chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated that she is feeling dizzy, nauseous, and shaky. patient is 3 months pregnant. Assessed done by the paramedics. patient stabilized and sent home in stable condition. No hospitalization needed.
Pt c/o nauesa during the first night after injection. vomitting in the morning and loose stools.
Client reports that eyes started itching, lips swelled, then began having problems breathing.  sx. started around 5 pm.  was taken to the er and given 3 injections.
Received flu vaccine on 12/04/2007.  Has never had a flu vaccine in the past.  Awoke this morning with erythema to bilateral elbows and knees.  Affected areas also tender to touch, and itchy.  No limits to ROM.  Vital signs: temp 96, bp 125/80, hr 62 regular.  Other employees received flu shots from the same multi-dose vial without similar symptoms.
Information has been received from a pharmacist concerning an immunocompromised male patient who in 2004 was vaccinated with a dose of Pneumovax 23.  In September 2006, a titer did not show that he responded to the vaccine.  No product quality complaint is involved.  Additional information has been requested.
12/27/2020  night head ache, ear popping, off balance,  12/28/2020  period  upset and blood  pressure was  180/117 and husband took her to the hospital.
Severe nausea that lasted for 1 week. Profound weakness and fatigue. Chills, loss bowel and very upset stomach. She said she felt like she was going to die. She had shortness of breath. The of being very exhausted.
Information has been received from a lawyer regarding a case in litigation concerning an approximately 67 year old female. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2006, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date in 2011, the patient was treated by a by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Received varicella immunization when she was 4 yrs old. Had a mild case of chicken pos when she was nine years old.
Information has been received from a consumer concerning a male child with no allergies, who in 04 May 2001 at one year of age, was vaccinated with a dose of varicella virus vaccine. On 8/6/01, the patient was vaccinated with a dose of MMR II. It was noted that the child also received other routine childhood vaccinations. Although it was reported that the child had no past medical history, it was also indicated that in approximately 11/00 at six to nine months of age, the patient began to develop the symptoms of autism. Additional information indicated an onset of symptoms od autism as Sept 2002. Unspecified medical attention was sought. On 12/3/02 at the age of approximately 31 months, the reporter indicated that the patient's current medical conditions included intestinal issues, gastrointestinal yeast infections and does not speak. Upon internal review, symptoms of autism were considered to be an other important medical event (OMIC) Additional information has been requested.
Itching rash; This is a spontaneous case, initially received from other health professional via Med Communication (reference number: SEQ19-03751) on 02-Oct-2019, concerning a 61-year-old, male patient.   The patient's relevant medical history included high blood pressure, morbid obesity, testicular hypofunction and diabetes.  The patient's concomitant medications included amlodipine, losartan, testosterone, Flomax 0.4 (morniflumate) and citalopram.  On 20-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: P100110954 and expiration date: 22-May-2020] for influenza prophylaxis.   On the same day, an hour after vaccination as reported, the patient started breaking out in a rash, with was itching. The patient was treated with prednisone and Benadryl (diphenhydramine hydrochloride) as needed and was advised to avoid any other influenza vaccine in the future. It was reported that rash lasted for a few days. The patient did not visit clinic ever since. No further informations available.  The case was assessed as non-serious.   The reporter did not provide causality assessment to Afluria.  Follow up was received from other health Professional on 13-Nov-2019: The reporter could not reach out the patient for further informations. Narrative was amended accordingly.; Sender's Comments: Itching rash was considered as related to Afluria.
2:50 c/o dizziness, tingling to all extremities. BP 188/103, O2 sat 99%, HR 90,  2:55 BP 190/124 911 called.  3:03 BP 177/100, O2 sat 75 % 3:04 O2 administered at 2L via NC. 3:06 BP 178/103 O2 sat 72% - Epi pen given by RN 3:08 BP 165/101, O2 sat 94% 3:09 EMS arrived 3:15 vitals improving, pt declined ambulance to hospital, AMA 3:30, standing BP 149/85, O2 sat 100% HR 93, transferred to w/c, escorted out by EMS, for pt to call daughter for ride home, AMA.
temperature excursion that was intermittent beginning, but not previously reported, involving VARIVAX; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.   Since 28-JUL-2020, varicella virus vaccine live (oka/merck)(VARIVAX) were improperly stored and had temperature excursions.   On 25-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml for prophylaxis, lot #T002843 and expiration date reported as 23-JAN-2022.   The temperature excursion was reported from -14°C to -10°C (max -9.5°C), during a time frame of 38 hours and 30 minutes. There was no previous temperature excursion.   A digital data logger was involved.
This spontaneous report was received from a 73 years old female patient. There was not medical history. On 19-JUN-2014 the patient was vaccinated with ZOSTAVAX (dose, route and lot # were not provided). Concomitant therapies included blood pressure medicines (unspecified). There were not drug reactions and allergies. On 20-JUN-2014 the patient experienced itching and marks at the injection site, nausea, chills, severe spinal pain after receiving ZOSTAVAX. On unknown date X-ray test was performed (results were not provided). ON 23-JUN-2014, the patient sought medical attention (office visit). The patient did not receive any treatment. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L020861, expiration date 25-JAN-2017 (dose was not reported). Administered doses of vaccines experienced the temperature excursion of 48 degrees Fahrenheit for 89 hours. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
2 days p/vax pt devel cellulitis @ the pnu immune 23 inj site;pt was seen in ER dx of cellulitis made;tx w/ATB & advil;
On day 5 after vaccine, I experienced fever, chills, headache, and increasing pain in my lower right abdomen. Symptoms increased until I went to Urgent Care and then hospital ER where I was diagnosed with appendicitis on March 5.  Had appendectomy late on March 5 and discovered appendix had ruptured.  2 days in hospital after surgery.
Severe ear ringing  in both ears. I have experienced temporary deafness in my left ear. I had no prior issues with this before getting the vaccine.
GERD and acid reflux has disappeared after her COVID-19 vaccines; has GERD and acid reflux and this disappeared 2 days after the first shot up to a couple days before her second shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: FM7553) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Her asthma is not severe. She has had asthma for probably 10 years.; "GERD" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing), notes: Acid reflux. Concomitant medication(s) included: PANTOPRAZOLE taken for gastrooesophageal reflux disease. Past drug history included: Nexium for acid reflux, reaction(s): "didn't work"; Tums for acid reflux, reaction(s): "didn't work"; Rolaids for acid reflux, reaction(s): "didn't work". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 27Feb2021, outcome "unknown", described as "GERD and acid reflux has disappeared after her COVID-19 vaccines"; DISEASE RECURRENCE (non-serious) with onset 27Feb2021, outcome "unknown", described as "has GERD and acid reflux and this disappeared 2 days after the first shot up to a couple days before her second shot".  Additional information: Caller reported a positive reaction to the Pfizer COVID-19 Vaccine. She mentions that her gastric reflux is gone away. Caller would like to know if there's any information on what's in the vaccine that can cause this acid production to go down. The acid reflux and asthma together enhanced the breathing problems from the acid coming up her esophagus. Pantoprazole: She was unsuccessfully taking Pantoprazole at the time of her first COVID-19 Vaccine. This worked best of the medications she tried. Worked in the beginning and then stopped working. She need to report a positive reaction to the COVID-19 Vaccine. She had GERD and acid reflux and this disappeared 2 days after the first shot up to a couple days before her second shot and then 2 days after her second shot this went away. She thought there was something in the product that resolves acid reflux problems. She is not sure if she is cured but her symptoms are gone. She believed she was 74-year-old when the acid reflux and GERD went away the first time. She hesitated to even get the COVID-19 Vaccine and was afraid the vaccine wouldn't work with her stomach problems. No vaccines administered on same date with the Pfizer vaccine considered as suspect. The patient has not taken any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The patient did not experience any AE(s) following prior vaccinations; she has never had any.  No follow-up attempts are possible. No further information is expected.
a low grade fever; she is swollen under her armpit, which is very sore; she is swollen under her armpit, which is very sore; headache; body aches; tiredness; This is a spontaneous report from Pfizer sponsored program support. A contactable 55-year-old female consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 10Apr2021 as single dose for COVID-19 immunization. Patient had historical vaccine first dose of BNT162B2 (at 55-year-old) for COVID-19 immunization. The patient medical history was not reported. Patient concomitant medications included paracetamol (TYLENOL); ibuprofen, diphenhydramine citrate (IBU-PROFEN,DIPHENHYDRAMINE CITRATE). On 11Apr2021, the patient experienced headache, body aches, tiredness and on 13Apr2021, patient experienced a low grade fever, she is swollen under her armpit, which is very sore. Patient reports on Sunday, 24 hours after administration, she started experiencing a headache, body aches, and tiredness. She reports today, 3 days later, she has a low grade fever and she is swollen under her armpit, which is very sore. She called to ask how long she typically experience the side effects after her second dose of the vaccine given on Saturday afternoon, 10Apr2021. She was feeling a terrible headache, achiness, arm sore and feeling exhausted with low grade fever and she is taking Tylenol and Ibuprofen, she wanted to know how long she will take these medications. There was no PQC. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The day after I received my second dose of Pfizer, I woke up with a swollen face that lasted for 2 days. My eyes, nose, cheek and lips were swollen. I also had, body aches, chill and a headache. I took Motrin, slept most of the day. The following day/day 2 most of the swelling was gone and my flu symptoms were gone. By day three all of the swelling was gone.   I did not go to the doctor.
This patient was 31 weeks pregnant at the time of exposure and was IgG negative. The partner of this individual received the Varicella vaccine on 4/3/17. He developed lesions on 4/24/17 which were PCR tested and found to be Varicella vaccine-strain (Merck). Patient received VZIgG on 5/4/17 but developed lesions on 5/9/17 and was admitted to hospital 5/10/17-5/20/17. Her lesions were PCR tested and confirmed to be Varicella (PCR testing for wild vs vaccine testing not performed).  For further details please contact County Public Health department.
Symptoms- swollen lymph nodes for a little over 2 weeks, lymph nodes were very painful, diarrhea for over a week, mucus in stool for almost 3 weeks, stomach pain for almost 2 weeks, trouble swallowing for over a week, extreme fatigue for about a week, heartburn for several months
Bruising under right eye by tear duct.  Have photos.  Happened overnight I believe, as I don't remember it from bedtime on the same day.
This spontaneous case was reported by a physician and describes the occurrence of PAIN (Pain in the whole body), PAIN IN EXTREMITY (Pain in arm of injection), HEADACHE (Headaches), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disease, unspecified. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication.   On 04-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 PAIN (Pain in the whole body), PAIN IN EXTREMITY (Pain in arm of injection), HEADACHE (Headaches), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Injection site redness), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). At the time of the report, PAIN (Pain in the whole body), PAIN IN EXTREMITY (Pain in arm of injection), HEADACHE (Headaches), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Injection site redness), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-031240 (Patient Link).
Patient reports itching on arm, possible allergy to vaccine. Vital signs are P88 BP 100/60, R 21, Dext 117, Sat 99, Temp 36.4. Ambulance transported to hospital. Paramedic informs of Doctor administering BENADRYL.
This case was reported by a consumer via call center representative and described the occurrence of erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported redness the size of a cigarette pack located an inch next to the injection site. Caller refused to answer any question and hung up. No additional details was provided.
This spontaneous report as received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) lot # L011079, expiration date- 01-OCT-2016, lot # L017140, expiration date- 13-NOV-2016, lot # L016394, expiration date- 08-NOV-2016, lot # L019997, expiration date- 2-DEC-2016, lot # K018144, expiration date- 10-APR-2016 and lot # K008185, expiration date- 05-DEC-2015. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
headache, sore arm, body aches, fatigue, chills, night sweats Took OTC Motrin, Tylenol and Aspirin
18 year old female presents with complaints of Moderna COVID-19 vaccine still present two weeks after receiving her first vaccine. Received on the left Deltoid Intramuscular. Complaint of reduced EOM movement on the left side of body.  was referred to: Emergency Room was referred to: Neurology
ongoing dizziness; really bad vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (ongoing dizziness) and VERTIGO (really bad vertigo) in a female patient of an unknown age 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 DIZZINESS (ongoing dizziness) and VERTIGO (really bad vertigo). At the time of the report, DIZZINESS (ongoing dizziness) and VERTIGO (really bad vertigo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
Guillain-Barré syndrome and weakness started two days after vaccine administered. Diagnostic treatment and physical therapy. Bullous pemphigoid.
Numbness on the left side of face Tingling on left side of head Some intermittent tingling around the left eye
patient described itching and tingling on trunk, both front and back, beginning about 7 pm the night of the vaccination.  Symptoms had continued into the next evening when it was reported at the pharmacy.  It was recommended the patient try benadryl for the itching, and contact the doctor if symptoms progressed or did not resolve.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies from the patients were not provided. From 29-AUG-2017 to 07-SEP-2017 (specific dates unknown), the patients were vaccinated with improperly stored doses of VARIVAX lot # M049127, expiration date: 15-DEC-2018, and lot # M045204, expiration date 11-NOV-2018, for prophylaxis. Concomitant therapies included sterile diluent. The temperature excursion was reported as: -14°C to -10°C for 8 minutes. It was also reported that doses experienced a previous temperature excursion: -14°C to -10°C for 17 minutes and -9°C to 8°C for 1hr and 17 minutes. Data logger was reported as "Yes". No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004196.
painful arm; chills; sweating; fever; nausea; coughing; extreme headache; joint pain; Difficulty sleeping; This is a spontaneous report from a contactable healthcare professional. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via intramuscular route of administration in the left arm on 31Mar2021 at 14:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included long haul COVID. The patient had no allergies to medications, food, or other products. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and multivitamin (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 17:00, the patient experienced painful arm, chills, sweating, fever, nausea, coughing, extreme headache, joint pain and difficulty sleeping. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with tylenol and pain creams for joints. The clinical outcome of the events painful arm, chills, sweating, fever, nausea, coughing, extreme headache, joint pain and difficulty sleeping were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
pt recvd flu vax & devel redness, pain & swelling @ site of inject;
7 days post vaccine, patient developed an approximately 5 cm area of pink erythema. Edges not well demarcated, some central clearing. Warm to touch but non-tender. Concern that shot may have been given subcutaneously (parents report skin buckled up as soon as shot was given, but resorbed quickly). No lesions until today. Child otherwise well.  6 day old newborn in home is of some concern.
on Jul-20-2021 / patient was administered an expired dose / (expiration date: 5/14/2021); This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix) (batch number 9PL5A, expiry date 14th May 2021) for prophylaxis.   On 20th July 2021, the patient received Havrix. On 20th July 2021, unknown after receiving Havrix and Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Age at vaccination was not reported. Nurse reported that a patient received an expired dose of havrix. She did not have information about the patient. Consented to follow-up was by phone/mail
11/17/07 considerable swelling, erythema, warmth & pain in the right upper arm.  Overall fever & malaise.  Reports arm pain, inability to use arm & weakness.  Needs help with all activities.
Case number PHEH2014US020510 is an initial spontaneous report received from a consumer on 13 OCT 2014. This report refers to a 47 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 146401) intramuscularly on unknown date . On OCT 11 2014 he experienced swelling in his arm pit to the left side only. The outcome of the event was reported as resolving. The seriousness and causality of the event was not reported.