chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWOLLEN LIPS; SICK; NAUSEA; FATIGUE; This spontaneous report received from a patient by a Business partner on 15-APR-2021 was received on 15-APR-2021 and concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included waldenstrom's macroglobulinemia, and sulfa antibiotics allergy, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Concomitant medications included alprazolam, ascorbic acid, bifidobacterium lactis, chlordiazepoxide hydrochloride/clidinium bromide, denosumab, fluoxetine hydrochloride, ibuprofen, nebivolol hydrochloride, and vitamin d nos. On an unspecified date, the subject experienced swollen lips, sick, nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, fatigue, swollen lips and sick was not reported. This report was non-serious. This case, involving the same patient is linked to 20201245161.
I had a fever of about 103 degree, arm was stiff, red hive like bumps. I when to the ER and they gave me tylenol and my fever continued to increase. Then they gave my potassium pills because it was low. Then after an hour they had to give me motrin. They said that my heartrate was high. They gave my IV fluids.
Patient has had history of fainting following immunization when he was "little" but hasn't had a reaction recently except for when doing a blood draw. Patient anticipated that if there were an issue it would happen immediately. Patient was for a few moments after administration and was moved from our immunization room to the patient waiting area. About 10 minutes after administration patient fainted and fell from chair to the floor. Patient came around after a few moments and was breathing and had a pulse throughout this time. When patient started to feel better he sat up and waited on the floor for about 10 additional minutes prior to standing up. Patient was feeling better at this time and was able to leave the pharmacy area.
After getting the 2nd dose of the Pfizer COVID-19 vaccine - patient's left arm (arm in which the vaccine was administered) began to tingle all the way down to his hands, also included some numbness.
Rash started on face, spread to entire body. Examined by doctor, diagnosed as measles. No treatment.
pt recv vax 1997 & 18FEB98 lab eval revealed that the pt had elevated liver function tests;other lab results included: GGTP: 2X normal;SGPT 1-1/2x normal;
Patient had Gardasil (1st injection of series) on 2/26/07 10:00 am, 24 hours later developed pink rash on arms. torso and neck. Patient complain of itching, denies using any new meds or products. Patient came in for OV with doctor, was given Medrol dose pack.
Information has been received from a consumer concerning her 12 year old son with a skin allergy to thimerosal who on 8/4/03, also reported as 4/5/03, was vaccinated IM with a first dose of hepatitis B virus vaccine (lot # 643247/0316M). There was no concomitant medication. On 8/6/03, the next day, the patient began to have skin reactions. The skin reactions included sunburn-like condition all over and eye pain and blistering and diminished vision during the flare up. The patient has been treated with prednisone, topical creams, and eye drops. It was noted that the reaction begins to go away and within 4-5 days it flares up again. A dermatologist has diagnosed the condition as atopic dermatitis. The reporter indicated that the child has missed 1 to 2 days of school each week, and that he has had all kinds of testing. A skin test showed an allergy to thimerosal. The health staff that administered the vaccine reported that the vaccine the child received was preservative free. Unspecified medical attention was sought. The outcome was reported as not recovered. The reporter indicated that the atopic dermatitis was considered to be disabling. Additional information has been requested. Follow up on 11/17/2003: "Follow up information received on 11/05/2003 from a health care professional which indicated that the child received a diphtheria toxoid (+) tetanus toxoid on 07/21/2003.   The reporter indicated that the atopic dermatitis was probably related to the diphtheria toxoid (+) tetanus toxoid immunization that contained thimerosal, and not the hepatitis B virus vaccine rHBsAg (yeast).  The reporter indicated that the atopic dermatitis was considered to be disabling.  No further information is expected."
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. On 24-JUN-2008, the patient was vaccinated with dose 1 of GARDASIL (lot# and expiry not reported). No concomitant medications were reported. On 20-JUN-2012, the patient received dose 2 of GARDASIL (lot# and expiry not reported). Dose 3 had not yet been administered. No symptoms were reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
This is spontaneous report from a contactable Physician via Pfizer sales representative and from a contactable other healthcare professional. A 11-year-old male patient of an unspecified ethnicity received TRUMENBA, lot number M37315, expiry date 30Apr2017, at 0.5 ml single in the right arm; diphtheria vaccine, pertussis vaccine, tetanus vaccine (DTAP) at 0.5 ml (frequency not reported) in the left arm, MENACTRA, lot number 45390AA, expiry date 12Sep2017 at 0.5 ml (frequency not reported) in the left arm and diphtheria vaccine, pertussis vaccine, tetanus vaccine (TDAP, Sanofi Pasteur, lot number 41543AA, expiry date 05Jun2018) at 0.5 ml (frequency not reported) in the left arm all via an unspecified route of administration on 02Jun2016 at 15:30. Relevant medical history and concomitant medications were not reported. The patient passed out after vaccinations and experienced blood pressure fluctuation on 02Jun2016. The patient was not admitted to the hospital due to the events and no emergency room or physician visit was required. Blood pressure was 80/68 when entered office. The patient passed out after vaccinations. He came right to. He was alert and oriented. They had him lay down in a patient room with cold compress for approximately 20 minutes. Blood pressure after 20 minutes was 92/60. Patient was released to go home. The patient recovered from faint while the outcome of blood pressure fluctuation was unknown. The other healthcare professional stated that the patient did not provide to him/her information regarding the reported adverse events with the use of the vaccines. Follow-up (28Jun2016): New information reported from a contactable other healthcare professional includes: time of vaccination, dose, lot number and expiry date of vaccines, new suspect vaccine (TDAP), no admission to the hospital due to the events and no emergency room or physician visit was required, outcome, the patient did not provide to the other healthcare professional information regarding the reported adverse events with the use of the vaccines.
Itching (resulting scratches) from day one to 14. Fever (mild 38 degrees C) two weeks after injection for one week. Rash (face, arms, legs, chest) two weeks after injection. Strong behavioral changes from day one for about 3 weeks.
Patient reports received PNEUMOVAX 3 days ago on 7/31. He felt very "wiped out." About 48 hours after the vaccine, he developed redness of upper arm. He denies fever. He outlined the area of redness. Today, it has significantly improved.
Mouth dry; Looked like cellulitis; Fever; red at the injection site; Pain at the injection site; fatigue; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Looked like cellulitis), DRY MOUTH (Mouth dry), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE PAIN (Pain at the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hashimoto's thyroiditis. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (fatigue). On 17-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Looked like cellulitis), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (red at the injection site). On 20-Jan-2021, the patient experienced DRY MOUTH (Mouth dry). On 10-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (fatigue) had resolved. On 24-Jan-2021, VACCINATION SITE CELLULITIS (Looked like cellulitis) and VACCINATION SITE ERYTHEMA (red at the injection site) had resolved. At the time of the report, DRY MOUTH (Mouth dry) and PYREXIA (Fever) 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 medication included clindamycin for cellulitis.
Patient is a 66-year-old female with a past medical history of diabetes mellitus, vertigo, hyperlipidemia, fall, syncope who presents to the  hospital with right eye pain/infection that started about 3 days ago.  Patient tested positive for COVID-19 upon admission on 7/17/21; but was asymptomatic. Please note: Patient received First dose of Pfizer COVID-19 vaccine on 3/22/2021, followed by the second dose 22 days later, on 4/12/2021 (confirmed from health department)
Narrative:  76yo male patient with hx of DM, HTN, prostate cancer, CAD, HLD presented to community emergency facility (hospital) on 9/11/2021. Pt arrived unconscious. Pt died on 9/11/2021 at this hospital. Pt had received covid vaccines on 1/12/21 & 2/9/21. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
Tremors/ shaking uncontrollably; Cried for 28hours; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremors/ shaking uncontrollably) and CRYING (Cried for 28hours) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced TREMOR (Tremors/ shaking uncontrollably) and CRYING (Cried for 28hours). On 31-Mar-2021, TREMOR (Tremors/ shaking uncontrollably) and CRYING (Cried for 28hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information included Tylenol and drinking plenty of fluid   This case was linked to MOD-2021-162234 (Patient Link).
Moderna COVID-19 Vaccine EUA Starting about 6pm 3/31 - Chills, fever, vomiting, headache, fatigue Lasted from 6pm 3/31 and resolved completely on 4/2 in the evening.  Took Tylenol and kept hydrated.
This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 45-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 at 17:00 (Lot number: FJ1620) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included None. There were no concomitant medications. Vaccination history included Bnt162b2 (DOSE 1, SINGLE; Lot number: CR8731, Route of administration: Unknown), administration date: 14Apr2021, when the patient was 45 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: FW0167; Anatomical site: left arm, Route of administration: Unknown), administration date: 05May2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported IMMUNISATION (non-serious) with onset 19Dec2021 at 17:00, outcome unknown, described as Dose number 3; FATIGUE (non-serious) with onset 20Dec2021 at 17:00, outcome not recovered; MYALGIA (non-serious) with onset 20Dec2021 at 17:00, outcome not recovered; BURNING SENSATION (non-serious) with onset 20Dec2021 at 17:00, outcome not recovered; AXILLARY MASS (non-serious) and AXILLARY PAIN (non-serious), all with onset 20Dec2021 at 17:00, outcome not recovered. Therapeutic measures were not taken as a result of fatigue, myalgia, burning sensation, axillary mass, and axillary pain.  The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Body aches, cough - unclear if adverse reaction to vaccine or just symptom onset with some time proximity to vaccine administration
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL3247) and on 12Feb2021 as dose 2, single (Lot number: EL9266) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history was not reported. Patient had no Known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have Covid again after testing negative twice". Therapeutic measures were taken as a result of drug ineffective, Covid-19.
Patient had pain at previous site where he had shingles in the past. Also had a temperature the evening after the vaccine. He also had swelling and pain at site of injection along with rash that Dr. thought looked similar to shingles.
This spontaneous report as received from a health professional refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The health professional reported that on an unspecified date, unspecified patients received doses of improperly stored PNEUMOVAX 23 injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT AT CLINIC TO RECEIVE SECOND DOSE OF HPV9. FIRST DOSE WAS GIVEN 11/23/21 AND SECOND DOSE WAS GIVEN ON 5/5/22.  UPON FURTHER REVIEW, PATIENT RECEIVED A DOSE OF HPV4 ON 11/6/12 AT PCPS OFFICE. THIRD DOSE OF HPV9 WAS NOT NEEDED. NO ADVERSE REACTIONS OCCURED AND PATIENT DENIED ANY SIDE EFFECTS FROM RECEIVING HPV9 DOSE ON 5/5/22.
Diarrhea, cough, irritability, poor sleep, vomiting, sneezing that began 24 hours following vaccines.
VACCINE WAS ADMINISTERED AFTER 6 HOURS AND 20 MINUTES AFTER VIAL WAS OPENED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 29-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced incorrect product storage. On 29-NOV-2021, the patient experienced vaccine was administered after 6 hours and 20 minutes after vial was opened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and vaccine was administered after 6 hours and 20 minutes after vial was opened was not reported. This report was non-serious.
Narrative:  Patient received two doses of Pfizer COVID 19 vaccine Jan/Feb 2021. The patient tested positive on 17 Jan 2022. The patient presented to the ED with dizziness, post-nasal drip, and cough and was admitted for monitoring. The patient was monitored and discharged on 19 Jan 2022.
Red rash around middle of my body from below my bra line to below my panties and on my back, it doesn't itch or hurt, just lots of red spots everywhere.  Leg and foot cramps.
5pm Headache one hour after vaccine and continued to be fatigued. Then at 10/20 03:30am vomited, then during afternoon feeling better.
Temperature of 99.7°F; Pain in the arm; Joint pains; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature of 99.7°F), PAIN IN EXTREMITY (Pain in the arm), ARTHRALGIA (Joint pains) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature of 99.7°F), PAIN IN EXTREMITY (Pain in the arm), ARTHRALGIA (Joint pains) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE INCREASED (Temperature of 99.7°F), PAIN IN EXTREMITY (Pain in the arm), ARTHRALGIA (Joint pains) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 99.7°f (High) 99.7°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This person is the healthcare worker providing the Rotavirus vaccine to an infant in our Public Health Clinic upon receiving the vaccine the infant splatter it out of his mouth (projectile like) and the vaccine landed in the eyes and mouth of the Nurse. She didn't rinse her eyes and continued about her day, she developed nausea, vomiting and diarrhea lasting 48 hours.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date in July 2014 the patient was vaccinated with MMR II (subcutaneous, dose, units, route of administration, anatomical location, lot number were not reported). The reporter stated that a patient received less than a full dose of MMR II due to poor administration technique on the part of the administering nurse on an unspecified ate within the last week (in July 2014). The reporter also stated that some of the MMR II leaked out the administration site and leaked onto patient's skin. No other adverse effects reported. Additional information is not expected because the reporter did not wish to be contacted.
During the 15 minute observation period, pt reported upper lip swelling and hives on face.
Approx 3 hours after MMR pt felt "fatigued", slept for 2 hours. On awakening, felt "lump in throat," difficulty swallowing, head pressure. Took acetaminophen and pushed fluids rest of day. Afebrile. Cont to rest on 5/2/13, still difficulty swallowing. After full nights rest, on 5/3/13 the pt feels "fine". Declined any medical treatment. Denies sx.
pink 4 inch area at injection site; warm to touch at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number LD3NH, expiry date 11th December 2021) for prophylaxis.   On 7th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient developed a 4-inch area around the injection site on her right arm that was pink and warm to the touch.   There was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and in the database it was reported as not recovered/ not resolved.
Quarter size lump, redness , rash. Inflammation, painful if  pressure placed on area.
Starting in May I started experiencing compete exhaustion. I would sleep with my sleep apnea machine and get a good night's sleep wake up and within two hours be ready to take a nap. I have started to experience extreme hot flashes that not related menopause as I had a hysterectomy years ago. My doctors have run blood work to test for iron deficiency, I had a blood transfusion as my iron was extremely low. They were checking make sure I did not have internal bleeding. The doctors are still trying to find what is causing my exhaustion.
MON CALLED NURSE ON CALL (1/25/05 @ 2119) AND STATED THAT CHILD HAD RASH ON BACK AND LEGS.  ADVISED TO GIVE 1/2 TSP BENADRYL. IF WORSENS, GO TO ER.  MOM TOOK CHILD TO ER AND CHILD WAS GIVEN A DOSE OF STEROID.  I SPOKE WITH MOM THIS AM, RASH IS NOW GONE AND CHILD IS DOING WELL.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medial history, drug reactions or allergies and concomitant therapies were reported. On 10-OCT-2016, the patient was vaccinated was an expired dose of ZOSTAVAX one vial, once, subcutaneously (lot # L017139, expiration date 13-AUG-2016). No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unkonwn age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on an unknown date the patient was vaccinated with VARIVAX (Merck) (route therapy dates not reported) that was stored improperly. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information is not expected.