chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Registered Nurse referring to a 6 month old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 02-APR-2018, the patients was vaccinated with an improperly stored dose of ROTATEQ per oral (Strength, dose, frequency, and anatomical location were unknown), with lot # N013992 and expiration date 27-JAN-2019 for prophylaxis. The administered doses of the vaccines experienced the temperature excursion of 9°C to 25°C Celsius degrees for 1 hour. There was a digital data logger involved, but there was no previous temperature excursion, and no adverse effects were reported.
Pfizer-BioNTech COVID-19 vaccine: Vaccine recipient received 3rd dose in the morning and went to work. She reported she felt tired during work. The next morning she woke up and did not feel good. She reported feeling lightheaded, nauseous and chills. She did not go to work. She took aspirin for a headache. She then notice that she developed lip and eye swelling (angioedema). She  went to the ED. In the ED they administered epinephrine, diphenhydramine and steroids. She was discharged to home. The next day the swelling had gone down and improved. She has reported taking aspirin in the past with no issues.
Patient presented to ED and was subsequently hospitalized twice within 6 weeks of receiving COVID vaccination. The first ED visit was 3/16/21, the second time was 4/1/21. She was also admitted to the hospital on 4/11/21.
shoulder deltoid pain/Shoulder joint pain anterior and posterior; pain sometimes is in the upper arm muscles/radiates to the lower arm muscle; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 7557J, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknwon date).   On 9th October 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shoulder pain and muscle pain. On an unknown date, the outcome of the shoulder pain and muscle pain were unknown.   It was unknown if the reporter considered the shoulder pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: Pharmacist reported that after receiving the dose of Shingrix patient experienced worsening left shoulder deltoid pain and has been working on range of motion exercises. The pain sometimes was in the upper arm muscles, occasionally radiates to the lower arm muscles and sometimes was around the shoulder joint anterior greater than posterior. It was stated that the pain got worse a couple weeks after the vaccination and fluctuated. The patient did not have any sign of mass/abscess palpable or inflammation at site. Pharmacist did not have the expiration date of this dose.  The reporter consented to follow up.
RA-> LA, (R) groin-> (L) groin, (R) ankle-> (L) ankle. Rash developed at sites in order listed above over 2-3 day period-took approximately 2 weeks ro resolve.
Parents report after that series of vaccines, child starting showing behavioral changes (not engaging with parents, isolating himself to play). Also reported GI symptoms that have persisted.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 3:25 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported. Patient received vaccine which was stored in an ultra-cold freezer at minus 82 degrees Fahrenheit.   This case was linked to MOD-2021-402935 (Patient Link).
Patient reported fever of 101.6, severe pain, redness at injection site, swelling of entire deltoid, stiffness of neck, difficulty swallowing/swollen throat, body aches/chills starting 1:30 AM 10/28/2010. Patient reports fever broke by 6 am. Patient saw her PCP 10/28 and was also diagnosed with a "bad case of bronchitis". Patient received cortisone shot and was given a prescription for a Z-pak.
Patient's father arrived here at county health department for a appointment. He did not have his son with him. Instead the father had a prescription written by the doctor stating child could not leave home. Father explained that at 1 AM on 12/12/04, the child had to be taken to the ER due to seizure activity. Father says patient was noted to have a fever. Father continued to say child was transported to hospital with fever of 107.8. Once the child arrived at the hospital, he was placed on life support by the neurologist taking care of the patient. Patient was then removed from life support after a while and is now breathing on his own. Father states child's brain damage is severe and child is comatose and doesn't respond to any stimuli. Father says last EEG was flat; patient's BP stays low, he is fed via G-tube and receives 12 different medications via G-tube also. Patient must be suctioned every 2-3 hours. Doctor is patient's local pediatrician. Father states either doctor give them much hope but he feels son will win this battle and walk again. Father states he questioned both doctors about whether or not the immunizations the child received on 12/8/04 could have caused this episode. Father states both doctors say, "No, the child's problem was not due to the shots he received." This is the first time the father reported this to us and when asked why, he stated, "I have just been so busy with his care I didn't think about it." 60 Day follow up: father refuses to discuss the case. Per follow up report-Primary pediatrician states patients problems were not due to vaccinations. Medical doctor states patient originaly came to ER with a cough, cold, runny nose symptoms. While in ER temp rose to 107F. Child had several massive convulsions, stopped breathing 2 times. Patient had to much oxygen loss to his brain during decreased breathing episodes. Patient has a diagnosis of severe brain damage. He also has a seizure disorder. He has many other problems-he has trach and permanent G-tube. He is a total care, bed ridden patient now.
This case was reported by a nurse and described the occurrence of limb swelling in a 5 year old male who received DTAP (Infanrix) for prophylaxis. On 07/09/03 the pt received the fifth dose of Infanrix. Within 24 hours post-immunization on 07/10/03, the pt experienced a "more than usual reaction" characterized by a "large amount" of swelling extending from shoulder to elbow, redness, and warmth. The pt was seen by the physician. The events resolved after an unspecified period of time. The nurse considered the events to be possibly related to vaccination with Infanrix.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities and influenza-like symptoms. On an unknown date, the outcome of the erythema of extremities was unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the erythema of extremities and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The caller stated one of her friends received SHINGRIX vaccine on left arm around the end of December 2018. The patient experienced a red band around and underneath the arm. The patient also experienced flu like symptoms which lasted for about 2 days. The patient does not know if the red band had resolved for her friend. No further details were provided. The caller calling in adverse event for herself and her friend. This case has been linked with US2019013718, reported by same reporter.
rash around the injection site; This case was reported by a consumer via call center representative and described the occurrence of rash in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 27th January 2020, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: On monday, the patient noticed a rash around the injection site. The patient consented to follow up.
This spontaneous report as received from a 72 year old female patient refers to herself. The patient had drug reactions / allergies for Penicillin. The patient had a prior history of shingles in approximately 2000 (reported as "between 12 to 14 years ago"). On 18-DEC-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency and route unknown). There was no concomitant medication. After few days a receiving ZOSTAVAX, on 22-DEC-2014 the patient experienced severe vertigo. The patient also experienced a very mild irritation ("C" shaped non-raised, red patch) on the area of her hip, where she had shingles around 14 years ago. She also reported that "her glands were swollen" before she took back to back airline flights on 23-DEC-2014 and 27-DEC-2014 respectively as well. The patient sought to medical attention to explain she had vertigo by calling. Her physician recommended the patient took an unspecified decongestant for the events. The patient was told by her physician to come into the office for a patient visit if the vertigo did not resolve itself. No product quality complaint (PQC) was involved. The outcome of the events was reported as not recovered. The relationship between ZOSTAVAX and the events was unknown. Additional information has been requested.
103 fever and extreme body aches that lasted for approximately 3 days, about 2-3 days later had numbness/tingling all throughout my body followed by muscle tremors/spasms and muscle weakness.  Am still having the muscle tremors/spasms and increased weakness to this day.
After I got the vaccine my period came three days after but it was a week and a half early and I have never had that with my cycle; Then after the first shot my period went away for two and a half months; Then came back and I have been bleeding for 16 days straight.; My period is still flowing and my iron is very low due to how heavy it is.; This is a spontaneous report from a contactable consumer or other non hcp. A 29-years-old female patient received bnt162b2 (BNT162B2) Solution for injection, dose 1 (Lot number expiry date was not reported) via an unspecified route of administration at arm right on 21May2021 14:00 (at the age of 29-years-old) as a single dose, dose 2 (Lot number expiry date was not reported) via an unspecified route of administration at arm right on 06Jul2021 as a single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient did not have known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After she got the vaccine her period came three days after, but it was a week and a half early and she have never had that with her cycle. Then after the first shot her period went away for two and a half months. Then came back and she have been bleeding for 16 days straight. she went to the doctor and they can't find any reason why her period was doing this as they checked her hormone levels and did a pap. Her period was still flowing, and her iron was very low due to how heavy it was. Outcome of the events was not recovered.
1:36pm dizziness. Pt. receiving 1st dose of COVID-19 vaccine.  Shows dizziness right away after administration.  Pt. has severe allergies to nuts and was recommend to wait 39 minutes after vaccine administration.  Pt. refuse to go to hospital and seem stable.  Pt. stay extra 10 mins. to discard any complication and verbalize feel better.
Initial report received from Healthcare professional on 29 October 2014. A 71-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HIGH DOSE (Batch number U5019CA, expiry date and dose number was not reported) on 23 October 2014. The patient had experienced hoarse voice, joint pain, itching, weakness, fatigue and rash on tongue on an unspecified date. Lab investigation and corrective treatments were not reported. The patient illness at the time of vaccination, pre-existing diagnosed allergies and birth defects were not reported. At the time of this report the outcome of the event was not resolved. List of documents held by sender: none. Follow-up information received from a health-care professional on 03 April 2015. Patient had received an injection of FLUZONE HIGH DOSE. Concomitant medications included Acetaminophen w/codeine 300-30 mg, Amoxicillin 500 mg and Ventolin HFA aerosol. No additional information reported. Documents held by sender: none.
My legs were very weak.  When I got out of the car, I could not stand and I fell .  This happened twice within an hour. I hurt my right foot when someone was trying to get me up.
Patient states she was waiting in post vaccination area when she began to become very anxious. Her heart was racing, felt hot, rash on chest, and felt throat feel thick. EMS was on site and took vital signs. Transported patient to Emergency Department via ambulance. Benedryl and Prednisone were administered IV. Patient was monitored for 4 hours at Emergency Department. Followed up with patient today. She is continuing to take Benedryl. Feels much better.
One week after injection I experienced pain in my left armpit. I presume it was a lymph node. It has lasted for 3 days with the pain being worst on the second day. I took ibuprofen and acetaminophen  which helped with the pain.
Shortness of Breath, chest pain, heart fluttering, started Monday after vaccine. When she breathes  she feels like coughing.
Vial of covid vaccine was punctured at 430p and then kept in the fridge, Vial expired at 1030p that night, but was mistakenly administered to patient at 930a the next day. Call the patient to let them know and to see how they were feeling. He said he was feeling groggy.
Inflammation and swelling the leg was observed pcp ordered ultrasound and results showed  DVT on right leg. Following investigation for causes of DVT patient was diagnosed with sjogren's syndrome.  No history of DVT or any autoimmune diseases in the past for patient and relatives. No other risk factors for DVT was found
After my second shot after approximately 8 hours I got a severe headache perfuse sweating and vomiting, this went on continuously until Monday when I went to a family practitioner, she blew off my symptoms and sent me home where I continued to have these symptoms on and off. When on I was completely disabled. I filed a complaint they called on 4/15/2021, and told me I should go to ER, I told them I was flying the next day to see my mother who is passing away. I promised if my symptoms were still there in morning I would go to ER. I woke up feeling great and then I had a bowel movement my headache was so bad I thought I was having a stroke, I started sweating bullets and vomiting. it was so bad the only thing I can compare it to was when I had  Tick fever in the early 90's. I called 911 at hospital I was in a dangerous arrhythmia throwing PAC's and going in and out of 2nd third degree heart blocks. They can not figure out why, the neurologist I saw theory is the same I had, a severe inflammatory reaction to the 2nd moderna shot. He put me on a 3 day course of prednisone which helped a lot in my recovery. I am currently on a heart monitor to see if the heart block was just temporary. I see the neurologist again in 3 weeks.
Lightheadedness / slight dizziness persistent throughout much of the day.  Began approximately 2 weeks after first injection.  Hasn't yet subsided.  Has not worsened either
Post vax, pt had small red lumps on inner forearm (L) and 1 bump on (R) inner forearm. She complained of problem breathing, about 1 hour, post vax.
Patient experienced some extreme "charlie horse" cramps in her legs occasionally in the weeks following vaccination. She did not report them to the pharmacy until 4/13/21 when she saw the news regarding the blood clot adverse events and thought it may be relevant. She had charlie horses in the past but had not had them in recent history until after her vaccine. It happened 3 times, all in the middle of the night, mostly in her right leg. She did not need to see medical attention for any of them.
Woke up next morning with low grade fever, elevated heart rate, body aches, and sizable painful lump swelling under arm that I got the shot in.  Low grade fever resolved with motrin.  Heart remained elevated for almost 48  hours.  My resting heart rate is in the upper 50's.  It was in the 90's during this time.  Lump (swelling) under arm is getting smaller but still noticeably there 3 days later.
his legs still bother him every once in a while; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LIMB DISCOMFORT (non-serious), outcome "not recovered", described as "his legs still bother him every once in a while".  Additional information: The only thing the reporter would like to add to the previously filed safety report is that the patient is much better and his legs still bother him every once in a while.   The lot number for bnt162b2 was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.
Systemic: Dizziness/Lightheadedness-Mild, Systemic: Flushed/Sweating-Mild, Additional Details: Patient felt faint and was slightly sweating with a feeling of dizziness. She never went unconscious. She was given water and food to help with uneasiness. After a 15-minute period, she felt better and has reported no other difficulties.
Hallucinations/didn't know where she was; Fear; didn't know where she was; very high fever over 104 degree, extremely high fever; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations/didn't know where she was), FEAR (Fear), DISORIENTATION (didn't know where she was) and PYREXIA (very high fever over 104 degree, extremely high fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21a, 031l20a and 013l20a) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SERTRALINE, VIT D [VITAMIN D NOS] and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced HALLUCINATION (Hallucinations/didn't know where she was), FEAR (Fear), DISORIENTATION (didn't know where she was) and PYREXIA (very high fever over 104 degree, extremely high fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HALLUCINATION (Hallucinations/didn't know where she was), FEAR (Fear), DISORIENTATION (didn't know where she was) and PYREXIA (very high fever over 104 degree, extremely high fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2021, Body temperature: 104 (High) 104 degree.         No medical history information reported.  Following vaccination with the booster patient started to experience the next morning: worst side effects, very high fever over 104 degree, did not know where she was, extremely high fever, hallucinations and fear which lasted for several days. Patient started to experience a condition following vaccination which make her to take Myrbetriq.   This case was linked to MOD-2022-530858 (Patient Link).
Sore arm at injection site; Sore arm/He is still experiencing soreness of the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm/He is still experiencing soreness of the arm of the injection) and VACCINATION SITE PAIN (Sore arm at injection site) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 030m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm/He is still experiencing soreness of the arm of the injection). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm/He is still experiencing soreness of the arm of the injection) and VACCINATION SITE PAIN (Sore arm at injection site) had not resolved.            No Concomitant medications were provided  No Treatment information provided   This case was linked to MOD21-116785, MOD-2021-014458, MOD-2021-266235 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up information contains no new information On 26-Jul-2021: Follow-up received: does not contain any new information. On 27-Jul-2021: Follow up received and does not contain new confirmation. On 28-Jul-2021: Significant Follow-up received and event added