chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/8/21 - received #1 Moderna vaccine in upper left arm.  It immediately caused intense pain throughout my upper arm.  By 5:30 pm, my arm felt like I was carrying a 15 pound dumbell in it.  I could barely move my arm.   3/9/21 - immediately noticed the whole upper arm was swollen with a lump.  I felt very fatigued throughout my whole body and my legs felt very heavy (could not go to work) 3/10/21 - very fatigued and my legs continued to feel heavy and lethargic.  I went to work but could not dance and sing like I typically do in class with my students.  I also noticed I could not lift up my left arm.  I also felt like my brain was very foggy.  I felt that I could have fallen asleep while driving to work and while driving home from work.  That evening I fell asleep at 7:00 pm standing up, leaning on a counter while waiting for my son to brush his teeth.  I have NEVER fallen asleep standing up in my life.  I had to go to bed at 7:30 pm due to extreme exhaustion. 3/11/21 - very fatigued and extreme leg pain.  My calves feel like there are knots twisting inside of them and as if they might explode from the inside out.  Still could not lift my arm high for more than a few seconds.  Could not sleep that night due to the severity of the leg pain. 3/12/21 - very fatigued and extreme leg pain continued and pain in both arms down into my forearms.   My calves feel like there are knots twisting inside of them and as if they might explode from the inside out.  Still could not lift my arm high for more than a few seconds.  I went to bed at 6:30 pm (not normal for me) due to extreme exhaustion and pain throughout my body.    I laid in bed for hours crying in pain until I got up to take Advil PM and finally fell asleep sometime after 11:00 pm. 3/13/21 - had to cancel my weekly class at the gym due to continued fatigue, pain throughout both arms and legs.  Unable to lift my arm long enough to brush hair and do a ponytail for my daughter.  My forearms had so much pain at night.   3/14/21 - could not go to the gym due to continued fatigue and pain throughout my muscles.  I can't lift my left arm to use a hair dryer.  My left arm has severe pain if I try to even hold my macbook in my left arm. This is horrific.  I am miserable and cannot yet function normally.
Administered first dose of GARDASIL - HPV vaccine to left deltoid. Patient immediately complained of pain and experienced syncope, nausea. Lasted approx. 2 mins then awoke, didn't remember event. B/P was low at 80/32 given fluids, rest. Felt better after 30 mins, left office - normal next day.
Having a hernia surgery 28Apr2022, two and half weeks from now, he got his first booster in October; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: HERNIA (medically significant), outcome "unknown", described as "Having a hernia surgery 28Apr2022, two and half weeks from now, he got his first booster in October". Is report related to a study or programme: Yes. Consumer wanted to get the booster shot, he was having surgery in a few weeks and wants to know if it is safe to get the second booster or does he need to wait until after surgery. Having a hernia surgery 28Apr2022, two and half weeks from now, he got his first booster in October, should he get the second booster now or after surgery.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant; death), outcome "fatal", described as "blood clots". The patient date of death was unknown. Reported cause of death: "blood clots".  Clinical course: why Pfizer have the covid-19 vaccine and Paxlovid which are approved under an EUA at the same time. When will the FDA-approved vaccine labeled as "Comirnaty" be available. Will the Pfizer-BioNTech COVID-19 Vaccine product distributed under an EUA still be useable since the FDA has approved for Comirnaty. why Pfizer have the covid-19 vaccine and Paxlovid which are approved under an EUA at the same time. Caller is consumer that is asking "How can Pfizer have 2 EUA approved products Paxlovid, and Pfizer COVID 19 vaccine, that treat the same thing at the same time is there a loop hole here". Reporter stated that his wife's grandfather died of blood clots from a COVID vaccine. Reporter mentioned that many Conspiracy Theories during call and frustration with the system. Transmitting A/E information. Is there any information on the study that states people who received the vaccine had restructured DNA in their liver or Kidney cells, Does the MRNA shot alter the DNA of those that have been given it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: blood clots
Chills; fever; body aches; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Jun2021 10:30 (Lot number: EW0185) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Peaches" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PHENTERMINE; TOPIRAMATE. Past drug history included: Levaquin, reaction(s): "known allergies: Levaquin"; Amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (dose number 1, product COVID 19, brand Pfizer, lot number EW0182, administration date 28May2021, administration time 10:15 AM, vaccine location Right arm), administration date: 28May2021, when the patient was 30 years old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 18Jun2021 21:00, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 18Jun2021 21:00, outcome "recovering", described as "fever"; PAIN (non-serious) with onset 18Jun2021 21:00, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 18Jun2021 21:00, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of chills, pyrexia, pain, headache.  No follow-up attempts are possible. No further information is expected.
Headache, nausea, 4/14.  0600. Lasted throughout the day  Fever, chills 4/14 6p.  Through the night till about 4a
Patient was given HIB that was reconstituted with sterile water instead of the packaged diluent.  Patient will have HIB repeated as soon as possible with correct diluent.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 009C21A and 009C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter. No treatment medication was reported by the reporter. This case was linked to MOD-2022-503162, MOD-2022-503133, MOD-2022-503157 (Patient Link).
Started having a headache on Tuesday afternoon, took migraine pill (excedrin) with minimal improvement.  Went out to dinner later that night and couldn't finish dinner d/t HA.  Describes head pressure, pain, and pounding sensation.  On Wednesday worked from home, felt like she was in a fog and continued to have pain/pressure in the back of her head.  Pt took a nasal decongestant which pt is unsure if made any better.  Thursday continued to have headache but improved compared to Tuesday and Wednesday.    Had taken benadryl at school which was somewhat helpful.  Saw PCP today via telemedicine visit. PCP prescribed steroid; had not started taking this because started feeling worse and came into the ED for this.     Earlier today, had worsened HA and felt like she was going to pass out (did not pass out).  She felt like her left hand was numb/pins/needles as her son was taking her BP; lasted for a few minutes.  Later, her right hand started feeling numb/pins/needles and had difficulty picking up objects.   57-year-old female  presented with a headache and found to have a subdural hematoma of unknown etiology.   Neurosurgery was consulted.   Patient was initiated on Keppra 500 mg b.i.d. for seizure prophylaxis. Serial CT scans were done  Which showed stable subdural hemorrhage.  Blood pressure was monitored during her stay but did not require any as needed medication.  Further imaging including MRI and MRV were performed to assess for aneurysm or venous malformation however nothing was seen.  Bleeding disorder workup was not performed. Neurology was consulted.  EEG was ordered to assess for seizure activity however this was negative.
Coughing and my throat was hurting, I was taking over the counter eye drops but I didn't have any fever.
Injection site erythema starting with 24 hrs of vaccination increasing in size over 4 days to 8.5 x 9 cm with tenderness and fixed nodule at injection site. Erythema is hot to the touch. Started BACTRIM DS on day 4. Resolved by day 8.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 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, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. 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 including 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. The outcome of the events was considered to be not recovered.
The day after receiving the vaccine and shortly after receiving his immunotherapy infusion, he began to experience back pain on left side and some abdominal pain. Pain increased in intensity slowly and after almost 48 hours, he needed to take a percoset to control pain. Shortly after that, he develped a rash on back from midline and wrapping around torso above waiset level to front midline. Went to oncologist office and nurse practitioner diagnosed it as shingles and prescribed acyclovir.  Has been taking that for 24 hours and pain in improving.
At moment of injection with Fluzone Inradermal 0.1ML a slight sensation of pain in left shoulder was felt, followed by raised or localize swelling at injection zone, followed by systemic sensation throughout body which is best described as cold sweat, disorientation, feeling of cold arms and legs, followed by uncontrolled shaking (i.e. as if low blood sugar).
pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore R arm; LOSS OF TASTE; partial throat swelling 90 min after 2nd injection; drowsy; This is a spontaneous report from a contactable health care professional.  A 48-years-old female received 2nd dose,  bnt162b2 (BNT162B2) Lot number= Lot EL3247 , intramuscular in right arm, on 29Jan2021 at 15:30 as a single dose for COVID-19 immunization .  Medical history included sjogren's syndrome, irritable bowel syndrome , raynaud's phenomenon, fibromyalgia , food allergy to peanuts, honey, oranges, strawberries, lobster, molasses, brown sugar, cinnamon. She had the  first dose of COVID-19 on 08Jan2021 at 1545 in the right arm.  There were no other vaccinations given in the past 4 weeks. She was not tested for Covid prior to vaccination.Concomitant medication included collagen (COLLAGEN), medium-chain triglycerides (MCT OIL [MEDIUM-CHAIN TRIGLYCERIDES]), ergocalciferol (VIT D), fish oil (FISH OIL).  The patient previously took gluten and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity. Course as follows: On 29Jan2021: partial throat swelling 90 min after 2nd injection. Took 50mg Benadryl. Became very drowsy and went to bed at 7:30pm. 30Jan2021: Woke at 5am w/chills, headache, body aches, sore R arm, temp of 101.3, dry mouth & LOSS OF TASTE. By 11:30am, fever went up to 103.5. Took 400mg ibuprofen. Went and got a Rapid Covid test (It was negative/undetectable). 4pm diarrhea. Took 400mg Ibuprofen at 6pm and 11:30pm. 31Jan2021: fever 100-101, headache, body aches, sore R-arm, diarrhea, loss of taste, sore throat. 01Feb2021: fever 99-100, headache, body aches, sore R-arm, dry mouth, loss of taste, sore throat. Went to get a 2nd Covid Rapid Test to r/o a false negative (It was negative/undetectable again). 02Feb2021: Fever 99-100, headache, dry mouth, loss of taste. 03Feb2021: temp normal, headache, dry mouth, loss of taste. 04Feb2021- 07Feb2021: temp normal, headache, dry mouth, weird continuous hot/cold flashes, pins & needles tingling all persist. Appt w/PCP scheduled for 17Feb2021. The patient was not hospitalized for the events. The patient was tested for Covid-19  on 01Feb2021 and was negative. The outcome of the events was recovering.
2 weeks post vaccine: Paresthesia (numbness and tingling) in feet and grew over whole body in 48 hours; weakness in legs - ER visit in April to rule-out Guillain-Barré and others. Started B12 - symptoms did not improve. Second ER visit in July after experience right-side, sudden onset weakness (leg, hip, arm), hard to walk and hold a fork. Tested for blood clots, none found. All tests have been unremarkable. Long-term symptoms: Loss of sensation over whole body. Numbness in feet/toes, tingling comes and goes. Fatigue for weeks at the time. Muscle fatigue intermittent (legs/arms), symptoms tend to be more severe on/around period.
Several hours after the shot was given patient had allergic reaction to the vaccine at home. Had swellings, red and itchy eyes. Went to a walk in clinica got steroid shot and collapsed and passed out after returning home from clinic and was taken to ER. Was discharged from hospital and was stable.
Syncopal espisodes, three consecutive  in a row, ambulance transport to ER for suspected seizure activity,  fever in ER, admitted to inpatient for 4 days.
pt recv vax 1JAN94 & JUN97 respectively;1AUG95 pt devel a cold which lasted for 6mo & lost one thrid of liver function;pt was hosp NOV95 & spent 7 wk there;pt MD said the cold was r/t vax;pt has been back in the hosp 3 or 4X since then;
Bell's Palsy.  10/26/09:  Primary care records received for date of service 9/30/09 to 10/5/09. Dx:  Headache post Flumist, Bell's Palsy.    Assessment:  Presented one week after Flumist with c/o flu-like symptoms and HA w/o rash, fever, vomiting, photophobia, neck stiffness, nasal bleeding or facial pressure.  Given IM Toradol without relief.  Prescribed Epidrin for HA. Two weeks post Flumist presents with R facial sagging.  VSS.  Alert and oriented in NAD, normal speech, sensation and reflexes. Prescribed Acyclovir.
Body aches; Fever of 102.9 (degree Fahrenheit); Joint pain; Chills; Nausea; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever of 102.9 (degree Fahrenheit)), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No prior medical history was reported).    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), PYREXIA (Fever of 102.9 (degree Fahrenheit)), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Extreme fatigue). At the time of the report, PAIN (Body aches), PYREXIA (Fever of 102.9 (degree Fahrenheit)), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Extreme fatigue) had resolved.            concomitant medications were not provided by the reporter.  Treatment medication include anti-nausea medication.  Action taken with m-RNA-123 is not applicable.
Headache  Fatigue  Blurry vision  Watering eye Cloudy judgment
Information has been received from a licensed practical nurse concerning a 22 year old female who on 24-APR-2007 and on approximately 18-JUN-2007 was IM vaccinated with a first and second 0.5 ml dose of Gardasil (lot# 657868/0523U), respectively. Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). On 18-JUN-2007,the patient experienced redness and a rash at the injection site. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. On 18-JUN-2007, the patient recovered. It was reported that there were no problems after she received the first dose. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a other health professional regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored M-M-R II, lot # K012473, expiration date- 26-AUG-2016 and lot # K011189, expiration date- 12-AUG-2016, (dose strength was unknown). No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Shoulder sore first 2 days. Second day low temp., headache, and some body ache.  Headache never stops, does not stop even after taking Tylenol. Feeling a bit drowsy, a bit off, almost confusing. 03/07 excruciating  forearm bone and muscle pain started. Both arms from elbow to wrist, started in the evening.  Pain was horrible, felt as if my bones were being crushed. Tylenol does not work to stop the pain. After one full week the pain is finally subsiding some.
This spontaneous report as received from a Licensed Vocational Nurse (LVN) refers to a patient of unknown age. In 2007 the patient was vaccinated with the first does of GARDASIL. In 2008 the patient was vaccinated with the second dose of GARDASIL. The patient received the first two doses of vaccine on time. on 08-OCT-2012 the patient was vaccinated with the third dose of GARDASIL in the office. No adverse effects reported. Additional information has been requested.
Moderna COVID-19 Vaccine, Bivalent EUA  COPY/PASTE of visit note with provider 11/08/22: Pt presents for evaluation of left upper arm swelling, blistering and redness, which he noticed the day after he received both his bivalent COVID booster and the flu shot in the left deltoid. He requested that the vaccines be given in the same arm so he would have one good arm as he is the caregiver for his 93-year old mom.   His arm felt sore within hours of the vaccine, but he did not examine the site. The following day, the soreness was worse and he observed redness, swelling, warmth and a large blister. He took no measures to treat this. The blistering resolved and now it looks like a burn. It feels like a burn. There is no deep pain or arm weakness. He has not experienced fever.or chills.
Staring in March I had non stop menstrual bleeding that made me feel like I was going to pass out. I have been put on birth control it has help to lessen the bleeding but I am still bleeding daily.
10-27-16 Yellow fever vaccine. 11-2-16 thru 11-3-16 back pain, soreness, joint pain. 11-9-16 aches and pain better (at work) but now has groin pain.
Pt vaccinated with DTP/OPV slept for 10 hrs after lst injection.
Patient stated a rash started to develop on day 8 after receiving the vaccination. It is tender to touch, warm, and itchy. Started getting headaches as well when the rash started. Overall, it is getting better. Patient notified healthcare staff of reaction at day 15 after receiving vaccination.
First night couldn't breathe and she took benadryl. Saturday left arm was itching and pain in right arm. Blood spot appeared on right arm. Had stomach cramps, called ER. Was told to medicate for symptoms she was having. Can't sleep but is tired.
Patient experienced syncope. Smelling salts utilized. Patient recovered and removed to lie on floor with feet elevated. He chatted calmly during a 30-minute recuperation before departing.
Slight rash on left arm at injection site 8 days after vaccination date. Rash became more red and has doubled in size after 24 hours. No itchiness, pain, or other symptoms.
Puffyness on upper right chest one day after. Subsided in a day and then a slight painful (like a sunburn feeing) point which seemed to be on a lymph node site near collar bone for a couple days. Then on the seventh day, redness and swelling on upper chest in same area. Got worse for two days then began to get better. Spot grew initially but then stopped growing. Slightly itchy, slightly painful, and very warm on second day.