chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1-2 hours after injection had sore arm 20 hours after injection had fatigue, chills and body aches. I rested and it helped.  27 hours after injection i had fatigue, chills, low grade fever and body aches. Took 400 mg ibuprofin and slept.  woke up feeling better 30 hours after injection started my menses (I had had it the week prior. I am very regular every 28 days) only lasted 1-2 days 60 hours after injection arm got swollen, red and hot for about 12 hours and then it started to subside and was better by the follwoing morning.  Only residula is a small muscle twitch every now and then. getting less with each day
excessive hair loss on the head; had bitty fever; soreness / arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (excessive hair loss on the head), PYREXIA (had bitty fever) and MYALGIA (soreness / arm is still sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had been infected with Covid and hospitalized for 2-3 weeks.).    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (excessive hair loss on the head), PYREXIA (had bitty fever) and MYALGIA (soreness / arm is still sore). At the time of the report, ALOPECIA (excessive hair loss on the head) and PYREXIA (had bitty fever) outcome was unknown and MYALGIA (soreness / arm is still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer stated that  she does not take any medications and had no medical history. No treatment information were provided.
Wheezing after vaccine administered.  Wheezing resolved after use of inhaler. (Teacher recalled that student also needed nebulizer treatments for about a week after first dose given 11/10/2009.  Did not relate this to vaccine at the time.)
3JAN97 pt recv vax 11AM-APAP given 1230AM;vomiting, temp nl, extremities cold;circumoral pallor, quivering of face & hands;pt lethargic to ER;low grade temp & fussy;dx acute rxn to DTP ? teething vs gingival infect;
patient was given the liquid portion (DTAP-IPV) but not the powder (ACTHIB) portion/no AE;Initial information was received on 21-Sep-2021 regarding an unsolicited valid non-serious case from other health professional and non-healthcare professional via call center via Medical Information (Reference number- 00779266).   This case involves a patient of (unknown demographics) who received the liquid (dtap-ipv) portion but not the powder (acthib) portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (on the same day).  It was reported "The doctors office contacted the pharmacy to obtain the correct diluent to reconstitute the ACTHIB with. The pharmacy technician would like to obtain the correct diluent from Sanofi."  At the time of report, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported).  Subsequently the patient experienced persistent headache. The patient contacted the physician regarding the persistent headache.  The outcome of the patient's experience was unknown. This is in follow-up to report(s) previously submitted on 2/13/2009. Follow-up information has been received from the physician concerning a 16 year old female with sleep difficulty and a history of wisdom teeth extracted in September 2008 and allergy to PROACTIV, who on 13-AUG-2008 was vaccinated with a first dose of GARDASIL (lot number 0250X). On 30-OCT-2008 the patient was vaccinated with a second dose of GARDASIL (lot number 0947X) (injection site and route not reported). Concomitant therapy included topical acne medication. On 23-AUG-2008 the patient experienced severe frontal headache. The physician reported that the patient was not able to swim and experienced mood changes. The patient was examined by a dentist, neurologist and ophthalmologist. MRI was normal except for minimal paranasal sinus disease. The patient was treated with antibiotics for nasal congestion. The patient experienced syncope while swimming and was taken to the Emergency Room. The patient was not admitted. The patient started ELAVIL on 17-OCT-2008. The physician reported that the patient's symptoms resolved since starting ELAVIL. The physician stated that the patient was not going to be administered her third dose of GARDASIL. Additional information has been requested.
pt recvd MMR vax FEB91 & w/in 3 months following vax on 28MAY91 pt exp mild dec in vision; next day to ophthalmologist & dx mild capsulitis & optic neuritis; CT scan n 31MAY91; devel worsening vision w/fever & stiff neck & poss MS;
This case was reported by a pharmacist via call center representative and described the occurrence of knee pain in a 59-year-old male patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 25th March 2019, the patient received SHINGRIX (intramuscular). On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced knee pain, numbness, walking difficulty and throbbing pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the knee pain, numbness, walking difficulty and throbbing pain were not recovered/not resolved. It was unknown if the reporter considered the knee pain, numbness, walking difficulty and throbbing pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX and experienced knee pain in the same side of his body where he got injection. The patient had very sharp pain climbing stairs, to the point that almost couldn't climb the stairs. The sharp pain had dissipated, was walking, and had full range of motion. The reporter consented to follow up.
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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 14:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021 22:00, the subject experienced body pains. On 15-MAR-2021 22:00, the subject experienced head felt like a giant balloon. On 15-MAR-2021 22:00, the subject experienced light headed and super woozy. On 15-MAR-2021 22:00, the subject experienced trouble walking. On 15-MAR-2021 22:00, the subject experienced arm has a big circle. On 15-MAR-2021 22:00, the subject experienced couldn't rest. On 15-MAR-2021 22:00, the subject experienced every joint was throbbing. On 15-MAR-2021 22:00, the subject experienced sore arm. On 15-MAR-2021 22:00, the subject experienced chills (superduper chills/vibrating). On 15-MAR-2021 22:00, the subject experienced hard knot at the injection site. On 15-MAR-2021 22:00, the subject experienced mild fever. On 15-MAR-2021 22:00, the subject experienced arm red. On 15-MAR-2021 22:00, the subject experienced serious headache. On 16-MAR-2021, treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pains, head felt like a giant balloon, light headed and super woozy, trouble walking, couldn't rest, every joint was throbbing, chills (superduper chills/vibrating), mild fever, and serious headache on 16-MAR-2021, and had not recovered from arm has a big circle, arm red, sore arm, and hard knot at the injection site. This report was non-serious.
This case was considered medically important (OMIC). Information regarding poliovirus vaccine was received from an attorney regarding a female patient who developed a brain tumor. The patient received vaccine. Relevant medical history was not provided. Indication for poliovirus vaccine was immunization. Product was administered sometime in the 1960's. Dose regimen was not provided. Concomitant medications were not reported. The attorney alleges that the polio vaccine product received by the plaintiff contained a harmful prohibited animal virus known as Simian virus 40. The SV40 contained within the patient's polio vaccine product was a cause of the brain tumor she suffered. No additional information was available at the time of this report.
5/28/04: Client received laceration on leg while shopping on 5/18/04. She saw physician 5/20/04 who recommended at TD booster. On 5/26/04 client developed itch on left arm and noticed erythema extending about 4" down from site she believes TD who given on left arm. Saw physicians 5/27/04 in relation to laceration and showed him the site on left arm. Dr. stated it
Pt felt dizzy, became pale, and saw black spots 2 min post administration of vaccine. No LOC, no nausea or vomiting. Pt responding normal- no signs of an allergic reaction. Laid pt back and elevated legs, put an ice pack on and checked vitals. BP: 91/57, pulse 66 at 3:50 pm, 3:56 pm BP: 95/60 , P: 67. Pt ate lunch prior to vaccine- sucker given during it- pt drank apple juice after reaction. Kept pt in office X 30 min total and left with mom after pt was stable and had no dizziness, not seeing black spots anymore and color returned. discharge vitals 4:12 pm:  BP: 95/63, P: 69
Intense, full body, radiating  pain lasting 15 hours (2 am - 5 pm on the day of 4/29/21). So intense that it was difficult to move, caused nausea. Used 400 mg of Motrin every 6 hours to try to dull the pain with mild success. Pain mostly resolved itself after hour 15.
Injection site pain; Tiredness; Headache; Chills; Nausea; General malaise; This is a spontaneous report from a contactable pharmacist who reported for himself. A 59-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EK5730) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunization. Medical history included hypertension and type 2 diabetic, both from unspecified dates and unspecified if ongoing. Concomitant medications included metoprolol taken for hypertension and metformin taken for type 2 diabetic. The patient experienced "injection site pain", "tiredness", "headache", "chills", "nausea" and "general malaise", all on unspecified dates. The reporter stated that he "was calling about the side effects of the COVID-19 vaccination. What I had, of course, the injection site pain, tiredness, headache, chills, nausea, just the general feeling of malaise. I slept at 10 O'clock and its 3 O'clock in the morning now, I just woke up I lay down at 6 O'clock so I sleep for about 8-9 hours." (as reported). The patient stated that he self-medicated with Acetaminophen prior to the vaccination and again 7 hours later and that he took Zofran for nausea. The patient further stated "the injection site pain that (Incomplete sentence). The nurse gave the injection very high to the deltoid muscle and have pushed it very quickly, like I never have experienced the injection itself, having pain upon injection. I have given thousands of Flu shots never so high of deltoid muscle and nowhere had I ever pushed the same." (as reported). The patient was informed about the Pfizer Medical information department and he was also encouraged to visit the website (website name) for additional information. The clinical outcomes of the events "injection site pain", "tiredness", "headache", "chills", "nausea" and "general malaise" were all unknown. The reporter believed that there was a reasonable possibility (method of assessment: global introspection) that the events were all related to the suspect product BNT162B2.
Pain in both arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in both arms) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID), BEMPEDOIC ACID (NEXLETOL), METOPROLOL, Ozempic                                                        Taken once a week, FISH OIL, MULTIVITAMINS & MINERALS PLUS LUTEIN, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CURCUMA LONGA, PIPER NIGRUM (TURMERIC & BLACK PEPPAR) and UBIDECARENONE (CO Q-10) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in both arms). At the time of the report, PAIN IN EXTREMITY (Pain in both arms) outcome was unknown. 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.   The treatment information was  not provided.   This case was linked to MOD-2021-114670 (Patient Link).
patient receiving Menquadfi 8-9 days to earlier than it should have with no reported adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 64 years old female patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] 8-9 days to earlier than it should have with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (CRM197) (Menveo) for Prophylactic vaccination (Immunisation).  On an unknown date, the patient received a dose of 0.5 ml of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot number; expiry date; strength not reported) via unknown route in unknown administration site for Immunization.  Information regarding batch number will be requested in the case.   On an unknown date the patient received menquadfi 8-9 days to earlier than it should have with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  It was reported, "RN inquiring if a patient that received menquadfi how long is the waiting period until the patient receives a second dose."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number K7T79, expiry date 14th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only adjuvant portion of shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that did not know, if the Shingrix adjuvant was administered to a patient or if it went missing. The reporter unable to provide patient details.
Shortness of breath in early March, hospitalized on 3/17/2021, was COVID positive and was found to have pulmonary emboli
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 26-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1 drink/month) from 19-Sep-2015 to 13-Oct-2020, Cigarette smoker (5 cigarettes/week) from 19-Sep-2012 to 01-May-2013 and Marijuana use (1 gram/month) from 19-Sep-2015 to 01-Sep-2019. Concurrent medical conditions included Psoriasis (Improvement, no treatment changes) since 01-Jan-2006. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 13-Oct-2020 to an unknown date for Pregnancy.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form(s). The patient's last menstrual period was on 08-Sep-2020 and the estimated date of delivery was 15-Jun-2021. On 16-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy. For neonate 1, the birth weight was 3085 grams (6lbs 13oz) with an APGAR score of 8 and 10 at (1, 5 minutes). The outcome was reported as Unknown. On 19-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Ultrasound breast: inconclusive (Inconclusive) Lump on breast during ultrasound. On 13-Oct-2020, Pregnancy test: positive (Positive) Positive. On 10-Jan-2021, Ultrasound uterus: inconclusive (Inconclusive) Small for gestational age, growth scans on 2/22, 3/25, & 4/22 showed normal growth. On 10-Mar-2021, Glucose tolerance test: inconclusive (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Non-invasive pregnancy testing (NIPT) showed low/no risk.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Significant follow up On 12-Aug-2021: Significant FU: PREGNANACY OUTCOME added   as per follow-up 2 received on 12th AUG 2021 updated the following: gestational period, delivery type, birth type, weight of the fetus, and that the patient is breast feeding
person devel muscular soreness & swelling lasting for several wks; an area of firmness size of walnut & extreme tenderness @ site of inject remaining on day 12;
Local redness,swelling, hives on arm with yellow fever shot; no SOB. Pt given ice at site; VS-WNL; Pt advised re: antihistamine use if desired and or sx persist.
Welling in left arm, redness and pain. Following day in bed night fever, chills, headache and body aches. Fever lasted for 3 days.  One week later developed tinnitus in both ears.
This initial spontaneous case, was received on 22-Sep-2017, from other health professional (nurse), concerning a 31-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date: 31-May-2018, anatomical location: not reported). It was reported that the patient was administered the vaccine with a 0.5 inches needle (explicitly considered as wrong injection technique), hence possibly received only a partial dose (explicitly considered as incomplete dose administered). It was reported that, the patient had not experienced any adverse event. At the time of this report, the outcome was not reported for the events. The reporter considered the events as non-serious. Follow-up received on 25-Oct-2017: The additional event (no adverse event) was added. It was reported that, the patient had not experienced any adverse event. The narrative was amended accordingly.
Red swollen area around the injection site.  Area is hot and tender to the touch.  High fevers of 103 and above, prior to taking Aleve and Tylenol.  Low grade after taking meds.  Overall feeling of malaise or fatigue.  Chills and hot flashes.
Vaccinated on Feb 25, 2021. Starting March 6, 2021, all around insertion area there is a wide spread redness and itching. I have photo of arm if there is a way to send to you. Other than that, I am feeling ok at the present time of this report.
Vacine site turned red; nose began to run; on the day after the vaccination the site of vaccine was bigger and redder and nose continued to run; by 6/5/2009 the site size had doubled, the color had turned bright red, the site was bumpy, the childs nose was still runny and the child now had a hoarse voice.
Numbness and tingling in right foot and lower right leg.; Tingling in right foot and lower right leg.; Drop foot on right leg.; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 07May2021 at 11:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 16Apr2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29May2021 at 08:00, the patient experienced numbness and tingling in right foot and lower right leg and drop foot on right leg. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling in right foot and lower right leg and drop foot on right leg was recovering at the time of this report.