chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history included pacemaker. Patient had none of drug reactions/allergies. On 01-MAY-2014, the patient was vaccinated with ZOSTAVAX, (lot # and expiry date unspecified) 0.65 ml once, subcutaneously for his wife had shingles and he didn't want to go through the same pain that she did. Concomitant medication was unspecified. On 01-MAY-2014 (also reported as immediately after administration of vaccine), patient developed a "red welt the size of a dime in diameter" at the injection site. The pharmacist instructed the patient to put ice on the reaction and take TYLENOL when he got home (it was unknown whether patient took prescribed medicine). Lab diagnostics studies were not performed. There was no product quality complaint. Action taken with the ZOSTAVAX was not applicable. Patient did not recover from the reported event. Causality of the reported event was unspecified for ZOSTAVAX. Additional information is not expected.
client should have received the 12 plus formulation  but received the 5-11 yrs formulation of Pfizer
Dry Eye Bone Pain Bronchitis Polyarticular arthritis  Symptoms began day after second shot and have not improved. Currently being treated with Prednisone
Injection site was red and swollen and itched.  About 24 hours after injection  got headache and muscle aches.  During the night I got up and was sweating profusely, assumed slight fever had broken.  Injection site is very red, swollen and very sore, about the size of the palm of my hand.  Feeling better today, now waiting for injection site to get better, at least a week.  That's how long it took the first injection site to go away.
61-year-old female who was admitted to the intensive care unit after noted to have sepsis from multiple sources from urinary and pulmonary source. Patient had acute respiratory failure with hypoxia on admission required mechanical ventilation noted to have acute renal failure with severe hypokalemia nephrology followed during hospitalization hypokalemia was replaced acidosis was being slowly replaced to prevent worsening of hypokalemia. Patient had non-ST elevated MI cardiology was consult the patient was placed on a heparin drip patient noted to have Covid pneumonia infectious disease was consult the patient was placed on IV steroids was not placed on remdesivir S patient was arty intubated. Patient received initial sepsis fluid bolus in the emergency room was transferred to the intensive care unit had continued deterioration in the intensive care unit CODE BLUE was called patient underwent 2 codes with return of spontaneous circulation obtained with both. Case was discussed with family who wished patient be comfort care aggressive measures were discontinued patient was extubated the patient was pronounced deceased at 2259 on February 6 2022
After she waited for 30 minutes after receiving vaccine she stated that she had generalized itching and 2 small hives on her right arm. She said it started about 3 mins after receiving the vaccine.  She was given 25mg of Benadryl syrup po. She stayed at facility another 30 minutes before being cleared to leave after she said the itching was better and no further hives formed.  12/23/20 -9:56am She was contacted by phone. She said she woke in the night and felt like "asthma" and had a rash at the site. She took another 25mg of Benadryl. She took another dose of Benadryl at 06:00am. As of this time, 9:56am, she states, no shortness of breath, no more rash at site, and the itching has subsided. She will follow up as needed.
Arm hurt; Achy; Tired; Not feeling well; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Not feeling well), PAIN IN EXTREMITY (Arm hurt), PAIN (Achy) and FATIGUE (Tired) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ROPINIROL [ROPINIROLE] and VERAPAMIL for an unknown indication.   On 28-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced MALAISE (Not feeling well), PAIN (Achy) and FATIGUE (Tired). On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). At the time of the report, MALAISE (Not feeling well), PAIN IN EXTREMITY (Arm hurt), PAIN (Achy) and FATIGUE (Tired) outcome was unknown.            Treatment included ibuprofen
Noticeable weakness on Thursday 4/22/21 during Pilates workout also pain in the left armpit. Saturday 4/24/21 woke up around 4am with an overall ache in the whole left arm as well as swelling and pain in the upper arm immediately around the injection site.
Patient stated she developed rash of red itchy bumps all over her body today (1/28/20) after getting flu vaccination yesterday (1/27/20). No fever or other symptoms besides topical discomfort.  Counseled patient to take benadyl for the time being to alleviate the itchiness and rash and to see medical professional advise if symptoms worsen. Pharmacy will follow-up with patient in the morning
Lethargic, very tired. Achy. Chest tightness, cough with burning feeling inside throat and chest. Runny nose, sneezing. Hoarse voice; lost voice 3-4 days. No noted fever.
Patient was in waiting room for 15 mins, mom notified the front desk that the patient was saying that his arm was hurting. Patient and mom was brought back to the room, injection site was observed by MA and Dr. There was redness and 1 welt around the injection site of the PEDIARIX. Dr. advised MA to place an ice pack on the site and informed mom to keep an eye on it too for if there are further reactions and that he should be fine within a few hours.
5:00 PM soreness and knot where vaccine given.  8:00 AM on 7/1/2014 larger knot around vaccine area, entire body soreness, body aches, diarrhea, tiredness.  10:00 AM weakness, tiredness, joint pain, headache.  11:00 AM very fatigue left work to go home. 12:00 PM slept for an hour now redness, pain and swelling along with knot around vaccine area.  Symptoms continued through the day it is now 9:33 PM same day and no change or relief in syptoms above.
Tested positive for covid-19 on September 17, 2021.  Patient was only experiencing mild symptoms of runny nose, sniffles, congestion.
per child mom cried 2-3hr p/vax & other vax on 19MAR97;went to MD who told mom to give child advil;mom states it helped some rx for ped DT written 4AUG97;
This spontaneous report was received from a nurse via Pfizer, Inc. and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of unspecified HIB vaccine (lot #, expiration date, dose and route of administration were not reported). Administered doses of vaccines experienced the highest temperature of 9.1 degrees Celsius and "out of range for five days, was at 8 degrees Celsius". It was not specified if a digital data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010426: US-009507513-1703USA011908: US-009507513-1703USA011909: US-009507513-1703USA011910:
17APR evening child was seen & had a rash on her face, on 18APR child was dx as having ear infection;
Patient had pain: headache or migraine . Onsite EMS was called vitals BP 148/94 HR 54  100% O2. Patient refused evaluation/care  and released against medical advise.
soreness in left arm; tiredness, fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in left arm) and FATIGUE (tiredness, fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History was reported.  Concomitant products included METOPROLOL for Blood pressure high, ROSUVASTATIN for Cholesterol, METFORMIN for Diabetes, LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness in left arm) and FATIGUE (tiredness, fatigue). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness in left arm) and FATIGUE (tiredness, fatigue) 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.   Concomitant medication included Low Dose Aspirin   This case was linked to MOD-2021-313941 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up received and contains NNI
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. On an unknown date in November 2014 (also reported as within the last week) on dose of improperly stored PROQUAD (Merck) injection (strength, dosage, route, lot # and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Incorrect moderna product administered to patient; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Incorrect moderna product administered to patient) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Incorrect moderna product administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Incorrect moderna product administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Incorrect moderna product administered to patient).    No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
8 hours after injection developed a fever and went to bed.  Slept on an off for 30 hours with fever up to 104F.  When I got out of bed, the effort to walk 10 steps to the bathroom caused vomiting due to exertion.  Head ache was severe.  Saw blinding white light at corners of my vision when I closed my eyes.  Had vision problems and eye swelling.  Could not get to Tylenol in upper bathroom (too many steps) for 30 hours.  Drank 8 bottles of water during this time.  Spent next 30 hours on couch taking Tylenol for 48 hours as often as possible, with the fever under contol, maxiing out at 100F.  .  Fever ended by day 4. Bone marrow pain at hips, ankles and back.  By day 5 I could do light activity for up to 10 minutes and I was able to eat something other than water.   All energy went to immunological response, could not even drink chicken broth for 5+ days.  Arm had a lemon sized bulge at injection site and heat locally.  Back on my feet by day 7.
Allergic reaction; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Agency (Reference number- 00814371) and transmitted to Sanofi on 15-Oct-2021.  This case involves a female patient (unknown age) who had allergic reaction (hypersensitivity) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Caller would like to know the ingredients in FLUZONE QUAD from 2020. She states she had an allergic reaction to it. Suggested that the call go to the website My Daily Med. The caller was calling from work and in a hurry. Was not able to obtain template info."  No laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.  There will be no information available on the batch number for this case.
"A mother reported that her 4 month old daughter received Rota shield, hib-Titer, IPV (Aventis pasteur SA, hepatitis b (Manufacturer unknown) and DTP (manufacturer unknown) vaccines on 05/26/1999. The infant has a history of lactose intolerance and soy and formula allergies. The mother stated that the infant began 'spitting up" soon after receiving the vaccine, and that recently she is spitting up more and her stools became darker. The mother also reported that the infant has had had more vegatables and fruits introduced into her diet. From mailed follow up #1 received on 06/04/01, it was stated the patient recovered from this experience. No further information available regarding this patient or this case.
pt recv vax SEP98 & pt noted became pregnant around christmas eve;approx 27FEB99 pt exp a miscarriage;pt wondered if miscarriage was poss related;
Hot swollen and tender on evening of the immunization. Next morning feeling sick to stomach and sweaty and feeling like passing out.
After giving vaccine, 1 drop of liquid was on arm.  Patient got more than half the dose, so we did not repeat dose.
Pt received vaccine at 10a - during course of day site of injection (R deltoid) became more painful. By 10pm - pain was severe. Pt also experienced some chills. No fever. No redness, warmth, swelling at site.
Case number PHEH2013US018843, is an initial spontaneous report received from a medical assistant on 29 Aug 2013: This case refers to a 10 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with expired MENVEO (batch number: A10054 and expiry date: Jan 2013) on 11 Jun 2013. No adverse reaction reported following this administration error.
Within a few minutes of receiving the shot, the left side of my lower lip started to go numb.   I received the shot in my left arm.  I am allergic to bees and this is the reaction that I get when I get stung.  I started a regiment of Benadryl and Pepcid. the same as I do when stung with a bee.  I reached out to my physician the next morning.  He instructed me to continue with the regiment.  Each day the numbness did decrease.  Today is day 6 after my shot, and I only have an area smaller than a finger tip that is numb feeling in the middle of my lip.    I originally had the J & J shot in March 2021.  I had the same reaction, but it was gone within 18 hours.  The J & J shot was in my right arm and I had the reaction on the right side of my lower lip.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was stored in freezer, one to two vials were taken out and placed in the fridge each day as needed. No concomitant medications were reported.  No treatment was given.
Nervousness; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Nervousness) and MYALGIA (myalgia) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced NERVOUSNESS (Nervousness) and MYALGIA (myalgia). At the time of the report, NERVOUSNESS (Nervousness) and MYALGIA (myalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided by the reporter and no concomitant medication reported.; 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.
Pt presented for 2nd dose and stated  that she developed hives ~ 72 hours after receiving fist dose. She never reported to MD. Take Zyrtec QD, so did not take Benadryl. Called Dr. who stated she should stay for 30 minutes observation. During this time, she reported feeling tingly, a ?strange feeling?, thought she was going to faint and had some chest tightness. She was observed for 45 minutes and was without complaint  when she left.
Adverse effect from mRNA COVID-19 vaccine mady by Moderna. CT Scan showed patient's lungs has severe interstitial lung disease. Patient has symptomatic shortness of breath.
Body aches within 24 hours of vaccine administration for about 48 hours. Low grade fever and chills 72 hours after administration. site wram to touch, red, and itchy.
SHAKING TO THE BONE; RADIATING MUSCLE PAIN; LOW GRADE FEVER; ARM BRUISED FROM INSIDE; DISCOMFORT UNPTO THE SHOULDER; STOMACH PAIN; ARM HURTS ALL THE TIME; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced arm bruised from inside. On MAR-2021, the subject experienced discomfort up to the shoulder. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced arm hurts all the time. On MAR-2021, the subject experienced loss of energy. On 23-MAR-2021, the subject experienced shaking to the bone. On 23-MAR-2021, the subject experienced radiating muscle pain. On 23-MAR-2021, the subject experienced low grade fever. The patient recovered from arm bruised from inside, discomfort up to the shoulder, shaking to the bone, stomach pain, loss of energy, and low grade fever on MAR-2021, and had not recovered from arm hurts all the time, and radiating muscle pain. This report was non-serious.
Patient indicated on the consent that she was not pregnant by checking the "no" box. After the nurse administered H1N1 LAIV she learned that the patient was in fact pregnant. She was given a note to take to her health care provider indicating that she had been given LAIV. 11/25/2009 MD records indicated preganat patient, EDC 4/23/2010 received H1 N1, no side effects noted.
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). The patient was treated with DIETHYLAMINE SALICYLATE, METHYL NICOTINATE (ASPERCREME [DIETHYLAMINE SALICYLATE;METHYL NICOTINATE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Treatment medications also included: Bio-freeze and bengay cream.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information received: Updated event outcome to recovered. Patient had declined further follow-up.
Pt developed a rash 36 hrs post vaccine administration. R/o impetigo, poison oak.
He had a stiffening, seizure like episode that lasted for about 4-5 seconds.  His whole body tightened, his face got bright red, it looked involuntary, and he cried afterward like he was scared and didn't know what had just happened.  This happened two times on 1/10 in the morning, one time on 1/12 in the late afternoon and two times on 1/14 in the evening.  Patient was hospitalized on 1/15 to 1/16 due to these episodes.  There was no fever and he did not have any more of these episodes after 1/14.  They did an EEG while sleeping and awake and did not find any irregular brain activity.  A neurologist saw him and thought it might be a reaction to his immunizations.
Headache (everyday), tingling in both arms & numbness, memory loss, difficulty concentrating, chronic fatigue, lethargic, cough, hair loss, knees, ankles & backache, blurred vision, anxiety, cannot sleep. Tx: Norflex, Xanax, Motrin 800.
Patient received Pfizer COVID-19 Vaccination on 04/07/21. Presented in clinic at 0745 PM on 04/08/21. States he's had vertigo and nausea today, and has been at work all day. States vertigo and nausea are relatively mild, but worrisome. Alert and oriented and in no apparent distress, grossly normal gait and balance at time of presentation to clinic. Advised to go to ER for further evaluation, given potential relationship of symptoms to Pfizer COVID-19 vaccine.
Vomiting & diarrhea in pm? Seizure /p vomiting unresponsive @ home,crying on arrival to ER 530pm,T 102.9 (R).DX:Febrile seizure 15 /p adm more alert. D/C from hosp-13Apr T 100.5(R) on discharge.
This spontaneous report as received from a Licensed Practical Nurse refers to a 9 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided. On 06-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # N028258, expiration date on 30-MAY-2019, oral for prophylaxis. (dosage schedule was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.