chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J003227, exp date: 15-MAR-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
grandmother reported 2hr p/vax pt stiffened, jerky, et eyes rolled back in head;
66 year old male reported to have an anaphylactic reaction to the zoster vaccine on 6/5/12. He has no prior history of a reaction to vaccinations. The vaccine was administer subcutaneously in the deltoid (records do not specify which) and within a minute of administration, the patient complained of numbness and tingling of the left side of the mouth. He was observed to have swelling of the mouth, slurred speech, and tongue thickening. Patient denied difficulty breathing or swallowing. Nurses called 911 immediately and he was brought to the closest ED. Patient was given IV steroids, ranitidine, and diphenhydramine and symptoms resolved with some residual soreness in the teeth. Medications to treat anaphylaxis given at ED therefore doses not specified.
Papules on hands and feet. Both palmar and dorsal aspects. Associated with tenderness.
6 days p/vax devel a runny nose 10 days later spots which appeared to be red chickenpox on lower stomach, chest, upper arms, thighs & more on back of shoulders especially rt side;stuffy nose;low grade temp;became fluid filled scabbed;
Around 2 hours after received the H1N1 vaccine developed upper respiratory congestion and difficulty breathing. C/o dizziness during night and had to sleep with vaporizer to relieve upper respiratory symptoms.
Received the flu shot Oct. 3. I started having headaches approximately 2 1/2 weeks later. On October 31st 1/2 of my tongue felt odd on the way home from work and I had a severe headache almost enough to pull over and vomit. I got home and went to bed and woke up at 9:30 am the next morning unable to close my right eye and my right side of my face drooped and a horrid headache. I thought I was having an aneurysm or stroke so I called 911. After blood work and a CT Scan I was DX with bells palsy. I  was started on  an antiviral and prednisone and given Norco 5/325mg. I returned to work about 10 days later after following up with an ENT and my primary Dr.  I continued to have increasing symptons. Numbness in my left arm and tingling and jolts down my left arm. My pulse would run up into the 130's and my BP up into the 140/96. My BP is normally 115/70. While I was at work on Nov 27th,  I felt my heart racing and my left arm ached and felt numb so I went up to the nurses station and they took my blood pressure. 70/40 is the last I heard and then woke up on the nurses station floor with a code team around me and pads attached had I needed shocked. I was taken down to the ER and told I just had a syncope episode and sent home. Headaches continued as well as the numbness and my left arm. I believe on the 17th of December my right arm started to go numb and the chest pains and severe headaches continued so I went to the ER and was admitted for a stroke workup. 3 days later I was discharged with no answers. My Primary Dr had let me know I had a vitamin b12 deficiency, my level is 232 and should be up around 450. Vit B12 deficiency has a lot of the symptoms I have been experiencing.  So I started a supplement. Now the question is why am i deficient A. Stomach stapled = No B. Bowel surgery = No C. Autoimmune disease stirred up by something viral that could have caused the bells palsy and this deficiency. So I am now taking a Vitamin B supplement and continue to take  nortriptoline for nerve pain. All of this...from the Flu shot.
9-8-08 "Patient" comes in today after being see at the ER last night for cellulitis. Did receive his 4 year shots on Friday, two days ago. Was given DTaP and the flu vaccine in his left leg. Mom states that there was a small red area on Friday, usual of his immunizations. On Saturday it had grown somewhat and yesterday it spread quite a bit. Was complaining of tenderness and a low grade fever up to 99. Went onto the ER and was placed on Bactrim and Keflex. A circle was drawn around the area. This had not spread any. Is red and indurated when pressed. Is very tender to the touch. Mom states that the redness was much worse yesterday. He does not have a fever currently. Temp is 98.9 A: Cellulitis, possibly secondary to a vaccine reaction. We will go ahead and report this to the vaccine adverse reaction secondary to the large area of cellulitis. He will continue on the Bactrim and Keflex. Mom knows to call me right away if he gets fever or if this area is spreading outside the lines that were drawn at the ER. She will keep a close eye on this and let me know how he does. Otherwise we will see "patient" as needed.
One week after shot developed hives, itchy, painful  redness on same arm injected. Near injection site.
At about 8pm the night of the day I got the vaccination, I began to experience pretty bad muscle & joint pains from my hips down to my ankles. I was also going back and forth between being very cold and very hot. I have not gotten a fever so far. The pain was so bad that I wasn?t able to sleep at all. The following morning, today, I am still experiencing pain in my hips, thighs, and knees, as well as a faint headache every so often.
Per patient file in Alert  Moderna vaccine was given 06/19/2021 at this location but Pfizer vaccine was also given the same day 06/19/2021 at a different Pharmacy location. No lot number on record for Moderna on 06/19/2021.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "mild asthla (sports/allergy induced)" (unspecified if ongoing), notes: other medical history: mild asthla (sports/allergy induced); "covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gluten, reaction(s): "Allergy to gluten". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Adverse event: Patient was starting at the end of the 5-day cycle into the weekend her COVID line was faint and she thought that the virus was going away. It remained faint until day 10. At that time, it became dark red again. We are now unclear if this was a relapse and if she was still contagious. Being that the drug was new, her doctor was also unclear. She just have what she have read in articles on the internet where this was a gray area. Her doctor's guidance it to start he 10-day count again until. She would like more guidance. She have mild cold like symptoms: stuffiness and cough. Patient was not received other medication in 2weeks of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Increasing pain in neck and shoulders (beginning with left shoulder and spreading to right shoulder) and significant pressure in chest area, similar to pain experienced with pericarditis after heart attack in November 2020. I had been off of several heart meds for several months, but after the pericarditis event in June, Dr. prescribed that I resume Colchicine for inflammation related to pericarditis. I continue to take Colchicine, and will do so until my next appointment with him in February. I have not had any further symptoms such as those described above.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 2:38 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 2:38 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 69.49   Concomitant products were not provided.  On 27-Oct-2021, Excursion time was 09 AM and 10 AM, temperature was 29 and 32, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021 and 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 2 and 4 vials were sent to clinic. Vaccine BUD date was 29-Oct-2021 and 04-Nov-2021  Vial was stored on cooler 1, on 27-Oct-2021, Excursion duration At 8 AM:41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46, 5 PM: 45  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
pt recv vax 15MAY97 & 16MAY97 pt devel a swollen gland;
feel my head pounding; rapid heartbeats; Muscle aches on neck & shoulders (has eased up); can't sleep, side effects, unable to sleep; This case was reported by a consumer and described the occurrence of pounding in head in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2023 17:00, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced muscle pain and sleeplessness. On 30th January 2023 21:00, the patient experienced pounding in head and heartbeats increased. On an unknown date, the outcome of the pounding in head, heartbeats increased and sleeplessness were not recovered/not resolved and the outcome of the muscle pain was recovering/resolving.   It was unknown if the reporter considered the pounding in head, heartbeats increased, muscle pain and sleeplessness to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comment:  On 30th January 2023 4 hours after receiving Shingrix, the patient experienced pounding in head and heartbeats increased. The patient reported that received Shingrix vaccine on 30th January 2023 at 5 pm. Patient felt fine for couple of hours however around 9 pm patient began to feel pounding head, radid heartbeats and muscles aches neck and shoulder. Patient also reported could not sleep. The patient still experienced pounding head, rapid heartbeats and unable to sleep. The muscle aches around neck and shoulder has eased up little. Reporter consented to follow up.
Allergic reaction 12 hours after vaccination. Diahrea, hives, flushing, rapid heart rate, swollen lips
I experienced severe headaches, body aches, didn't ease up until 11/2/2021. I also experienced temperature of 101 and discomfort at the injection sit, very uncomfortable to sleep. I contacted my doctor she told me to take Tylenol and make sure I was hydrated.
stomach cramps; gas all in the upper abdomen; bloated; nausea; chills; shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR, ABDOMINAL PAIN UPPER (stomach cramps), FLATULENCE (gas), ABDOMINAL DISTENSION (bloated), and NAUSEA in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 08-Apr-2021, the patient experienced TREMOR and CHILLS. On 09-Apr-2021, the patient experienced NAUSEA. On 10-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), FLATULENCE (gas) and ABDOMINAL DISTENSION (bloated). On 08-Apr-2021, TREMOR and CHILLS had resolved. On 10-Apr-2021, NAUSEA had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), FLATULENCE (gas) and ABDOMINAL DISTENSION (bloated) 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.   Treatment information.
Was pregnant; Rash; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant) and RASH (Rash) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis, Illness and Allergic rhinitis.    Concurrent medical conditions included Pollen allergy. Concomitant products included TRIAMCINOLONE ACETONIDE, FLUOCINONIDE (FLUOCINONIDE-E), TACROLIMUS MONOHYDRATE (PROTOPIC), LEVONORGESTREL (MIRENA) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for an unknown indication.   On 16-Nov-2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram every two weeks. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant) and RASH (Rash). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by the reporter.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancies.  She was not sure if it was due to the pollen currently, missed her dupixent dose or moderna covid vaccine. has missed 3 doses in the last 6 months due to "refill issues" with them always having to get authorization from her doctor or some other problem. It was unknown if there were lab data or results available. The reporter doesn't believe the events are related to the vaccine in any way.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up was received. The causality  of the event was updated.
This spontaneous report was received from a pharmacist, reporting on her 23 year old son. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with dose of (Oka/Merck) VARIVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. Pharmacist reported that her son, who was vaccinated with (Oka/Merck) VARIVAX on an unspecified date, experienced an episode of shingles "recently" on unspecified dates. At the time of the report the outcome of experienced an episode of shingles "recently" was unknown. Patient sought medical attention on an unknown date. Additional information has been requested.
I'm not sure of the exact type of flu shot I got. I just know it was a flu shot. A little over a week after getting the shot I experience extreme headache in the morning. As the day went by I started feeling body ache and tiredness. At night the symptoms got severe and I also developed a high fever and chills. I took ADVIL and it improve the symptoms. The fever eventually went away but the headache did not. The night of the symptoms I could not sleep because of the headache.
Information has been received from a registered nurse concerning an approximately 36 month old male patient with penicillin allergy who on 08-MAY-2001, was vaccinated SC with the first 0.5 ml dose of VARIVAX (Merck). In approximately 2003 ("when the patient was 3 years old"), the patient experienced shingles. The patient did not get the second dose of VARIVAX (Merck). The patient had an office visit, and recovered from shingles on an unspecified date. Additional information has been requested.
Pt recvd vax 8NOV91 & 2DEC91 lump node devel in left neck; lymph node inflamed pt recvd ATB; 4DEC91 surgery;
Large, 3 cm area of induration on the left leg, and smaller area of induration on the right leg.  Area painful to touch.  No erythema.  Approximately 7 hours after the administration.
Pt presents to clinic on 10/12/00 at 15:00 with a temperature of 101.6F. Mother states child has had a temperature since early AM. Pt did not sleep during the night and has been crying a lot. Mother has been giving Tylenol every 6 hours. Called mother on 10/13/00 and she states temperature broke at 23:00 on 10/12/00 and he is better today.
Information has been received from a physician concerning a 6 month old patient who was vaccinated with the third dose of oral Rotateq. Subsequently the patient experienced significant diarrhea. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 7/16/2007.  Information has been received from a physician concerning a 6-month-old white female who on 06-MAR-2007 (1521) and 07-MAY-2007 (1151) was vaccinated PO with the second and third 2.0 mL doses, respectively, of ROTATEQ (Lot #656191/1365F).  Concomitant vaccinations administered on 07-MAY-2007 included the third 0.5 mL, IM dose in the left thigh of PREVNAR (Lot #B08670K), the thrid 0.5 mL IM dose in the right lateral thigh of ACTHIB (Lot #UE923AA) and the third 0.5 mL IM dose in the left lateral thigh of PEDIARIX (Lot #AC218092AA).  There was no illness at the time of vaccination.  Prior vaccinations administered on 06-MAR-2007 included the second 0.5 mL dose in the right thigh of PREVNAR (Lot #B0B670K) and the second 0.5 mL IM dose in the left lateral thigh of PEDIARIX (Lot #AC21B092AA).  On 07-MAY-2007, a few hours after being vaccinated, the patient developed significant diarrhea.  On 15-MAY-2007, the patient was seen by the physician.  At that time, the patient had no abdominal pain, hematocheria or nausea, fever or vomiting.  She was noted to have a stool frequency (diarrhea) of every 1-2 hours.  The patient was also noted to have a good appetite and had gained weight.  Clear liquids had been tried without improvement.  She had no known contact with contaminated food.  Bowel sounds were normal.  There was no tenderness, organomegaly, masses or hernia.  A large erythematous rash on her buttocks was noted characterized by several pinpoint erythematous papules on her entire genitourinary region.  A diagnosis of gastroenteritis and diaper dermatitis (suspect yeast component) was made.  A stool test for ova and parasitos and culture was negative.  It was recommended that A&D ointment with monistat cream be applied to the diaper region.  Diet as tolerated.  On 16-MAY-2007, the patient recovered.  Additional information is not expected.
Covid-19 vaccine  mild cough, runny nose and mild HA. Used my inhaler due to some wheezing.
Broke out in rash on face, arms, hands, legs. Took Benadryl- helped. Advised to continue Benadryl and to f/u with her PCP or go to ER if symptoms worsened.
Patient is feeling sore and a little tired the day after but that could be due to getting Twinrix and Ipol vaccines together per patient request.
got sick; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (demographics) who got sick (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-OCT-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011133.