chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ALLERGIES /INFLAMMATION REGARDING TO EAR; LEFT EAR NOT DRAIN WELL DUE TO HER EUSTACHIAN TUBE; CHILLS; HIP ACHE; GENERAL FATIGUE; LEFT EAR CLOGGED; RUNNY NOSE; FELT FOGGY; TOP OF LIP WAS SLIGHTLY NUMB/TINGLING; FEELING OF VACCINE TRAVELING DOWN TO HER RIGHT  HIP SOCKET; RIGHT LEG SORE NEAR THE HIP AREA/RIGHT LEG HURT AND HURT THE REST OF THE NIGHT/STILL SORE,COMES AND GOES INTERMITTENTLY ,ESPECIALLY AT NIGHT; FEEL HER HEART BEAT IN HER EARS; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer, and removal of 2 lymph node, and concurrent conditions included ear does not well due to eustachian tube. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980,expiry: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced general fatigue. On 03-APR-2021, the subject experienced top of lip was slightly numb/tingling. On 03-APR-2021, the subject experienced feeling of vaccine traveling down to her right hip socket. On 03-APR-2021, the subject experienced right leg sore near the hip area/right leg hurt and hurt the rest of the night/still sore, comes and goes intermittently, especially at night. On 03-APR-2021, the subject experienced hip ache. On 03-APR-2021, the subject experienced feel her heart beat in her ears. On 03-APR-2021, the subject experienced felt foggy. On 03-APR-2021, the subject experienced left ear clogged. On 03-APR-2021, the subject experienced runny nose. On 04-APR-2021, the subject experienced chills. On an unspecified date, the subject experienced allergies /inflammation regarding to ear, and left ear not drain well due to her eustachian tube. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general fatigue, top of lip was slightly numb/tingling, feeling of vaccine traveling down to her right hip socket, hip ache, feel her heart beat in her ears, felt foggy, left ear clogged, runny nose, and chills on 04-APR-2021, had not recovered from right leg sore near the hip area/right leg hurt and hurt the rest of the night/still sore, comes and goes intermittently ,especially at night, and the outcome of left ear not drain well due to her eustachian tube and allergies /inflammation regarding to ear was not reported. This report was non-serious.
A non serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a fifteen-month-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. During the week of 10-Oct-2008 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Received the 1st COVID vaccine Pfizer EW0171 Expiration date 04/17/21 at 5:51pm. Client reported to EMT that she was experiencing "pins and needles sensation throughout her entire body" at 12:43pm. RN responded. Client sitting in chair complaining of "pins and needles sensation in her legs and arms". Client denies experiencing itchiness, shortness of breath, flushing of face, head, palms, hives, pruritus of legs/hand/arms/or palms, urticaria, dizziness, GI symptoms, swelling, or chest pain at this time. Client reports she began to experience the pins and needles sensation about 1 minutes after receiving the vaccine, but decided not to say anything during her 30 min observation period until 2 minutes prior to her 30 min observation period ending. She reports experiencing a non-radiating left sided chest tightness which lasted one minute which occurred a few minutes after receiving the vaccine. Client reports medical history Raynaud's Syndrome. Client reports receiving approval from PCP to receive this vaccine. Client reports history of intermittent chest pains/tightness which has been evaluated multiple times. Client report this incident of chest pain felt similar. Client notes she was prescribed Aspirin 81 mg by her Rheumatologist and she usually takes the Aspirin when she has chest pains or arm pains. Per Client, she has experienced pins and needles sensation in the past. She reports the last time she experienced a pins and needles sensation was after drinking. She denies similar incident with other vaccines.   Client was placed in semi-fowlers position, offered water. Client is a/o x4. RN offered client activation of 911. Client denied. RN gave pt strong recommendation for activation of 911 or further evaluation given symptoms reported. Client verbalized understanding and reported she does not want activation of 911. Client was observed for an additional 45 minutes. VS at 1244 BP 11/78 HR 82 RR18, VS at 1255 BP 114/76 HR 76 RR 14, VS at 1303 116/74 HR 72 RR 14, VS 1315 BP 114/72 HR 76 RR 15, VS 1335 BP 116/76 HR 74 RR 14.  Symptoms resolved at 1328. Client notes Fiance is driving client home. At this time, RN offered EMS activation for transport to the hospital x2. Client denied. bRN provided client with ER precautions. RN walked client to Fiance's car. Client walking with steady gait. No additional concerns reported. RN provided client with education on F/U with PCP regarding current situation provided, importance of reporting symptoms as soon as they occur, and s/s concerning symptoms of anaphylaxis and allergic reaction.  Client verbalized understanding. No further RN interventions required at this time. RN
nausea, light headed, vss checked with patient brought to obs room. seen by MD. released home after 1050
This non-serious spontaneous case, was initially received on 14-Sep-2017 from a pharmacist and concern a 60-year-old adult female patient. The patient had not received any relevant concomitant medication. On 12-Sep-2017, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, batch number: 195214, expiry date: Apr-2018, route of administration and anatomical location: not reported). On the same day, after an hour of vaccination (flu shot), the patient had difficult in breathing and was admitted to the emergency room. She was diagnosed with pleurisy and left the emergency room on the same day. At the time of this report, the outcome of the event was recovering (reported as 'patient was ok after leaving from the hospital'). Follow-up received from the reporter on 22-Sep-2017: As per the follow-up the case was downgraded from serious to non-serious, as the patient was admitted to emergency room, but not hospitalized due to event. The outcome of the event was updated from unknown to recovering. It was reported that, patient had not received any relevant concomitant medication. Narrative amended accordingly. Non-significant follow-up report received on 06-Oct-2017: The patient was recovering and reported no further problems. Amended narrative accordingly. Non-significant case correction received 14-Sep-2017: Batch no. (195214) was captured in the case from and narrative was amended accordingly.
head to toe vesicles w/low grade fever 100-orally for 24hr;vesiclesencrusted 5-7 days p/rash;
Pt with 1.5 cm circular lesions on leg and arm with swollen raised red border.
Next day had fever of 101.7; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the arm left on 06Apr2021 at 15:00 (at the age of 68-Year-Old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included ubidecarenone (Q10), fluorescein sodium (FLORES), dutasteride (AVODART), rosuvastatin calcium (CRESTOR) and omeprazole (MANUFACTURER UNKNOWN); all from an unknown for unspecified indication. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6204) via an unspecified route of administration in the left arm on 03Apr2021 at 15:00 (at the age of 67-Year-Old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was 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 4 weeks prior to the COVID vaccine. On 07Apr2021 at 10:00 (next day), the patient experienced fever of 101.7. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. On 07Apr2021, the patient underwent body temperature test and the result was 101.7 (Unspecified units). The clinical outcome of the event fever of 101.7 was recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Nasal congestion; Unevaluable event. Information regarding Flumist 2003-4 Formula influenza virus vaccine, live intranasal 2003-4 formula nasal solution frozen was received from a female consumer who received a dose on an unspecified date and experienced an adverse event. A consumer reported that she developed a stuffy nose, nasal congestion and upper respiratory symptoms (unevaluable event) after receiving a dose of Flumist on an unspecified date. No additional information was available at the time of this report.
can't be stand for too long because start feeling malaise, she only can be lying down; intense pressure on her back head; Intense pressure on her neck; Sometimes feels like pins sticking on head; Dizziness; Panic attack in the night; Isn't able to sleep; Feeling malaise; still have strong headache/ did some exercise and on the afternoon she get up and felt a strong headache/ this headache doesn't go away; felt like I was going to die; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like I was going to die), DYSSTASIA (can't be stand for too long because start feeling malaise, she only can be lying down), HEAD DISCOMFORT (intense pressure on her back head), NECK PAIN (Intense pressure on her neck) and PARAESTHESIA (Sometimes feels like pins sticking on head) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety disorder (treatment with natural things).    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced FEELING ABNORMAL (felt like I was going to die) and HEADACHE (still have strong headache/ did some exercise and on the afternoon she get up and felt a strong headache/ this headache doesn't go away). On an unknown date, the patient experienced DYSSTASIA (can't be stand for too long because start feeling malaise, she only can be lying down), HEAD DISCOMFORT (intense pressure on her back head), NECK PAIN (Intense pressure on her neck), PARAESTHESIA (Sometimes feels like pins sticking on head), DIZZINESS (Dizziness), PANIC ATTACK (Panic attack in the night), INSOMNIA (Isn't able to sleep) and MALAISE (Feeling malaise). The patient was treated with PARACETAMOL (TYLENOL) 03-Aug-2021 for Headache, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt like I was going to die), DYSSTASIA (can't be stand for too long because start feeling malaise, she only can be lying down), HEAD DISCOMFORT (intense pressure on her back head), NECK PAIN (Intense pressure on her neck), PARAESTHESIA (Sometimes feels like pins sticking on head), DIZZINESS (Dizziness), PANIC ATTACK (Panic attack in the night), INSOMNIA (Isn't able to sleep) and MALAISE (Feeling malaise) outcome was unknown and HEADACHE (still have strong headache/ did some exercise and on the afternoon she get up and felt a strong headache/ this headache doesn't go away) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received included information about patient demographics, additional events, other relevant history, dose 1 details  and treatment medication was added to the case.
is experiencing "facial nerve issues" / first division of the trigeminal nerve up to his eye noted; burning on the left side of his face; scalp, and skin tenderness noted as well when shaving; tingling on the left side of his face; This case was reported by a physician via call center representative and described the occurrence of facial nerve disorder in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced facial nerve disorder, burning sensation in face, skin tenderness and tingling. On an unknown date, the outcome of the facial nerve disorder, burning sensation in face, skin tenderness and tingling were unknown.   It was unknown if the reporter considered the facial nerve disorder, burning sensation in face, skin tenderness and tingling to be related to Shingrix.  Additional details were provided as follows: The patient experienced "facial nerve issues, burning and tingling on the left side of his face, first division of the trigeminal nerve up to his eye, and scalp, and skin tenderness noted as well when shaving." Consented to follow up.
Became immediately woozy and started seeing stars; Felt fatigued; rapid heart rate/heart rate was pretty high, in the 160s-170s; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 at single dose for COVID-19 immunisation. The patient's medical history included COVID-19 on an unspecified date in 2020. She had COVID in the month of December and ended up in the hospital and received the monoclonal antibodies by day 2 or 3. The patient reported she had a cardiac implant to monitor her heart rate (a loop recorder). The patient's concomitant medications were not reported. On an unspecified date in Mar2021 at about 5 in the evening, the patient reported that she had her first dose of the vaccination, the moment vaccine was injected, she became immediately woozy and started seeing stars which subsided within a few seconds. The patient reported that within an hour, she felt fatigued and nothing more than that. The patient reported that at about 8, she started out of nowhere getting a rapid heart rate and so she called her local doctor. The patient reported that she to local emergency room and called a nurse and explained what she was feeling. Her heart rate was pretty high, in the 160s to 170s, electrocardiogram (EKG) was taken and her heart was fine. The patient reported that she never had shortness of breath or rash. They asked her if she had taken a pain reliever and she said no and she had not taken anything before or after and the nurse suggested Ibuprofen. The patient took an Ibuprofen 800mg. The patient reported when she left, they had put on her paperwork she had an adverse reaction to the vaccination, and she needed to contact her primary care doctor and her cardiologist before she proceeded to get the second dose. The patient reported that she was fine when she woke up the next morning. The patient reported she did not have that much pain in her arm either and she was struggling on deciding whether she should get the second dose or not. The patient reported her husband is concerned because of the new delta variant and she only had one dose. The patient reported that about an hour after the Ibuprofen intake, her heart rate came down. The patient reported her doctor told it could have reduced the inflammation response to the vaccine but could not explain why the moment she received vaccine, she became lightheaded and woozy. The patient had recovered from the events on an unspecified date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Within 2 days I had a fever and pain and swelling at site and area was hot to the touch. Was told this was a normal reaction so I took Advil for the pain and fever. Affected area continued to grow larger. By day 6 my fever was up to 103.4 and I felt extremely ill. Went to the doctor and he had me go to the ER. They ran bloodwork and cultures and did a CT scan of the area (no abscess). IV antibiotics were administered along with Toradol for pain and fever and Zofran for nausea. They admitted me to the Rapid Care Unit for observation and continued IV meds. My fever continued to spike over the next two days as they changed around my antibiotics. Once I was fever free for 24 hours I was released on oral antibiotics on Friday 5/24. I have been sleeping a lot since then and have significant soreness in my right hand from the IVs (needed 4 different ones because they became occluded).
Anaphylaxis- full-body itching, lightheadedness, scratchy throat.
Vomitting; severe abdominal pain secondary to pancreatitis; severe abdominal pain secondary to pancreatitis; This is a spontaneous report from a contactable Consumer (patient). A 72-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 19Feb2021 10:15 at single dose at right arm for covid-19 immunisation. No pregnant at time of vaccination.  Medical history included Diabetes, three prior strokes, cardiac stent, Seafood and pollen allergy.  Concomitant medication included paracetamol (TYLENOL) and unspecified medication.  The patient experienced Vomitting, severe abdominal pain secondary to pancreatitis for nonalcoholic patient with no history of abdominal pain or gallstone on 19Feb2021 18:00, which lead to Emergency room/department or urgent care, Hospitalization. Hospitalization lasted 4 days. Therapeutic measures were taken as a result of events included unspecified therapy. The outcome of events was recovering.  information on the lot/batch number has been requested.
tremors and headache; tremors and headache; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included methotrexate sodium taken for an unspecified indication, start and stop date were not reported; adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported; infliximab (REMICADE) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), on an unspecified date as 1st dose, single dose for covid-19 immunisation. On an unspecified date, the patient experienced tremors and headache. After 15th infusion, patient experienced tremors and headache, post 2nd Vaccination for Covid believed to be Pfizers. Patient used Humira, prior to switching to Remicade. Had received 2nd Covid Vaccination at least two weeks prior to their infusion. (Name) said it was unknown if it was Pfizer or Moderna, but Pfizer was more commonly available being it came out first. No previous issues with Remicade until 2nd Covid shot. Event took place after use of product. The outcome of the events was unknown.  Information on lot/ batch number has been requested.
My life pass before me. I come to shaking violently I felt like my body core temperature was extremely low. I could not move 4 quite a while. Made it into a hot shower for about 30 to 45 minutes. Could hardly walk into the next day. The soreness travel from my left arm all the way across my back into my right arm
anaphylactic reaction from Covid vaccine; nausea; This is a spontaneous report from a contactable Other Health Professional (HCP). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown) on an unspecified date (unknown age at the time of vaccination), at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received pegvisomant (SOMAVERT) and experienced nausea. Patient reported the following: pegvisomant 30 mg daily; five missed does due to anaphylactic reaction from Covid vaccine and missed doses (amount missed or dates unknown) due to nausea. MD aware. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available and the known product safety profile, a causal association between the reported event 'anaphylactic reaction' and the suspect product BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sore upper left arm at injection site  has continued to current date.  Especially painful in morning when getting up and moving about. Cannot sleep on left side without pain.
Breastfeeding; This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0161321A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment taken was reported.
Very sore arm and shoulder in area of flu shot injection. More painful as hours and days and weeks went on. Can't move my right arm past 90 degrees from my side with out pain. Pain wakes me up every night since 10-16-15.