chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea really bad; Uncontrollably, terribly vomiting /he was violently throwing up; Chills; Muscle spasm; stomach bug; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 24Mar2021 08:45 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 24Mar2021 18:00, outcome "unknown", described as "Diarrhea really bad"; VOMITING (non-serious) with onset 24Mar2021 18:00, outcome "unknown", described as "Uncontrollably, terribly vomiting /he was violently throwing up"; CHILLS (non-serious) with onset 24Mar2021 18:00, outcome "unknown", described as "Chills"; MUSCLE SPASMS (non-serious) with onset 24Mar2021 18:00, outcome "unknown", described as "Muscle spasm"; GASTRIC DISORDER (non-serious) with onset 24Mar2021 18:00, outcome "unknown", described as "stomach bug".  Additional information: Reporter stated that her husband got his first dose (Unspecified medication) yesterday morning at 8:45 and then at about 6 o'clock last night, he had diarrhea really bad and then it ended up like uncontrollably, terribly vomiting and then had chills. They were not even chills, like more of muscle spasms. She doesn't know if he was having a reaction or there was a stomach bug going around and he may have had the stomach bug. She was trying to figure out if like violently throwing up is one of the symptoms or just throwing up. Like he was violently throwing up then he had to run to the bathroom with diarrhea. Reporter stated that she was just trying to figure out if he had a severe reaction and should not get the second one or maybe there was a stomach bug going around their area and maybe it was just, he happened to get the shot that morning and then had the stomach bug as well. Reporter further stated that he had muscle spasms too.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client received her first dose of Pediatric Pfizer. Client then went to observation area with Mother. While sitting down client started vomiting and reported feeling dizzy.  Nurse came to assist client and an emesis bag was provided. Client denied shortness of breath. Client was AAOx3. Parent, Mother reported that she believes this happened due to nervousness. She reports her daughter has experienced vomiting with other shots in the past. Nurse observed no pallor on face, neck or arms. Vitals were taken 1224 BP 110/70 HR 111 RR 21 02 97%. vitals taken at 1234 BP 116/77 HR 107 RR 21 02 97%. Due to the symptoms client was experiencing Mother was offered to administer Benadryl to client. Mother refused for daughter to receive Benadryl. Mother was offered to call Paramedics for further assessment. Mother accepted for Paramedics to be called. At 1220 Paramedics were called to Vaccination site. At 1228 client was asked how she was feeling, client stated she was feeling ?better?. Dizziness had resolved. At 1235 Paramedics arrived and client was further assessed. Paramedics assessed client and Mother declined any further assessment at local hospital. Mother was offered to keep monitoring daughter in observation area but Mother stated her daughter was ready to go by stating, ?she?s going to be alright? Emergency precautions were given to Mother and to follow up with PCP in 24 hrs. Mother was also informed about Vsafe for her daughter. Mother verbalized understanding.  Client left vaccination site with parent in a steady gait and in no distress.
Patient experienced edema in the arm and redness with no lymph node and no axillary involvement. Patient denied itching or concerns anywhere else on the body.  Patient has been taking Ibuprofen and symptoms have been slowly decreasing.  Patient saw physician who determined that it may have been cellulitis and was treated with antibiotics (or could have been a hypersensitivity reaction).  Patient has recovered fully.
This spontaneous report was received from a healthcare worker refers to a 29 years old female patient without pregnancy and pertinent medical history and with allergic to penicillin. The patient was vaccinated with the first dose of RECOMBIVAX HB (lot # 671032/1106AA, exp. Date: 05-APR-2014, route, dose not reported) on 12-JUN-2012. The patient was with no concomitant medications. On 12-JUN-2012 the patient experienced flushing, warmth and sweating within 10 minutes of receiving her first RECOMBIVAX HB. No treatment was given for the AE. The patient was recovered on 12-JUN-2012. The re was no lab diagnostics studies performed. The patient sought unspecified medical attention. The patient was observed in the office until her symptoms resolved and was then sent home. Additional information has been requested.
Patient had sudden onset of flushing/erythema of skin (no pruritus, but warm to touch), diaphoresis, and itchy throat.  She denies shortness of breath or any respiratory problems. Symptoms started 20 min prior to arrival at the Emergency Department. When the patient arrived at the ED, all of her signs and symptoms had started to subside.
Two weeks after the booster I started getting hives on my legs . They started at night and would be gone by morning . However now says later they are coming and going all day and have also shown up on my back and arms . Hydrocortisone doesn't seem to help much . Allegra helped in the morning for a while .
Fingers locked down; inflammation/swelling of fingers; Feeling feverish; Pin mark left in her right arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TRIGGER FINGER (Fingers locked down), PERIPHERAL SWELLING (inflammation/swelling of fingers), VACCINATION SITE SCAR (Pin mark left in her right arm at the injection site) and PYREXIA (Feeling feverish) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included CARVEDILOL, LOSARTAN, HCTZ, Trulicity once a week, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), GLIPIZIDE, LEVOTHYROXINE SODIUM (LEVOXYL), PRAVASTATIN, DULOXETINE HYDROCHLORIDE (CYMBALTA), OMEPRAZOLE and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. Treatment medication include Prednisone.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE SCAR (Pin mark left in her right arm at the injection site). On an unknown date, the patient experienced TRIGGER FINGER (Fingers locked down), PERIPHERAL SWELLING (inflammation/swelling of fingers) and PYREXIA (Feeling feverish). At the time of the report, TRIGGER FINGER (Fingers locked down), PERIPHERAL SWELLING (inflammation/swelling of fingers), VACCINATION SITE SCAR (Pin mark left in her right arm at the injection site) and PYREXIA (Feeling feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment :Three separate rounds of a Prednisone Medrol pack.   This case was linked to MOD-2021-083617 (Patient Link).
When I initially got the vaccine I had a typical reaction of fatigue, headache and muscle aches etc. That went away fairly quickly. I have not had COVID-19 to my knowledge. on 04/19/2022 I first noticed that my eyelids were retaining a lot of liquid. To my knowledge I'm not allergic to anything so I was confused by this. Then I began to feel more allergy like symptoms, so I started taking Benadryl at night. It did not help the swelling of my eyes. This has been going on for the last two weeks and is worse in the mornings. This past Saturday I developed a very painful sore throat that woke me up. I have also been coughing up phlegm and I have been running warm but not feverish. I went to urgent care yesterday 05/01/2022 and got tested for strep and COVID-19. Strep came back negative but I am still waiting for the COVID-19 results.
Red spot on her arm; Fatigue; Chills; A spontaneous report was received from a 60-year-old, female patient who was also a nurse and received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, red spot on her arm, fatigue and chills.  The patient's medical history was not provided. Concomitant medications were not reported.  On 23 Dec 2020 prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 vaccine intramuscularly for prophylaxis of COVID-19 infection. After vaccination, the patient reported experiencing a red spot on her arm, fatigue and chills.The patient reported she gets the same side effects with the flu vaccine but said this was more. Treatment given for the events was not reported.  The events, red spot on arm and fatigue, were considered not resolved. The event, chills, was considered resolved on 24 Dec 2020.  Action taken with mRNA-1273 in response to the events was not provided.; Reporter's Comments: This case concerns a 60-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and experienced the listed events of fatigue and chills and the unlisted event of erythema. The events were considered related to the vaccine due to the temporal relationship with onset on day of dosing.
Allergic reaction: Body hives, most severely on the face. Left eye swelling. Top lip itching and blistered. OTC allergy medication taken at approximately 10:00 PM same day.
Patient recieved improperly stored vaccine; This spontaneous report was received from a registered nurse refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 30-SEP-2019, the patient was vaccinated with improperly stored therapy type: rHA, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # S001332 (expiry date: 14-JAN-2021), 1 dose for prophylaxis (strength, route and anatomical location were not reported) (product storage error). The vaccine underwent a temperature excursion at 10.5 celsius (C) for a time frame of 56 minutes. There was no previous temperature excursion. The call was because of a data logger. No product quality complaint (PQC) was involved.
pt recv vax & exp a very severe rxn;consumer also reported that exp a worsening of arthritis;
Fever 100.5°, hypothermic chills lasting hours, headache, nausea, lack of hunger  Treatment: 1 Advil every 5 hours,  liquids ingested as frequently as possible
Rash resembles contact dermatitis; mild pruritis; Papular rash noted on left arm/rash has spread to encompass arm - mainly inside of arm (adjacent to main vasculature); This is a spontaneous report from a contactable other healthcare professional (regarding a patient). A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) (age at the time of vaccination was 37 years, patient was non-pregnant at the time of vaccination), via an unspecified route of administration in the left arm on 09Apr2021 at 16:00 (at the age of 37-year-old) as a dose 2, single for COVID-19 immunization. Concomitant medications included venlafaxine (VENLAFAXINE) and numerous supplements recommended by primary care provider from unknown date for unspecified indications. The patient previously received morphine injections and experienced adverse cutaneous reaction. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6206) via an unspecified route of administration in the left arm on 12Mar2021 at 16:00 (at the age of 37-year-old) as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not 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 09Apr2021 at 18:00 the patient experienced papular rash on left arm approximately two hours after vaccination, seemed to coincide with the flush side effect of onset on niacin 1000mg supplementation. 18hours post vaccination, rash has spread to encompass arm mainly inside of arm adjacent to main vasculature. The rash resembled contact dermatitis with mild pruritus. The patient didn't visited physician or other health professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment with self administered diphenhydramine. The outcome of the events was not recovered at the time of this report.  No follow-up attempts were needed. No further information was expected.
Large (3 in diameter), round, warm, red, and raised rash formed a half inch below the injection site.  Present at time of report which is approximately 53 hours after injection. Sore to the touch. Plan to monitor for next few days. Patient also experienced fever of 101 for 14 hours, headache, chills and aches with second dose of vaccine. No rash, fever or chills with first dose.
March 22 increased liver function lab tests. ALT 95 AST 67 ALKP 126  March 29 liver function lab tests increased again ALT 181 AST 111 ALKP 151  April 2 liver biopsy performed.  April 3 admission to Medical Center for liver rejection.  IV Solumedrol 1g daily x3. April 4 lliver function lab tests: ALT 288 AST 132 ALKP 275.  April 5 liver function lab tests: ALT 218 AST 65 ALKP 222  April 5 discharged to home with prednisone taper. April 8 Liver function labs decreasing. ALT 94 AST 8 ALKP 164.  April 3 - April 5 Hospitalization at Medical Center, for 2.5 days.  Unable to type info in Box 21.
Initial report was received from a health care professional on 03 April 2012. A 57-year-old male patient had received an injection of ADACEL, sanofi pasteur Ltd. lot number C3962 (sanofi pasteur Inc. lot number U4104AA) on 23 August 2011 and at the time of the report continued to have a sore, achy deltoid. The patient had no illness at the time of vaccination and had no known drug allergies. The patient's outcome was not recovered. Documents held by sender: None.
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 3/27/2021 ATRIAL FIBRILLATION, UNSPECIFIED ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 3/27/2021 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, W OTHER BEHAVIORAL DISTURBANCE
Headache around 10pm. Took an ibuprofen. In the middle of the night woke up with shivers and chills. Slept poorly. In the morning work up with nausea and sweats.
Menstruation (period) cycle started 4 days earlier than normal and lasting longer than normal.; Menstruation (period) cycle lasting longer than normal/Bleeding has gone on for 8 days now, when "my" normal cycle is 3-4 days.; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 (Lot number: FL3209) at the age of 25 Year(s) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa Drugs; "Food allergy" (unspecified if ongoing), notes: Known allergies: Mushrooms and "Shellfish allergy" (unspecified if ongoing), notes: Known allergies: Shellfish. The patient had received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8727; Anatomical Location: Left arm), administration date: 26Mar2021, when the patient was 24 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE;  Lot Number: EW0164; Anatomical Location: Left arm), administration date: 16Apr2021, when the patient was 24 years old, for COVID-19 immunisation. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 02Feb2022, outcome "not recovered", described as "Menstruation (period) cycle started 4 days earlier than normal and lasting longer than normal"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 02Feb2022, outcome "not recovered", described as "Menstruation (period) cycle lasting longer than normal/Bleeding has gone on for 8 days now, when "my" normal cycle is 3-4 days. Therapeutic measures were not taken as a result of menstruation irregular and heavy menstrual bleeding.  Additional information: It was reported that the patient's menstruation (period) cycle started 4 days earlier than normal and lasting longer than normal. Bleeding started while she was still taking the pills that have the active medication. Bleeding had gone on for 8 days at the time of reporting, when the normal cycle was 3-4 days. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Initially there was redness right at the injection site of the varicella vaccine.  Over night the swelling and redness increased.  on exam redness measuring 15 1/2 cm X 12 1/2 cm on the right upper arm.  Induration worse n the 4 cm area around the injection site then to a less degree for the remaining area of redness
Information has been received from a physician concerning a retired 67 year old white female with an allergy to aspirin who on 09/09/2002 was vaccinated intramuscularly in the right deltoid with a 0.5mL dose of pneumococcal vaccine 23 polyvalent (Lot # 1353-invalid lot).  It was reported that the patient had previous exposure to this or a related drug.  Following the vaccination, the patient experienced right arm inflammation and soreness.  It is unknown if medical attention was sought.  On 09/09/2002, the patient was reported as not being recovered and the experience was not still being treated.  Additional information has been requested.
Received vaccine on 12/10/02 on 12/11/02 in the pm mother states crying, stiffness lasting like 15-20 every 3-5 hr. Acted like he was irritable and mad during this time-last through 12/13/02 no fever.
pt recv vax in 31AUG95 & broke out in rash 2 days ago-typical varicella rash w/lesion in mouth & nose;
Cough; Body ache; Runny nose; Sore throat; Loss of taste and smell; Loss of taste and smell; Missed 2nd dose, at recommended interval; Muscle ache; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN (Body ache), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat) and AGEUSIA (Loss of taste and smell) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced COUGH (Cough), PAIN (Body ache), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose, at recommended interval), MYALGIA (Muscle ache) and FATIGUE (Feeling very tired). At the time of the report, COUGH (Cough), PAIN (Body ache), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose, at recommended interval), MYALGIA (Muscle ache) and FATIGUE (Feeling very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included Tylenol.
child completely withdrew from family members, mom, dad, sister. No eye contact for verbal sounds made again.
Severe chills and muslce aches.  Continued periodically over several weeks and then at the end of March he was admitted with group B strep bacteremia
Weak, SOB, tired, confused, decreased appetite, balance Pulmonary Embolus-hospitalization-TPA
Sustained flu-like symptoms (x 5 days) of moderate severity, with coryza, aches, severe congestion.
Pt called Sunday am stating that had baseball sized raised red, hot, itchy area where ZOSTAVAX was administered on 2-16-13.
Swelling, bruising, soreness in the arm, still do not have full range of motion left arm.
No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 18-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
The patient was very anxious and hyperventilating before shot.  Sat in car with father and passed out.   He was sweaty, pale, but otherwise okay. Patient came to and was given orange juice and squad was called.
Terrible headache; High blood pressure; Stiff neck; A spontaneous report was received from a consumer in the  concerning a 74-year-old female patient who experienced headache/MedDRA PT: headache, high blood pressure/MedDRA PT: hypertension and stiff neck/MedDRA PT: musculoskeletal stiffness.   No medical history was reported. Concomitant medications include montelukast and hydrochlorothiazide.  On 18-Feb-2021, this patient received their first planned dose of mRNA-1273 solution for injection, dosage not provided, (Lot/Batch number: 011L20A) in her right arm for prophylaxis of COVID-19 infection.   On 18-Feb-2021, following the administration of the vaccine, the patient experienced a terrible headache, high blood pressure and a stiff neck. On 25-Feb-2021, she was transported to the Emergency Department by her friend because she was unable to drive. She was hospitalized and administered IV fluid, Ativan (lorazepam) and a "cocktail".  She was discharged from the hospital on 26-Feb-2021. She has not recovered from the headaches. Her physician advised her not to get the second dose of the vaccine.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome for the event headache/MedDRA PT: headache is not recovered. The outcome for the events high blood pressure/MedDRA PT: high blood pressure and stiff neck/MedDRA PT: musculoskeletal stiffness is recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.