chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COUGH; FEELS BAD; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced cough, and feels bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cough and feels bad was not reported. This report was non-serious.
This spontaneous prospective pregnancy report as received from a administrator refers to a 34 year old female patient with no medical history and no drug reactions/allergies. On 17-OCT-2014 the patient was inadvertently vaccinated with a dose of GARDASIL (lot # K001500, expiration date: 06-NOV-2016), 0.5 ml, intramuscular. Concomitant therapies included unspecified prenatal vitamin. The patient was in 36 gestation week at the time of vaccination. Approximated date for last menstrual period (LMP) was 07-FEB-2014 and estimated delivery date (EDD) was 14-NOV-2014, pregnancy outcome pending. There was no treatment given for adverse event. No lab diagnostics studies were performed. The patient did not seek medical attention. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist from a non-clinical study program. A male patient of an unspecified age and ethnicity received a single dose of PREVNAR (Lot number: L62072), via an unspecified route of administration on 30May2015. The pharmacist provided a number 405197102; and mentioned another NDC number as 00005197102; and the UPC number as 300051971022. The patient's medical history was not reported. The pharmacist mentioned that patient was not taking any other medication. On 31May2015, the patient experienced really big red rash that went to the inside of the arm right after the shot was given. The clinical outcome for the event of really big red rash was unknown; however it lasted longer than a week. Causality was reported as the pharmacist confirmed that the patient had most likely these side effects from PREVNAR. Follow-up (22JUL2015): Follow-up attempts completed. No further information expected.
second shot things have gotten much worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Colon Cancer" (unspecified if ongoing); "HELLP syndrome" (unspecified if ongoing); "carrier for hemochromatosis" (unspecified if ongoing). Concomitant medication(s) included: VITAMINS A & D. Vaccination history included: Bnt162b2 (Dose:1, Lot No:EN6199, vaccine location=Left arm,), administration date: 31Mar2021, for COVID-19 Immunization, reaction(s): "swollen, red,hot itchy ears"; Bnt162b2, for COVID-19 Immunization, reaction(s): "swollen, red,hot itchy ears", "swollen, red,hot itchy ears", "swollen, red,hot itchy ears". The following information was reported: CONDITION AGGRAVATED (non-serious) with onset Mar2021, outcome "not recovered", described as "second shot things have gotten much worse". The event "second shot things have gotten much worse" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of condition aggravated.  Additional information: Stated that the patient received treatment with Steroids and antibiotics. The patient was not diagnosed with covid-19, before or after vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
upset stomach; diarrhea; This case was reported by a consumer via interactive digital media and described the occurrence of upset stomach in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In October 2022, unknown after receiving Shingrix, the patient experienced upset stomach and diarrhea. On an unknown date, the outcome of the upset stomach and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach and diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-OCT-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had got the second Shingrix shot and had an upset stomach and diarrhea for four days now. Additional supportive information: Follow-up would not possible as no contact details were available.
Patient reported bruising on left arm near deltoid area where the shot was given spanning to almost the elbow.
Is it still safe and does the vaccine work 2 weeks after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Is it still safe and does the vaccine work 2 weeks after expiration date) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Is it still safe and does the vaccine work 2 weeks after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Is it still safe and does the vaccine work 2 weeks after expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
He was getting antsy and nervous, got worse and worse; Antsy; Fever went to 104 and some temps last night 27Oct2021; He started sweating and feels better today 28Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (He was getting antsy and nervous, got worse and worse), FEELING ABNORMAL (Antsy), HYPERHIDROSIS (He started sweating and feels better today 28Oct2021) and PYREXIA (Fever went to 104 and some temps last night 27Oct2021) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 037A21B and 045A21A) for COVID-19 vaccination.     Concomitant products included IPRATROPIUM BROMIDE (ATROVENT), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and MELOXICAM for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced HYPERHIDROSIS (He started sweating and feels better today 28Oct2021). On 27-Oct-2021, the patient experienced PYREXIA (Fever went to 104 and some temps last night 27Oct2021). On an unknown date, the patient experienced NERVOUSNESS (He was getting antsy and nervous, got worse and worse) and FEELING ABNORMAL (Antsy). At the time of the report, NERVOUSNESS (He was getting antsy and nervous, got worse and worse), FEELING ABNORMAL (Antsy) and PYREXIA (Fever went to 104 and some temps last night 27Oct2021) outcome was unknown and HYPERHIDROSIS (He started sweating and feels better today 28Oct2021) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Pyrexia: 104 (High) fever went to 104.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.  Patient Reported that he took  inhalers and a nebulizer four times a day.
Felt tired; Injection arm became sore; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) and VACCINATION SITE PAIN (Injection arm became sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 0492119) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy in 1983. Concurrent medical conditions included Acromegaly since 1970. Concomitant products included PROGESTERONE and ESTRADIOL (ESTROGEN) for Pituitary disorder, HYDROCORTISONE for Pituitary gland operation, LIOTHYRONINE SODIUM (CYTOMEL) for Thyroid disorder.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 25-Feb-2021, the patient experienced FATIGUE (Felt tired) and VACCINATION SITE PAIN (Injection arm became sore). At the time of the report, FATIGUE (Felt tired) and VACCINATION SITE PAIN (Injection arm became sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.    This case was linked to MOD-2021-073158 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up information was received on 12-May-2021, HCP details updated, patient details, past medical history, Vaccine facility details and concomitant medication details were updated.
Patient in ER w/difficulty breathing and cough.  Onset was 08/02/2021. The symptoms are worsening during course.  Fever, SOB, dizziness, muscle pain and nausea.
On 3/6/21 - One hour after the shot, left facility and drove home -- my nose became quite stuffy -- muscus membrane swelling mainly -- not much phlegm to be cleared out - settled down about an hour later without taking any medications.  Starting on 3/7/21 - Sore & stiff muscles in both arms - aching joints and muscles in legs also, stiff neck and waves of nausea that come and go. - also very groggy &  fatigued  On 3/8/21 - Woke up more aching, swollen glands under left arm and headache starting -  took only Tylenol for the headache .  Rest of symptoms still in effect.  Stayed home from work to take it easy.  Hoping things will pass by tomorrow or Wednesday
Rash (size: 2"X3") developed on left arm around and just below injection shot. Was tender to the touch and swollen. Was not itchy. Decreased significantly in size and redness in less than 24hrs.
Reported numbness and tingling and swelling in arm where flu shot was given and numbness in legs and swelling. L arm and hand where shot was given was darker that R hand and arm. State her brain felt "foggy". Sent to ED.
Elevated temp on 7DEC91 & 8DEC91 mom states inc to 105; Called ER gave tepid baths; also crying abnormally for 1 hr @ a time; crying in sleep also; wakes up w/palms of hands red & rubs them together;
Headache; Vomiting; Fever; Chills; This is a spontaneous report from a contactable 13-year-old male consumer (patient) reported for himself that received bnt162b2 (PFIZER COVID 19, Solution for injection, Lot Number: EWO180), via an unspecified route of administration, administered in arm left on 08Jun2021 11:45 (at the age of 13-year-old) as dose number unknown, single for covid-19 immunisation. Medical history was none. No known allergies. No other vaccine in four weeks. Also, no other medications in two weeks. Prior to vaccination, patient had not diagnosed with Covid. Post vaccination, the patient had not tested Covid. There were no concomitant medications. Facility type vaccine was pharmacy or drug store. The patient experienced headache, vomiting, fever and chills on 09Jun2021 00:15. No treatment received for adverse events. The outcome of events was resolved on Jun2021.  Follow-up attempts are completed. No further information is expected.
headache; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 49-year-old patient received BNT162B2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 16Apr2021, outcome "unknown", described as "headache". Additional Information: The patient received first dose of vaccine yesterday, Pfizer, COVID. The patient was a 49 year old, healthy adult, athlete. On 16Apr2021, the patient experienced pretty good headaches and asked if it was safe at this point to take Excedrin or Tylenol for the headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchy, irritated, red swollen rash at the injection and muscle aches in upper arm
2 weeks after Pediarix administration, patient had several seizures; seen in clinic. Called apnea. Vax given 4/29/05. Hospitalized 5/11/05.
VACCINE EXPOSED TO TEMP. OUTSIDE REC. STORAGE RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER.
10:50 - Patient complained of itchy throat, reports this is the same reaction she had to the first two shots, took a benadryl and dose of albuterol inhaler last time and it went away.   10:55 - 25mg of Benadryl taken per patient request.  Given by school nurse.  SpO2 99% RA, HR 104, RR - 21, unlabored, BP 136/78, patient reports BP high for her.  Reports itchy throat, no trouble breathing, cough, raspy voice noted, 2 RN's monitoring patient, patient refusing epinephrine.   11:00 - Patient tearful, reportedly due to "attention", No trouble breathing, however is still having cough, raspy voice, itchy throat.  Continues to refuse epinephrine.  "I know when I need epi and I'm no where close to that."  Spo2 96% RA, HR 99, RR 26 - crying.  No swelling noted to tongue.   11:05 - Patient agreeable to epinephrine, RN told patient that once epinephrine was given, ambulance needs to be called or patient needs to go to ED.  Patient adamently refused ambulance/ED and then refused epi again.  Husband brought patient her inhaler, took 2 puffs off albuterol inhaler - reports this is what she does for allergic reactions.  Both RNs continued counseling patient on dangers of allergic reactions and subsequent exposures being worse, that previous interventions may not work this time, swelling could return, albuterol won't help the reaction itself, continued encouraging epinephrine and ambulance?ED. Patient continued to refuse.  SpO2 just prior to albuterol 93-94% RA, RR 22 unlabored, HR-99, voice still raspy. 11:08 - Post albuterol, patient SpO2 99%, HR 93, RR 21 unlabored, BP 117/72.  Continues to refuse epi despite education and encouragement from nurses.  Reports she is feeling better - itchiness still present but improved, adament on attending her personal development for teachers that was occurring at that time, reporting, "there's a whole library full of people to watch me."  This RN walked her down to library where her table was informed of her status and told to notify RN immediately upon changes in coughing, breathing, appearance, or reported by patient. 11:48 - Reports chest tightness, raspy voice, but reports improvement in itchiness.  Continues to refuse epi, ambulance, or ED.  SpO2 99% Ra, HR 93, BP 116/72, RR 18.
Swelling, redness, itching, pain, tenderness, dizziness, nausea.
pt recvd vax & 2months p/vax pt exp swelling in lt arm (inj site) which was warm to touch,had red & white mottling;pt seen by MD;sx persist;
PATIENT REPORTS STOMACH UPSET (NO VOMITING), EXTREME FATIGUE, VISUAL DISTURBANCE (BLACK SPOTS OBSTRUCTING VISION), PT REPORTS HE DID NOT SLEEP WELL DURING THE NIGHT. GOT UP IN THE MORNING FEELING BETTER BUT STILL TIRED. PT RETURNED TO BED AND SLEPT UNTIL 11 AM-UPON WAKING HE FELT BETTER.
Pt was given FLUARIX (IM form of influenza) nasally to left nare - nurses made error thinking it was FLUMIST. No ill effect no adverse symptoms occurred. Mother was with child. Error caught minutes after pt left. Parent notified, state, and appropriate forms filled out.
I didn't really have any problem with the doses. But in October 2022, I was completely short of breath and I fainted. I passed out. I went to the hospital and then was released. But the same night, I passed out again and went back to the hospital. I was hospitalized for two days.
Arm swelling; Arm redness; Arm warmness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), ERYTHEMA (Arm redness) and VACCINATION SITE WARMTH (Arm warmness) in a 71-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 reported medical history).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), ERYTHEMA (Arm redness) and VACCINATION SITE WARMTH (Arm warmness). At the time of the report, PERIPHERAL SWELLING (Arm swelling), ERYTHEMA (Arm redness) and VACCINATION SITE WARMTH (Arm warmness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment for the events included Tyelnol (paracetamol).
Pain on the left side of the hip; it is preventing her from walking; she said felt heavy; This is a spontaneous report from a contactable pharmacist. A 12-years-old patient of an unspecified gender received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 31Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Jul2021 the patient experienced pain on the left side of the hip, it is preventing her from walking, she said felt heavy lot number and expiration date of the suspected medication were not provided limited information was available from the reporter. The outcome of the events arthralgia, gait disturbance, limb discomfort was unknown.  Information on lot/batch number has been requested.
0700-Vaccinated -0907- C/o lightheadedness 0930- Symptoms improved and patient was sent home
Patient developed diarhea following rotovirus vaccine that has persisted for 2 weeks. No other symptoms present.
Narrative: Myalgia, NauseaVomiting, fatigue missed work following second dose due to the above symptoms
This spontaneous report as received from a Licensed Practical nurse refers to two patients aged "15 to 18 months". The patients were vaccinated with dose 1, 0.5 ml PROQUAD, SC (site of administration and lot # not reported) in 2011 ("about a year ago"). No other co-suspects were reported. No concomitant medications were reported. It was reported that about a week after immunization, the patients experienced febrile seizure (medically significant). No treatment information was reported. The outcome of febrile seizure was reported as recovered/resolved. The relatedness for febrile seizure is unknown for PROQUAD (Merck). Upon internal review febrile seizures were considered medically significant. This is one of several reports from the same source (MARRS # 1210000193). Additional information is not expected.
I was having trouble falling asleep. It developed into air hunger. I could not take a deep breath and it evolved into an anxiety episode. I asked to go to the emergency room after an hour of this. My oxygen saturation was at 94. I was going to be sent home, but they gave me a short walk and my oxygen got desaturated to 88 or 89 on the walk. I have hypertension and my O2 stat I was given Regeneron. Due to the lung modules, it was decided that I would need five injections of this. I stayed in the hospital for5 days to receive them. Ultimately, I was put on bed rest at the hospital. I came home after five days and developed into a cough and congestion. The hospital tested me for COVID-19 and it came back positive. However, before I went to the hospital I tested myself and it came back negative. I developed a cough that was productive.  They also gave me Decadron in the hospital and after that my breathing was better. I believe the x-ray they did was negative; they did not see anything new. My cough was unbelievably productive when I got home into the night. I was erythromycin when the cough got really bad. My symptoms were fatigue, cough, and brain fog. The brain fog lasted for about two weeks. The cough lasted another four weeks or so. After two weeks of being home the COVID-19 test started reading negative.
The week after I got the 2nd dose I started getting cramps in lower back, stomach, my calves and all the way down to my feet. I saw my doctor, they did some bloodwork. The doctor told me to take some prenatal vitamins and B3 vitamin, eat a banana and drink juice. The cramps got a little better but they are still there, they come and go.
Lymphadema under the left axilla, fever of 101, allegra and tylenol, and feels ok but lymphadema still present
This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received ENGERIX B. On an unknown date, the patient received ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.
Case number PHEH2016US005850 is an initial spontaneous report received from a consumer who was a physician on 09 Mar 2016. This report refers to a 75 year old male patient. His medical history included Hong Kong flu in 1957. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly on 03 Sep 2015. In Dec 2015, he developed flu. He stated that he went to visit friends and flew in Dec 2015 and within 8 to 10 days after returning home, he developed a "text book" case of flu with back pain, dry cough and achiness. He recovered from the flu in Dec 2015. The outcome of back pain, dry cough and achiness was not reported. The seriousness of the events was not reported, but the events flu and vaccination failure was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
I had an instant sore arm, chills that evening, extreme nausea, extreme fatigue. Next morning I was getting excruciating pain in my lower left abdomen. Around noon I went to the ER. Gave me Amoxicillin for 2 weeks. Symptoms subsided within a few days. I returned to the ER a couple of weeks ago with the same infection which was worse and needed hospitalization for several days. I am still on antibiotics. I have not felt well all Summer & Fall. I had a colonoscopy in end of March which everything was normal.