chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Notified today at 0915 by mother that her son received is 2nd dose of Pfizer here yesterday afternoon. Stated that he c/o throat swelling. Mother states she gave him 2 Zyrtec while in parking lot. States was seen by staff and O2 sat was ok. Stated she then took him to the ER. States the lowest his O2 saturation got was 93%. Stated he could drink liquids but was unable to swallow foods. He f/u with PCP today and was told to take benadryl every 4 hours form 24 hours. States primary MD, states she was told to call and report to us.   Upon investigation there were no allergies noted on assessment either visit. Covid team states they were never informed of any problem.I then spoke with APN who states that she happened to be out front when car pulled back up into parking lot. Mother states patient c/o Itchy throat and was drinking water so able to swallow. APN checked in breathing, lung sounds, oxygen saturation, etc. States he was absolutely fine but had him wait another 10-15 minutes.  She stated that mom said she had Zyrtec at home and that she instructed that she could give that to him. Mother never disclosed that she gave him 2 in parking lot as reported above. After, waiting period she rechecked him with no new or worsening complaints.
pt recv vax;7 days later,devel rash under lt arm;not noticeably itchy;2x2cm scattered red rash, denies changing detergents,soaps ,deodorant; to er at noc; recv antihistamine for rash;
Information has been received from a physician concerning a 5 year old female who on 08-SEP-2003  was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 644974/0196N). It was noted that on 17 AUG 2007 the patient was vaccinated subcutaneously into the left arm with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # 657749/0616U). On 24 MAR 2008 the mother reported that she had noticed a little lesion on the patient's inner thigh. She reported that she did not think much of it at the time because the patient has had problems with dry skin. On the evening of 25 MAR 2008, the mother reported she noticed that the lesions were starting to spread. The patient complained of a little bit of itching. The patient had not had a temperature. Upon examination the physician noted that patient to be alert and cooperative. The patient presented with scattered small erythematous papular lesions. Some of the lesions had a little whitish dot in the center. The original lesion that she had was actually scabbed ever. In the opinion of the physician this was highly suspicious for atypical varicella. Treatment included BENADRYL and TYLENOL, as long as the patient does not run a temperature, a review of routine care with the mother, and abstinence from school for one day. At the time of reporting the patient had recovered, on an unspecified date. Additional information is not expected.
Swelling of lips and redness of face. Pt. went to ER, got RX for prednisone & BENADRYL.
Assessment 3" x 3" area of cellulitis and induration, and warm to the touch  noted in left deltoid. Limited motion of left arm also noted. Referred to Pediatrician or ER for further evaluation. Telephone call to client's mom to follow up regarding swelling and limited motion left arm, mom stated child is much improved and that it went away using warm compresses and Tylenol.
low grade fever 100.9, shaking chills, extreme fatigue, severe muscle aches, mild headache
Within hours of receiving the vaccine, the injection site broke out into hives followed by a headache.  By the next morning, I had a severe headache, fever above 100F, body aches and nausea, and my upper arm was covered in huge red welts.  The welts merged to form a large itchy swelling covering my upper arm that was painful to the touch.  I had difficulty lifting my arm above shoulder level.  The severe headache did not dissipate until two days after the injection, and the swelling lasted for several more days.
Pt recvd vax 2JUN89 & devel fever & cont to look drunk; was unresponsive; seemed like a slow pt; ER did blood test; slept alot; unresponsive when awake;
fever; migraine; This is a spontaneous report from a Pfizer-sponsored program Covax US Support. A contactable female consumer (Patient) reported.  A female patient of an unspecified age received first dose of BNT162B2 (solution for injection, lot number: unknown) via an unspecified route of administration, on 23Jun2021, as a dose 1, single for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date after her first dose, she experienced migraine and on 26Jun2021 (today), she was having a fever. She took naproxen 2 hours prior to this report (2 hours ago) but her fever was not coming down. She wanted to know if she can take Tylenol. The outcome of the event of fever was reported as not recovered, while the outcome of the event of migraine was unknown.   Information on the lot/batch number has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 15-MAR-2015, the patient was inoculated with ZOSTAVAX at a pharmacy for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a family physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Arm pain; Had a pulsating tingling feeling by side of head next to left eye; Cold sore on lip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PARAESTHESIA (Had a pulsating tingling feeling by side of head next to left eye) and ORAL HERPES (Cold sore on lip) in a 69-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 in 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ALENDRONATE SODIUM (FOSAMAX) and FAMOTIDINE (PEPCID AC) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PARAESTHESIA (Had a pulsating tingling feeling by side of head next to left eye) and ORAL HERPES (Cold sore on lip). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). The patient was treated with ACYCLOVIR [ACICLOVIR] ongoing since an unknown date for Cold sores, at a dose of 800 mg three times a day and PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), PARAESTHESIA (Had a pulsating tingling feeling by side of head next to left eye) and ORAL HERPES (Cold sore on lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient 2: given booster >12hrs post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient 2: given booster >12hrs post puncture) in an 84-year-old female patient 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 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient 2: given booster >12hrs post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient 2: given booster >12hrs post puncture) had resolved.        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.   This case was linked to MOD-2021-407042, MOD-2021-407056, MOD-2021-407133 (Patient Link).
After receiving H1N1 influenza vaccine injectable returned to nurse stating her throat felt tight. Raised area on tongue noted. BP-120/84 p-100 resp-12 lungs clear. Benadryl 75mg Im administered. No epi administered. Patient transported to Hospital via ambulance.
The day after on 12/18 soreness at at the injection  site. On 12/19 symptoms exp headache and fatigue. Then on 12/20 started chills, fever and headache. I went to see the doctor on 12/21 and got several test Covid ,Flu and Strep results positive for all. Since then symptoms has continued. I have had to miss 6 days of work.
Large, congruent patches of hives present over >50% of the surface area of the body including: underarms and back, behind ears, along anterior and posterior surfaces of the legs, and down both forearms.
Pain at injection site,  Muscle Aches Fatigue Vaginal bleeding (previous endometrial ablation completed over 1 year ago- first time bleeding since procedure) Abdominal Cramping
Roughly 2-3  minutes post injection as I was sitting in the designated waiting area, (as instructed by the nurse to sit there for 15 minutes post injection to assure no adverse effects) I began to get very short of breath, I felt that I had to take my mask off  to breath properly. ( I did not remove my mask)  My heart then started to race and I felt a warming, tingling feeling throughout my body.  I felt a little hot and light headed.  I stayed sitting in my chair, tried to take some deep breath, and everything went away.  This lasted about 30 to 60 seconds.  I did  NOT report this to anyone there, as I was unsure if I was actually having a reaction or not. Since it went away on it's own, I did NOT report it to anyone.  I stayed for about 15-20 minutes post injection and then  I left and drove home.  I did feel tired and my arm is sore at injection site, but other than that, no other effects.
Throbbing pain at injection site radiation to arm pit area, inj site deltoid, began 8-9 hours after immunization, difficulty lifting arm, driving gradually got better over 48-72 hrs.
mom called 330PM on 24FEB93 stating pt was crying for prolonged periods; has napped 5 to 10 mins p/APAP; advised to call MD 29FEB92; crying lasted 10 hrs;
mental weirdness; eye twitches; A week and 2 days after the vaccination had a rash on L arm where she was vaccinated; fever; cramps; felt quite sick, cramps, shakes, fever, mental weirdness; shakes; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps), MENTAL DISORDER (mental weirdness), MYOKYMIA (eye twitches), ILLNESS (felt quite sick, cramps, shakes, fever, mental weirdness) and TREMOR (shakes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034CZDA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.   On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced MUSCLE SPASMS (cramps), ILLNESS (felt quite sick, cramps, shakes, fever, mental weirdness), TREMOR (shakes) and PYREXIA (fever). On an unknown date, the patient experienced MENTAL DISORDER (mental weirdness), MYOKYMIA (eye twitches) and VACCINATION SITE RASH (A week and 2 days after the vaccination had a rash on L arm where she was vaccinated). At the time of the report, MUSCLE SPASMS (cramps), MENTAL DISORDER (mental weirdness), ILLNESS (felt quite sick, cramps, shakes, fever, mental weirdness), TREMOR (shakes), VACCINATION SITE RASH (A week and 2 days after the vaccination had a rash on L arm where she was vaccinated) and PYREXIA (fever) had resolved and MYOKYMIA (eye twitches) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medications included vitamins and unspecified inhaler.   No treatment reported.
The pt developed a flat, red rash concentrated on her trunk. Pt still has rash.
Vaccine received on 6/7/12 by 6/8/12 arm became swollen, red, hot. 6/8/12 went to Emergency Room with high fever 102+, low blood pressure, high heart rate was admitted and treated for infection and blood clots.
***the most concerning symptom is the tinnitus  Beginning the evening of the second dose and lasting until about 48 hours after injection: fever, chills, and profuse night sweats   ~7 weeks after 2nd dose- began experiencing tinnitus. It has continued to persist. I have no prior history of tinnitus or hearing problems. This is very concerning because  it is starting to negatively impact my sleeping habits.   I am extremely healthy. I exercises 6x a week for about 1.5 hours and drink about a gallon of water daily. I only eat sweets 1x per week as a treat on Fridays, but otherwise eat fruits, veggies, and protein while limiting processed foods.
Adverse effect started with stiff joints and muscles and has progressed to the stage of severe pain, hair loss and inability to walk or hardly even move.
This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (watery eyes), FEELING ABNORMAL (did not feel too good) and CONDITION AGGRAVATED (flare up of his allergies) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced LACRIMATION INCREASED (watery eyes), FEELING ABNORMAL (did not feel too good) and CONDITION AGGRAVATED (flare up of his allergies). At the time of the report, LACRIMATION INCREASED (watery eyes), FEELING ABNORMAL (did not feel too good) and CONDITION AGGRAVATED (flare up of his allergies) had resolved. Not provided for mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that the patient scheduled for a cortisone shot on 01Apr2021. Med Agent received call from Moderna case number 00166416 crosslinked with MOD21-065494. Patient states that he got a call from Moderna and is returning the call. Patient states that he has never called Moderna to report anything because he is feeling fine and doing well. He received full cycle of vaccine few months ago. He is not sure what the voicemail stated and provided no case number. Agent checked the case query and no results found with name and phone number. Concomitant medication information was not reported. Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: No new information.
HYPOXIA 3/28/2023 DM 2 W HYPERGLYCEMIA
Patient signed up for vaccine through portal stating they had received pfizer doses for the first and second shot. After vaccinating for the booster, I noticed the vaccine card stated moderna as the first two initial doses. When I spoke to the patient and her daughter, the daughter said she thought the patient had received the pfizer shots initially and so had signed her up for the booster.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. Initial information was processed along with the additional information received on 16-JUL-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and expiry: Unknown), 1 total, dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JUL-2021, the patient experienced slight fever. Laboratory data included: body temperature (NR: not provided) 98.9 to 100.1. On 08-JUL-2021, the patient went to doctor office for slight fever over 3 days and wanted to be sure that he was not affected with COVID-19. Assistant of physician conducted three tests. Laboratory data included: COVID-19 antibody test and SARS-CoV-2 rapid diagnostic test which showed negative and unspecified test to evaluate immunity to COVID-19 however, unspecified immunity test showed negative results (captured as confirmed immunological vaccine failure) and the patient had no signs of antibody in his system. It was reported that, patients physician did not have any recommendation due to the limited data and information on this matter, and he will contacting them to have a recommendation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure and slight fever was not reported. This report was serious (Other Medically Important Condition). This report was associated with RA:90000186307.; Sender's Comments: V0:20210733506-Covid-19 vaccine ad26.cov2.s -Confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient experienced pain, numbness and impairment of left arm from shoulder to hand soon after receiving the vaccine. Patient reported that the pain and numbness did not go away and after 2 months she went to physical therapy where they massaged her arm on 2 separate visits. Patient was reluctant to return for her second dose of SHINGRIX, however, currently she reports she has regained full use of her left arm.
This spontaneous report was received from a Licensed Practical Nurse refers to a 18 year old female patient. No medical history was reported. Patient had no drug allergies or reactions. The nurse reported that the patient developed abnormal menstrual bleeding after receiving her first 2 doses of GARDASIL. The nurse mentioned the bleeding started on unspecified dates right after the patient received GARDASIL on both occasions. No concomitant medications were reported. On 25-MAR-2013, the patient was vaccinated with a dose 1 of GARDASIL (lot # H016238, expiry: 11-APR-2013) and experienced abnormal menstrual bleeding approximately on an unknown date in March 2013, that lasted for one month (approximately till an unknown date in April 2013). On 01-MAY-2013, the patient was vaccinated with dose 2 of GARDASIL (lot # H017698, expiry: 02-APR-2015). On an unknown date approximately in May 2013, the patient experienced abnormal menstrual bleeding which had not yet stopped bleeding. The patient sought medical attention. The patient was seen in the office today and was prescribed an unspecified oral contraceptive. No laboratory diagnostics studies were performed. Additional information has been requested.
he had fatigue; pain in his arm; pain in his arm at the injection site; pain was worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 17:30 as dose 4 (booster), single (Lot number: GJ2524) at the age of 55 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 28Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "past MI" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; CARVEDILOL; LISINOPRIL; ATORVASTATIN; EZETIMIBE; ASPRIN. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (booster); Unknown manufacturer), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 29Sep2022, outcome "recovering", described as "he had fatigue"; PAIN IN EXTREMITY (non-serious) with onset 29Sep2022, outcome "recovering", described as "pain in his arm"; VACCINATION SITE PAIN (non-serious) with onset 29Sep2022, outcome "recovering", described as "pain in his arm at the injection site"; CONDITION AGGRAVATED (non-serious) with onset 29Sep2022, outcome "not recovered", described as "pain was worse". Therapeutic measures were not taken as a result of fatigue, pain in extremity, vaccination site pain, condition aggravated.  Additional information: The patient received his vaccine on 28Sep2022 at approximately 5:30 pm. At approximately midnight on 29Sep2022 he said he had pain in his arm at the injection site. Therefore 29Sep2022 is the date for Pfizer first awareness as reporter was Pfizer employee. At approximately 8:00 am on 29Sep2022 he said the pain was worse and he had fatigue. No other adverse events were reported to him. Patient had covid prior vaccination and was not tested for covid post vaccination. Patient had no known allergies. Patient was taking unspecified vitamins.  Follow-up attempts are completed. No further information is expected.
Patient received vaccine at approximately 3:10PM. After receiving she seemed fine and was able to walk to the waiting area. After approximately 1-2 minutes she reported to her boyfriend that she did not feel well and "needed some water." Immediately following she began to lose consciousness and went completely limp with her eyes rolled back, according to her boyfriend who caught her and placed her on the ground. The boyfriend also reported some muscle tremors occurring during this. After another minute the patient regained consciousness and was awake and oriented to person and place but not time. She was able to see properly and was vocalizing effectively. 911 was called immediately following initial loss of consciousness and EMS arrived to collect vitals. Patient was given a few sips of water. No medications were given. Following EMS assessment, patient was hypotensive and unable to stand on their own; EMS transported the patient to the emergency department.
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 27-JUL-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336(dose, route and the expiration date were not reported). The total cumulative hours out of range were 120 hours with 53 C as the highest recorded temperature. On the other hand, the total cumulative hours out of range were 24 hours with 34 C as the lowest recorded temperature. 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.
Tingling/numbness in right arm where injection given (patient states PNEUMOVAX given in right arm).