On an unknown date the patient experienced a rash at the injection site. The outcome of the event was unknown. Additional information has been requested.
Patient was vaccinated with vaccine that had expired 2 days prior.  Per Pfizer the vaccine was stable and does not need to be repeated.
This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received PREVNAR 13 at the physician's office via intra-articular (injected into the left shoulder joint) on 10Oct2017 as pneumonia vaccine. Medical history included cataract. He stated no other medical conditions but that he will be having cataract surgery next month. There were no concomitant medications. The patient previously took cortisone injections in his shoulder joint. The patient experienced vaccine administered in the shoulder joint on 10Oct2017 and the next day he saw his orthopedic specialist on 11Oct2017. The patient knew that the injection was not going into the correct place because he had received cortisone injections in his shoulder joint before and he knew it was too high for the vaccine site in the muscle. He stated that this condition was called SIRVA and there was a federal fund set up for claims about this injury. He commented that people have had shoulder replacements due to this. He reported that the injector should have been seated instead of standing when injecting him with the vaccine. He stated that the orthopedic physician confirmed that the vaccine was administered into the left shoulder joint because he could still see the injection site. He experienced a stiffness shoulder and could not move his arm for a week. His orthopedist gave him a cortisone injection for treatment and he was unsure of the dose. It did allow him to move his shoulder again but he still experiences some shoulder and arm pain with movement of his arm. He now had complete movement of his arm, but with pain. He did not have any testing related to the event. He did have a routine physical the day of the injections and routine labwork to include a CBC, lipid panel, and HCV antibody testing that were all normal. The patient just had a shingles vaccine on 14Feb2018 in his right arm. Outcome of the event of could not move his arm was recovered on an unspecified date, for the events of shoulder and arm pain was not recovered, while unknown for the other events. The information on the batch number had been requested.
0900-Patient reported itching to site about 5 minutes after injection to right arm. MA reported reaction to nurse. RN noted redness and hives, reported to provider, PA. Patient denied any trouble breathing and reported itching to site only. At 0910 Benadryl 25mg given IM to right ventro-gluteal per PA's verbal order. Patient monitored post injection x 30 minutes. At 0940 patient verbalized no itching to site, redness decreased to site. Patient d/c per PA, stable at time of d/c.
Dizzy spells. Feels like I have motion sickness in my head. Blurred vision. Overall loopy feeling. It started with waking up and turning over in bed and it felt like I was getting the spins. Now I regularly have the dizzy spells throughout the day. Sometimes they last for a few minutes or a few seconds.  EXTREME brain fog! Simple tasks that I perform routinely for work take me days versus minutes. I can seem to get the dots to connect. Feel like I am stupid, completely brain dead at times. It started with just feeling a bit out of sorts and in most cases, it is debilitating preventing me from meeting work deadlines and function normally in day to day tasks. I am physically and mentally drained.
Headache, among other symptoms, began the day after the 1st shot.  After 6 weeks (second shot after 4 weeks) the headache has not stopped.   Doctor has now placed me on 6-day regimen of Prednisone.
This spontaneous report was received from a currently 67 year old female patient of unknown age. The patient's concurrent conditions included high blood pressure. She reported that on an unspecified date in approximately 2004 (reported as when she was 55), she had her first shingles outbreak on her lower back, then on an unspecified date in approximately 2008 (reported as when she was 59) her shingles virus progressed to the point where "she felt like 1 thousand mosquitoes had stung all at once" and experienced extreme itching at which point she met with a physician who was against getting the ZOSTAVAX vaccine until he saw how bad her shingles were. On an unspecified date,  the patient was vaccinated with the first dose of ZOSTAVAX via subcutaneous, for prevention of herpes zoster (Strength, dose, lot # and expiration date were not reported). The patient's concomitant medications included an unspecified blood pressure medication. After getting the vaccination she experienced relief instantly. But she stated that after a couple of years on an unspecified date, started to get herpes zoster outbreaks (vaccination failure and herpes zoster) "here and there". She described the outbreaks as "small and pea sized bumps" with "no itch as all". She then started to get these outbreaks more and more but they were still small and pea sized bumps. On an unspecified date in approximately 2014 (reported as at the age of 65), the patient was vaccinated with the second dose of ZOSTAVAX via subcutaneous route, for prevention of shingles (Strength, dose, lot # and expiration date were not reported). The patient reported that it helped as much as the first time she "got the shot". At the time of this report she was still experiencing small outbreaks once to twice a year but referred at them as "barely nothing compared to what she had before getting ZOSTAVAX". No treatment was given for the events and no lab diagnostics studies were performed to the patient. The outcome of vaccination failure and herpes zoster was reported as not recovered. The reporter did not provide the causality between the events and ZOSTAVAX. Upon internal review, the event vaccination failure was determined to be medically significant. Additional information has been requested.
Patient presented to the ED and was subsequently admitted to the hospital on 3/6/21; within 6 weeks of receiving COVID vaccination.
Pt was given influenza add HPV9 on 11/17/2022, approx 10 minutes later pt complained of itchiness, tingling and tightening sensation in her throat. Pt was brought back into the clinic and placed on a pulse ox; reading was 100 on room air, Hr was 99. Pt then stated that she felt light headed and has abdominal cramps. At this time I gave 50mg of diphenhydramine. Dr. was consulted and he recommend that I administer a EPI pen. Pt was then evaluated by the EMT and transported to the ER.
Pt was given booster,  .25cc of Moderna, and he is 13 years of age. Pt was monitored for 30 minutes.  Pt did not experince any adverse event or reaction  from receiving the vaccine. Pt's Mother  was informed of the error. Pt was monitored for 30 mintuse
Pts R arm swelled up to the size of a half dollar the first day of injection, two days later on 6/15/12 pts had swelling the size of a baseball. No other symptoms noted. Pt in no distress. Pt was was advised to ice the area, take ibuprofen scheduled 3 times a day for the next two days as well as take Zyrtec 10mg once daily x3 days.
Rash on the left arm; Large red area; very warm almost hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the left arm), INJECTION SITE ERYTHEMA (Large red area) and INJECTION SITE WARMTH (very warm almost hot to touch) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced RASH (Rash on the left arm), INJECTION SITE ERYTHEMA (Large red area) and INJECTION SITE WARMTH (very warm almost hot to touch). At the time of the report, RASH (Rash on the left arm), INJECTION SITE ERYTHEMA (Large red area) and INJECTION SITE WARMTH (very warm almost hot to touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: No specific follow-up information recorded.
6-8 hours after immunizations, increased pain right arm. Most arm red and swollen; presented to MD at 24 hours with large indurated area.
Headache, Myalgia & NauseaVomiting Narrative:  Other Relevant History: