chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got vaccine and I'm feeling iller; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I got vaccine and I'm feeling iller) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I got vaccine and I'm feeling iller). At the time of the report, VACCINATION COMPLICATION (I got vaccine and I'm feeling iller) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information provided.
screaming, fever 102.5-24 hrs; APAP given prior to vax, cont x 3 days; lt leg very warm; MD contacted x 2 by phone;
This case was considered medically important. Information regarding PREVNAR 7 was received from a consumer regarding a 28-month-old male patient who experienced apraxia. The patient received a dose on an  unspecified date. The patient experienced apraxia in Jul-2010. Treatment was unknown. The event persists. The reporter (mother) thinks that the event occurred because her son was given the PREVNAR at a too early age. See related case (s): US-WYE-H17365410 (adverse event, expedited). No additional information was available at the time of this report.
I started with a headache and chest pains about hr. after shot 1:30 PM. Around 3:30 PM (3 hrs. after shot) my body got tingly, throat felt like it was tight, my tongue felt heavy and tingly, I had diarrhea continually into the evening, nausea, itching all over, hot, body aches, earache, dizziness, headache and I have been tired and weak feeling. Some of the symptoms have lessened but I continue to have a tingly tongue, body aches, headache, ear ache, I just don't feel good.
Fever, chills, mild headache the night of the vaccine - treated with aleve  Felt Feverish the next morning still - treated with ibuprofen Dizziness/vertigo the evening of 04/13/21
10/20/2023-Flu vaccine and COVID booster admin at approx 1000.  Employee returned to the Occ Health office at 1015 with c/o itching at flu admin site and right arm.  Hives noted to R arm and chest.  Employee denied SOB.  Benadryl 25mg po given per S.O.  Employee remained in Occ Health for observation.  BP 122/84, pulse 76.  EE c/o itching to lips, denies SOB.  Additional dose of Benadryl 25mg po given.  Employee drinking water.  Rechecked BP at 1030.  BP 127/85, Pulse 75, lungs clear.  Employee reports feeling slightly dizzy.  Employee declines to go to ER.  S/s resolved at 1050.  Employee left work with family to go home and rest.
Fever 101 for 2 days, chills, fatique, soar and swollen left arm at shot site with redness. Soar left shoulder blade. Joint pain. On 4th day all symptoms gone but arm still remains swollen, hard and warm to touch. Using ice and ibuprofen. Much worse then pain with a usual flu shot.
Information has been received form a registered nurse through a pregnancy registry concerning an approximately 21 year old white female with no concurrent conditions and a history of one previous pregnancy (pre-term birth at 36 weeks) and no history of birth defects, stillbirth, or miscarriage who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the patient was now pregnant and may have been pregnant at the time of vaccination. The patient was not tested for varicella antibodies before vaccination. It was noted that no other medications were used during pregnancy. The patient's last menstrual period was on 12/20/02 and her estimated delivery date was 9/26/03. A pregnancy test confirmed pregnancy. Unspecified medical attention was sought. Follow up information was received from the registered nurse who indicated that in April 2003, the patient had a routine ultrasound at 21 weeks that was within normal limits. The patient had no local reaction at the vaccination site and no varicella or herpes zoster symptoms post vaccination. On 7/31/03, the patient gave birth to a live born normal male infant weighing 3 pounds and 11 ounces at 30.5 weeks from her last menstrual period. There were no congenital anomalies. Complications included immature lungs. The patient was hospitalized for five weeks requiring mechanical ventilation, a feeding tube, and a heart monitor. The patient improved and was discharged from the hospital on a heart monitor. It was noted that this was done more for the mother's peace of mind than due to the patient's health status. The patient had a fine recovery with a good outcome. There were no other complications during pregnancy or labor. There were no infections or illnesses during pregnancy. The infant had no feature of congenital varicella zoster syndrome. No further information is expected.
Woke up with vertigo, dizzy, off balance, severe headache.  Evaluation at primary care. Tests at ER. Received anti dizziness and nausea meds.
Shortness of breath.  Could not breath. Wooping coughing. Dizziness / headache, Swollen arm. Abdominal pain.  Chest pain running nose with clear liquid. Water eyes. High blood pressure.
Bright red rash hot to the touch and sligtly raised.  Rash was about 4" by 3" in size on left arm around deltoid area.
lost the hearing in her right ear; This spontaneous case was reported by an other health care professional and describes the occurrence of DEAFNESS (lost the hearing in her right ear) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEAFNESS (lost the hearing in her right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS (lost the hearing in her right ear) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I got red swollen arm of 2 inches where the shot was given. The left arm is swollen and paining . I am hopeful to dissolve it soon. This symptom referred as 'Covid arm' at some places.
This spontaneous report was received from a back office lead and refers to a 24 year old of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-MAR-2016, the patient was vaccinated with an improperly stored dose of VAQTA lot # L018498, expiration date: 28-APR-2016, 1 ml, intramuscularly, in left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
my tummy was upset nowhere near the severity of the first one; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (my tummy was upset nowhere near the severity of the first one) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    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 ABDOMINAL DISCOMFORT (my tummy was upset nowhere near the severity of the first one). At the time of the report, ABDOMINAL DISCOMFORT (my tummy was upset nowhere near the severity of the first one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-133883 (Patient Link).
After the vaccination, the patient informed me that it was her booster Janssen dose and it has been 47 days after the 1st Janssen dose on 11/5/21.
Day 0 (day of immunization): no issue Day 1: sore arm Day 2: flu-like symptoms (fever of 101F, vomiting, headahce) Day 3: coughing up blood (may be related to current chronic lung issues, patient unsure) Day 4: hives all over body
Moderna 2/22/21 and 3/25/21. Positive on 1/4
Immunizations given 7/2/03 at 3:45 PM - reaction within 15 minutes. Both thighs red, swelling with blotching. Infant was crying hard before immunizations were given. Observed in office and rechecked by physician. Benadryl given, redness declining after 20 minutes.
A 3-year-old was inadvertently given FluShield vaccine under the deltoid muscles, which was supposed to be given in the deltoid muscle. The area below the deltoid muscle became red and hot with a large induration on the day following the vaccination.
A health care professional reported that a 22 year old male patient received a dose of Flumist nasal solution on 12/10/03. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on 12/10/03. Dose regimen was 1 dose 1 time per day. Patient was not taking concomitant therapy. Three days after receiving Flumist, a nasal swab test was performed; the results were positive. On 12/10/03 the patient reported that he was experiencing a slight scratchy throat. On 12/13/03, the patient developed fever, muscle aches, sore throat, and nasal congestion. A diagnosis of influenza was made. No additional information was available at the time of this report. Additional information received on 26-Jan-2004 provided no new safety information.
flu-like symptoms; some of the alpha-gal allergy symptoms/It was a similar reaction to when she has allergic reactions to mammal ingredients/ It affected the digestive system.; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FOOD ALLERGY (some of the alpha-gal allergy symptoms/It was a similar reaction to when she has allergic reactions to mammal ingredients/ It affected the digestive system.) and FATIGUE (fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FOOD ALLERGY (some of the alpha-gal allergy symptoms/It was a similar reaction to when she has allergic reactions to mammal ingredients/ It affected the digestive system.) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), FOOD ALLERGY (some of the alpha-gal allergy symptoms/It was a similar reaction to when she has allergic reactions to mammal ingredients/ It affected the digestive system.) and FATIGUE (fatigue) had resolved.            No treatment medications were reported. It was reported that patient experienced fatigue, flu-like symptoms, some of the alpha-gal allergy symptoms. It was a similar reaction to when she has allergic reactions to mammal ingredients. It affected the digestive system. These symptoms lasted 4-5 days.
Left deltoid region with 4 x 8 cm red erythematous lesion with warmth and slight induration noted, minimal amoth of raised papulovesicular region about 2 x 2 cm.
reports one patient received one dose of improperly stored VARIVAX; No additional adverse effects reported; Information has been received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.  On 24-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot number S022756 and expiration date of 22-JUL-2021 and lot number R020654 and expiration date of 18-JUL-2020 (route of administration, dose and anatomical location were unknown) for prophylaxis; the sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck)(VARIVAX) was properly stored (lot number and expiration date were not provided). The vaccine was exposed to a temperature excursion of 5.7°F with a time frame of 18 minutes. The previous temperature excursion was -13.3 °C for 18 minutes; -13.2 °C for 18 minutes. A "data logger" was involved. No additional adverse effects reported.
Flulike symptoms started eve of shot. On 11/12/09, woke with a red bump on arm, very hot to touch and feeling very dizzy/weak when walking; flulike symptoms continued thru 11/13 with heat subsiding but redness/bump remained thru 11/14.
Thigh around injection shot became swollen, red, and hot to the touch. Swollen area extended down to the knee. Remained swollen, red, and hot to touch through 9/1/2010.
Information was received on 28-JUN-2017 from a registered nurse regarding a 21 year old male patient. Medical history, concurrent conditions and concomitant medications were not reported. On 28-JUN-2017, the patient was inadvertently vaccinated with ZOSTAVAX 19400 PFU (lot # M035696, expiration date 07-NOV-2017) (dose, route, and site of administration not reported) reconstituted with sterile diluent (lot # M01218, expiration date 10-NOV-2017). The outcome of the event was not reported. No adverse effects were reported. No further information was reported. Additional information has been requested.
One hour after injection c/o hoarse throat and red eyes. As day progressed c/o chest pressure/pain. Called her physician and advised 2 go to ED. Per patient "had many tests - all normal" Discharged after 4-5 hours and advised to return if feels ill again. Patient has had flu shots in past without any problems.
Fever up to 103 following immunization x 2 days. Swelling at site.
This spontaneous report was received from a registered nurse and refers to a 16 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 07-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Patient received primary smallpox on 11/15/2003.  On day 3 he developed nocturnal chills (temp. not taken), tender axillary lymph nodes, mild headachex 2-3 days.  On D8. he developed a macular, pruritic rash on the arms, torso and legs following.  He presented to the ER at the hospital.  He was evaluated and released the same day.  Patient is not sure if cultures wre taken.  He was given oral antibiotics for 10 days.  Patient report that the rash has resolved.
1 of 3 pts who exp an inject site react which included 3-4" of induration & erythema; w/in 48 hrs p/vax treated w/Pediatrofen & amoxicillin; pt recovered;
I broke out in hives on my shins, neck, scalp, upper back and forearms.  They started after the first dose and got much worse with the second dose.
Fainting spell for about 2mins. Woke up with wheezing and need to clea throat.
Client reported metallic taste in her mouth approx. 1 minute after receiving the vaccine. She said her trouble breathing was before the vaccine, not after. " I have trouble breathing because of my COPD and my back hurting". Client says she was diagnosed this week with pneumonia. She tried to take Trilogy but she couldn't tolerate it.
skin rashes/rash neck /rash shoulder area/rash back/rash foot (both)/rash wrists (both)/rash hands (both); itchy (where shot was done); soreness/soreness in the back of the neck area.; itchy neck, back, feet and hands; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy neck, back, feet and hands), RASH (skin rashes/rash neck /rash shoulder area/rash back/rash foot (both)/rash wrists (both)/rash hands (both)), VACCINATION SITE PRURITUS (itchy (where shot was done)) and MYALGIA (soreness/soreness in the back of the neck area.) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] and FISH OIL for an unknown indication.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2022, the patient experienced PRURITUS (itchy neck, back, feet and hands). On an unknown date, the patient experienced RASH (skin rashes/rash neck /rash shoulder area/rash back/rash foot (both)/rash wrists (both)/rash hands (both)), VACCINATION SITE PRURITUS (itchy (where shot was done)) and MYALGIA (soreness/soreness in the back of the neck area.). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PRURITUS (itchy neck, back, feet and hands) and VACCINATION SITE PRURITUS (itchy (where shot was done)) had not resolved, RASH (skin rashes/rash neck /rash shoulder area/rash back/rash foot (both)/rash wrists (both)/rash hands (both)) was resolving and MYALGIA (soreness/soreness in the back of the neck area.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Patient is also taking allergy medicine.   This case was linked to MOD-2022-450491 (Patient Link).
He received the second dose of his covid vaccine on 6/7, began to experience sharp chest pain with exertion on 6/11. Pain is central, to the right of the sternum, without radiation. The pain then became more dull, aching, and has been interfering with his sleep. It does seem to be worse when he is thinking about it, better when he is distracted. He went to basketball tryouts 6/15 and the pain has been more frequent since that episode of strenuous exercise. He has not taken anything for the pain. He also notes more frequent fatigue. He denies any prior covid infection. No recent illness or sick contacts. Denies cough, fever, GI upset, diarrhea. He is going to school in-person, they all wear masks.
Facial drooping and eyelid not closing completely. Diagnosed as suspected bell's palsy at local emergency room.
Pt states had sz at time of injection. Pt states after going home had numbness/tingling and facial droop as well as swelling to face/lips or tongue
This is a spontaneous case, initially received from other non-health professional on 12-Nov-2018, concerning a 74-year-old, elderly, female patient. The patient had no relevant medical history and concomitant medications. On 09-Nov-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250805 and expiry date: 30-Jun-2019]. On 10-Nov-2018, 1 day after vaccination, the patient developed a red, itchy rash around the injection site. It was reported that the patient experienced the rash till date (as reported). No treatment measures were taken for the events. The outcome of the events was not recovered. The reporter assessed the case as non-serious.
This case was reported by a healthcare professional and described the occurrence of arm pain in a subject of unspecified age and gender who was vaccinated with TWINRIX(manufacturer unspecified) for prophylaxis. On an unspecified date the subject received unspecified dose of TWINRIX. At the time of injection with TWINRIX, the subject experienced arm pain and shoulder pain. The reporter stated that it seems to occur irrespective of the person giving the vaccination, technique used or the dose number. Subjects complain of a sudden, brief, but significant pain that shoots down the arm to elbow or sometimes up into the shoulder and neck. This was considered to be a product complaint. At the time of reporting the outcome of the events was unspecified. These events occurred in a number of different subjects from the same source, But with different contacts. Linked cases include A0732483A, A0732491A, A0732492A, A0732500A, A0732501A, A0732515A, A0732528A, A0732533A, A0732539A, A0732540A, A0732936A, and A0732944A.
PT. AWOKE WITH NUMBNESS AND TINGLING OF BOTH HANDS AND FEET AND DECREASED SENSATION ACCOMPANIED WITH PINS AND NEEDLES ON TOUCH. PROGRESSING TO WEAKNESS OF EXTREMITIES DECREASED REFLEXES AND THEN PROGRESSING TO NUMBNESS AND TINGLING OF TONGUE, NOSE, EARS AND HEAD OFF AND ON.
Information has been received on 12-SEP-2017 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not reported. On or about 14-APR-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 14-MAY-2016, the patient was treated by a health care professional for a persistent blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient has been prescribed VALTREX, MOTRIN and ibuprofen for management of his painful symptoms and herpetic complications. As a direct and proximate result of these malfunctions, 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, pain and suffering, and other damages. Additional information has been requested.
he is still feeling very very tired; This is the spontaneous report from a contactable consumer (patient). This 44-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 20May2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 24May2021, the patient was still feeling very very tired. He wanted to know if this was normal. The outcome of very very tired was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be obtained.
Dizziness Narrative: After patient was dismissed from observation after receiving Pfizer Vaccine. He walked out to go to his car with wife at side. when got to the patient garage elevators, he reported to the staff he felt dizzy. The staff then reported to the patient gym to inform a nurse. Nurse assessed patient and took vitals at 10:45 BP: 110/60 P: 55 T: 97.3. Patient reported he felt fine and declined to elevate care to emergency room. Patient condition resolved and the nurse provided a wheelchair for his wife to transport him to his car for safety.
Patient presented to the ED and was subsequently hospitalized for sepsis and diabetic ketoacidoses within 6 weeks of receiving COVID vaccination.