chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When child got undressed for bath time mother noticed a red raised area on the back of Left arm.  Mother states area is larger today. Child has a red induration which is warm to touch. Area measures 51/2 cm at widest part x 7 cm at longest part. Child denies itching or pain.  Area looks like she has scratch marks in it.
Veteran states that after receiving his COVID SpikeX vaccine on 10/25/23 in Left  Deltoid that he developed what he thought was normal vaccine arm pain of 3/10  within 1hr. The next day, less than 48hrs he developed bright redness and  bruising of injection site and hot to the touch. Denies fever or change in  muscle strength of left arm.    Today he presents to clinic and bruising of left deltoid noted with slight  warmness remaining. Bruising is darkened redness with areas which appear to be  resolving yellow/green, 9cm X 6.5cm.   Discussed that no S/S of infection noted today other than slight warmness of his  left deltoid. Recommended that if any other symptoms develop to let Team know.  Will report thru VAERS of his reaction.
Second dose adverse events:  Extremely horrid headache, chills and low grade fever, fatigue, sore arm.  Slept almost all day and all night of the second day. Second dose-second day:  Headache almost gone but very sore eyes, the arm was better, fatigue lingers, and noticeably breathless. Later but don't remember exact day;  Rt jaw bone by the ear sore; hard to open my mouth to eat.  This side had the Bells Palsy in 1996.
died on hospice Narrative:  Patient died on hospice, it is my clinical recommendation that death was r/t chronic anema, advanced dementia, COPD, CAD, and not related to prior administration of COVID-19 vaccination
inappropriate schedule of vaccine administered; fever; sick all day; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick all day), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered ) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ILLNESS (sick all day), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever). On 23-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered ). On 23-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered ) had resolved. At the time of the report, ILLNESS (sick all day), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever) outcome was unknown.            Patient did not specify if he was immunocompromised. He did not have his vaccination card nearby but he said the third dose was given last Thursday 23 SEP 2021.   At the facility they told him they were authorized to mix the doses  No concomitant medication was provided  Treatment medication was not provided by the reporter   Reporter did not allow further contact
I have like a golf ball size knot under my kneecap right below where kneecap is; Golf ball size is pink in color; My knee hurts when I walk/ When I touch my knee it really hurts.; Left ankle was swollen; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Left ankle was swollen), SWELLING (I have like a golf ball size knot under my kneecap right below where kneecap is), SKIN DISCOLOURATION (Golf ball size is pink in color) and ARTHRALGIA (My knee hurts when I walk/ When I touch my knee it really hurts.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included Neck surgery (Neck surgery due to tumor in neck). Concurrent medical conditions included Blood pressure, Thyroiditis, Depression, Anxiety and Nerve damage (Nerve damage in Patient's right arm due to surgery because of tumor on neck).   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced JOINT SWELLING (Left ankle was swollen). On 28-May-2021, the patient experienced SWELLING (I have like a golf ball size knot under my kneecap right below where kneecap is), SKIN DISCOLOURATION (Golf ball size is pink in color) and ARTHRALGIA (My knee hurts when I walk/ When I touch my knee it really hurts.). On 28-May-2021, JOINT SWELLING (Left ankle was swollen) had resolved. At the time of the report, SWELLING (I have like a golf ball size knot under my kneecap right below where kneecap is), SKIN DISCOLOURATION (Golf ball size is pink in color) and ARTHRALGIA (My knee hurts when I walk/ When I touch my knee it really hurts.) outcome was unknown.            Concomitant medicine included Unspecified Blood pressure medicine, Unspecified Thyroid medicine ,Unspecified Medicine for depression, Unspecified Medicine for anxiety, Unspecified Medicine for nerve damage in right arm due to surgery because of tumor on neck. No treatment medicine was reported by the reporter.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.
Severe chills, severe muscle aches, nausea, and headache. Began around 12:15 am. Severe chills got better with Tylenol after 8 hours. Then fluctuated between hot and cold. Nausea/ vomiting comes and goes. The muscle aches got better, then came back.
AM 10/19/10 patient presented to clinic with very swollen (L) arm. Felt "tight" since same AM. No fever. No pain, redness or warmth. No injury known. Was seen here, by a local orthopaedist, and in ER in his hometown. Patient on prednisone.
Sharp pain in lower left of abdomen, in pelvis area; Pressure on bladder; bloated abdomen; Pain increasing overnight; Epiploic appendagitis descending colon; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 17:00 (Lot number: ER8730) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Penicillin, reaction(s): "Known allergies: Gastric intolerance "; Amoxicillin, reaction(s): "Known allergies: Gastric intolerance "; Morphine, reaction(s): "Known allergies: Gastric intolerance "; Toradol, reaction(s): "Known allergies: Gastric intolerance ". The following information was reported: ABDOMINAL PAIN LOWER (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (07Apr2021), described as "Sharp pain in lower left of abdomen, in pelvis area"; BLADDER DISCOMFORT (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (2021), described as "Pressure on bladder"; ABDOMINAL DISTENSION (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (2021), described as "bloated abdomen"; PAIN (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (07Apr2021), described as "Pain increasing overnight"; EPIPLOIC APPENDAGITIS (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (2021), described as "Epiploic appendagitis descending colon". The events "sharp pain in lower left of abdomen, in pelvis area", "pressure on bladder", "bloated abdomen", "pain increasing overnight" and "epiploic appendagitis descending colon" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain lower, bladder discomfort, abdominal distension, pain, epiploic appendagitis.  Clinical course: Sharp pain in lower left of abdomen, in pelvis area. Pressure on bladder, and bloated abdomen. Pain increasing overnight. Visit with GP on 07Apr at 10:15am. Instructed to go to the Emergency Room for a CT scan of the abdomen. Diagnosis: Epiploic appendagitis descending colon. Instructed to take Tylenol for a few days. Pain disappeared in 24 hours. Phone conversation with Gastroenterologist to establish a cause: none found. Due to recent vaccination (5 days prior), out of precaution, they decided to report it to Pfizer. Other medications in two weeks: Dietary supplements. The patient received treatment of Tylenol to calm inflammation. No covid prior vaccination and not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Moderna COVID-19 Vaccine   Slight headache, pain at injection site and in arm of injection, fatigue.
I just developed this rash on my stomach and I can't remember exactly when it was either 10/11 or 10/12. And it was itching. When I looked at my stomach, I saw this darker circle the size of a plum. And then there were margins, it was a bit discolored. And it was the size of an open hand that enveloped that. And if I itched it, it would raise, like a hive. Which it's still doing. So I called the doctor on 10/13/2021. And I was calling her mostly because I have poison ivy. I have bumps and oozing and itching and it's on my forearms. And I showed her the rash on my belly on a telehealth call. And I told her there was no oozing but there was itching. And she thought it might be poison ivy. And it's still there and it's still itching so I started prednisone today 10/15/2021.
I had a little bit of a fever and body aches for a couples. A week after the flu shot, I got Bell's Palsy, It started from the back of my neck and my face started to droop. I went to the ER and they did a CAT scan, MRI, blood test.
tongue is numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 19 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "received the Pfizer booster shot on Friday"; HYPOAESTHESIA ORAL (non-serious) with onset 19Nov2021, outcome "unknown", described as "tongue is numb".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
UTI; Fall; A spontaneous report was received from a consumer (caregiver)  concerning a 93 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced urinary tract infection (UTI) and fall.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced the UTI and fall. The patient is currently in a rehab facility due to the fall. The patient received treatment medication with unspecified antibiotics for the UTI. The patient was re-scheduled for the second vaccine on 12 Mar 2021, which falls outside the 42-day timeframe (which would be 49 days after the first vaccine). No further information was provided.   Action taken with second dose of mRNA-1273 in response to the events was unknown.   The outcome of the events, UTI and fall, were not reported.; Reporter's Comments: This case concerns a 93 year old, female patient, who is in a rehab facility due to fall, experienced a serious unexpected event of urinary tract infection, after receiving mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
Began as rash on scalp, right ear, right side of neck, chest, back.   Lead to very weeping, very painful sores in this area.  Diagnosed as shingles by a physician, and treated with Valtrex and prednisone as of 10/10/2014.  Rash/blisters remain painful, have dried and hardened.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a healthcare worker concerning a 13 weeks old male with ear infection and no drug reactions/allergies who on 07-OCT-2010 was vaccinated with a dose of MMR II (LOT# 667006/0256Z). On the same day the patient received AUGMENTIN to treat an ear infection. On 17-OCT-2010 the patient experienced rash and fever. Ear infection had not "cleared up". The patient sought medical attention via coming to the office. The outcome of rash and fever were not reported at the time of this report. Follow-up information has been received from the healthcare worker who reported that the 15 month old (previous reported as 13 weeks old) male patient with right otitis media at time of vaccination who on 07-OCT-2010 was vaccinated subcutaneously at right arm with the first dose of MMR II (LOT# 667006/0256Z). On 18-OCT-2010 (also reported as 17-OCT-2010) the patient broken out with rash over entire body. The patient was also on AUGMENTIN X10 days for right ear infection. No lab tests were performed. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
patient was sitting in chair after receiving first covid shot. after 15 minutes, patient says felt light headed and dizzy. 20 minutes after administration, patient froze and became unresponsive, staring straight ahead. After 10-15 seconds, patient came to and was responsive again. Over a period of about 10 minutes the patient stated she felt better but waited for EMS. She was transported to a local hospital ER.
cough, both head and chest congestion, sneezing, loss of taste and smell, did a home test and was pos.,. starting on 12/22/21
Child received the flu shot on Thursday afternoon and by Friday afternoon (10/27) noted to have half-dollar sized hives on his torso. Was given allergy medication and they went away but on Saturday, 10/28, had dime-sized hives on torso, given more allergy medication and on Sunday, 10/29/17 the hives were gone. Mother reports that child did not scratch the hives, no fever and otherwise felt fine. Child was at the end of the course of antibiotics, per mother he only had a couple days left when he received the flu shot. Child has received flu shots in the past without any problems. Child has follow-up apt for ear infection in a couple of weeks. Instructed mother to share this incident with Dr. to determine if further studies are needed. Mother verbalized understanding.
Mother called c/o left arm, neck and shoulder pain. Pt is unable to get out of bed. Client reported mild soreness at site of injection the night before, but the next morning (02/22/05) didn't go to school because of pain.
I had nausea; fever; cough; rash; congestion; headache; and sore throat for 4 days and my rash is still going on. I'm taking over the counter hydrocortisone.
1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and aspirin. 1100 to 01/07/2021, 0200 severe lethargy lasting till around this time. Heart rate excess of 130, dizziness, severe weakness, muscle pain, fever 103 to 104 F. 650mg oral Tylenol and aspirin 325mg every 6 hours does not control temp. Intermittent periods of extreme perspiration. 0200 1/07/2021 to 1200, slow decline in body pain with ongoing Tylenol and aspirin every 6 hours. No more elevated temps. Injection site/arm remains painful.
Within an hour, I started having a headache and feeling a little "prodromal".  Within 12 hours, I started having severe diffuse muscle aches.   The next 17-29 hours, I continued with severe diffuse muscle aches, headache, nausea, and chills.  Symptoms subsided after 29 hours.
Patient's right eyelid started swelling yesterday morning 8:00 am and has since started to increase. The following day it has continued to swell up even more. There is minor pain when blinking.
On 3/7/2021, the patient experienced a cerebrovascular accident, was hospitalized for acute care then rehabilitation until 4/1/2021.  Patient has a previous history of CVA.
This spontaneous report as received from a 62 year old male consumer with no pertinent medical history and drug reactions/allergies refers to himself. On 07-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX, 1 injection, under the skin of the left arm (lot# and expiration date unknown). Concomitant therapies included AFLURIA in the right arm on 07-OCT-2013. About 2 days after the patient received the ZOSTAVAX vaccine he noticed his left arm in the back was hurting very badly on 09-OCT-2013. He said a few hours later it turned a very dark black color in the entire back of his arm. He said it was very painful and it was starting to fade at the time of reporting. The patient also said that he was experiencing numbness in his left arm all the way from his elbow down into his fingers. He said it was so bad that he was not able to grasp objects or to lift anything. The patient did mention he received the flu shot on the same day 07-OCT-2013, but in the right arm and had no problems with it, only the left arm. No treatment was given for the events. No lab diagnostics studies were performed. The patient didn't seek medical attention. Outcome of left arm in the back hurting and numbness in his left arm all the way from his elbow down into his fingers was unknown. Additional information has been requested.
That second one reactivated lymphedema; This is a spontaneous report from a contactable consumer (patient's wife) reported for a male patient (reporter's husband). This is the second case out of two cases. A male patient of unknown age received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EN6208, Expiration date: Unknown), via an unspecified route in the left shoulder on 18Mar2021 as a single dose for covid-19 immunization. Medical history included diabetes, cancer, overweight, blood pressure high, thyroid, asthma and glands removed/ skin cancers removed all the time one skin cancer went too deep and went into his glands and they removed that was 3 years ago I believe that is June 13th. Concomitant medications included levothyroxine for thyroid, pioglitazone for diabetes, budesonide, formoterol fumarate (SYMBICORT) for asthma and salbutamol (ALBUTEROL HFA) for asthma. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EN6198, Expiration date: Unknown), via an unspecified route in the left shoulder on 25Feb2021, as a single dose for covid-19 immunization. On an unknown date, patient experienced reactivated lymphedema. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
3/26/2021 - arm started to itch near shot site. By the end of the day it had developed into a full rash (covid arm). Put cortisone cream on it.  3/27/2021 - rash had doubled in size. Took Benadryl before bed. 3/28/2021 - rash gone.
A patient was administered a third dose of Shingrix today; sore arm after injection; received 1st 12/8/2020, 2nd dose 01/20/2021; 1-2 days of fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of pain in am in a 56 years old, adult patient who received Herpes zoster (Shingrix) (batch number 744AH, expiry date 3rd October 2022) (adjuvant batch number 4JH43, expiry date 13th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st two doses on unknown date).   On 16th March 2021, the patient received the 3rd dose of Shingrix. On 16th March 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.   Follow up information was received from the pharmacist on 30th March 2021: The patient's demographics details were updated. The batch number was updated. The patient received 1st dose of the Shingrix on 8th December 2020 and 2nd dose was received on 20th January 2021 earlier than recommended schedule time, which led to shortening of vaccination schedule. The patient had 3rd dose of 0.5 ml on unknown arm via intramuscular route. The VAERS details were updated. Less than 2 weeks after vaccination, the patient had sore arm after injection and 1 or 2 days of fatigue, but no other adverse events. On an unknown date, the event fatigue was recovered. The reporter considered extra dose administered to be related to the Shingrix. It was unknown if the reporter considered the fatigue and sore arm to be related to the Shingrix.
Patient is 4 years old but was administered 0.5ml COVID vaccine for 12+ years instead of the 0.25ml vaccine for 6mo-11years.