chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Pounding headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (Medical history reported as patient has normal migraine).   On 11-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Pounding headache). At the time of the report, HEADACHE (Pounding headache) outcome was unknown. Not Provided          Concomitant product use was not provided. No treatment was reported. Action taken in response to mRNA-1273 was not applicable.; 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.
Like the form states no reaction with my first Shingle vaccine on my second one I did experience Shivering muscle ache neck and shoulders, felt cold and then hot a little nauseousness.
Patient had no adverse reaction as of 11/03/15 at 01:49 PM.
Diagnosed with chicken pox 3/16/2006.  Fever per parent report.  Scattered, small, mildly pruritic vesicles on back, face and legs.
The patient reported feeling tired and diziness beginning February 20, 2021 and had a stroke later that day. She was treated in the hospital for 4 days and later released. She did not get her second dose.
Vaccine failure- Child had Varivax- Saw doctor on 6-10-04. Diagnosed chicken pox 20-30 vesicles face, axilla and scalp.
About 14 hours after first dose I woke with a moderate headache that lasted 36 hours and continued mild/moderate since (i.e. nine days) most intense in the early hours. I've taken aspirin intermittently for the pain.
This spontaneous report as received from an other healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, patients were vaccinated with M-M-R II (dose, route, albumin status and lot number were not reported) that in January 2014 were exposed to 69.5F for 72 hours. No adverse effects reported. This case is linked to cases 1403USA014177, 1403USA014487, 1403USA014488 and 1403USA014486 via same reporter link. Additional information has been requested.
PATIENT GOT HER FIRST COVID PFIZER VACCINE AT 12/31 IN THE AM. HAD GOTTEN FLU LIKE SYMPTOMS AND HAD BEEN SICK FOR A COUPLE OF DAYS. HAD NAUSEA AND VOMITTING DURING THIS TIME AS WELL. ON 1/3 THE CARE GIVER WENT TO CHECK ON HER PT AT HER LTC FACILITY WHERE SHE LIVES AND SHE WASN'T ACTING RIGHT. SHE WAS UNABLE TO DO A STROKE EXAM. PT HAD NO MOVEMNET IN ARMS OR LEGS AND WAS UNABLE TO SPEAK. PT WAS VITALLY STABLE AT THE TIME. EMS RECORDED THAT THEY THOUGHT DIAGNOSIS WOULD BE STROKE, PNEUMONIA OR SEPSIS. AFTER ARRIVAL AT THE HOSPITIAL DETERMED THAT SHE HAD A STORKE, ACUTE KIDNEY INJURY, ABNORMAL LFTS.
I had a breakthrough case of Covid-19 with body ache, I also experienced headache and joint pain. I also fatigue with nasal congestion during my Covid infection.
Swelling on the right side of my body. My lymph nodes in my armpit were painfully swollen and now my right armpit right  peck, right side and right shoulder and bicep are all swollen.  The lymph node swelling has subsided a little after 4 days and is no longer painful but the ancillary swelling has not gone down.
10 minutes after receiving the injection, my ears began to ring. They have steadily rang since, except today it has increased slightly.
5/20 High fever developed within 24 hrs (5/21)  of receiving 5 yr boosters. Temp went 103 and ranged from 101 to 105 for 6 days (5/26). After 72 hours from shots, she got congested. Antibiotics (5/24) were given as a precaution for infection but she reacted then to that. Fever broke 5/26-5/27 middle of night.
PT REPORTS ACUTE ONSET OF HEADACHE ON 4/13/2021. SEVERITY OF HEADACHE IS MILD. HA IS INTERMITTENT AND SEEMS TO COME ON AFTER EATING PIZZA
Became SOB but used her inhaler with resolution of SOB but then at the end of her 30 minute observation period she developed a rash on her left LE. 4 quarter sized, erythematous raised, round lesions. She reported they were itchy. Skin exam and additional direct observation by NP completed for 30 minutes.  She was given 25 mg Benadryl. Itching resolved, rash began to fade. No additional rash or SOB. was released home with instruction for second benadryl if needed in 4-6 hours and call 911 if SOB, dyspnea or any other serious symptoms arise.
This spontaneous report has been received from a pharmacist referring to an unspecified patient of unknown age and gender. Information regarding the patient's medical history, drug reactions and concomitant therapies was not provided. On 30-JAN-2017,  the patient was vaccinated with an expired dose of ZOSTAVAX, (strength, dose, frequency, and route of administration were not provided),  lot # L039095 and expiration date 08-JAN-2017 for prophylaxis. No adverse effects were reported. Product quality complaint was not involved. Additional information is not expected because the reporter refused additional contact.
My son was given a flu shot 9/1/2017. He has cold symptoms and he is breaking out in hives all over his face, arms, and chest.
Full body soreness.  Legs feel extremely heavy, Left shoulder extremely painful as is my right wrist up to my elbow, Both legs and hip joints sore and painful. Lower left leg throbs and is hot.  Every now and then a rush of heat from my feet to my head overcomes me. This event even impacts my jaws. Difficult sleep as I cannot adjust with out waking up in pain. Sitting then standing very difficult. I am a 190 lb. fit male. Runner, gym guy, non-smoker, light drinker and aware of what I eat.  I have been working through these symptoms for 2 years, but they worsened after the shots.
her wife tested positive for COVID-19 between Oct 20-21 of this year; her wife tested positive for COVID-19 between Oct 20-21 of this year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset Oct2021, outcome "unknown" and all described as "her wife tested positive for COVID-19 between Oct 20-21 of this year". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Oct2021) positive. Therapeutic measures were taken as a result of vaccination failure, sars-cov-2 test positive. Clinical course: the reporter called on behalf of his wife, stating that she received the first and second dose of the Pfizer Biontech COVID 19 vaccine adult formulation in Jan2021 and Feb2021. He also stated that her wife tested positive for COVID-19 between Oct 20-21 of 2021 while she was in a skilled nursing facility after a fall. It was asked how long should the patient wait until receiving the booster dose. They also gave her an antibody shot while she was in the nursing facility and she's wanting to get the third shot or the booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I received the Pfizer third vaccination as a booster September 27,2021. Initially I only experienced pain at the injection site. Within 24 hours I was extremely tied and began to experience joint pain, a mild temperature and weakness in my extremities making it difficult for me to stand or walk. I also experienced trouble controlling my bladder for 12 hours. The headache persisted for more than 24 hours. I drank a lot of water and tried to rest to alleviate the symptoms and within 24 hours I started to recover. I was still to weak to get out of bathtub unassisted. Within 48 hours the symptoms had subsided.
This spontaneous report was received from a female consumer of unknown age regarding herself. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23, (dose, anatomical location, route, lot number and expiration date were not reported). There was no concomitant medication reported. The reported stated that after she was vaccinated with PNEUMOVAX23 she broke out (adverse event), the patient did not specify what she meant by broke out. The patient also mentioned that she had an unspecified injection site reaction after being vaccinated. At the time of the report, the outcome of the broke out and the unspecified injection site reaction after being vaccinated was unknown. The relatedness between the event and therapy with PNEUMOVAX23 was not reported. Additional information is not expected because no contact details were available.
Fever100.5, body aches, chills, shaking, headache, rapid heart rate
Very swollen 1 min aft Injection cont to swell one w/e reddened, sore.
Stiffness in hips, knee, and generalized body aches; felt like arthritis and frozen joints in hips and knees. Patient walked three miles at 1 PM. She normally walks 3 miles a day. Symptoms resolved 11/7/02.
Severe Arm pain, fever (only up to 100), body aches, head ache, brain fog, dizzyness; shortness of breath; profuse sweating, fatigue; nite sweats; stomach pain  LASTED FOR 10 DAYS
No adverse event; Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered).    No concomitant product reported by reporter. Patient received Moderna COVID-19 vaccine with Blue Capped Purple-Bordered (Ages 6-11 years Monovalent) instead of Blue Capped Gray-Bordered (Ages 6 and older BIVALENT) doses. No treatment medication reported by reporter.
pain at injection site Narrative:  Patient received first dose of COVID-19 Pfizer vaccine in a drive-through vaccination clinic. Patient reported warmth in the arm that received the injection and feeling like he was about to pass out approximately 15 minutes following vaccine administration. Patient then became lethargic with shortness of breath. Two doses of 0.3mg IM epinephrine were administered (Adrenaclick generic equivalent and 1 Epi-Pen) and patient was placed on oxygen. Following second dose of epinephrine shortness of breath improved and patient became more responsive. Patient was able to converse normally, refused an injection of IM diphenhydramine, and accepted an IM dose of methylprednisolone. Emergency response was called and patient was taken by Fire Rescue to MC. Upon arrival to ED, patient was alert and oriented x3. Only symptom verbalized was aching pain, score of 4 out of 10, in arm that received injection (right arm). Patient did not have a prior history of anaphylaxis.
Fatigue, low grade fever 99-102 on/off for 24 hours, muscle aches for two days
Headache for six weeks after first administration. On 5/2/18 patient suffered a ruptured aneurysm (pca). In June 2018/July2018, patient developed a rash on right side of neck/ear lobe area, which was thought to be an allergic dermatitis. 12/10/18, the same rash/same location developed. This time diagnosed as Shingles.
Severe lumbar pain with radiation down right leg. Lumbar radiculopathy. Lasted 7 days with use of analgesics, OTC, moist heat, ice.
Child screamed a high pitched squeal, went pale and then a gray/blue color.  Was lethargic and glazed over eyes, slow breathing.  Called 9-1-1.  Took child to Hospital--and they performed every test to rule out everything.  (Episode happened again while in Emergency room.)  Monitored for 2 days in hospital with cause documented as reaction to immunization shots.
PARENT CALLED STATING THAT CLIENT EXPIERENCED SWELLING/ REDNESS/ SORENESS. THE NEXT DAY CLIENT DEVELOPED FEVER OF 101 AND BLISTER ON THE OUTER AREA OF THE LEFT ARM. CLIENT WAS TAKEN TO ER BUT NO TREATMENT WAS GIVEN.  CLIENT WILL SEE PMD TODAY.
blood pressure was high; headache; itching; sorenessin arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), PAIN IN EXTREMITY (sorenessin arm), HYPERTENSION (blood pressure was high) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included Tooth implant. Concurrent medical conditions included Hypersensitivity (Sensitive to adhesive.). Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR), ROSUVASTATIN CALCIUM (CRESTOR), CENTRUM SILVER +50, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), ASCORBIC ACID (VITAMIN C FLAVOUR), VITAMIN D3, BIOTIN, FISH OIL, UBIDECARENONE, VITAMIN E NOS (COQ10 COMPLEX) and CALCIUM for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (itching), PAIN IN EXTREMITY (sorenessin arm) and HEADACHE (headache). On 02-Feb-2021, the patient experienced HYPERTENSION (blood pressure was high). On 02-Feb-2021, PRURITUS (itching) and PAIN IN EXTREMITY (sorenessin arm) had resolved. At the time of the report, HYPERTENSION (blood pressure was high) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: negative and negative. On 24-Feb-2021, SARS-CoV-2 antibody test: negative.         Treatment received for the events was not reported. Action taken with mRNA-1273 in response to events was considered unknown.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Contact information updated
Information has been received from a registered pharmacist, via a physician, concerning a female patient of unknown age. On 19-MAY-2013, 3 months ago, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and frequency were not reported) (Lot # and expiration date not reported). The patient sought medical attention by seeing the physician. At the time of the report, the patient's outcome of redness, pain and significant arm swelling "up to the shoulder" was unknown. Additional information has been requested.
sinusitis, bronchitis, otitis, tonsilitis; fever on & off was seen by MD; missed 2wks of work;
Awoke on Tues 12th @ 3AM c/o severely sore arm c/o feeling hot & sl nauseated; stayed awake @ 4AM exp 5 min episode of shaking & twitching all over; slept rest of hs unable to raise arm over head for 1-2 days; reduced ROM due to soreness;
Fatigue, headache, moderate nausea, muscle aches, joint aches, pain at and around site of injection, took two tylenol migraine pills after 3 hours (7pm on 1.12) and again after 14 hours (9am 1.13) along with promethazine for nausea and at 24 hours (7pm on 1.13). Symptoms all diminished; now after 51 hours (1.14 2pm) only mild headache and fatigue remain.
COVID-19 mRNA LNP-S, bivalen7 PF 12yrs-adult booster (Pfizer), 30 mcg/0.3mL. this information is taken from my app (Immunizations section).  On 12/28/22 one day after vaccine I noticed inability to raise voice as if losing voice.  Unable to "vocalize" like before.  Voice sort of strains, so I have to speak in a lower tone.  Described almost as if a teenage boy with changes trying to speak,  voice cracks. It's been several weeks and no change.  I've belonged to choirs previously but cannot "sound" off loudly anymore. Mentioned this to my primary physician as well as an ER doctor (visit unrelated to vaccine).  Not sure if anyone has had this side effect before after a booster, but I will no longer take another.
I am moving in with my daughter and getting all new health care providers. Now I had my first ablation on my heart about 20 years ago and things had been good but in the last years I have been troubles with PCV's and have started a medication and have had helped. I do have white coats syndrome and when I see health care providers my blood pressure will be high but when I saw my new cardiologist my systolic blood pressure was at 177 which is really high. I did have an instant in summer of 2022 where it was at 166 for the Systolic blood pressure but I had not thought too much about it but this new instant made me remember that. The new cardiologist checked my pulse, and we did two EKG's as well. He had me do a 24-hour monitoring of my blood pressure as well. I did have a follow up and we felt that we are okay to keep things the way they are with my medication and to keep monitoring my blood pressure. Some of my readings will be up in 130 range but I am supposed to be under 120 so I am having to watch going forward.
Cold sore appeared on lip by the morning of the second day.  Also felt some neck and back pain.
The day after recieving the Vaccine patient called and left message on our Voice mail complaining of an itch red rash with bumps. Patient also stated she ahd started Ginko Goldmax for mentla health on the same day. Patient was unreachable for further information
Multiple small blood clots in lungs. Put on blood thinners and is now home. Symptoms began as pain and trouble taking deep breaths on left side of upper side/back.
Approximately 6 hours after immunization administration, patient started with itching. The side effect lasted approximately 1 hour, but 15 minutes prior to the itching starting, she had taken her 50 mg routine scheduled dose of Benadryl. After the one hour of itching , the  patient reports she had no other issues.
Initial report receive from a nurse practitioner on 5/25/06. An 18 year old male pt developed nausea, indigestion, loss of appetite, loose stools and dizziness the day after receiving the injection of Imovax rabies, dose one lot number not reported, Ipol, lot number not reported, and hepatitis A vaccine lot number and manufacturer not reported on 4/20/06. The route and site and administrations for all vaccines was not provided. Per reporter, it is not known if the pt had any illness at the time of vaccination. The pt was seen by a physician. No treatment was reported. AT the time of this report the pt continues to have dizziness. Follow up information received on 5/22/06. On 4/20/06 the pt had received an IM dose of RabAvert, lot number 348011A, in the left deltoid, and IM dose of Hep A vaccine, lot number 1067R, in the right deltoid, and a 0.5cc SC dose of Ipol, lot number Y0824-2 in the left arm. The pt was seen by the physician on 4/25/06 for symptoms of nausea, decreased appetite, indigestion, diarrhea and inability to tolerate a regular diet. The pt reported that the symptoms had begun on 4/20/06, a few hours post immunization. The symptoms were still persisting on 4/25/06 and he was instructed to start a BRAT diet. The health center subsequently received 15 additional reports of students with similar symptoms as the pt. When the health center investigated, they discovered that all 15 students lived in the same dorm as the pt. They were all subsequently diagnosed with viral gastroenteritis. Of those 15 students, the pt was the only one who had received the RabAvert vaccine. It was concluded that the pt did not have a reaction to the rabies vaccine. The pt was diagnosed with viral gastroenteritis. On 4/27/06 the pt was again seen by the physician for persistent diarrhea and was prescribed Imodium. On 4/28/06 the pt reported to the health center that all of his symptoms had resolved.
Patient developed actual shingles approximately 2 weeks after receiving the vaccine 04/04/07-records received from facility for DOS 11/22-11/23/06 DC DX: chest pain syndrome status post coronary angiography which revealed normal coronary anatomy on 11/22/06-HX of pulmonary embolism 2002. Hyperlipidemia. Depression/anxiety. Chronic urticaria. Asthma. Records do not mention shingles. 04/10/07-records received from PCP-note for DOS 11/29/06-rash on left shoulder reddish evidence of healing vesicles.
Breakthrough Covid infection with headache, congestion, cough and body aches starting 7-3-2022. Negative home test on 7-4-2022 and 7-5-2022.  Positive Covid test 7-6-2022
Pt came into the pharmacy and requested a Covid vaccine. Pt filled out the form and discussed the screening questions and EUA with the RPh. Pt said this was her 1st covid dose. She was administered the vaccine and reminded to come back in a minimum of 3 weeks for a 2nd dose to complete the series.Pt's family member called later upset. They said she already completed the series and has memory issues. Apparently she was sent here to request a Covid test but requested and went through with a 3rd Pfizer vaccine instead. She was not scheduled to get a Covid test either at our store. Pt's family member was urged to come in and fill out a  form if pt is not able to manage her prescriptions/healthcare, but no form has been received yet. An internal pharmacy report was also made on the 3rd dose.
death 4/24/2021 causes of death listed on death certificate: 1) Pneumonia Due to COVID 19  2) Acute Respiratory Failure with Hypoxia  3) COVID 19  4) Acute Exacerbation of Chronic Obstructive Pulmonary Disease