chrisvoncsefalvay/vaers-outcomes huggingface dataset:
approx 2hr p/vax pt became blue around mouth & on abd;dad reported pt very irritable, cold & clammy, mottled;cyanosis lasted 15-30min observed in hosp x 1 day w/o further problems x/temp
Erythema noted on (L) arm at varicella injection site 2.5 in wide 3 in in length.
less than 24 hr p/last vax temp to 105f for 2 days w/on & off diarrhea & crying
This spontaneous report was received from a licensed practical nurse (L.P.N) refers to a patient of unknown age and gender. On 06-NOV-2012 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 671663/1159AA, expiration date 18-OCT-2012) dose and route not reported. No concomitant medications were reported. No adverse effect reported. No further information is available. Additional information has been requested.
Red pin point rash area at injection site about the size of a tennis ball and it is larger then yesterday. Patient went to go see her Dr. and he informed her to taking Advil or Tylenol and also take Benadryl at night and also gave the patient a perscription for steroid. The Dr. also told her to never again to get the flu shot again or it could be fatal.
shingles; Information has been received from a lawyer regarding a case in litigation concerning to a male patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.   On or about 05-JUL-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, anatomical application, lot number and expiration date were not reported) for the long-term prevention of shingles and or zoster-related conditions.   On an unknown date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles, and he was treated by a health care professional. The patient had and would continue suffer ongoing injuries; significant medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies.   The causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was related.
Tinnitus within the hour of shot. Ringing continues in ears indefinitely. Other symptoms that went away within 48 hours were fatigue,  cold chills,  lethargy, and head ache.
Headache; Elevated temperatures; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in right arm, on 06Mar2021 at 12:00 PM (at the age of 32 years), as dose 1, single, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 07Mar2021 at 12:00 AM, the patient experienced headache, elevated temperatures, and joint pain. No treatment was received for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from the events in Mar2021.   No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Pt reported feeling symptoms approx 10 minutes after receiving injection. She complained of mild shortness of breath and "itchy throat." She was questioned about having any other symptoms and immediately escorted to the medical attention tent. She was seated, and EMS began evaluation; her vital signs were taken: RR 22, HR 82, BP 156/102, PULSE OX 98%. She then reported an increase in symptoms, as face itching, increased tightness in her throat. Objective symptoms observed by myself and EMS: cough/clearing of the throat, increased SOB/labored breathing, facial erythema, hoarseness. EMS asked for her consent to give her Benadryl and Epinephrine. She repeatedly refused this, and refused any attempt at IV placement. She eventually agreed to IM Benadryl, of which 50mg were administered by EMS. Both EMS and I suggested more than once that she allow us to transfer her to the hospital for further management and preparation in the event that she needs further care. I explained that she was having symptoms of anaphylaxis. She repeatedly refused transfer. She reported a decrease in symptoms, saying she felt well enough to go home. Her objective symptoms observed by myself: continued hoarseness and clearing of the throat. VS were repeated: RR 18, HR 68, BP 160/98, PULSE OX 99%. Airway remained patent and clear. Patient again requested to leave, and agreed to EMS escorting her to her car.
Breakthrough COVID Case: Thursday night going into Friday when I was sleeping I noticed I kept waking up because My throat was really dry and sore on the left side. I had no BMs for the whole day that was really unusual for me. I also had congestion. I took a home test on Friday and it was negative. I went about my business. Friday night going into Saturday, I was coughing al night and my stomach was really hurting. I think it was more my intestinal system was hurting as opposed to my stomach. That morning, I tested positive. Sunday, I had a lot of mucus. My nose was running a whole lot. On Monday, I started coughing a lot. I had a headache. I had a lot of congestion in my head. I was exhausted. My breathing felt tight. I started Paxlovid that evening.
Pt tested positive 11/3/21. Symptoms started 11/2/21: cough, body aches, head ache, fever, chest congestion
05/16/2003: Administered DTAP in right thigh-case is on 05/19/2003 with right thigh and swollen & warm to touch.  On Omnicef for OM
Initial report received on 03/24/2006, from a health care provider. A 51 year old female patient with allergies to Demerol and Toradol had received an administration (route not reported) of Adacel (lot number C2454AA) in the left deltoid on 03/17/2006. 24 hours later, she complained of have pain and swelling at the injection site, general malaise and stiffness in the arm up to her neck, that required a physician visit on 03/22/2006. At the time of this report it was unknown if the patient had recovered from these events. Follow up information received on 05/01/2006: The patient had a history of allergic rhinitis. Treatment included ice and over the counter Benadryl. At the time of this report the patient had recovered.
Patient reported loss of muscle movement in eye and face.  He want to see doctor and was told suspicion of Bells Palsy related to vaccination.   The doctor is having a CAT scan with patient for follow up tomorrow 07/10/2015.
Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # L048209 with expiration date of 31-MAY-2018 administered intramuscularly for prophylaxis (dose was not provided). It was reported that the vaccine had been stored for 5 hours at 59 degrees Fahrenheit as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA002933: US-009507513-1702USA008024: US-009507513-1702USA008022:
Missed dose/ We're out 7 weeks now/ missing the 42 day window; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose/ We're out 7 weeks now/ missing the 42 day window) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose/ We're out 7 weeks now/ missing the 42 day window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose/ We're out 7 weeks now/ missing the 42 day window) had resolved. Not Provided      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.   No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Non significant follow up appended.
Arm started itching; bright red area about the size of the palm of her hand; This spontaneous case was reported by a consumer and describes the occurrence of   in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID), VITAMIN D NOS, CYANOCOBALAMIN (B12-VITAMIIN), CALCIUM and MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient was treated with HYDROCORTISONE ACETATE (CORTIZONE [HYDROCORTISONE ACETATE]) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       TUMERIC SUPPLEMENT used as a Concomitant medication; 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.
she started sweating; weakness in legs/weak; Couldn't walk; had a very bad headache; am having some side effects/I'm not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (am having some side effects/I'm not feeling well), HYPERHIDROSIS (she started sweating), ASTHENIA (weakness in legs/weak), GAIT DISTURBANCE (Couldn't walk) and HEADACHE (had a very bad headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 08UJ21A, 042120A and 025520-2A) for COVID-19 vaccination.     The patient's past medical history included Spasms. Concomitant products included TIZANIDINE for Spasms, BUPROPION, DULOXETINE, AMLODIPINE and OLMESARTAN MEDOXOMIL for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced VACCINATION COMPLICATION (am having some side effects/I'm not feeling well). On 27-Jan-2022, the patient experienced HYPERHIDROSIS (she started sweating), ASTHENIA (weakness in legs/weak), GAIT DISTURBANCE (Couldn't walk) and HEADACHE (had a very bad headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for No adverse event, at an unspecified dose and frequency. On 29-Jan-2022, HYPERHIDROSIS (she started sweating), ASTHENIA (weakness in legs/weak), GAIT DISTURBANCE (Couldn't walk) and HEADACHE (had a very bad headache) was resolving. At the time of the report, VACCINATION COMPLICATION (am having some side effects/I'm not feeling well) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient states that a few hours later, she started experiencing events sweating, felt weak, and couldn't walk and headache. Patient stated that she was still not 100% normal, but was getting back to feel like herself.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2022: Significant Follow Up Appended; Events added On 31-Jan-2022: Updated Reporter's details, dose details, concomitant medications, treatment medication, additional events and outcome were added and additional information added in I narrative
3 hours after receiving vaccine developed pinpoint spots around eyes and temple areas. Low grade fever also. 8/6/15 TC. Fever subsided rash areas subsiding. Spoke with physician on 08/05 and physician indicated patient was screaming while imms were given and spots were due to blood vessels rupturing.
5 minutes post flu shot went limp & unresponsive skin became red & blotchy. EMS activated. Epinephrine (0.5mLx2) administered. Became alert and oriented - transported to urgent care.
Case number PHEH2013US025758 is an initial spontaneous report from a pharmacist received on 12 Dec 2013. This report refers to a 61-year-old female patient. Her medical history was not reported. Concomitant medication included ZYRTEC. She was vaccinated with 0.5 ml dose of FLUVIRIN (batch number: 1309701 and expiry date: 01 May 2014) intramuscularly into left arm on 10 Dec 2013. She experienced numbness and tingling in both arms since administration of vaccine. It was reported that the left arm (site of FLUVIRIN administration) has stronger sensations of numbness and tingling than the right arm. It was also reported that the feeling comes and goes but has not ended. Seriousness and causality of the event was not reported.
Miscarriage; This is a spontaneous report from a contactable consumer (patient). This is the mother case.   A 34-year-old female patient received the 1st single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in left arm on 18Apr2021 (Batch/Lot Number: Ew161), and the 2nd single dose, always in the left arm, on 02May2021 (Batch/Lot Number: Ew0171), for COVID-19 immunisation. First and second dose were administered at the age of 34 years old. Relevant medical history was reported as none. The patient's last menstrual period was on 18Feb2021 and pregnancy due date was 26Dec2021. Concomitant medications included unspecified pre-natal vitamins. Relevant past drug history included sulfa. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was never diagnosed with COVID-19, and since the vaccination the patient had not been tested for COVID-19. The patient reported having miscarriage on 13May2021, diagnosed after the 2nd shot of BNT162b2. A doctor or other healthcare professional office/clinic visit was needed. The fetus had died sometime between the 1st and 2nd shot based on gestational age. Gestation period when the event was observed was reported as 4 weeks. The patient had to undergo dilation and curettage from which the patient was recovering. The seriousness criterion was reported as 'Congenital anomaly/birth defect' (no further information reported about the congenital anomaly).  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021602308 mother/baby case
Syncope after ADACEL and MENACTRA. Still dizzy - 7-19-17. Then fine. 2:46PM, child was walking to the door after picking a sticker and fainted and has a small seizure for approximately 2 seconds. Patient was very alert after. She knew where she was, todays date, day. She knew her name and her age. She also had no problem reading. Her pulse was 86 however is was faint and steady. 2:51 PM add to notes- she did not hit her head. Another patient was coming the office and caught her head as she was falling. 5:07 PM Note being entered at end of day -fter patient received her shots, she felt fine and walked to the front of the office to leave. She was inspecting the stickers and there was a large spider nearby, though she said later that this did not bother her. She then started to take a few steps and had a brief syncopal episode. Another patient who arriving then caught her head before she hit the ground. She apparently had a very brief tonic clinic seizure-for a few seconds. I was called and found her already awake lying on the ground with mom. She was a little dazed at first but then immediately knew where she was, who I was, the date, events that are happening soon for her family that we discussed during her visit, etc. She had some water and fruit cup and stayed on the floor for a few minutes. Then we moved her to a chair, where she continued to drink and had fruit cup. I saw another patient and checked on her again, at which time she felt fine. We had her get up on her own and she was completely fine. Mom will call us if she has any concerns and I will check on her tomorrow. I advised mom that in the future, she should sit and relax for a while after she receives shots.
Johnson and Johnson Covid-19 vaccine given on 03Mar2021 and Moderna Covid-19vaccine given on 04Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson Covid-19 vaccine given on 03Mar2021 and Moderna Covid-19vaccine given on 04Aug2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE (lot number 1805018 and expiration date not provided. This was given at 0.5ml intramuscular on the right deltoid.) on 03-Mar-2021.    On 04-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson Covid-19 vaccine given on 03Mar2021 and Moderna Covid-19vaccine given on 04Aug2021). On 04-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson Covid-19 vaccine given on 03Mar2021 and Moderna Covid-19vaccine given on 04Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.
This spontaneous report as received from a health care professional refers to multiple patients of unknown ages. The patients' medical history and concurrent conditions were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored (temperature/time: to 32F for 60 hours and a previous excursion of 33F for 12 hours) PNEUMOVAX23. The nurse stated that it was unknown at the end and could not be denied or confirmed that doses were administered. No adverse effects reported. The outcome of the events was unknown. Additional information had been requested.
Information has been received from a Pharmacy Technician (Pharm. T.)/Healthcare Worker concerning a patient who on an unknown date was vaccinated with MMR II (albumin status and Lot # unspecified). It was reported that a family came into the pharmacy and stated that the patient (family member) received MMR II, some time after this, the patient was diagnosed with autism. It was unknown if the patient had sought any medical attention. At the time of report, the adverse event's outcome was unknown. Upon internal review, autism was determined to be other important medical events. Additional information has been requested.
Positive Covid test; Positive Covid test; This is a spontaneous report from a contactable other health care professional. A 64-year-old female patient received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EH9899), via Intramuscular route of administration, on 17Dec2020 and on 07Jan2021 respectively, as single dose in Deltoid Right, for Covid-19 immunization. The patient's medical history included asplenia and she was former smoker. The patient's concomitant medications were not reported. On 17Mar2021, the patient had positive covid test. During COVID-19 illness she experienced congestion, cough, and headaches. It was unknown if the patient taking any medications routinely prior to the event or not and unknown if the patient received any treatment for the events or not. The patient visited the physician office. The patient also provided the information regarding the reported adverse events with the use of the product. The patient underwent lab tests which included Covid-19 PCR with positive result on 17Mar2021. The outcome of the event was resolved on 02Apr2021 while the outcome of the other event vaccination failure was unknown.   No follow up attempts are needed. No further information expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between Vaccination Failure, COVID-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
Within 12 hours of receiving vaccine, experienced typical flu-like symptoms: shivering, fever, body ache.  Woke Thursday morning with extreme pain in left ear; went to ENT and Allergy Associates to see if ear was infected/negative.  Friday morning, face paralysis - Bell's Palsy - began and has persisted ever since.  Primary care physician referred her over -the-phone to neurologist.  Neurologist Dr. examined and confirmed Bell's Palsy.  Ordered an MRI to double-check for possible mild stroke due to age.  MRI performed 11/1, still awaiting results.  Mom cannot sleep; pain is extreme at night.  She cannot have steroids due to herpes in left eye, which she has had for decades, but is not currently flaring.  Mouth drooping, ear is red and hot and sore.  All of this is on the left side of face.  Jaw pain, ear pain, miserable.
moderate fever to 102 x 3 days;vomiting x 3 days;lethargy x 3 days;
This case was reported by a physician via sales representative and described the occurrence of intussusception in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced intussusception. Per the reporter, the subject required medical attention and that "it has been taken care of". This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unknown. The physician inquired on 7 February 2014 or 10 February 2014 if the subject should receive another ROTARIX dose.
initial site soreness then approx rt 3-4 days;later muscle like weakness & rt shoulder joint discomfort/throb which persists;
I had a cold in February with coughing. The cold went away, but the coughing remained. It's a nagging cough. I still have it, but it is infrequent. I didn't have any type of lingering cough after the other vaccines so this is new for me. My husband is experiencing the same symptoms after receiving his third dose as well. There is no distinguishing time when the cough come and goes, but it lasted about 8 weeks back when it started in February. I've been taking allergy medicine, and it helps. It's a non-productive dry cough. It's similar to my experience after taking Metoprolol. I mentioned the cough to my doctor in my annual well visit.
Around 8pm my throat felt tight I was shaking an felt wheezy my husband gave me Benadryl an an took me too ER  on 12-31-20
1st shot - tingling/little itchy on face ,arms ,and legs. 7hrs after shot. Lasted 2 days 2nd shot - 4 hours after shot tingling turned to pins and needles on face and arms. Face was hot to touch. Lasted til next day. Took atarax at 4 he post shot but still felt pins and needles on face and arms til next day
mom noted hives staring @ 8AM today on buttocks & legs;no fever;temp 97.6;hives starting now on face;pt seen by MD;no wheezing noted by MD;