chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient Patient presented to vaccine clinic for first covid-19 vaccine. Just prior to Pfizer vaccine administration, Mother stated pt to receive Moderna vaccine--back and forth distracted writer, patient appeared older/mature. Pfizer was initially chosen to be given to patient, debate ensued resulting in moderna was administered. Once error was noted patient was made aware, Pediatrician Dr. notified, and case discussed with Dr. Per Dr. patient will receive Pfizer second dose 4 weeks from today. Dr. confident that there will be no adverse effects, as moderna pursues approval for pediatric dose, no significant adverse effects have been reported. Patient left clinic alert, orientated, offered no complaints.
Patient received the vaccine, and 15 minutes or so after she experienced dizziness and nausea. She sat in her walker, and the ambulance was called as it was deemed it may not be safe for patient to drive. She agreed to having the ambulance called. When the ambulance came they asked her a series of questions, and they left without taking her.
fatigue, joint pain, chills, muscle pain, headache, redness at injection site, hardness at injection site (Self administered Ibuprofen 600 mg q8 X 3 doses)
Developed bruising/ecchymoses on various parts of body. 5 days after Flu vaccination seen in my office 10/30/09, referred to a Hematologist, seen same day-Platelet count = 2. Dx: Acute ITP.
Sweating, nausea, weakness, chills, diarrhea, several abdominal pain, trembling
Info has been received from a physician concerning a 7 year old male who, at 12 months of age, was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 2/23/06, the pt presented with about 25 lesions on his torso that they thought might be chickenpox but the physician was unsure of the diagnosis. Unspecified medical attention was sought. No diagnostic lab tests were performed. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Additional info has been requested.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 17-FEB-2016, the patient was vaccinated with a dose of GARDASIL (lot # L020015 and expiration date August 2017, unknown route), which was exposed to temperature outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Shoulder suddenly swollen, hot and red; Shoulder suddenly swollen, hot and red; Shoulder suddenly swollen, hot and red; Increasingly worse seasonal allergies; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (Increasingly worse seasonal allergies), SWELLING (Shoulder suddenly swollen, hot and red), ERYTHEMA (Shoulder suddenly swollen, hot and red) and SKIN WARM (Shoulder suddenly swollen, hot and red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced SEASONAL ALLERGY (Increasingly worse seasonal allergies). On 10-Jan-2021, the patient experienced SWELLING (Shoulder suddenly swollen, hot and red), ERYTHEMA (Shoulder suddenly swollen, hot and red) and SKIN WARM (Shoulder suddenly swollen, hot and red). At the time of the report, SEASONAL ALLERGY (Increasingly worse seasonal allergies), SWELLING (Shoulder suddenly swollen, hot and red), ERYTHEMA (Shoulder suddenly swollen, hot and red) and SKIN WARM (Shoulder suddenly swollen, hot and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
She experienced diarrhea; She became constipated; She felt a cramp and pain in the stomach; She was sleepy; She was very tired; She experienced off balance feeling; She experienced soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She experienced soreness of arm), BALANCE DISORDER (She experienced off balance feeling), SOMNOLENCE (She was sleepy), ABDOMINAL PAIN UPPER (She felt a cramp and pain in the stomach) and CONSTIPATION (She became constipated) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (She experienced soreness of arm). On 27-Feb-2021, the patient experienced BALANCE DISORDER (She experienced off balance feeling). On 03-Mar-2021, the patient experienced SOMNOLENCE (She was sleepy) and FATIGUE (She was very tired). On 04-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (She felt a cramp and pain in the stomach). On 08-Mar-2021, the patient experienced CONSTIPATION (She became constipated). On an unknown date, the patient experienced DIARRHOEA (She experienced diarrhea). At the time of the report, PAIN IN EXTREMITY (She experienced soreness of arm), BALANCE DISORDER (She experienced off balance feeling), SOMNOLENCE (She was sleepy), ABDOMINAL PAIN UPPER (She felt a cramp and pain in the stomach), CONSTIPATION (She became constipated) and DIARRHOEA (She experienced diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  Treatment information included ice and anti diarrhea medication for the diarrhea.
6/20/05 4:30pm Employee reported a "sunburn" sensation along the top of her left arm within one minute after receiving first rabies vaccination. Skin was sensitive to light touch as if "sunburned". There was a faint pinkness to the dorsal area of the left arm from the injection site to the wrist. No rash, itching or hives. She also developed a distinct triangular "wing" shaped area of flusing on both sides of her chest just below her clavicle and above her breast area . These were not present prior to vaccination. No hives, dyspnea, itching, or swelling noted. B/P 138/80 p. 88 regular, R. 22.  Alert and oriented. Given 25mg Benadryl Elixir p.o. and observed. 4:45pm - B/P 138/80  P. 74 R. 20. No change in flusing or burning sensation to left arm. Given 25mg Benadryl Elixir p.o. Noted some localized reddening around the injection site. No other symptoms. 5:35pm B/P 138/78 P. 70 R. 20 slightly drowsy, but alert and oriented. Flush over chest resolving. No change in sunburn sensation on left arm. 5:50pm Seen by M.D., examined and discharged to complete her shift at the shelter (15 min.) 6/21/05 Contacted employee at home. States no additional flusing experienced. Left arm is mildly sore when she uses it, "like a tetanus shot". No hives or other reactions developed.
Acute onset lower extremity weakness and ataxic gait presented to ED at 1104, absent reflexes. Receiving IVIG.
This spontaneous report as received from a pharmacy technician refers to a 3 patients of unknown ages whose on an unspecified dates was vaccinated with an expired dose of PNEUMOVAX23 during the time period of 14-SEP-2012 thought 18-SEP-2012. The PNEUMOVAX23 had an expiration date of 14-AUG-2012. No symptoms were reported. Additional information has been requested.
Narrative: Patient received the J&J COVID-19 vaccine on 3/30/21. On 4/6/21 patient awoke with acute onset of dizziness and nausea. He presented to a local ED for evaluation. Described a sensation of the "room is spinning" and resulting in nausea. Physical exam was unremarkable, but BP elevated 231/101. EKG normal. Head CT with no acute findings. Denies history of vertigo. Pt has diabetes, with recent history of hypoglycemia, but BG at the time not reported.
improperly stored vaccine administered; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were unknown.       On 17-NOV-2019, the patient received an improperly stored dose (product storage error) of hepatitis b vaccine thimerosal free (recombinant) (RECOMBIVAX HB) injection, 5 microgram (mcg) per 0.5 milliliter (ml), lot # R021372 and expiry date 25-MAY-2021 reported, for prophylaxis (strength, anatomical location and route not reported). The time frame for multiple temperature excursions was 25 Fahrenheit (F) for 6 hours 28 minutes and 55F temperature for seven hours. It was reported that there was no previous temperature excursions done. Data logger was involved. The outcome of product storage error was unknown. No product quality complaint involved.
Really fatigued, called out from work; even called out from; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2021, the patient received the 2nd dose of Shingrix. In December 2021, less than a week after receiving Shingrix, the patient experienced fatigue and activities of daily living impaired. On an unknown date, the outcome of the fatigue and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the fatigue and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received second dose of Shingrix and experienced fatigue. The patient even called out from work. The reporter wanted to know how long, on average, do recipients felt like this. Consent to follow up was not possible as no contact details were available.
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 11-FEB-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 360 hours with 34 degrees C and 168 hours with 33 degrees C as the lowest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint (PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.   Reporter did not allow further contact
Significant ringing in ears and feeling of fullness.  Noise is rushing and a bit pulsate. Some mild lightheadedness.
Pt returned to office with c/o left arm hard, red area, & warm to touch 2 days after receiving vaccine. Diagnosed with cellulitis and prescribed BACTRIM.
Burning in her arms and down sides of her legs; Leg muscle weakness; Tripping; Felt like she could not lift her legs; Burning in her trigeminal nerves in her face and eyes; Allergic reaction to Imovax/Imogam; Initial information was received on 15-Nov-2021 regarding an unsolicited valid non-serious case received from consumer or non-healthcare professional via Medical Information (MI) - 00857352.  This case involves a 41-year-old female patient who experienced tripping (Gait disturbance), burning in her arms and down sides of her legs (burning sensation), leg muscle weakness(muscular weakness), allergic reaction to imovax/imogam (hypersensitivity), burning in her trigeminal nerves in her face and eyes (trigeminal neuralgia) and felt like she could not lift her legs (asthenia) after receiving IPV (VERO) [IMOVAX] and while treated with HUMAN RABIES IMMUNOGLOBULIN [IMOGAM].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On Sep-2021, the patient received a dose of suspect IPV (VERO) [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On Sep-2021, the patient started taking IMOGAM (HUMAN RABIES IMMUNOGLOBULIN) [Solution for injection, lot - T1E94, expiry date not reported] via unknown route at an unknown administration site.  On an unknown date the patient developed a serious tripping (gait disturbance), burning in her arms and down sides of her legs (burning sensation), leg muscle weakness (muscular weakness), allergic reaction to imovax/imogam (hypersensitivity), serious burning in her trigeminal nerves in her face and eyes (trigeminal neuralgia), felt like she could not lift her legs (asthenia) (unknown latency) following the administration of IPV (VERO) and following the first dose intake and (unknown latency) following the last dose intake of HUMAN RABIES IMMUNOGLOBULIN.   Relevant laboratory test results included: On an unknown date: Magnetic resonance imaging (was ok), Scan brain (was ok).  it was reported "Caller reports she had Imovax and Imogam starting in SEP2021. She reports increasing neurological reaction with each vaccine. She had 3 injections in the series and did not finish. She states after first vaccine she had burning in her arms and down sides of her legs, which she reported to health department but it was recommended she continue the vaccine. She got the second in the series and had burning in her trigeminal nerves in her face and eyes. She again reported this and it was recommended she get the third in the series. She then had leg muscle weakness, tripping and it felt like she could not lift her legs. She was referred to neurologist. She had brain scan and MRI which were ok and was told it was an allergic reaction to Imovax/Imogam."  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the reported events.  There will be no information available on the batch number for this case.
Starting slightly before the vaccine, I had some dizziness. After the vaccine, the dizziness progressively worsened especially when getting up from sitting down or laying down (mostly from getting up from laying down and going back down). I tested my blood pressure and it was high. I saw my doctor on 06/10/2022 and he then had me come back on 06/13/2022 for tests. The test results are just starting to come back and I will not see him for another 3 weeks unless there is a big issue. I was started on a blood pressure medication and its seeming to help but not 100%.
5:30 began vomiting, total of symptoms: dizzy, lightheadedness. Left arm numb. At 9PM, afraid to go to sleep, but did. In AM, a little lightheaded and arm just sore.
On 11-5-2007 patient received Dtap, MMR, IPV in right arm - On 11-6-07 am the right Deltoid was Red and Swollen and hot-
Migraine; Severe bloody nose; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), EPISTAXIS (Severe bloody nose) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced MIGRAINE (Migraine), EPISTAXIS (Severe bloody nose) and HEADACHE (Headache). At the time of the report, MIGRAINE (Migraine), EPISTAXIS (Severe bloody nose) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication and concomitant medications were not provided.
Severe Neuropathy - nerve pain in feet , unable to stand and walk without assistance for 2 weeks.  Self-described as "crippled" and unable to sleep while pain was going on.  patient said he only walks (doesn't drive) and wasn't able to see the doctor or go to the hospital because he couldn't walk.  It resolved after 2 weeks.
Swelling, urticaria in entire arm.  Extreme pain in arm/shoulder. Neck pain
Significant swelling, redness, warmth, and discomfort of left upper arm. Patient reports there is a bump on her arm the size of a softball.
Edema of left thigh and knee, severe pain, normal pulse, no erythema a induration noted with overall tightness of thigh, Arthus type reaction.
On 10/18/00, the pt received his first dose of Havrix. On 10/18/00 he experienced malaise, myalgia, arthralgias, fever of 102 and tingling body. He was treated with acetaminophen and rest. Symptoms resolved on 10/20/00. Havrix was discontinued. As of 10/20/00, the outcome of the events is resolved.
She gets so many symptoms for 3 days/she has had all the side effects that are on the list of general side effects; Loses control of her bladder/She could not control her urine; She was just as sick if not more sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She gets so many symptoms for 3 days/she has had all the side effects that are on the list of general side effects), URINARY INCONTINENCE (Loses control of her bladder/She could not control her urine) and ILLNESS (She was just as sick if not more sick) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Halloween last year) in 2020. Concurrent medical conditions included Shortness of breath (shortness of breathe of when she had COVID-19). Concomitant products included OMEPRAZOLE, METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SIMVASTATIN, AMLODIPINE, VERAPAMIL, CHONDROITIN SULFATE SODIUM, GELATINE HYDROLYSATE, GLUCOSAMINE SULFATE, HYALURONIC ACID (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GELATINE HYDROLYSATE;GLUCOSAMINE SULFATE;HYALURONIC ACID]) and RISEDRONATE SODIUM (RISEDRONATE) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She gets so many symptoms for 3 days/she has had all the side effects that are on the list of general side effects), URINARY INCONTINENCE (Loses control of her bladder/She could not control her urine) and ILLNESS (She was just as sick if not more sick). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (She gets so many symptoms for 3 days/she has had all the side effects that are on the list of general side effects), URINARY INCONTINENCE (Loses control of her bladder/She could not control her urine) and ILLNESS (She was just as sick if not more sick) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient told her doctor how sick she got and her doctor said she never heard all that before.  Patient still had shortness of breathe of when she had COVID-19 but it had not gotten worse.   This case was linked to MOD-2021-378251, MOD-2021-378340 (Patient Link).
Instant swelling at injection site. Patient lightheaded and had to lay down. Swelling did not cease so we administered an EpiPen 0.3mg within 2mg and called 911. Blood pressure climbed to 191/101. EMS arrived within 15 minutes. Reaction was diagnosed as a hematoma. EMS recommended patient to ER but patient refused.
upper part of her arm started getting itchy; upper part of her arm started getting red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (upper part of her arm started getting itchy) and VACCINATION SITE ERYTHEMA (upper part of her arm started getting red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Bee sting hypersensitivity.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (upper part of her arm started getting itchy) and VACCINATION SITE ERYTHEMA (upper part of her arm started getting red). At the time of the report, VACCINATION SITE PRURITUS (upper part of her arm started getting itchy) and VACCINATION SITE ERYTHEMA (upper part of her arm started getting red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
16 minutes post vaccination patient reported dizziness. Vitals: 114/72, 92, 100%. VSS. Patient declined wheelchair and walked to the exit by RN. Patient had steady gait and in stable condition at 19:20.
unk fever, local react-pain, swelling, warm to touch; adenopathy-generalized; 30 day f/up-pt recovered;
Severe Itching, rash, blurry vision.  Benadryl, monitoring
After vaccines were all completed, the pt was seated and stated she wasn't feeling well and was very hot and that she might pass out. Two RNs were present in the room the entire time. Pt was seated in the chair and passed out. One RN was on each side of the pt to ensure she did not fall out of the chair. She was kept in a sitting position while unconscious. Pt experienced seizure like activity for a few seconds and then regained consciousness. Two other RNs were called to the room. Total amount of time the patient was unconscious was less than one minute. Pt was alert and oriented x 3. She was escorted to an exam room where she laid on a cot with feet up and had some juice and crackers. She stated that she has never
hospitalized 10/5/21 and illness onset 10/2/21. symptoms of runny nose and fatigue
Patient came in for second Covid vaccine Pfizer. Patient recieved 0.1ml vs 0.3mL IM. No adverse event noted.
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL, lot number was L035105 and expiration date of 04-MAY-2017 (strength, route of administration and dose were not reported). There was no concomitant therapies nor adverse effect reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.