chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Missed second dose of the Moderna COVID-19 Vaccine; I suffer from arthritis; My arm is still sore; Headache; I didn't want to open my eyes; Bone pain; Joints hurts; Osteoporosis; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), EYE PAIN (I didn't want to open my eyes), BONE PAIN (Bone pain), ARTHRALGIA (Joints hurts) and OSTEOPOROSIS (Osteoporosis) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SIMVASTATIN, METFORMIN, OMEPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO), GLYCERYL TRINITRATE (NITROGLYCERINE) and LOSARTAN for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced HEADACHE (Headache), EYE PAIN (I didn't want to open my eyes), BONE PAIN (Bone pain), ARTHRALGIA (Joints hurts) and OSTEOPOROSIS (Osteoporosis). On 11-May-2021, the patient experienced ARTHRITIS (I suffer from arthritis) and PAIN IN EXTREMITY (My arm is still sore). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 Vaccine). At the time of the report, HEADACHE (Headache), EYE PAIN (I didn't want to open my eyes), BONE PAIN (Bone pain), ARTHRALGIA (Joints hurts), OSTEOPOROSIS (Osteoporosis), ARTHRITIS (I suffer from arthritis) and PAIN IN EXTREMITY (My arm is still sore) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Information about treatment was not given.
This case was reported by a physician and described the occurrence of an injection site reaction in a 4 year old female pt who received Infanrix. On 8/4/04, the pt received the 5th dose of Infanrix in the right hip (lot DTPA633A2). Approximately 2 days following the administration of Infanrix, on 8/6/04, the pt experienced an injection site reaction characterized as inflammation, redness and was "warm to touch". The pt was seen at a physician's office and was treated with unspecified anti-inflammatories and antihistamines. The event resolved on an unspecified date in 8/04. The reporting physician considered the injection site reaction to probably be related to the lot of Infanrix administered.
No additional information provided about AE; Caller was unsure if the PROQUAD that was involved in the temperature excursion was administered; This spontaneous report has been received from a registered nurse referring to an unspecified patient of unreported age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the reporter was unsure if the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD), 0.5 milliliters (ml) was possibly administered after a temperature excursion (product storage error) (lot# U019288 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 15-DEC-2022) (vaccination schemes, frequencies, routes of administration and anatomical site of vaccination were not reported) for prophylaxis. The excursion occurred on 15-NOV-2021. No additional information provided about adverse event (AE) or about patient demographics was reported.   This case was considered non-valid due the lack of patient's identifiers.  On 25-JAN-2022, an inbound call was received from the reporter. It was confirmed the company fax number and also provided a Company mailing address.  Follow up information has been received from the reporter on 25-JAN-2022. The case was changed to a valid case (previously reported as non-valid). It was confirmed on 01-DEC-2021, the vaccine was administered to a 5 years old female patient: 0.5 milliliter, subcutaneously. The vaccine administration information was added. The vaccine was used according to the instruction leaflet. The temperature in freezer out of range for less than 3 hours. The reported was advised not to use this vaccine and repointed any additional temperature excursion immediately to Company. There was no other temperature excursion.
nightime temp 103 x 48 hrs; irritable, consolable crying, diarrhea; visted MD on Friday;
Developed rash on forearms (3/4/21) which gradually worsened in scope and severity. By am of 3/5/21 rash was covering abdomen, chest, arms and buttocks.  By 3/6  the rash was present on thighs, knees, behind knees.  On 3/7 rash was present on face, top of head, throat and back.  Severe itching and burning accompanied rash.  The rash started out as patches of red raised areas that within 24 hours of emergence morphed into diffuse red splotches (appearance of severe sunburn).  Drs. Visit on 3/5 with injection of 120mg cortisone and direction to take benadryl up to 6 tabs/day.  No other body symptoms other than rash and itching/burning.  Call to Drs office 3/8 to report continuation of rash and he was instructed to take Zyrtec.  As of 1:59 pm today 3/9, the rash has improved on stomach, legs, buttocks but remains present in varying degrees on other parts of body.
administered an expired DAPTACEL with no reported adverse event; Initial information received on 29-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 15 months old male patient who was administered an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Jun-2023, the patient was administered an expired standard total dose 4 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection at a dose of 0.5 mL (lot C5893AA, expiry date:21-JUN-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient still has a sore arm from the vaccines administered two months ago on 3/13/19. Both vaccines were administered in the same arm about 1 inch apart. She has iced her arm many times and has seen her chiropractor for muscle soreness. The second dose of Shingrix was administered in her other arm today. I encouraged her to massage the arm several times throughout the day to try to prevent the extended soreness this time.
-Patient died unexpectedly on Thursday, April 22, 2021 at her home (found unresponsive by spouse) -No reactions were observed at the pharmacy (within 15 min waiting period) following either covid-19 vaccine (1st dose administered 8am on 3/26/21 -Left Deltoid) -When asked (4-16-21) how she tolerated the 1st dose, Patient reported minor side effects (mild Headache, tiredness) but had no reservations about receiving the 2nd dose. No additional information.
Left deltoid pain, 10 x 6cm erythematous raised lesion, 10 days post vaccination.
Left hip hive, red arm itching & redness itching throughout body. Treated with 50 mg Benadryl & closely monitored x 30 minutes. No breathing difficulty v/s stable!
@ 1412 patient reported feeling dizziness and lightheaded  @1425 BP 107/60 @1430 denied any s/s of allergic reaction @1437 Pt was cleared to be discharged
Acute appendicitis occurring three days after injection. Doubtful the events are connected; thought I'd report it just in case.
Cellulitis of R upper arm, bursitis of R elbow, low grade fever. Redness evening of vaccine within 24 hrs of vac. Rx duracef 1gm x 2 days 500mg BID x 8 days 12/12 - feeling much better.
Patient states she was given influenza vaccine on 10/03/2022, she developed right shoulder pain on 10/07/2022
Injection site area is hot; Injection site area is hard; Injection site area is itchy; Injection site area is red; Injection site area is raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site area is hot), VACCINATION SITE INDURATION (Injection site area is hard), VACCINATION SITE PRURITUS (Injection site area is itchy), VACCINATION SITE ERYTHEMA (Injection site area is red) and VACCINATION SITE SWELLING (Injection site area is raised) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site area is hot), VACCINATION SITE INDURATION (Injection site area is hard), VACCINATION SITE PRURITUS (Injection site area is itchy), VACCINATION SITE ERYTHEMA (Injection site area is red) and VACCINATION SITE SWELLING (Injection site area is raised). At the time of the report, VACCINATION SITE WARMTH (Injection site area is hot), VACCINATION SITE INDURATION (Injection site area is hard), VACCINATION SITE PRURITUS (Injection site area is itchy), VACCINATION SITE ERYTHEMA (Injection site area is red) and VACCINATION SITE SWELLING (Injection site area is raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
patient developed numbness on face and around mouth  that lasted for 10 minutes while driving home after the 15 minutes wait time in our office.
Sore throat; Chills; Tired; Sore arm from first injection; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore arm from first injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore arm from first injection). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore arm from first injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not reported.   Treatment included Claritin and an unspecified antibiotic.
I received the vaccine in my right arm and my right hand started to have a trigger finger effect in my thumb and ring finger. It was painful to flex the fingers and the snapped in place with pain. I went to a hand specialist on June 24, 2021. He gave a shot of cortisone in the area and that helped. However, it kind of crept back in. I have a weakness in my hand. In July, I started having pain in my quadricep. Starting in December, I started having pain in my right knee as well. It became in flexible and I was using a crutch for a few months. I still have a limited range of motion in the right leg. I have not been able to ride my bike since middle of December. I went to a rheumatologist since my knee was bloated and blown up. I had blood test done to see if it was lime disease. That was ruled out along with autoimmune. I had an MRI done for my knee and they located a bakers fist. They did not treat this condition. They recommended physical therapy but did not provide any other treatment. I was doing 10,000 steps a day in November but I am unable to do that as it causes swelling. I went to the emergency room right after Christmas. I had an ultrasound done which was normal but my creatinine levels were high.
Dosage Error Booster Dose: Pfizer-BIonTech 5-11 formulation (orange cap) administered to a person 18 years or older  Patient notified and offered repeat dose.
Found lifeless, unresponsive and transported to hospital; CPR unsuccessful. SIDS. A follow up report received 6/12/2000 adds: Spoke to reporter who gave info from pt's chart. Pt was a 33 week preemie and had bradycardia at birth which resolved almost immediately. Remained in hospital 13 days with twin who was smaller and was born with a cardiac defect. The baby was put to sleep on his side and was found by parents on stomach - resuscitation unsuccessful. He had not exhibited any problems in the evening before he was put to bed. Twin had no adverse reaction after vaccines. Pt was developmentally as advanced as full term baby. ME gave preliminary cause of death as SIDS.
Pt had erythematous, hot hard, area on right thigh measuring 15 X 181/2 cm. Circumference of right thigh 30cm, left thigh 27 cm.
Received letter from client stating that when he received his vaccine the vaccinator stated as he pulled the needle out...something to the effect: I may have inserted the needle too deep.  States it felt to me at the time that it was a deep penetration.  We waited 15 minutes and was dismissed, arm was not hurting.  1/9/2021noticed upper right arm had a mixed red, yellow and black discoloration from bicep to elbow.  There was a large elevated knot on top of biceps.  1/10 discoloration lessened but the large discolored now on bicep remained. 1/11/21 more discoloration lessened but large elevated knot still remains on bicep - swelling, discoloration and hardness.  Made appointment with Dr. and his
Pt was given PNEUMOVAX in right deltoid on 3-6-15. Pt started having myalgia in right arm. Pt seen by doctor 3-11-2015.
Child had 102 temp on the evening of injection, fever resolved on 9/30/2010 AM and patient Discharged to home with fever returning on 9/30/2010 PM and swelling and pain at injection site. Child unwilling to walk on left leg.
2/27/2022 got Tested Positive for COVID. Mild symptoms. Took Zithromax. Home test.
throat sore to swallow on left side for 4 days then was gone. Arm is still sore 10 days later but improving.
redness, swollen on injection site appeared on 1/10/2021, two days after injection.
Tinnitus.   More prevalent in the right ear than the left.  The high pitch noise in my ears will not go away.  The right ear ringing worse the left.  This did not result from any loud noises (I came directly home and had been in the house the entire time), the tinnitus started  with 18 hrs after the 2nd covid shot was administered.   There was no issue with the first shot.
dizzy,nauseaus,headache. sick on sunday the 4th  called 911 on Tuesday night the 6th for transport to hospital. couldn't walk.  had a stoke.
Upon day 4 lymph node under left collar bone became swollen...midday through day 5...the supraclavicular lymph nodes became swollen and tender on the left side.  At a week from the second occurrence there is still swelling.   It was a sudden swelling half way through day 5...I felt for those lymph nodes in the am as I knew of their proximity to other.. nothing in a.m.   but by afternoon - sudden at noticeable  swelling and tenderness.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that vials had not undergone any temperature excursion. Total of 102 doses were given from LOT 026C21A.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live FU received with non significant information.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 63-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19May2023 at 13:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 5 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History of exercise-induced asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The evening of 11Sep2020 I started to have recurrent URI symptoms, nasal congestion, cough and body aches. My last day of a 7-day course of Paxlovid was 4 days earlier.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Urticaria- benadryl, prednisolone Fever- tylenol and ibuprofen Abdominal pain
Larger than normal dose administered. Patient monitored for 30 minutes post administration. called that evening for checkup and 24 hours post. patient reported feeling good and arm is swollen
The patient initially presented (3/3/21) with headache, fevers, nausea, vomiting, diarrhea, myalgias, malaise. Patient related she was in her normal state of health and only started to feel poorly after she received her second COVID-19 vaccination three days earlier.  She interestingly related that after her first Pfizer COVID-19 vaccination she had significant burning in her stomach that she noted but no other major symptoms and notably did not experience this severe burning in her stomach after the second dose. She denied any chest pain, current dyspnea, productive cough, sore throat, urinary symptoms, sick contacts.  She has no history of C. difficile, no recent antibiotics, no recent spoiled foods, no recent travel, no history of radiation.  She does have a history of GERD and has had gastritis with mild gastrointestinal bleeding in the past and undergone EGD negative for H. pylori infection.  She also has undergone colonoscopies with polyps that have been removed and reported as tubular adenomas.  As her hospitalization progressed, she was diagnosed with Severe Sepsis due to E. Coli bacteremia in setting of liver abscess, Cholelithiasis without acute cholecystitis, Atrial Fibrillation with rapid ventricular response, Transaminitis (which resolved). Patient was appropriately treated for these conditions. Also, her known uncontrolled diabetes was treated. Per an Infection Disease note on 3/9/21: The patient has had hx of biliary colic (self diagnosis) now with discovery of non-obstructive cholelithiasis on RUQ US it is plausible that the abscess originated from self limiting cholecystitis/cholangitis which would be consistent with recent abdominal pain exacerbated with oral intake. Difficult to state definitively any relation to COVID-19 vaccination, though may have resulted from associated dehydration.   Additional COVID vaccine info (both Pfizer): first dose: 2/7/21 lot# EN 5318 second dose: 2/28/21 lot# EN6202
pt recv vax;devel hives,was itching almost 1 wk later;on 21aug95 recv PPD test & devel hives on arms & legs;to PMD & was put on meds;
Pt had reaction 24 hrs after injection of redness, pain, swelling. Redness - size of baseball. Pain - shoulder to elbow. Tx: Cool compress/ADVIL or TYLENOL.
About 2 weeks after receiving the 2nd Moderna vaccine, I had a flare up of herpes zoster in my left eye.  I had not had any problems with this virus for about 3-4 years.