chrisvoncsefalvay/vaers-outcomes huggingface dataset:
breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) 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.
Fever 102.88, chills, nausea, coughing, and headache.
This case was reported by a healthcare professional and described the occurrence of arm pain in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness and arm swelling. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752229A, A0752231A, A0752232A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.
patient felt dizzy and  feeling like passing out  - administered epinephrine - one shot patient then complained of a feeling of flushing - administered benadryl
feeling very shaky; fells like she has low blood sugar; Feels jittery; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (feeling very shaky), BLOOD GLUCOSE DECREASED (fells like she has low blood sugar) and FEELING JITTERY (Feels jittery) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced NERVOUSNESS (feeling very shaky), BLOOD GLUCOSE DECREASED (fells like she has low blood sugar) and FEELING JITTERY (Feels jittery). At the time of the report, NERVOUSNESS (feeling very shaky), BLOOD GLUCOSE DECREASED (fells like she has low blood sugar) and FEELING JITTERY (Feels jittery) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.
Flu-like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Shingrix.  Additional information was reported as follows: The case was reported by patient's a friend The age at vaccination was not reported. The patient was vaccinated with Shingrix. The patient had flu-like symptoms begin within 12 hours after the shot and resolved after 1-2 days. The reporter did not feel comfortable giving her friends' initials or their ages. The reporter provided limited information. This was 1 of 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020245582:same reporter US-GLAXOSMITHKLINE-US2020245591:same reporter US-GLAXOSMITHKLINE-US2020AMR246336:same reporter US-GLAXOSMITHKLINE-US2020AMR246110:same reporter US-GLAXOSMITHKLINE-US2020245580:same reporter
Pain at site of injection/soreness at the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: ER8733) at the age of 33 years as dose 1, single and administration date 05Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "migraines" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Known allergies: Scented soaps/perfumes" (unspecified if ongoing), notes: known allergies: Scented soaps/perfumes. Concomitant medication(s) included: VIIBRYD; WELLBUTRIN; BUSPAR; TERAZOSIN; VIT D; CLARITIN [CLARITHROMYCIN]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Apr2021, outcome "recovered" (2021), described as "Pain at site of injection/soreness at the injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: patient had not received other vaccine in four weeks. Patient not had covid prior vaccination and patient was not tested to covid post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is under 16, will turn 16 in a little over 1 month. Patient's mother and patient consented under the reccomendation of PCP to receive vaccine ASAP because patient works in high risk child care facility.
Redness and tenderness at Tdap injection site.  9cm x 5cm area of erythema and tenderness at time of exam on 4/22/15.
Doses were expired 06 Jul 2022, Date the vial was initially stored in the refrigerator was on 12 Jul 2022; Gave 4 doses that were expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 4 doses that were expired) and PRODUCT STORAGE ERROR (Doses were expired 06 Jul 2022, Date the vial was initially stored in the refrigerator was on 12 Jul 2022) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 4 doses that were expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses were expired 06 Jul 2022, Date the vial was initially stored in the refrigerator was on 12 Jul 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave 4 doses that were expired) and PRODUCT STORAGE ERROR (Doses were expired 06 Jul 2022, Date the vial was initially stored in the refrigerator was on 12 Jul 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.     Date the vial was initially stored in the refrigerator was on 12-Jul-2022. The vial did not undergo any temperature excursions. Patient was administered with booster dose. (Not specified first or second booster dose)  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-609299, US-MODERNATX, INC.-MOD-2022-609300, US-MODERNATX, INC.-MOD-2022-609296 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-609299: US-MODERNATX, INC.-MOD-2022-609300: US-MODERNATX, INC.-MOD-2022-609296:
headache, fever (99-101), aches, chills for 48 hours, treated with Tylenol, headache remains 72 hours after-- still treating with ibuprofen
Flu like symptoms, axillary pain and fluctuant edema on the side of injection 48 hours after injection. keflex and benadryl.
low grade temp 10 days ago.....in the afternoon  his temp is 99.5, in the am its low or normal
Since getting my third booster shot I started getting bloated, headaches, bleeding (period) and its already past the time I usually have it. I have been bleeding since the shot.
Hematoma; Vaccination site burning; Vaccination site erythema; Vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOMA (Hematoma ), VACCINATION SITE PAIN (Vaccination site burning), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04LL20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMATOMA (Hematoma ), VACCINATION SITE PAIN (Vaccination site burning), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form; NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form and HYDROCORTISONE at a dose of 1 dosage form. At the time of the report, HAEMATOMA (Hematoma ), VACCINATION SITE PAIN (Vaccination site burning), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.
I had two episodes of near fainting. It was very severe and then, I begin to notice that I had a sensation. My heartbeat was irregular and the next day, I had another fainting episode. Then I had seven episodes of near fainting and I called the Cardiologist. I was diagnosed with Bradycardia.
TM developed left sided facial numbness that progressed to 1st left arm, then right.  Symptoms have progressed to include both legs and feet.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient stated that itching, red, swollen at injection site and red from vaccine site down to elbow area. As of Saturday, she said swelling was improving. Recommended patient contact health care worker from nursing home to monitor.
Patient started getting a nasty cold on 4/24/17.  Fever of 101 degrees started on 4/29/17.  Rash covering entire body, including eyeballs appeared on 5/1/17. Fever on and off over next 7 days. Rash started going away 8 days later.  Painful sores on buttocks, back, one arm and one leg are still present today on 5/17/17. Doctor confirmed on May 4th that he has the measles from the vaccine.  We were instructed to observe.  No medication was administered. We saw Dr on May 9th, rash was starting to go away.  She instructed we give another MMR vaccine.  I declined.  No medication was given and no follow up appointment was suggested.
PT HAD SHOULDER PAIN AND NECK PAIN AFTER VAX (IM,DELT) ON 3-15-90.  TREATMENT: NSAID (OTC).  OUTCOME:  TO DATE, SYMTOMS CONTINUE WITH "LITTLE ABAITMENT".
7/24/2021: Patient presented to the ER with complaints of fever,headache, nasuea, vomiting and diarrhea. Remdesivir started 7/24 200mg IVPB Diagnosed with COVID-19 upon admission, multifocal pneumonitis. Note patient received 2 doses of Moderna COVID-19 vaccine in Feb/Mar 2021.  7/29/21: discharged
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient received Pfizer covid vaccine, experienced some lip swelling on the way home and stopped by another pharmacy and was given 2 pills of benadryl 25mg. Swelling went down, patient is fine. Reported by pharmacy manager.
Horrid smells since March 2021. Recurrent headaches. Coughing spells. Weak spells. Irritability. Sweating. Chills. Rash. Spontaneous and various times every day.
Temperature excursion; A spontaneous report was received from a physician concerning twenty patients who received Moderna's COVID-19 vaccine (mRNA-1273) that underwent a temperature excursion   The patients' medical history was not provided. No relevant concomitant medications were reported.   On 11 Jan 2021, mRNA-1273 vaccines were exposed to a temperature excursion (peak temperature 51 degrees Fahrenheit) for 1 hour and 18 minutes. It is unknown how long the temperature was at 51 degrees Fahrenheit.  From two (2) vials exposed to temperature excursions, twenty(20) doses were given.  On 12 Jan 2021, the twenty patients received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event, temperature excursion, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of Out of specification product use for mRNA-1273. There were no reported AEs associated with this case.
Muscle aches. Chills. Nausea. Vomiting. TX with Promethazine, APAP & supportive care.
Pain, swelling, and redness around injection site that started one day after receiving the second dose of Shingrix. Rash is hot to the touch and extends from left shoulder to forearm. Recommended OTC acetaminophen prn in addition to her Rx meloxicam daily and OTC hydrocortisone cream until rash resolves. Recommended she follow up with her PCP in the mean time.
pt recvd vax & had a tender lump on the lt side of neck since had  immun on Monday; 23FEB93 immun had been given 21FEB94; advised APAP & warm compresses to lump & calling MD to report this;
fingers were numb and tingling; 12 hours post 2nd dose the left side of patient face and left ear were numb as well as both arms and both legs/fingers were numb and tingling; This is a spontaneous report from a contactable consumer. A 23-year-old female patient (not pregnant) received the second dose of bnt162b2 (BNT162B2 also reported as BIONTECH Covid vaccine, lot EL3247), via an unspecified route of administration in the left arm on 25Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history was not reported.  There were no concomitant medications. She received her first dose of bnt162b2 (lot EK9231) on 05Jan2021 in the left arm. On 26Jan2021, the left side of patient's face and left ear were numb as well as both arms and both legs and 800mg of ibuprofen was taken. Next morning (27Jan2021), the numbness in legs gone but the left arm from shoulder to fingers were numb and tingling. The outcome of events was recovered.
Patient experienced an episode vasovagal syncope within a few minutes of receipt of vaccine while waiting the recommended 15 minutes in the waiting area. Patient was seated while episode occurred and hit their forehead on the ground as a result of falling out of chair. EMS was contacted as a result of this
rash, swelling of face, urticaria, angina & hypertension;1st noticed sl rash Friday PM;much worse Sat AM w/swelling, angina & hypertension;angioedema;had angina & Hypertension before;
This spontaneous report was received from a nurse prescriber refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 22-SEP-2017, the patient was vaccinated with first dose of GARDASIL 9 (dose, units and frequency not reported) (lot# and expiration date not reported) intramuscularly. On 28-MAR-2018, the patient was vaccinated with second dose of GARDASIL 9 (dose, units and frequency not reported) (lot# and expiration date not reported) intramuscularly and received about half of the second dose in the series for an unspecified reason. No adverse effects reported. No product quality complaint was involved.
Pt noticed itching feeling and looked at arm.  It was hot & raised, about 2 inches wide and 4 inches in height.  That day she started to feel more fatigued, "feeling heavy" and more tired than normal.  On Thursday, 1/15 she also felt disoriented.  She came to show me the reaction on Fri 1/16 which was still raised, red and warm to touch. She was told to take some diphenhydramine if the itching bothered her.
Day 1 - headaches, nausea, body aches, fever, chills Day2  to present- Body rash
Large swollen rectangle with a lump in the middle at injection site; Large swollen rectangle with a lump in the middle at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Large swollen rectangle with a lump in the middle at injection site) and VACCINATION SITE SWELLING (Large swollen rectangle with a lump in the middle at injection site) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Large swollen rectangle with a lump in the middle at injection site) and VACCINATION SITE SWELLING (Large swollen rectangle with a lump in the middle at injection site). At the time of the report, VACCINATION SITE MASS (Large swollen rectangle with a lump in the middle at injection site) and VACCINATION SITE SWELLING (Large swollen rectangle with a lump in the middle at injection site) had resolved.            No treatment of events was reported.  No concomitant medications were reported.
Fever, lethargy, headache, muscle + joint ache, skin sensitivity, hair sensitivity, swollen lymph nodes. 3 days out axillary lymph nodes still swollen with joint pain, all other symptoms subsided on day 2.
Pt. developed cellulitis (left upper arm redness, warmth, swelling (size of softball), red and black pustules. Treatment: BACTRIM DS: 1 bid #14 tabs, VALTREX 1 gm: 1 tid #14 tablets.
I had a cold a few weeks before booster, During virus was given Doxycycline for ear infection.  Cold symptons had subsided before I received booster. 1st night after getting booster, arm was painful.  Day 2 & 3 cold symptoms came back.  Lots of coughing, sore throat & developed spots on back of throat. Went to urgent care, they did covid test & strep throat test - both were negative.   Was told I had Oral Thrush & Upper Respiratory Infection.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 12-DEC-2014, the patient was vaccinated with an improperly stored dose od PNEUMOVAX 23, "10PJ-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 24 hours in which the lowest recorded temperature was 34 degrees Fahrenheit (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient with high blood pressure, high cholesterol, thyroid condition, allergy to penicillin. On 03-JUN-2014 the patient was vaccinated with ZOSTAVAX (lot #J013449, Expiration date: 24-JAN-2015, strength and dosage unknown, route unknown). Concomitant therapy included blood pressure medication, thyroid medication, cholesterol medication, medication for heartburn. On 04-JUN-2014, the patient experienced redness, warmth and swelling around injection site. The outcome of the events was reported as not recovered. The causality of the events and therapy with ZOSTAVAX was unknown. Additional information has been requested.
Pt came in 2 days later with slight swelling and redness around vaccine area on right leg.
Diarrhea; Body ache; Flu; Swelling  in the injection site; Pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Swelling  in the injection site), VACCINATION SITE PAIN (Pain in the injection site) and MYALGIA (Body ache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and AMLODIPINE BESILATE, VALSARTAN (AMLOSARTAN [AMLODIPINE BESILATE;VALSARTAN]) for Blood pressure.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, 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 experienced INFLUENZA (Flu), DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Swelling  in the injection site), VACCINATION SITE PAIN (Pain in the injection site) and MYALGIA (Body ache). At the time of the report, INFLUENZA (Flu), VACCINATION SITE SWELLING (Swelling  in the injection site) and VACCINATION SITE PAIN (Pain in the injection site) had resolved and DIARRHOEA (Diarrhea) and MYALGIA (Body ache) outcome was unknown.            Patient was taking steroids for COPD. Ammonium was used for two weeks to treat the diarrhea.   This case was linked to MOD-2021-404117 (Patient Link).
Received a Fluzone Influenza Virus Vaccine between 8-9:00am on 10-4-05.  At 2:00pm she developed fever (not measured), lethargy, tired, achy symptoms.  Did not sleep well.  Facial flushing.  She began taking ibuprofen every 6hrs. for symptoms.  On 10-5-05, continued having symptoms.  By 3pm, was feeling better, symptoms resolving.
Numbness in face: mostly in left side extending all the way to the ear; some on right side of face Numb lips Numb tongue Joint pain Significant Fatigue Mild to moderate headaches
Day 1 I had fever chills body aches Day 2 I got a rash on my arm and chest pains  Day 3 still having chest pain