chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had weakness in his arm and went to ER where his cardiac enzymes were high; had weakness in his arm and went to ER where his cardiac enzymes were high; This is a spontaneous report from contactable consumers. A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration in Apr2021 (lot number: ER8729) as single dose for COVID-19 immunisation. Medical history included Covid. Concomitant medications were not reported. The patient who previously had Covid received his first injection of vaccine. A few days after treatment he had weakness in his arm and went to ER where his cardiac enzymes were high (also reported as elevated cardiac enzymes and weakness in arm). He was admitted for observation. His doctor suspects that this may be linked to the vaccine and has reported to Pfizer and CDC. The doctors think the vaccine triggered what happened to put the patient in the hospital. The events required doctor clinic visit, emergency room visit and hospitalization. The patient was hospitalized from 16Apr2021 to an unspecified date. It was unknown if there was treatment given. It was unknown if the patient was tested for covid post vaccination. The patient was fine at the time of the report and was out of the hospital. The patient recovered completely from the event on an unspecified date in Apr2021.
This spontaneous report as received from a pharmacist via company representative refers to a 3 unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 inj (strength dose and frequency not reported) (lot# and expiration date not provided) (route). On an unknown date the patients developed injection site swelling and soreness after receiving PNEUMOVAX 23. The outcome of injection site swelling and soreness after receiving PNEUMOVAX 23 was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Information has been received regarding a case in litigation from a lawyer and a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The male patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2015, the patient, approximately 70 years old at time of vaccination, was administered the ZOSTAVAX by a physician at a physician's office (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician at the physician's office for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to self, loss of consortium, loss of services and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Rapid response called to Internal Medicine waiting room at 1010.    Pt found sitting upright in the waiting room chair alert with a patent airway and unlabored and adequate respirations. Pt is crying stating she is embarrassed. MD present along with MA and RN. Pt is assisted to the wheelchair and brought in to the infusion room for further monitoring assessment.    Pt received first covid vaccine today and states she was monitored for 15 minutes without side effects. She got in her car and started to drive away when she began to feel dizzy and experience slight lip swelling. Pt drove back to Medical Center and walked inside to IM waiting room.   Vitals obtained. BP slightly elevated and all other vitals WNL. Assessment performed by MD and 25 mg IM Benadryl is ordered at this time d/t slight lip swelling. 25 mg Benadryl given IM in right deltoid at 1020. Pt monitored for 15 minutes with signs of improvement. Lip swelling decreased and BP returned to normal range. MD reassess pt at 1035 and advises pt she can return home at this time.
Throbbing throughout the right arm/pain in the Right arm; Pain in the Right arm and right side of the neck; Warm to the touch injection site; pain woke her up last night; Red injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Throbbing throughout the right arm/pain in the Right arm), NECK PAIN (Pain in the Right arm and right side of the neck), VACCINATION SITE WARMTH (Warm to the touch injection site), INSOMNIA (pain woke her up last night) and VACCINATION SITE ERYTHEMA (Red injection site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced PAIN (Throbbing throughout the right arm/pain in the Right arm), NECK PAIN (Pain in the Right arm and right side of the neck), VACCINATION SITE WARMTH (Warm to the touch injection site), INSOMNIA (pain woke her up last night) and VACCINATION SITE ERYTHEMA (Red injection site). At the time of the report, PAIN (Throbbing throughout the right arm/pain in the Right arm), NECK PAIN (Pain in the Right arm and right side of the neck), VACCINATION SITE WARMTH (Warm to the touch injection site), INSOMNIA (pain woke her up last night) and VACCINATION SITE ERYTHEMA (Red injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported
About six years ago I had a hysterotomy but I did keep my ovaries- which means that while I did experience PMS I have been through menopause and have not dealt with PMS for a while now. After getting my booster about a month later I a period and experienced PMS. This was very strange as I had been done with menopause and and had my surgery. I was at my doctor for a normal and check up and due to family history we did an Ultrasound which showed that I had cysts on my ovaries. We did ultrasounds twice and both times cysts were seen on my left ovary and we also did a CA125. I ended up having my ovaries removed on January 19th 2022 and there were two more cysts on my right ovary. There is nothing that we found that could have brought this on other than having had my booster. No other life or health changes had occurred.
1213-patient receives vaccine 1225-tingling in mouth and lips 1230-itching Patient reports she takes many meds; has allergies which cause stomach aches and headaches 1240-No visible swelling of lips or face; no cough; no agitation; pulse strong, steady 70s; no breathing problems; no nausea; no redness visible. Possible mild hypertension vs. anxiety. Lotion applied to skin. Benedryl offered to  patient 25mg; patient prefers to take benedryl at home 1250-Patient ready to go home; offered to call EMS to check her; declined EMS, benedryl, water.  Was given nurse's phone number, RN, and asked to call as soon as patient arrived there. 1255-Walked patient to her car. 1425-Patient called RN, after running errand and is now home and reports feeling better.
got fever and fatigue for 2 days, then start to cough and lack of appetite continuously with weight loss gradually until annual checkup in May 2022 when doctor found swollen lymph node on his neck. Then a biopsy test indicate classic Hodgkin lymphoma disease. Although oncologist said there is no direct evidence this disease is because of covid 19 vaccine, we think it is related to our specific case as my son is very healthy without any health condition or issues for many years.
Patient described feeling her heart racing, palpitations, and gastrointestinal upset that lasted from approximately 11pm 8/27/18  to 7am 8/28/18.
Reported day after vaccine having faintness, tachycardia, hypertension, flushness, went to ER where treated and released with no further incident.
Approximately 2 hours post injection began to experience swelling  with numbness from Humeral head area to mid radial shaft of left arm. Palmar surface of left hand showed pallor with  reports of coolness. Fingers tingling. No decrease in range of movement.  Symptoms started to resolve by mid afternoon and improved gradually last evening last evening Today site appears normal, no numbness at present. Reports residual ache which is relieved by NSAID.
Upon injection of vaccine a small hard raised spot appeared at the injection site about half the size of a dime in diameter. There was no redness or fever at the site. Patient did not indicate any feelings of illness.
No adverse event; Patient received 0.25 ml of bivalent Moderna COVID-19 vaccine instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml of bivalent Moderna COVID-19 vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml of bivalent Moderna COVID-19 vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml of bivalent Moderna COVID-19 vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.25 ml of bivalent Moderna COVID-19 vaccine instead of 0.5 ml).    No concomitant medications were reported.  The patient received vaccine from a time period between 01-Sep-2022 to 26-Oct-2022. The reporter asked what to do next after the medication error incident occurred.  No treatment information was reported.  This case contains information for the seventeenth patient out of 20 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-665494 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665494:same reporter
Patient received 3 dose of pre-exposure rabies vaccine. No previous reaction reported by patient with first two. About 1.5 hr later pt. called back reporting vomiting x 1, headache, bad/metallic taste in mouth, eyes twitching and watery, tongue feeling tingling. Seen PA and told to take 2 BENADRYL, PEPCID and go home to rest.
Had 4 days of flu symptoms, followed by 3 days of sore throat/congestion and cough. Followed by severe tinnitus which is unresolved.
anaphylactic reaction; she felt funny, and states she felt fuzzy; her lips were fuzzy and a little numb; blood pressure and pulse that were elevated; blood pressure and pulse that were elevated; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of the Pfizer vaccine on 01Mar2021. Within 10 minutes of the vaccine she developed a mild anaphylactic reaction/mild allergic reaction, and wants to know if she can receive the second dose? Within 10 minutes of receiving the vaccine she felt funny, and states she felt fuzzy and her lips were fuzzy and a little numb. She denies any swelling and no numbness of the tongue. The doctor on site checked her blood pressure and pulse that were elevated, but she does take blood pressure medication. The outcome of the events was unknown.   Information about the Lot/batch number has been requested.; Sender's Comments: A causal association between administration of bnt162b2 and the onset of anaphylactic reaction cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
On 8/31/2020, the patient was administered improperly stored VARIVAX (reconstituted with properly stored Merck STERILE DILUENT); This spontaneous report has been received from a medical assisstant concerning a 13-month-old male patient of unknown ethnicity. The patient's concurrent conditions, known allergies/reactions, and medical history were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).  On 31-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S038701 with expiration date 01-DEC-2021; dosage regimen not reported) (reconstituted with a properly stored sterile diluent), subcutaneously for prophylaxis (indication also reported as ''well check'') , exposed at multiple temperature excursions between -9 degrees centigrades (C) and 8C (average -6.1 C) (no previous temperature excursions). Additionally, varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S032355 with expiration date 14-OCT-2021; dosage regimen and route of administration not reported) was also involved in temperature excursion between -14C to 10C for 116 hours; and -9C to 8C (average -6.1C) for 13 hours (time frame also reported as 129 hours) (no previous temperature excursions for this lot #). The call was performed due to a data logger.; Sender's Comments:  US-009507513-2009USA005503:
PFIZER BIONTECH COVID-19 VACCINE EUA. ADMINISTERED VACCINE TO PATIENT AND SHE WENT TO THE OBSERVATION AREA.  AFTER APPROXIMATELY 10 MINUTES THE PATIENT CAME BACK INTO THE VACCINATION AREA AND SAT.  SHE WAS FEELING NAUSEOUS AND THOUGHT SHE MIGHT VOMIT.  PATIENT COMPLAINED OF BEING SHAKY AND CLAMMY AND COLD.  PATIENT'S BP AND PULSE WAS NORMAL.  PATIENT RETURNED TO NORMAL AFTER 20 MIN.
Day 1 - 9/12/21:Immediately felt tingling sensation throughout my body.  Both arms went numb. Shortness of breath, Dizziness, weakness, difficulty speaking.  Went to hospital emergency room.  Day 2 -9/14/21: Heart racing and palpitations with minimal exercise. Fatigue and Shortness of Breath. General unwell feeling.   Day 4 -9/16/21: Shortness of breath, Extreme Fatigue. General unwell feeling. Heart palpitations. Irregular heartbeat. Day 5 - 9/17/21.  Extreme Fatigue and Shortness of breath with regular walking, heart racing, heart palpitations, irregular heartbeat, Went to hospital emergency room.  EKG came back irregular.  Same symptoms 9/18/21 through 9/25/21.  Saw primary doctor, another irregular EKG. 14 day Heart halter monitor was ordered/appointment scheduled. Day 14- 9/26/21: Constant Chest Pain and irregular heartbeat. Shortness of breath, extreme fatigue.  Day 15-9/27: Woke up with my left arm completely numb, went to hospital emergency room.  EKG and X Ray were completed.  Symptoms continued. Echo-cardiogram and Stress Test completed 10/6/21
RECEIVED 1ST PFIZER COVID19 DOSE ON 02/10/21. ON 02/21/21 REPORTED TO ER  COMPLAINING OF SHORTNESS OF BREATH(HX OF AFIB AND DUE TO HAVE CARDIOVERSION SOON). DIAGNOSED WITH ACUTE ON CHRONIC CONGESTIVE HEART FAILURE, ELEVATED TROPONIN, ELEVATED BNP LEVEL, AND LOWER EXTREMEITY EDEMA.  ON 02/21/21 ADMITTED AS INPATINET IN HOSPITAL.
"Covid arm" inflamed and red area surrounding injection site, hot to the touch. sore for the first few days but still red irritated and inflamed, puffy and somewhat itchy 4/10/21
Nurse saw client over weekend and was told that patient had a fever, enlarged lymph nodes and redness at injection site.
No additional AEs; PROQUAD was administered on 24 SEP 2020 however, it expired on 16 SEP 2020.; This spontaneous report was received from a medical assistant, who refers to a 6-year-old female patient. On 22-SEP-2015, when the patient was "a little over 1 years old", she received a dose of measles (+) mumps (+) rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot # K024035, expiration date 26-NOV-2016). Information regarding the patient's drug reactions or allergies, concomitant therapies and her other pertinent medical history was not provided. On 24-SEP-2020, the patient was vaccinated with expired measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live(rHA) (PROQUAD) vial, first dose, 1 dosage form, for prophylaxis, lot # S008573, expiration date 16-SEP-2020 (concentration, route of administration, frequency were not reported). The fact the patient received an expired dose of vaccine was discovered during an internal audit. The medical assistant would like information regarding revaccination to provide to the physicians. No additional adverse event reported. No product quality complaint (PQC) was involved.
Headache, nausea, body aches for 48 hours. Severe arthritis flare 5-7 days. Over the next 3-4 weeks the following symptoms developed: extreme debilitating fatigue, heart palpitations, elevated heart rate (116 at rest), brain fog/short term memory loss/cognitive impairment , shortness of breath with any activity, elevated blood pressure & extreme fluctuations in BP (69/47 low), overwhelming dizziness upon standing & with prolonged (>10 min) standing, loss of appetite & unintended weight loss, excessive bloating & GI distress, chronic insomnia with alternating non-restorative sleep , arthritis flare & muscle weakness,debilitating myalgia in neck & back, swollen lymph nodes, sore throat, periodic metallic taste in mouth, tremors/ shaking in arms & hands, periodic tinnitus, painful crippling lower leg & foot cramps. These symptoms continue to present day.
hives on hands and feet that spread to face, neck, ears  dizziness sore throat
Injection site a red round (like circle) is worm in touch and itchy; Injection site a red round (like circle) is worm in touch and itchy; Injection site a red round (like circle) is worm in touch and itchy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site a red round (like circle) is worm in touch and itchy), VACCINATION SITE PRURITUS (Injection site a red round (like circle) is worm in touch and itchy) and VACCINATION SITE ERYTHEMA (Injection site a red round (like circle) is worm in touch and itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site a red round (like circle) is worm in touch and itchy), VACCINATION SITE PRURITUS (Injection site a red round (like circle) is worm in touch and itchy) and VACCINATION SITE ERYTHEMA (Injection site a red round (like circle) is worm in touch and itchy). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site a red round (like circle) is worm in touch and itchy), VACCINATION SITE PRURITUS (Injection site a red round (like circle) is worm in touch and itchy) and VACCINATION SITE ERYTHEMA (Injection site a red round (like circle) is worm in touch and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Non significant follow up received on 21-MAY-2021, no new information
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in Ejection Arm), PYREXIA (fever of 100.8 degrees), CHILLS (Chills), RETCHING (Dry Heaving) and POLLAKIURIA (Excess Urination) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE, BENAZEPRIL, LOVASTATIN, VITAMINS NOS (DAILY VITAMINS) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced FOOT FRACTURE (Fractured Toe). On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in Ejection Arm), PYREXIA (fever of 100.8 degrees), CHILLS (Chills), RETCHING (Dry Heaving), POLLAKIURIA (Excess Urination) and ABDOMINAL PAIN UPPER (Stomach Ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain in Ejection Arm), PYREXIA (fever of 100.8 degrees), CHILLS (Chills), RETCHING (Dry Heaving), POLLAKIURIA (Excess Urination), FOOT FRACTURE (Fractured Toe) and ABDOMINAL PAIN UPPER (Stomach Ache) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: ADR form received om 04-MAY-2021 Contains No New Information ( NNI )
pt reported inflammation of arm - swollen, red, tender.  resolved after a couple of days on it own.
3:00 - received vaccine in upper right arm 8:00 - pain in upper arm 12:00 - midnight - severe pain awakened me. Took 400 mg ibuprofen 6 am - visited dr as upper arm was very swollen, sore, and red & hard. 400 mg ibuprofen & 1000 mg acetaminophen every four hours. Took 6-7 days to get back to normal. I have never experienced any adverse reactions from any vaccines. I had been injected with every shot mandated and/or offered while working in developing countries from 9/89 thru 6/08. I have/had been on homeopathic drops prescribed by a naturopathic practitioner beginning on 2/04. Is there any possibility the interaction caused the reaction? I stopped taking them on 2/19. While the painful arm was painful and restrictive, I was more concerned with the accelerated speed of my heart & shortness of breath accompanying weakness. I do have an irregular heart beat & will be scheduled (unrelated to shot) for a stress test. As I was barely able to move/use my arm for a few days, I was unable to attend my thrice weekly yoga classes until March 23. On March 24, I also began taking strength, stability and stretch classes twice daily. All's well that ends well.
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. On 1st October 2018, the patient received SHINGRIX (intramuscular) .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced muscle pain and pain localized. On an unknown date, the outcome of the muscle pain and pain localized were not recovered/not resolved. It was unknown if the reporter considered the muscle pain and pain localized to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The pharmacist reported that the patient had received the SHINGRIX vaccine on 1st October 2018 and experienced muscle pain in the area where she had received the vaccine. She also reported that the area felt sore. The pharmacist did not have lot, expiration date or the patient date of birth details.