chrisvoncsefalvay/vaers-outcomes huggingface dataset:
While being monitored after receiving second dose of COVID 19 vaccine, patient developed fatigue and was noted to have a blood pressure of 76/41. No other physical complaints. Wife noted patient had decreased oral intake recently but otherwise denies any recent illness or positive sick contact. Was brought to the ED and given 500ml of normal saline IV.
Patient here today to receive moderna 022m20a 0.5 8/8/21. Approximately 10 minutes  after patient received vaccine to left deltoid. She c/o being a little light headedness. She asked for a snack or crackers  BP 129/71 Hr 60 No SOB observed. Patient reports  that patient only ate one egg this morning  and believe that to be  the cause of her being light headed.  Patient observed for 30 mins onsite.  She reports that she feels better after eating a piece of candy. She is able to ambulate via own will without issues.
Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PYREXIA (Slight fever). At the time of the report, PYREXIA (Slight fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Extreme Headache, Fatigue, Brain Fog, Bone and Joint Pain, Sinus Pressure,  pain at injection site and up into neck area on that side.
Flu like symptoms occurred on 8/2 (fever, body aches, chills, headache). On 8/3 flu like symptoms decreased in severity, but severely painful headache remained. Severe throbbing headache was a pain level 10. Throbbing pains worsened when bending over or moving head in any direction. Throbbing pain location was felt all over head, but mainly felt behind the eyes. No vision changes. Severe headache did not respond to medications. Two 500mg acetaminophen were taken on 8/3 around 3:30am, and the pain did not resolve. The throbbing pain occurred for the duration of the following dates: 8/2, 8/3, 8/4, and 8/5. On 8/5, there was an onset of lightheaded/dizzy sensation. Healthcare team was contacted on 8/5, and recommended going to the emergency room.  Lightheadedness is felt for the entirety of the day, with random spells of dizziness. Legs feel slightly sore.   Was advised to go to the emergency department on 08/05.  Given 1L IV fluids.  Blood test results: abnormal result -- > d-dimer level was elevated.  Because d-dimer level was elevated, healthcare team was concerned about a blood clot in the brain.  CT scan was necessary to check for clots in brain.  Brain CT scan came back normal, displaying no blood clot in brain.   Discharged, still feeling lightheaded and fatigue, and it has been over a week since receiving the vaccination.
Pt. reports hives on her face but nowhere else on body or near inj. site. She said occurred a little while after vaccine. Pt. also reports using a new moisturizer.
VASOVAGAL SYNCOPE- FAINT FOR A FEW SECONDS, BP-108/70, PR-68/ MIN. lAYED DOWN, FOR 10 MIN. AFTER 15 MIN, LEFT CLINIC WITH HIS DAD.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On 02-NOV-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M005971, expiry date: 02-FEB-2018) (dose and route not reported). Vaccine was improperly stored at temperature of 48.2 F for 21 hours and 57 minutes. Previous temperature excursion was reported at 57.6F 20 hours 27 minutes. Data logger was involved. No adverse effect was reported. Outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Significant shoulder pain immediately upon receiving vaccination in left shoulder.  I could feel the liquid going into my shoulder area as it was given.  Then I had fairly significant should soreness for several days, including under my arm near the armpit area.  It is now 2 weeks and I have shoulder pain at night while sleeping and limited range of motion in lifting my left arm, it gets worse at night and when lying down.
The only side effects I had from the vaccine was I had extreme tiredness; I slept a lot in 24 hours. I had a breakthrough COVID case. I went to the movie theater on 10/7/21. I started showing symptoms on 10/11/21 @ 5PM. I had fever of 103, body aches, nasal congestion, weakness and felt tired and fatigued. I was very weak I had trouble picking up a jug of water. I would get a fever every night and I would take Tylenol and it would go away and it would come back the next day @ 5PM same. I lost partial taste and smell on the last couple days of having it. I went to the doctor on 10/15/21 and they gave me antibiotics because the doctor thought I had a sinus infection, but I was tested for COVID. I started taking the antibiotics and started feeling a lot better. My results finally came back, and I did test positive for COVID-19 but by that time I was already feeling better, so I think I was almost recovered at that time. The medicine I was prescribed was amoxicillin and it really helped. I think I had a secondary infection on top of COVID, but the medicine helped a lot.
face burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 41-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE.), for COVID-19 Immunization, reaction(s): "He had this big knot that came up under his arm", "He ran a temperature". The following information was reported: BURNING SENSATION (non-serious), outcome "unknown", described as "face burning". The event "face burning" required physician office visit. Therapeutic measures were taken as a result of burning sensation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Site: Pain at injection site-Medium; Site: Redness at injection site-Medium; Site: Swelling at injection site-Medium.
Shingles-like rash on rib cage under left breast, tender skin on left rib cage front and back; extremely painful.  Ongoing.
Phlegm (color brownish); Voice changing; Sore throat, near where tonsils would be, though they have been removed.; Excessive phlegm (light tan) that returned every 30m after coughing to expunge.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on an unknown date in 12Jul2021 at 12:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. It was reported that the patient had none known allergies. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Jul2021, the patient experienced sore throat, near where tonsils would be, though they have been removed. Excessive phlegm (light tan) that returned every 30m after coughing to expunge on 13Jul2021. On 14Jul2021, the patient reported laryngitis type symptoms included voice changing, throat sore, phlegm (color brownish) now only every 2 hours at the time of reporting. The patient reported no fever, no nausea and no fatigue. Therapeutic measures were taken as a result of the events which included NYQUIL on Wednesday and Thursday, MUCINEX on Friday. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore throat, phlegm, coughing, laryngitis and voice changing was not recovered at the time of this report.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
administered, after gone out of range; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-APR-2022 Reporters comment: The patient received Boostrix after it had gone out of range. All information provided was reported.  It was reported that, for additional information, please reach out to the healthcare professional. Additional supportive information: The patient received Boostrix after it had gone out of range, which led to incorrect storage of drug. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070827:Same reporter. US-GLAXOSMITHKLINE-US2022070813:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071809:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071811:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071810:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071808:Same reporter. US-GLAXOSMITHKLINE-US2022070827:Same Reporter
Gland under armpit inflammation and pain; Gland under armpit inflammation and pain; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW-0165) via an unspecified route of administration in the left arm on 04May2021 at 01:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication taken within two weeks of vaccination was not reported. On 05May2021, the patient experienced gland under armpit inflammation and pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events gland under armpit inflammation and pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Breakthrough COVID-19 case. Symptom onset 7/21/2021:  Cough (new onset or worsening of chronic cough),  Fatigue or tiredness,  Diarrhea (>/=3 loose/looser stools in 24 hr period), alternating taste between food, loss of appetite, and lack of energy
Fever of 102 degrees for about 12 hours, frequent urination, Sunday 8/23 about 4 AM passed out in bathroom, lethargy, extremely tired for rest of 8/22, and 8/23, still tired 8/24
Severe gum bleeding and clotting that lasted 3 to 4 days. Severe jaw pain. Diarrhea. Headache. Chills.
Stroke; Blood clot on the brain; I Just sort of zoned out on them; Arm soreness; I Just kept getting tireder; A spontaneous report  was received from a consumer, concerning a 69-years old male patient, who received Moderna's COVID-19 vaccine and experienced stroke, blood clot on brain, arm soreness without redness and swelling, he just kept getting tireder, he just sort of zoned out on them.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 05 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 037K20A) via unknown route for COVID-19 infection prophylaxis. On 05-FEB-2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (lot number 032L20A) via unknown route for COVID-19 infection prophylaxis.  On 05 Feb 2021, after the second dose of vaccine, the patient experienced arm soreness and fatigue, He did not get any medication or treatments for his arm soreness without redness and swelling and and just kept getting tireder events. On10-MAR-2021 patient experienced just sort of zoned out of them, stroke, blood clot on brain. An ambulance was called for him and he was taken to the hospital where he received MRIs, and CT scans. He states they think it was a stroke. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events (arm soreness without redness and swelling and he was just kept getting tireder) was recovered but the events (stroke, blood clot on brain, he just sort of zoned out on them) not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
patient received the first dose on her left deltoid (arm was a little sore on an unspecified date); This is a spontaneous report from a contactable pharmacist (patient). A 35-year-old female patient (reported as 30-40 years old) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left deltoid on 22Dec2020 at a single dose for an COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on her left deltoid (arm was a little sore on an unspecified date). Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pfizer 3/22/21, 11/8/21, 12/9/21
bleeding heavily with small clots; has not had menstrual cycle since 2018; started spotting; bleeding heavily with small clots; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 08Apr2021 11:30 (at the age of 51-year-old) as a single dose for COVID-19 immunization. Medical history included endometriosis diagnosed in 1993 and subsequently she had laparoscopy twice by the age of 26-year-old; and ongoing menopause since 2018. History of Parity 1: the patient was pregnant with her daughter and have her naturally at 27 years old and never had another pregnancy again. The patient's concomitant medications were only women multi-vitamins. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she has not had menstrual cycle since 2018. On 23Apr2021, the patient started spotting. Since 26Apr2021, she has been bleeding heavily with small clots. All day today (on 28Apr2021) she has been bleeding very very heavy with clots. She was planning to go to her doctor by morning, but she was following through with her second dose tomorrow (29Apr2021). The clinical outcome of the events "have not had menstrual cycle since 2018; started spotting; bleeding heavily with small clots" were not resolved.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Patient (pt) was not ill and was vaccinated 9/18/14 5PM with Pneumovax 23 INJ 25/0.5 MERCK and Fluzone QUAD14-15 INJ SAN. By 9/19 @ 9AM pt was complaining of general malaise. Timeline was a steady increase of deep muscle aches and pains beginning in neck and flowing steadily downward thru both arms, spine, ribs, to waistline, as the day progressed. Headache onset by 9/19 @ 3PM. Skin surfaces from waist up to neck progressively sensitive and painful with severe pain @ both injection sites. Pt took temp @ 5PM & 99.6. Treated with 1000mg Tylenol and ice packs on injection sites & joints. Fever increased over evening as did muscle pain accompanied by severe joint pain. On 9/20 pt unable to get out of bed, headache increased, fever increased to 100.5. A local inflammation reaction developed at both inj sites by noon 9/20. It was redness of several inches with pain. Skin treated with ice packs. By evening of 9/20 fever increased to 101.3. Treated with 1250 mg Tylenol. On morning of 9/21 the local reaction at the Quad flu vaccine site had diminished. The local reaction at the pneumovax site increased with severe redness and very hot to the touch. On 9/21 the fever decreased to 99.3 by evening but the pneumovax site persisted with increasing swelling, heat, redness, despite ice packs. That site began severe itching. On morning of 9/22 fever had decreased to 98.8, but the local reaction to Pneumovax continued and is approx. 5 inches long down the bicep and wraps completely around (encircles) the bicep. The lower portion (bottom) of the bicep appears to suffer from edema. Treated with Benadryl gel as it feels more like a local allergic reaction at this point than systemic. Overall, the administration of these two vaccines at the same time caused a significant systemic immune reaction that put a healthy 50 year old man in bed with a fever of 101, with a concern that this could be too much for some immunocompromised or elderly individuals.
Headache started the evening of 10/22. Woke up around 6am to red and swollen uvula and surrounding lymph nodes with low grade fever and fatigue. Treated with acetaminophen, tea with honey and lemon, soup, and lots of water. Swelling and fatigue lessened slightly with treatment. Swelling of uvula was gone the next morning.
Broke out in blisters or sores that covered my scalp, stomach area, arms and face took shot on 3/26/2021 and felt the normal sore arm after, stiff neck felt ok Saturday and Sunday just tired and sore arm then monday is when i noticed the red spots popping up.
He had shot pain; This is a spontaneous report from a Pfizer sponsored program. A contactable unspecified aged male consumer (Patient himself) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection) via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date around after 2 days of vaccination, the patient experienced shot pain. He stated that recently he saw an article produced by (Company name) to avoid Ibuprofen / Advil because it may reduce the effectiveness of the vaccine. He wanted to know why the CDC or the HCP did not let them know or informed about it prior to the 1st dose and how many days he could take Cortisone shot after the 2nd dose of vaccine. The patient doesn't want to get transferred because he doesn't want to wait. The patient took Tylenol as a treatment for the event. The outcome of the event was unknown.  Information on the Lot/batch number has been requested.
Pain is stabbing and piercing whenthe arm is activated; Pain directly at the injection site whichis very localized and under the skin; Most pain comes up in the shoulderjoint. Sometimes pain is felt in or travels to the elbow joint.; Pain when the arm is not used isabout 4/10 and enough to wake patient up at night; This is a spontaneous report from a contactable healthcare professional. A 55-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 04Mar2021 at 15:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. It was unknown whether the patient had any concomitant medications within two weeks of vaccination. On 05Mar2021 at 15:30 the patient experienced stabbing pain and piercing when the arm was activated. The patient reported of "pain directly at the injection site which was very localized and under the skin, most pain comes up in the shoulder joint, sometimes pain is felt in or travels to the elbow joint, pain when the arm was not used was about 4/10 and enough to wake patient up at night". The patient experienced pain when doing the wrong movement "it was up to 7/10 and unbearable". This pain only lasted for seconds. It was reported that the patient had a lingering pain when not activated which feels like a tired "overused" joint and pressing on the rotator cuff tendon brought up the pain also the patient could not use his arm for normal physical work. There was no redness or lump around it and was never been. There were no secondary contributing factors like accidental injury and otherwise, patient was feeling quite well. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain is stabbing and piercing when the arm was activated, pain directly at the injection site which was very localized and under the skin, most pain comes up in the shoulder joint, sometimes pain was felt in or travels to the elbow joint and pain when the arm was not used is about 4/10 and enough to wake patient up at night were resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Left left with papulovesicular rash at injection site to 1 inch diameter around site.
Admin Error - Pt received second dose of Moderna COVID vaccine at day 20 outside of standing order and CDC recommendations. Note pt received 1st dose of Moderna COVID vaccine on 12/28/20 (Lot # 025J20-2A) and second dose accidentally on 1/17/21. Per ID pt was given a third dose on 2/14/21 (Lot #011M20A
This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with PROQUAD (Merck) lot no. L051098, expiration date- 17-JUN-2017. No adverse event was reported. The outcome of the event was unknown. Additional information is not expected as physician does not wants to get contacted.