chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got a small pimple in the armpit and it hurts; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (got a small pimple in the armpit and it hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced ACNE (got a small pimple in the armpit and it hurts). At the time of the report, ACNE (got a small pimple in the armpit and it hurts) outcome was unknown.
pain at injection site/tenderness at injection site; nausea; feeling cold; aches and pains/pain; feeling feverish; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th June 2019, immediately after receiving Shingrix, the patient experienced injection site pain, nausea, feeling cold, pain and feeling hot. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the nausea, feeling cold, pain and feeling hot were recovered/resolved.   It was unknown if the reporter considered the injection site pain, nausea, feeling cold, pain and feeling hot to be related to Shingrix.  Additional details were provided as follows: The caller was a patient.  The patient received Shingrix and experienced pain during the injection and tenderness at the injection site following the injection.  The patient reported that she was feeling nauseous, cold and feeling like she had a fever.  The patient also reports that she developed aches and pains following the vaccine. Symptoms started the same day that she received the vaccine.  The reporter did not consent to follow up.
She felt limp, couldn't speak, very weak and grey looking extremely high fever, low oxygen levels
4" x 4" reddened hard area around admin site without        streaking, lymphadenopathy, or fever.
rash on the back of her right leg/rash expands each day/now the rash goes to the patients foot and up to the patients right buttock.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (rash on the back of her right leg/rash expands each day/now the rash goes to the patients foot and up to the patients right buttock.) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2022, the patient experienced RASH (rash on the back of her right leg/rash expands each day/now the rash goes to the patients foot and up to the patients right buttock.). At the time of the report, RASH (rash on the back of her right leg/rash expands each day/now the rash goes to the patients foot and up to the patients right buttock.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Chronic disease state reported in this patient. It was reported that patient received the vaccine in right leg.  Concomitant medication included Vitamin D with Probiotic for weekly once. The patients Mom noticed a rash on the back of her right leg on 25AUG2022. The rash expanded each day and now the rash went to the patients foot and up to the patients right buttock. No other Adverse reactions reported. The Pediatrician felt that this was a reaction to the Moderna Covid-19 vaccine Treatment medications were not provided.   This case was linked (Patient Link).
HAIR LOSS - DR PRESCRIBED BIOTIN AND PRENATAL VITAMINS.  MY HAIR STARTED TO GROW BACK AND WHEN I GOT THE BOOSTER ON AUGUST 27, 2021, MY HAIR LOSS WAS MORE SIGNIFICANT
patient face got swollen around 6 pm on 07/19/2021. He feels numb on left side of face and this morning on 07/20/2021 around 5 am his eye almost was shut closed due to swelling. Now swelling got better. Still he feels numb on his face.
fussy & irritable in the evening, febrile temp measured w/ tympanic therometer 105 plus; bilateral ear infect;
Severe headache, chills alternating to hot and sweating, arm throbbing, nausea, no energy. Lasted approximately 24 to 36 hours. Within 24 hours felt significantly better but not 100%.
LIFE HASN'T BEEN THE SAME; TROUBLE WITH LEGS AND FEET GOING TO SLEEP; LEGS AND FEET ARE CONSTANTLY FATIGUED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Before the shot patient was an active person. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.   On an unspecified date, the patient experienced life hasn't been the same, trouble with legs and feet going to sleep, and legs and feet are constantly fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the life hasn't been the same, trouble with legs and feet going to sleep and legs and feet are constantly fatigued was not reported. This report was non-serious.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
States 48 hours after receiving vaccine developed an itchy rash on lower extremities. Loratidine 10 mg given with  inst to cont daily until resolved. Lasted 1 week.
patient was given the diluent DTaP-IPV portion of Pentacel in the left deltoid without mixing with the Hib powder portion/no AE; Initial information regarding an unsolicited valid non-serious case via Medical Information (Reference number- 00431824) was received from an other health professional and transmitted to Sanofi on 15-Jan-2021.  This case involved a six-month-old female patient who was given 0.5 ml of the diluent dtap-ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: U6842BA and expiry date: 05-Jul-2021) on 04-Jan-2021 via unknown route in the left deltoid for prophylactic vaccination without mixing with the Hib powder portion (Product preparation issue).  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) both for prophylactic vaccination.  The patient did not receive the Hib portion at all. The practice is aware of the video and has their staff review it annually. The caller stated that in this case, the mistake was human error and they are reviewing details to determine the contributing causes. The caller stated that in addition to this event, the same situation happened once before, a few years ago. Details were not asked for the previous case, as it was a few years ago. The caller was not at the location of the office today and was not able to pull the actual product for the lots numbers from other components). Administering physician Vaccine was administered by a Medical Assistant. Product used : Used First time product used : No Still using product : No.  It was an actual medication error case due to Inappropriate reconstitution technique (latency same day).   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
Pt developed a 3" X 3" red, warm and swollen area over the injection site with some swelling around axilla. It started the morning after the injection. Treated with warm and wet compresses.
client given pediatric dose instead of 12+ dose. No adverse reaction observed, allowed to leave clinic after 15 minute mandatory observation. F/U with mother today, reports no adverse reactions, states child "seems fine."
received a higher than recommended dose of the purple cap formulation; Redness of the area and usual pain from the injection; Redness of the area and usual pain from the injection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 14 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 19Nov2021 15:20 (Lot number: EW0182) at the age of 14 years as dose 1, 0.5 ml, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "received a higher than recommended dose of the purple cap formulation"; INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE PAIN (non-serious), outcome "unknown" and all described as "Redness of the area and usual pain from the injection". Therapeutic measures were not taken as a result of overdose, injection site erythema, injection site pain.  Additional information: Caller reported two patients received a higher than recommended dose of the purple cap formulation. A 12-year-old male and a 14-year-old female both received 0.5 ml dose instead of 0.3 ml dose. It was their first Comirnaty dose and it occurred on 19Nov2021.She wants to know what to do about the second dose. Vaccine LOT#EW0182. When probed for vaccine Expiration date, Nurse stated, "Nov2021, that are expiration date as far as when it was taken out of the cold and put into refrigerator because of the 30 days that's not the listed expiration date, that our expiration date. When probed to confirm if patients experienced any adverse event, Nurse stated, "No, just a generalized redness of the area and usual pain from the injection were the only complain." When probed for any treatment, Nurse stated, "The provider spoke with them, there was no treatment." The patient was administered Dose 2 of Pfizer Vaccine on 10Dec2021 at 15:48 on the Left Deltoid Intramuscularly. Batch/Lot number was reported FH8028. Vaccination Facility Type was Doctor's Office/Urgent Care. No concomitant drugs, Medical history, Relevant tests or specific tests reported.   No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101647432 same reporter/drug/AE, different patient
Felt cold; Fever of 104.0; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Felt cold) and PYREXIA (Fever of 104.0) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced PYREXIA (Fever of 104.0). On an unknown date, the patient experienced NASOPHARYNGITIS (Felt cold). At the time of the report, NASOPHARYNGITIS (Felt cold) and PYREXIA (Fever of 104.0) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Body temperature: 104.0 (High) Fever of 104.0.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
I began having shortness of breath, easily winded with little activity. I though it was my asthma and the inhaler made me feel worse. February I had chest pain diagnosed with pericardia's, pulmonary fibrosis and Epstein Barr. Continue to have pain in my chest during heavy activity. Following an anti inflammatory diet per doctor's recommendation. COVID 19 + September 2020 and then again December 2021.
(L) deltoid -> redness and pain and tenderness over the injection site few hours earlier TDAP on 11/13/2015.
Moderna COVID-19 Vaccine EUA; very bad headache, body aches and slight joint swelling, sore throat, fatigue, muscle pain, chills, moderate fever (100.6-101.0)
Instant Bruise on the injection site as soon as 2nd booster was injected; Pouring out blood injection site right after 2nd Booster; Could not stand up right after 2nd Booster; Felt terrible right after 2nd Booster; Sweating really bad after 2nd Booster; Felt like fainting right after 2nd Booster , and felt dizzy; Puffy Injection Site, Swollen Injection Site (1 inch) right after 2nd Booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Instant Bruise on the injection site as soon as 2nd booster was injected), VACCINATION SITE HAEMORRHAGE (Pouring out blood injection site right after 2nd Booster), DYSSTASIA (Could not stand up right after 2nd Booster), FEELING ABNORMAL (Felt terrible right after 2nd Booster) and HYPERHIDROSIS (Sweating really bad after 2nd Booster) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022 at 9:23 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, the patient experienced VACCINATION SITE BRUISING (Instant Bruise on the injection site as soon as 2nd booster was injected), VACCINATION SITE HAEMORRHAGE (Pouring out blood injection site right after 2nd Booster), DYSSTASIA (Could not stand up right after 2nd Booster), FEELING ABNORMAL (Felt terrible right after 2nd Booster), HYPERHIDROSIS (Sweating really bad after 2nd Booster), DIZZINESS (Felt like fainting right after 2nd Booster , and felt dizzy) and VACCINATION SITE SWELLING (Puffy Injection Site, Swollen Injection Site (1 inch) right after 2nd Booster). On 25-Apr-2022, VACCINATION SITE BRUISING (Instant Bruise on the injection site as soon as 2nd booster was injected), VACCINATION SITE HAEMORRHAGE (Pouring out blood injection site right after 2nd Booster), DYSSTASIA (Could not stand up right after 2nd Booster), FEELING ABNORMAL (Felt terrible right after 2nd Booster), HYPERHIDROSIS (Sweating really bad after 2nd Booster) and DIZZINESS (Felt like fainting right after 2nd Booster , and felt dizzy) had resolved. At the time of the report, VACCINATION SITE SWELLING (Puffy Injection Site, Swollen Injection Site (1 inch) right after 2nd Booster) outcome was unknown.            On 27-Nov-2021, the patient received first booster dose and on 25-Apr-2022 at 9:23 AM received 2nd booster dose.  No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-549161 (Patient Link).
Difficult breathing, headache, fatigue, muscle ache lasting approximately 2 weeks, 102 fever one day, skin lesions still on going.
Patient received a flu shot on 10/10/15 in left arm, and later that night the injection site became inflamed, approximately the size of a marble, and itched.  She stated scratching it worsened it.  Today there was a knot at the site of injection, it was still inflamed and very itchy and was now also giving off heat.  There was no pain at injection site and she stated it was more annoying than anything.  I recommended Benadryl for the itching and a cold compress to get the swelling down.
Decrease in appetite - vomiting 10 times - diarrhea twice - mild fever night of vaccination
high fever of 101.3; felt very exhausted; chills; muscle pain; joint pain; This is a spontaneous report from Pfizer program from a contactable consumer reported for a male patient. A male patient of an unspecified age received of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Verbatim and Event Description: The caller, said that she received her first dose of the Moderna vaccine 2 days ago. The caller was calling in for her husband who received his Pfizer Covid-19 Vaccine. The caller said that her husband experienced a high fever of 101.3, felt very exhausted, chills, muscle, and joint pain on an unspecified date. Medical Information (Were any medical questions addressed by this program forwarded/referred to Medical Information) was yes. The outcome of the events was unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
After 3 days he couldn't lift his arm at all. He just lost the use of his arm and also it became painful from his shoulder up to his neck. Saw his pcp and she informed him that the shot was given to high in the muscle. He also had a knot in his arm.
Pfizer Dose 1 7/17/21 (EW0164) Pfizer Dose 2 7/26/21 (EW0164) Two doses given 10 days apart  7/17/21: story of Present Illness  The patient presents with left breast tenderness. 70 y/o female Patient arrives to the emergency department with complaints of left breast discomfort beginning a week ago. She was concerned due to a family history of breast cancer. She denies injury, skin changes, lumps, or radiation of her pain. She also denies vaginal changes, bleeding, discharge, abdominal pain, or shortness of breath. She had her last mammogram 1 year ago which was not significant for any acute changes. Patient has a history of diabetes. Patient is requesting the first dose of the COVID-19 vaccine.  The onset was 1  weeks ago.  The course/duration of symptoms is constant.  Location: Left breast. The character of symptoms is pain and swelling.  The degree of pain is minimal.  Type of discharge: none.  Risk factors consist of diabetes mellitus and family history of breast cancer.   7/26/21: The patient presents with 70 y/o patient with history of polio and FHx of breast cancer, Patient presents to the emergency department with complaint of breast soreness. Pt. states that she is experiencing left breast swelling and soreness. She states that it began 3 weeks prior to her visit and began to get worse 1-2 days ago. She denies any trauma to her breast. Pt. also states that .  The onset was 2  days ago.  The course/duration of symptoms is constant.  Patient also received COVID Vaccine #2  NOTE: ED note from 7/26 has no acknowledgement that the patient had received a dose 10 days previously.  There were no notes following documenting any adverse reactions.
Vomiting for 24 hours starting  at noon 4/02/2021 and ending late 4/03/2021. Intestinal cramping yellow, watery diarrhea started 2:30PM 4/08/2021. Diarrhea continues, but getting better, more normal color.  Injection burned. I did not experience any serious soreness, but my arm still burns if something touches it. No swelling, redness, rash.
Pt recvd vax 3FEB92, 2MAR92, & 17AUG92 & following 3rd dose pt devel swollen lymph nodes of the groin, armpits, & neck; Pt was vaxed w/4th does & sx became more pronounced; biopsy showed that pt had malignant lymphoma;
experienced nausea and vomiting within 20-30min after receiving 2nd dose. Was given 25mg of benadryl PO at 10:50 then pepcid 20mg PO at 11:07am. Vitals remained stable from the start of the episode until the patient recovered at 12:30pm.  No reddness or swelling was ever observed. Patient reported some itchiness around the injection site that improved with benadryl.
Patient said since the day he got the vaccination he has had severe pain in the arm. He has full range of motion but he is in severe pain every day when he lifts his arm. He has to stretch, take OTC pain medication and will be consulting his doctor for further treatment.
Rash next day after receiving vaccine, started in bikini area and spread to thighs. Looked like little pimples and they exploded, became sores after.
Cold sore; Pain at site; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 52-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st May 2019, the patient received Shingrix. On 1st May 2019, 2 hrs after receiving Shingrix, the patient experienced injection site pain. On 2nd May 2019, the patient experienced cold sores. On an unknown date, the outcome of the cold sores and injection site pain were unknown.   It was unknown if the reporter considered the cold sores and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine on an unknown deltoid, 24 hours ago from the date of reporting and experienced pain at injection site 2 hours after administration on the whole deltoid and then the cold sore a bit before. The patient asked whether the event pain at injection site and cold sore were the possible site effect of the vaccine.  The reporter  gave consented to follow-up.
Breakthrough case admission after 2 vaccines Pfizer 3/17/21 lot# ER2613;  Pfizer 4/7/21 lot# ER2613