chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; AE submitted for confusion of vaccine dose; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted for confusion of vaccine dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On 28-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted for confusion of vaccine dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted for confusion of vaccine dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted for confusion of vaccine dose).    Dosage text for suspect product was reported as additional booster.  Concomitant drugs were not reported.  It was reported that patient was administered with vaccine but reporter was not sure if patient received monovalent or bivalent. So far patient received 5 doses of vaccine. It was also reported that patient came for bivalent vaccine but suspected that patient already had it.  Treatment medications were not provided.   Reporter did not allow further contact
Resident continued to progressively decline and was receiving Hospice services. Family and MD declined 2nd Covid vaccine on 5/3.  Resident passed away peacefully on 5/11/2021.
Fever of 99.5 sharp muscle pain all over, shortness of breath, joints aching, and severe fatigue. Took aspirin and vitamins and went to bed. Felt much after adding CoQ10 than when I had just did just aspirin earlier in the day. No fever,  plus less fatigue, pain, etc.  the next day.   About 48 hours afterward, a hard red bump the size of my hand over injection sight plus a smaller bright red spot nearby.
Hives on R forearm, no hives elsewhere, no hives at injection site, no SOB, no edema. Admin. diphenhydramine 50 mg PO.
high pitched screaming for 4 hrs, would rest asleep for only 1 minute then have cont inconsolable screaming;
Patient sat by self through entire vaccination process with no complaints.  SPHN had entered room just after right arm injections and stayed in room during left arm injections.  PHN turned around to complete immunization card information after injections completed and when turned back around again to patient at approximately 11:05 am, she was rigid in chair with body in a straight line except that head was flexed to the left facing down.  Her arms and legs were shaking and her eyes were open but gaze was fixed.  Drooling noted.  Patient did not respond initially when name called but approximately 15  30 seconds later was saying "What" when name called.  SPHN took BP which was 104/62 while PHN took pulse which was 88 and regular in rate and rhythm.  Patient's skin was non-febrile to touch.  patient then began complaining of nausea, became very pale and skin became very clammy.   PHN & SPHN had her sit for a few minutes with a cool compress to her forehead.  After 5 minutes, she was walked to exam table by SPHN where she laid down.  Observation continued and it was determined during questioning that she had not eaten yet today so apple juice given which she tolerated and kept down.  No emesis noted.  Father states there is not a family history of seizures except for his brother who began having them after an injury.  PHN recommended MD follow-up regarding episode and if further vaccines should be given when due in two months.   PHN left room to continue with other patients and SPHN remained in room.  SPHN walked them out of building at 11:20 am advising them to follow-up with MD.
fever for three days, muscles and joints so sore I could hardly stand or walk. Swollen in mouth and gums. Have been experiencing numbing in upper abdominal area into chest and shoulders out to both arms down to fingers on multiple occasions since receiving vaccination.
pt recvd vax; T 104; limp, listless & "gazing" off into space;
Adverse event - Injection site was hot, chills, nausea, faint, dizzy, headache, pain in left upper arm. Treatment - ibuprofen. Outcome - the event lasted about 7 hours at which time the adverse effects had subsided, however, I was fatigued for about 12 hours after. The injection site is still itchy as of 3/22/18.
Feel like flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza like illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza like illness (Verbatim: Feel like flu). The outcome of the influenza like illness was resolved (duration 3 days).   It was unknown if the reporter considered the influenza like illness to be related to Shingles vaccine.     It was unknown if the company considered the influenza like illness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that the second dose of Shingles vaccine really made him or her feel like flu for three days. The patient stated that he or she was glad as he or she was now safe though. Follow-up would not possible as no contact details were available.
Fever of 100.8-101.4 despite tylenol and motrin x 24 hrs, low grade temp 99-100.6 until 50 hrs post vaccine (also with tylenol and motrin), severe body aches and skin sensitivity, pounding persistent headache, racing heart. Localized redness and itchy rash with mild swelling around vaccination site. Continue with skin sensitivity, fogginess, fatigue, and intermittent mild HA at day 5 post vaccine.
On 07/17/2001 the patient's right arm became red, swollen, sore and developed a red blotchie rash at the injection site. On 07/18/2001 the patient was taken to the doctor who said the patient had an allergic reaction to Prevnar. Doctor stated his opinion; reaction 2 hours to Prevnar.
Pain, redness and swelling around site--started same day, lasted 4 days ever/headache/nausea/fatigue--started next day, only lasted one day.
Warm; Spot was sore; Swollen; Down below the injection site, there is a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PAIN (Spot was sore), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE RASH (Down below the injection site, there is a rash) 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 28-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE PAIN (Spot was sore), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE RASH (Down below the injection site, there is a rash). At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PAIN (Spot was sore), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE RASH (Down below the injection site, there is a rash) outcome was unknown.            No concomitant medication were reported. No treatment information were provided. Patient had her 2nd booster dose yesterday on 28-Apr-2022.   Reporter did not allow further contact
Muscle pain on the arm that radiated to shoulder, neck and head. The pain started in the arm but in half an hour the pain eventually progressed.  I had no fever but I felt feverish and achy. The injection site was so swollen.  It was so hard like I had the muscle of a body builder.  It was so painful too.  The pain  and swelling lasted for 2 days.
After my first dose, I felt lightheaded and had headaches. My back hurt really bad. I was really tired and felt sluggish for 4 days. I slept a lot the whole weekend. I had to remember exactly.
Parent described "hours of crying" after 2 mt, 4 mt and 6 mt vaccines.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    No concomitant medications were reported. Patient was over 18 years of age. Staff gave patients vaccines past the use date of 18 Jun 2023. On 20-Jun-2023, 5 doses were administered at administration site 2. Treatment medications were not reported.  This case is for 16th patient out of 47 patients reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live significant follow up received: vaccine administration date was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
After onset at 6:45, fever rapidly increased to over 102 by 8pm.  Muscle aches and soreness accompanied fever.  Very thirsty.  Fever stayed near 103 overnight until I took tylenol somewhere between 2-4 am.  By 5 am the fever was down to 101.5.  Fever stayed between 101-102 most of the following day (4/6/2021), dropping to 99.5-100 around  6pm.  Stayed low grade under 100 through the night and was back to normal by the morning of 4/7/2021.  I felt mostly normal on 4/7/2021 aside from severe muscle tightness in gluts, hamstrings, and thighs, with soreness in my lower back (unknown if that is related to the vaccine, but it was not present before 4/7/2021).  Today, 4/8/2021 the muscle tightness & soreness remains but the fever is still gone and I feel otherwise normal.
ischemic optic neuropathy; severe optic nerve damage; Information has been received from a lawyer concerning male patient of unknown age.    The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On 01-DEC-2017, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for prevention of shingles (lot #, dose, and frequency were not provided).  After receiving vaccine, the patient suffered debilitating injuries including vision loss and eye injuries. Shortly thereafter,  07-JUN-2018, the patient was diagnosed with ischemic optic neuropathy and severe optic nerve damage.  In addition, it was reported that the symptoms had resulted in physical injuries and limitations not present prior to using zoster vaccine live (ZOSTAVAX). Also, the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  Upon internal review, Optic ischaemic neuropathy and Optic nerve injury were considered to be an important medical event, and the events were considered to be disabling.  The reporter considered that these injuries were caused by zoster vaccine live (ZOSTAVAX).
is unusual this large welt; had a bodily reaction/never having a reaction like this before on any vaccine; arm start itching like crazy; arm started to swelled up; entire bicep from the top of my shoulder to the bend of the elbow got a huge rash on it/Bug bite/still have the rush, the welt on my entire arm, bicep; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (is unusual this large welt), VACCINATION COMPLICATION (had a bodily reaction/never having a reaction like this before on any vaccine), VACCINATION SITE PRURITUS (arm start itching like crazy), VACCINATION SITE SWELLING (arm started to swelled up) and VACCINATION SITE RASH (entire bicep from the top of my shoulder to the bend of the elbow got a huge rash on it/Bug bite/still have the rush, the welt on my entire arm, bicep) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033FC1A, 004M20A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (is unusual this large welt), VACCINATION COMPLICATION (had a bodily reaction/never having a reaction like this before on any vaccine), VACCINATION SITE PRURITUS (arm start itching like crazy), VACCINATION SITE SWELLING (arm started to swelled up) and VACCINATION SITE RASH (entire bicep from the top of my shoulder to the bend of the elbow got a huge rash on it/Bug bite/still have the rush, the welt on my entire arm, bicep). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (is unusual this large welt) and VACCINATION SITE RASH (entire bicep from the top of my shoulder to the bend of the elbow got a huge rash on it/Bug bite/still have the rush, the welt on my entire arm, bicep) had not resolved and VACCINATION COMPLICATION (had a bodily reaction/never having a reaction like this before on any vaccine), VACCINATION SITE PRURITUS (arm start itching like crazy) and VACCINATION SITE SWELLING (arm started to swelled up) outcome was unknown.            Concomitant medication was not provided.
Numb lips and face intermittently for 3 weeks after the injection.  Tingling on left side of body for 3 weeks after injection.  Swollen feet for 2 weeks after injection.
Moderna COVID 19 Vaccine EUA  after 12 hours - abdominal pain/cramping with one episode of diarrhea 12-24 hours - nausea and fatigue  improved day 1-2 pain at site of injection, resolved by day 3 - no redness or itching day 3-4 TMJ pain on side of injection Day 5 developed two painful palpable enlarged supraclavicular lymph nodes on side of injection - Started taking ibuprofen around the clock, seems to be improving slowly Day 6 - developed swelling, redness, and itching at site of injection, seems to be growing in size. Greater than a  half dollar in size. Continuing NSAIDS, applying cortizone cream. Day
8 hrs p/vax pt had episode of sz activity & lethargy; had 2 more episodes w/in 1 hr (twitching lt arm & passing out); revived upon shaking-to ER & hospitalized-later in noc episode of limpness & paleness-EEG neg;
UNDER ARM PAIN; UNDERARM BURNING LITTLE BIT; SHOULDER SORENESS IN INJECTION ARM; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced under arm pain, underarm burning little bit, shoulder soreness in injection arm, and injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site soreness, shoulder soreness in injection arm, under arm pain and underarm burning little bit was not reported. This report was non-serious.
Became nauseated and vomited 4-5 hours after Tdap.Diarrhea began at 10 pm that night. Had a fever of 100.6 degrees the following morning with headache and swelling, pain and hot to touch at site of injection. Today swelling is 1 3/4 inches in diameter, still painful and warm to touch. Client feels better today.
Felt like the usual flu building over 48 hours. Then major runny gastroenteritis unable to feel, be alerted to or control at all for 30 hours; was like colonoscopy but slow and at 5-10 minute intervals throughout the night and next day into the evening. Slowly gaining control over explosive runny bowels during the next 10 days. No respiratory symptoms; no cough, no shortness of breath, no pain. No runny nose/sinus throughout. Light, painless corona like headache for 72 hours, with significant loss of mental capacity including short-term memory, finding words, and slight difficulty in controlling emotional fears about these symptoms becoming long-term or permanent. Felt tired the first 5-7 days. Got tested but no treatment.
No adverse symptoms.  Vaccine given to someone under 50, assumed that she was immunocompromised but that turned out not to be true, but vaccine was administered before condition was verified.
Immediate adverse effects were consistent with what is considered to be normal. I am not here to complain about the immediate adverse effects.  The EXTREME fever, chills, fatigue, and extreme headache went away after a day. I can continue to experience a mild form of all of these symptoms since day one. I am now on day six.  I am also on day six of experiencing swelling in my feet and my legs.  As of day two or three, I am experiencing increasing chest discomfort and my fevers and clamminess are beginning to increase.    After gaslighting myself and telling myself everything from I am experiencing allergies too maybe I have a tight bra on... I am now trying to make an appointment with my doctor because I believe I might have a heart infection. Myocarditis.  Fingers crossed cause a heart issue would... kill me.
Fever; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 4-year-old male patient received BNT162b2 (BNT162B2), on 12Aug2022 as dose 2, single (Batch/Lot number: unknown) at the age of 4 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown), administration date: Jul2022, when the patient was 3 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 12Aug2022, outcome "recovered" (Aug2022), described as "Fever". Therapeutic measures were taken as a result of pyrexia.  Additional information: The patient had no medical history and no known allergies. The patient was not administered any other vaccine in four weeks. The patient did not receive any other medication in two weeks. The patient did not have Covid-19 and was not tested for Covid-19 prior to vaccination. The patient developed fever and was treated with Motrin and Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. developed local infection on Left upper arm. Pt went to Dr. office on 11/25/09 and had pus filled abcess. Pt put on antibiotics for 3days.
Immediately after the injection, I experienced  numbness and tingling down my entire left arm into my fingertips along with a heavy pressure sensation on my inner aspect of my wrist. My upper left arm felt incredibly sore and heavy for four weeks.  It is over one month post injection, and my left thumb has lost 20% of its strength. My left hand constantly tingles, especially my thumb and pointer finger. I continue with  random nerve impulses down my entire arm. It feels like spiders are crawling underneath my skin.
Increase heart rate; Very weak; Chills; A temperature; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he took the Pfizer vaccine on Tuesday 19Jan2021 and that same night he had a reaction. He had to go to the hospital on Wednesday/the next morning on 20Jan2021. He went to the hospital and they checked everything, and they were all negative. The patient reported that he had increase heart rate, chills, a temperature and very weak. While he was at the hospital, he saw a gentleman who works there who told him he took a vitamin combination/package before getting the vaccine and it helped him. The patient asked whether he can take it to prevent the side effects. The patient reported that it was his first vaccine with Pfizer and new he is going to get another one in 3 weeks, and the patient asked if there was anything he could take to help him as far as the after effects. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Left leg at anterior thigh red, warm, mild induration 15 cm X 18 cm.
Patient reported a mild shingles rash on her hand and wrist. No itching or pain was reported.