chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 year old received the Moderna vaccine; A spontaneous report was received from a consumer concerning a 17-years old, female patient who was received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced product administered to patient of inappropriate age.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and experienced product administered to patient of inappropriate age.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, product administered to patient of inappropriate age, was considered resolved.; Reporter's Comments: This case concerns a 17 year old, female patient, who received  the first dose of the mRNA-1273 on an unknown date. The patient's medical history is not provided.  This report refers to a case of medication error where mRNA-1273 has been administered to the patient of inappropriate age.
Nausea  Fever - 102. 2 Chills Body and head pain Injection site pain and tender
Facial swelling, throat swelling, fever 104 degrees, nausea vomiting.
This is a spontaneous report from a contactable physician (parent) via a Pfizer sales representative. A female patient of unknown age received on an unknown date (15 years before this report) a single dose of PREVNAR 13 for immunization. Medical history was none. Concomitant medications were not reported. The patient at the time received the shot and had a severe reaction including proximal and purple swirly discoloration at the injection site and was red and swollen up. Outcome was unknown.
Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FOLIC ACID, CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) and CARVEDILOL for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced DIARRHOEA (Diarrhoea). At the time of the report, DIARRHOEA (Diarrhoea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant products includes Heart medication and Statin Treatment was not received by the patient. Patient took crackers and drank coffee
We both had a sore arm around 3:30 in the afternoon; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Mar2021 15:30, outcome "unknown", described as "We both had a sore arm around 3:30 in the afternoon".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # M010212, expiration date 21-JAN-2019 (dose was not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of RECOMIBVAX HB were stored in the temperature of 13.98 degrees Celsius of 10 minutes and in the temperature of 10.58 degrees Celsius for 10 minutes. Data logger was involved. There were no previous temperature excursions reported. At the time of reporting, there was no further information to provide. This is one of four reports received from the same reporter. Additional information has been requested.
Upon laying in bed for sleep, heart began pounding with what seemed to be irregular heartbeat. Lasted approximately an hour. Woke in the night with numbness in left arm and hand.  After moving and flexing arm and hand, numbness began to deteriorate, and normal feeling began to come back.  Symptoms seemed to have subsided by the next morning.
Felt as if my legs were far more heavy when climbing stairs or walking; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) via an unspecified route of administration in the left arm on13Mar2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8734) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. Medical history included cancer in left breast from an unknown date. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, after the first dose of vaccination, the patient felt as if her legs were far more heavy when climbing stairs or walking and on an unknown date after the second dose of vaccination, the patient's legs felt super heavy so she weighed herself to make sure she had not gained weight. The patient had not gained any weight. Then her right leg felt horrible behind the knee area and on 01May2021 at 21:00, the patient felt her knee area give out and she grabbed the edge of the checkout conveyor belt area. The patient's right leg still felt horrible and she couldn't walk the same as prior to the vaccine. The patient's legs had no problems and she walked fine and her legs did not feel as if steel weights. The clinical outcome of the event felt as if my legs were far more heavy was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
L nodule on ant. lat thigh 2cm in lenght and 1 1/2 cm in width. the nodule is firm.
Left arm sore. Severe migraine headche with blurry vison in left eye( vision corrected later in the day) Onset of mentrual cycle with severe abdominal cramping , nausea, heav bleeding and headache.
mightily, described as being sick / deathly ill since receiving the series; chills; shakes; fever / fever of 102.5 degrees; sweats; nausea; diarrhea; migraine headache; a sore injection arm / continued to hurt for the entire month; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (mightily, described as being sick / deathly ill since receiving the series), CHILLS (chills), TREMOR (shakes), PYREXIA (fever / fever of 102.5 degrees) and HYPERHIDROSIS (sweats) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine headache (baseline history migraine headache).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ILLNESS (mightily, described as being sick / deathly ill since receiving the series), CHILLS (chills), TREMOR (shakes), PYREXIA (fever / fever of 102.5 degrees), HYPERHIDROSIS (sweats), NAUSEA (nausea), DIARRHOEA (diarrhea), MIGRAINE (migraine headache) and MYALGIA (a sore injection arm / continued to hurt for the entire month). At the time of the report, ILLNESS (mightily, described as being sick / deathly ill since receiving the series), CHILLS (chills), TREMOR (shakes), PYREXIA (fever / fever of 102.5 degrees), HYPERHIDROSIS (sweats), NAUSEA (nausea), DIARRHOEA (diarrhea), MIGRAINE (migraine headache) and MYALGIA (a sore injection arm / continued to hurt for the entire month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient applied ice for hurting arm and taken ibruprofen medication   This case was linked to US-MODERNATX, INC.-MOD-2021-073648 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073648:2nd dose case
little bit of body pain.; Tiredness; throat was already kind of itchy, irritated, 2 days before I got the 2nd dose of vaccine because I had consumed raspberry juice; Soar throat; This is a spontaneous report from a from a Pfizer-sponsored program, received from contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 10Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation, streptococcus salivarius (BLIS K12), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at an unknown dose for an unspecified indication. The patient medical history and concomitant medications were not reported. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 on 14May2021 as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced little bit of body pain, tiredness, throat was already kind of itchy, irritated and he wanted to know if he can take oral probiotic because after getting the 2nd dose, he took some raspberry juice and right now he is having a sore throat and itchy throat. He just mentioned oral probiotic and that one is containing the Manuka also he didn't mention the brand. Honey and the probiotic is for oral probiotic like throat health Known as K 12. The type of probiotic it has in it is Streptococcus K 12, 10 mg. It has honey in it it's of different type like it's Kamahi and Manuka honey. The patient throat was already kind of itchy, irritated, 2 days before he got the 2nd dose of vaccine because he had consumed raspberry juice and also got, it was really sour, it immediately hit his throat like when he consumed it. But the patient takes the nasal steam every other day any ways regardless of whether it is pandemic or what doesn't matter. He takes this probiotic for last year and a half like once in a while or as it is just one or two, every other week and it stays fine, I had no problem in throat or anything. So, he was just wondering if he can do it again or not, is there going be any kind of interaction with vaccination or defense mechanism. The patient would like to know if they can eat yoghurt after vaccination as yoghurt also has various kind of like culture and bacteria. The patient was not experiencing like any life threatening or any sickness kind of thing because of the vaccination and wanted to know if he can take that because he consumes lemon also every day in hot water or cold water so he was just wondering if he can take that probiotic you know. It should not be an issue, still want to make sure. The outcome of the events was unknown.  Follow up attempt needed, Information on the lot/batch number has been requested.
NAUSEA; VOMITED; This spontaneous report received from a patient concerned a female 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, batch number: 1805031, dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the Patient experienced nausea. On an unspecified date, the Patient  experienced vomited. after 4 days of vaccination she got nauseous and vomited. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and the outcome of vomited was not reported. This report was non-serious.
I came down with cold symptoms on 10/17/2015. It worsened to flu like symptoms the next day on 10/18/2015. When little improvement after taking over the counter, I went to the doctor on 10/22/2015.
PATIENT STATES THAT HE RECEIVED THE VACCINE ON FRIDAY AM, SATURDAY HIS LEFT ARM WAS SORE AND ON SUNDAY NIGHT HIS ARM WAS SO SORE HE HAD TROUBLE SLEEPING. ON TUESDAY AND WEDNESDAY HIS LEFT ARM STILL ACHED.  MOST PAINFUL WITH ARM MOVEMENT, NO PAIN WHEN ARM IS AT REST.  PAIN LOCALIZED TO THE INJECTION SITE. NO SIGNS OF REDNESS, HEAT OR SWELLING AT THE INJECTION SITE.  ADVISED PATEINT TO ICE THE AREA AND TRY AN OTC PAIN RELIVEVER SUCH AS APAP OR IBUPROFEN.  PATIENT WILL REPORT BACK IN A FEW DAYS IF NO IMPROVEMENT WILL CONSIDER SEEING HIS PCP.
Rash all over the arm around the injection site. Very weak unavailable to perform general activity for 2 days.
Two of nine cases: An event of Expired Drug Administered occurred in a seven year-old male.  The report was received from a registered nurse.  No medical or drug history was reported for this child.  The child received a one-time dose of FluMist intranasally on 15-Jan-2008.  On 15-Jan-2008, the child received FluMist with an expiration date of 19-Dec-2007.  The reporter stated this is one of nine children that was vaccinated on the same date.  In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box.  The reporter indicated they also administered a competitor's product, which is good for the entire season and does not expire until May/June timeframe.  One reporter also stated many of the vaccines they give do not have an expiration date.  She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season".  The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with a product that was to expire in less than three weeks.  Outcome: the child had no ill effects, the site has not had any contact from the child's family.  Further dosing with FluMist is not indicated.  Causality assessment is not applicable for this vaccination error.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
A non-serious, spontaneous report of administration of expired product was received from a nurse concerning a five year-old female subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 29-Jan-2009 and incorporated into the narrative: no adverse events reported after follow-up. Additional information received on 09-Apr-2009: product complaint investigation results.
Swollen lymph nodes of left axils. The next day, my left arm was bruised from my axils down to my elbow. My arm was extremely sore. It appeared as though I had thrombophlebitis.
Information has been received from a registered nurse (R.N.) concerning a male child in elementary school (who is between grades 3-5) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that an outbreak of chickenpox began in an elementary school in November 2005. "Recently", "since November 2005", the male child developed chickenpox and sought unspecified medical attention. No outcome was reported. No product quality complaint was involved.
This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number ER8730, Expiration date: 31Jul2021), via an unspecified route of administration on 30Mar2021 at 10:00 (at the age of 43-years old) as a single dose in the right arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No lab test was performed. Prior Vaccinations (within 4 weeks) and other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as None. Patient has a few concerns, states that patient and her husband got the first dose of their Pfizer vaccines 3 days ago, on 30Mar2021, states patient is experiencing typical side effects listed like headaches and not feeling well, clarifies she turned beet red in the face right after the vaccine and sore in arm on 30Mar2021, patient had a migraine on one side of her head, felt throw uppy, woke up with a sore throat and was coughing up blood on 02Apr2021. patient states she treated herself this morning with Excedrin migraine and has completely resolved. Patient states her throat is still sore but she is no longer coughing up blood. As per the reporter seriousness criteria for the event (coughing blood) was medically significant. The outcome of the event Sore throat was not recovered, coughing blood was recovered on an unspecified date in 2021, Pain in arm, migraine, vomiting was recovered on 02Apr2021, Face red was recovered on 30Mar201 and unknown for another events.  No follow-up attempts are needed. No further information is expected.
10 days post vax, the pt experienced a sudden generalized seizure and fever. Then she experienced a period of flaccid paralysis from her neck down. Sensory was intact. She improved over the next 4 hours. Possible post vax encephalomyelopathy.
This spontaneous report as received from a pharmacist refers to a currently 80 year old patient of unknown gender. On an unknown date the patient received a dose of improperly stored ZOSTAVAX (lot# not reported, dose 0.65 ml, subcutaneous), exposed to 32.3F for 70 hours. Concomitant medications were not provided. No adverse effects were reported. This is one of two reports received from the same reporter (other MARRS# 1409USA009261). Additional information has been requested.
2 DAYS AFTER VACCINE PATIENT WAS AT WORK AND STARTED TO GET CHEST PAIN, SHORTNESS OF BREATH, FELT LIKE AN ELEPHANT ON CHEST, LEFT WORK AND WENT TO AREA ER HOSPITAL IN . THEY GAVE HER A CHEST X RAY, EKG AND WAS TOLD WAS POSSIBLE MYOCARDITIS AND WAS GIVEN A STEROID AND TO FOLLOW UP WITH DR. WAS TOLD NOT TO GET THE SECOND DOSE OF THE PFIZER COVID 19 VACCINE.  PATIENT DID NOT PRESENT ANY PAPER WORK OR HAVE THE NAME OF THE ER PHYSICIAN. PATIENT REPORTED THIS INFORMATION TO PHARMACY 6/13/21 AT 3: 33PM . PATIENT STATES SHE STILL FEELS LIKE SHE HAS BRONCHITIS. NO REPORTS FROM A FAMILY PHYSICIAN GIVEN.  PATIENT WAS ASKED WHEN HER NEXT APPOINTMENT WAS AND IF  A FOLLOW UP EKG OR CHEST XRAY AND TO BE DONE, SHE WAS NOT SURE.
PM of 12/31/2020-shoulder blade, down left arm and 4th and 5th finger on left hand hurting.  About bedtime on 12/31/2020, left arm pain. sit note, no redness, chills , headache, myalgias and joint pain. 1/1/2021 AM temperature got over 103 degrees and weakness.  ok during the day of 1/1/2021.  About 7 PM on 1/1/2021 temperature went up to 102 degrees.  She did sweat during the night of 1/1/2021.  1/2/2021- temperature stayed about 99-100 and she felt "shivery".  Up until 1/4/2021, she had extreme tenderness and warmth to left arm.  No redness.  Better today, 1/5/2021.
pt recvd vax & w/in hrs p/vax exp twitching;w/in 12hras p/vax exp a rash on trunk,face,& extremities;these sx resolved w/o treatment;
Severe aches all over; Migraine headache; Chills; Nausea; 0 energy; not feeling well; Fever 99.5 / Constant fever over 102 up to 104.3 / 99.3 fever; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EP6955, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 28Mar2021 at 15:00 (at the age of 52-years-old) as dose 2, single for COVID-19 immunisation. Medical history included high blood pressure, seasonal migraine and known allergies to penicillin all from an unknown date. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included cyanocobalamin (VITAMIN B 12), colecalciferol (VITAMIN D), ascorbic acid (VITAMIN C), bupropion, carvedilol, and estradiol all taken for an unspecified indication, start and stop date were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number: EN6205, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 07Mar2021 at 15:00 (at the age of 52-years-old) for COVID-19 immunisation. The patient experienced not feeling well and fever 99.5/constant fever over 102 up to 104.3/99.3 fever both on 29Mar2021 at 12:00 AM and severe aches all over, migraine headache, chills, nausea, and 0 energy all on 30Mar2021. It was further reported that within 8 hrs the patient was not feeling well, with in 10 hrs the patient had fever 99.5 and next two days constant fever over 102 up to 104.3, severe aches all over, migraine headache, chills, nausea, 0 energy. On the 3rd day, the patient had 99.3 fever but able to function and on the 4th day the patient was fine. No treatment was received for the events. The outcome of the events was reported as recovered on 01Apr2021 with lasting effects/sequel.   No follow-up attempts are possible. No further information is expected.
pt had immed rxn @ time of flu inj of 15mm induration no c/o pain or itching;20 min later pt c/o redness & itching-arms-neck;cough, no SOB seen by MD;allerg rxn;
swollen lymph nodes at the neck collar of the same arm she got the shot in; vaccine was administered really high in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccine was administered really high in the muscle) and LYMPHADENOPATHY (swollen lymph nodes at the neck collar of the same arm she got the shot in) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccine was administered really high in the muscle). On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes at the neck collar of the same arm she got the shot in). On 16-Feb-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccine was administered really high in the muscle) had resolved. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes at the neck collar of the same arm she got the shot in) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Carvedilol. Treatment details were not provided.
Symptoms of HA resolved with time.  No treatment administered.  Pt comforted by father, pt sitting on father's lap.