chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported to pharmacist that a rash appeared on left side of stomach 1 day after vaccine was administered. The rash has since continued to spread across stomach and appear on top of right thigh. The rash is flat and papular causing pruritis.  Patient was advised to take Benadryl daily to twice daily to relieve rash. She will wait one additional week to received dose 2 of vaccine (day 28 instead of day 21).
Body started to itch sometime after first injection, then hives were all over body and nothing helped. I went to PCP got the prednisone punch pack which did not help was referred to dermatologist. At dermatologist received 18 day dose of prednisone and they took a sample.
Pt received vaccine (FLUZONE) on 10/19 - woke up on 10/20/12 with puffiness in eyes and body rash to both upper extremities, upper chest. Treated with BENADRYL every six hours.
hasn't been feeling good; Its also itchy; Chills; tired; it looks like it's been stung by a bee or a wasp and it's like a rash; Injection site has red circles; hurts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (hasn't been feeling good), VACCINATION SITE PRURITUS (Its also itchy), CHILLS (Chills), FATIGUE (tired) and VACCINATION SITE RASH (it looks like it's been stung by a bee or a wasp and it's like a rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A2113 and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ALBUTEROL [SALBUTAMOL], IPRATROPIUM, METOPROLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FEELING ABNORMAL (hasn't been feeling good), VACCINATION SITE PRURITUS (Its also itchy), CHILLS (Chills), FATIGUE (tired), VACCINATION SITE RASH (it looks like it's been stung by a bee or a wasp and it's like a rash), VACCINATION SITE ERYTHEMA (Injection site has red circles) and VACCINATION SITE PAIN (hurts). At the time of the report, FEELING ABNORMAL (hasn't been feeling good), VACCINATION SITE PRURITUS (Its also itchy), CHILLS (Chills), FATIGUE (tired), VACCINATION SITE RASH (it looks like it's been stung by a bee or a wasp and it's like a rash), VACCINATION SITE ERYTHEMA (Injection site has red circles) and VACCINATION SITE PAIN (hurts) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medications also included Oxygen. No treatment was given.
pt recvd vax & several hrs following vax pt became very nauseated & exp sweating, hot flashes & a recurrence of muscle pain in legs; later that evening felt like skin was crawling & was itching from the inside & all over;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of M-M-R II (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was given KINRIX in error. Should have received DTaP. No adverse events reported.
nauseated, dizziness off & on-feels kind of disorientated;neck stiffness burning @ site of inj;
Initial and follow-up information has been received through the Merck pregnancy registry through a 23 year old female consumer who was vaccinated with her first dose of GARDASIL (date not specified). On an unspecified date, the patient was vaccinated with her second dose of GARDASIL. On 19-OCT-2007, the patient was vaccinated with her third dose of GARDASIL. There was no concomitant medication. Subsequently, the patient found out she was 5 weeks pregnant (LMP approximately 02-OCT-2007). In follow-up information, the patient reported that on 02-JUL-2008, she had her baby boy. Follow up information has been received from the consumer and a completed questionnaire on 16-FEB-2009. The consumer reported that her son was now 7 months old and was healthy and well. He weighed 7lbs 14 oz, and was 21" long at birth. She stated she was told the baby is physically and developmentally at a 1 year old level, doing very well. The consumer said she had some minor complications during the pregnancy, starting with nausea and vomiting for the first five months, and at 25 weeks had a lot of premature contractions but only dilated to 1 cm. She was advised to increase her rest based on the number of contractions she was having. She never had any further cervical changes, and never had a diagnosis of preterm labor, just preterm contractions. Her labor was induced at 39 weeks (reason not provided) and had a normal vaginal delivery. It was reported on the questionnaire that the patient with no infections or illnesses during pregnancy, no concurrent medical conditions, on an unspecified date experienced low back pain during pregnancy. Other medications used during this pregnancy included REGLAN, ZOFRAN and prenatal vitamins (unspecified). The patient had a negative "CF" profile and 1st trimester ultrasound screening within range. On 02-JUL-2008 at 37 weeks from LMP, the patient delivered with no complications, a normal male liveborn infant with no congenital anomalies or other complications or abnormalities. He weighed 7lbs 14 oz, and was 21" long at birth, apgar score was 8/9. The reporting health professional considered low back pain to be a disabling/incapacitating event. Additional information is not expected.
Severe body ache; it has reached to the back area on both sides; nausea; vomiting; pain below her ribs; Stomach upset; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received bnt162b2 (Covid Vaccine) lot no: EK5730, expiry date: 23Dec2020 (as reported), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history included pre-diabetes, hypertension, and flu all from unspecified dates. Concomitant medication included losartan and metoprolol succinate both for hypertension, and atorvastatin (LIPITOR) and acetylsalicylic acid (ASPIRIN) both for preventative for stroke.  The patient received the Covid vaccine by Pfizer on 18Dec2020. Then on Saturday (unspecified date), the patient started having symptoms like Covid symptoms. She had severe body ache. She stated it has reached to the back area on both sides and she never had this before. She had nausea and vomiting but she only vomited once. At the time of report, she was still sick and stated that she felt like she was not getting well. Patient's causality for the events was yes and explained because she never had this kind of symptoms before. She always had the flu but the severity of it where it goes out below her ribs, she never had that. It was like her stomach was upset and she had the pain below her ribs. The patient had not recovered from the events.
PATIENT STATES GETTING HEADACHES ABOUT 3 DAYS AFTER GETTING VACCINE. SHE STOPPED BY PHARMACY ON 05/06/21  STATING HEADACHES WERE NOT TO BAD BUT SHE FELT LIKE THEY WOULD NOT GO AWAY.   FOLLOW CALL AFTER PT GOT HOME FROM LEAVING PHARMACY ON 05/06/21.  PER PATIENT AND NEPHEW TO CLARIFY ANY MISUNDERSTANDING OF LANGUAGE -  PATIENT DOING BETTER AFTER TAKING  IBUPROFEN.  STATES HEADACHE BETTER AND ONLY SLIGHTLY FEELING ANYTHING AND POSSIBLY NOTHING .  PATIENT CAME BY PHARMACY TO LET US KNOW, BUT THIS IS NOT A CLINIC OR DR OFFICE
So far she started having severe abdominal pain and we went to the doctor and they did an x-ray and they said she had severe constipation. And after he got her colon emptied she was still having pain so he referred her to an OBYN to see if there is a cyst on her ovary.  We went to the ER last night because her pain was where she couldn't handle it anymore and they doctor they will do an ultrasound scan of her gallbladder because they think it could be inflamed.  Her murphy's sign test came out positive.
3:00pm headache  10:30pm start of fever 101.8 followed by intense body aches all over the body but worse in the lower extremities. Cold chills developed as well with mild to moderate body shaking.  Symptoms lasted for 18 hours before totally stopping.
28SEP93 fever onset, rash which cont until 1OCT93 when neck became stiff;
probable trigeminal neuralgia.  severe pain in left side of face,  mainly in lower and upper jaw.  intensity comes and goes since the first episode.  in first 9 days, beginning July 9, had several episodes of severe pain daily, lasting from 5 min to 2+ hrs.  For next 12 days, had no severe pain episodes, but had constant dull pain in same area.  Had two more severe pain instances in same area over a 24 hr. period on July 30-31, and since then have had constant but bearable pain in same area.
In a constant mental fog; I have no short-term memory; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0180) via an unspecified route of administration in the arm left on 22Jun2021 at 16:00 as a single dose(at the age of 47-years-old) for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications within two weeks of the COVID vaccine. The patient had no known allergies. Prior to the vaccination the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID. On 22Jun2021, the patient reported that he was in a constant mental fog and had no short-term memory. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event in a constant mental fog and short term memory loss was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient was bit/scratch by feral cat. She received HRIG/Dose # 1 vaccine on 6/14/16, and remaining doses at emergency department. On 6/29/16 she call DOH service to complain of tingling/prickly feelings in both arms. By 6/30 930 patient felt better. At 1300 on 6/30 patient called DOH again c/p tingling, and abd pain. Patient was referred to her primary MD.
people she knows had side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (people she knows had side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (people she knows had side effects). At the time of the report, ADVERSE REACTION (people she knows had side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   Reporter did not allow further contact.
First had erythema nodosom on both knees, 5 days after vax. Tx'd with prednisone and ? other med. and they subsided. On 10/23 developed nausea,sweating and weakness and told by MD she had a flu virus. These symptoms continued and then she
24hrs post vaccination, patient developed bilateral arm swelling and redness with sandpaper like rash on both arms and chest. She developed throat tightness and went to ED and given IV steroids and benadryl.
9 blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (9 blood clots) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced THROMBOSIS (9 blood clots) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOSIS (9 blood clots) was resolving.            No concomitant medications were provided. The patient was in the ICU (intensive care unit) for 3 days. No additional treatment information was provided. The reporter stated that the patient thought that her Moderna COVID-19 vaccinations caused the blood clots.; 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. No further information is expected at this time.
Right upper arm started to become warm, itch, and swell 5 minutes after injection occurred. Took Tylenol  and placed cold pack on site.  Site remains painful, red, warm, and has formed a knot measuring 6.5 cm x 4.5 cm greater than 24 hours later.
I was 38 weeks pregnant. My baby's heart stopped beating. He was pronounced dead less than 24hrs after I got the flu shot.
(Health Fair) Client with mother. Received Tdap, HEB, MCV. Client c/o dizziness, nausea about 2 minutes after injections - head between knees, Mom gave apple juice. Became pale, diaphoretic, eyes rolled to back of head, fainted in chair - lowered to floor, feet elevated. Awakened 30-60 seconds after went. After 15 mins, sitting then standing, no SC.
Pt had red, raised rash over entire body with temperature of 100.5F and felt achy all over. Started on Friday night, 11/10/00, post vax, that same afternoon.
Received vaccine to left deltoid, developed immediate pain at injection site greater than typical for vaccines, then developed sudden blurred vision, lethargy, nausea, abdominal pain, chills, then fever to 100 degrees.
Pt recvd vax on 23FEB93 & on MAR93 devel OM & neutropenia & was hospitalized;
The patient did not feel well after her COVID vaccine. She reported feeling numbness on the left side of her tongue and lips in addition to itching just below her left shoulder. Her vitals were taking and she stated that the odd feeling is in the same location as a previous shingles outbreak. She was placed in a chair in a reclined position. She was oriented to place and time with no wheezing, shortness of breath, or chest pain. Face was symmetrical with no visible droop or swelling. She remained in a reclined position for 15 minutes, after which she reported feeling better. She was stable upon standing with no concerning symptoms. She was advised to call our facility or 911 depending on the severity of any additional symptoms. O2 Sat = 96%, BP 132/80
Felt a lump in left shoulder at injection site exactly 7 days after first injection. Approximately a 2x3 inch c it circular area was red and slightly itchy and mildly sore to the touch.
Pt recvd DTP/OPV/HIB 4SEP91 & was well in the PM; on 5SEP91 pt screamed for 1 hrs & then fell asleep, woke up later appeared restless; pt eyes very swollen, size of golf balls;
the problem is Adhesive Capsulitis; Soreness in the left arm; Developed into restricted motion of the left shoulder plus pain of motion; Developed into restricted motion of the left shoulder plus pain of motion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 09:30 (Lot number: ER8733) at the age of 64 years as dose 2, single and administered in arm left, administration date 29Mar2021 09:30 (Lot number: ER8734) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PERIARTHRITIS (non-serious) with onset Apr2021, outcome "not recovered", described as "the problem is Adhesive Capsulitis"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "not recovered", described as "Soreness in the left arm"; PAIN (non-serious), JOINT RANGE OF MOTION DECREASED (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "Developed into restricted motion of the left shoulder plus pain of motion". The events "the problem is adhesive capsulitis", "soreness in the left arm", "developed into restricted motion of the left shoulder plus pain of motion" and "developed into restricted motion of the left shoulder plus pain of motion" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of periarthritis. Therapeutic measures were taken as a result of pain in extremity, pain, joint range of motion decreased. Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
07/29/08, child seen for 12 month physical and follow-up on cat bite. On AUGMENTIN, treatment doing well. Received MMR, varicella, Hib, hepatitis B, Hib vaccines. 8/4/08, fever 102 X 1 1/2 days. Diarrhea X 1 day, excessive gas. Dx: Viral GE. 08/08/08, fever 102 X 2-3 days. When fever stopped, child got a rash to all body surfaces. She had runny nose, no diarrhea at that time. The rash was macular, with blanching, it was to all body surfaces, behind ears, palms. Dx: Viral exanthem. 08/08/08 at 5 PM, child crying, pulling on ears and hair. I asked to see the child. Appearance of rash changed. She was covered with herpes lesions to all body surfaces. Today, then skin is almost clear with some spots here and there.
Pt. reports "severe pain" in muscles, knee joints, ankle joints, extreme fatigue, feeling feverish ((no confirmed fever per pt). Severe shaking beginning in the morning on 6/16/09 and increasing in severity until about 2:30 am 6/17/09. Not relieved with ibuprofen or muscle relaxants. Pt advised to contact PMD for F/U, but had not done so yet.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021 at 2:17 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 2:17 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 66.07   Concomitant products were not provided. On 02-Mar-2021  Excursion time was reported at 9 am, 10 am, 11 am, 12 pm, 2pm and 3 pm with  temperature as 27,29,32,33,35 and 36 degrees Fahrenheit respectively , total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient was to receive BOOSTRIX and received TENIVAC in error. No adverse events were reported.
itching lips, itching tongue, mild disorientation, difficulty breathing.   Rash on arm at injection site 13 days later.
Severe rheumatoid arthritis pain in multiple joints. It was so painful that I had to use crutches due to my leg pain. Started taking ALEVE and naproxen for pain.
Patient started experiencing dizziness, flushing and rash. Vital signs obtained at 10:19, patient was feeling better and less dizzy, slight HA, swallowing fine. BP 166/57; HR 79; Temp 99.4. At 10:20 temp was 99.7. 650 mg of APAP given po at 10:22. At 10:30, patient c/o tension across shoulders, no c/o pain or pressure. At 10:32 dizziness improving with BP 167/63; O2 sats at 100%; HR 70, Temp 99.3. Benadryl 25 mg po given at 10:25. 10:47 O2 sats 100%; HR 72; BP 152/64.
This case was considered medically important. Information regarding PREVNAR was received from a consumer regarding a female patient who experienced developmental delays. The patient received a dose on an unspecified date. Additional suspect medication included HIBTITER. The patient experienced developmental delays on an unspecified date. The child is now 7 years old. No further information was provided.
flu-like symptoms: weakness, lack of energy, fever, were most severe about 12 hours after the shot. The next morning, I still felt weak, low energy. By 48 hours later, I felt I had fully recovered.
Right arm injection site-red/hard/pain  Narrative: On 1/12/21, right arm injection site was increased redness, pain. On 1/13 injection side redness increased/area became hard and shiny, reported to ER/ dx of cellulitis, given antibiotics.
Narrative:  Developed rash 11 days after initial covid vaccine, progressed & ultimately determined he had developed an aggressive peripheral T-cell lymphoma and the patient died of cardiac arrest likely precipitated by the lymphoma. The rash I believe is the T-cell lymphoma
2 days after this vaccine, Pt had paralysis of  left cheek and lower part of right cheek (closer to jawline), and paralysis and drooping of left eye, unable to fully close Left eye. Patient came to see me 4 days after the vaccination about this condition, and i suggested that he sees his medical provider.
2nd dose Moderna administered on Feb 3rd, fatigue/ shortness of breath week of Feb 23rd, admitted to Hospital on March 1st, spent 18 days in ICU, developed Blood CLOTS which one attached to lung, blood clots In left leg as well, no family history of blood clots and no injuries to cause blood clots.