chrisvoncsefalvay/vaers-outcomes huggingface dataset:
varicose veins; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing), notes: she takes thyroid medication. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose.), for Covid-19 immunization. The following information was reported: VARICOSE VEIN (non-serious) with onset 2021, outcome "unknown", described as "varicose veins".  Additional Information: The patient did not trust Moderna as much and trust Johnson and Johnson. She just trust the Pfizer vaccine, she probably work for Pfizer one day. She noticed after second vaccine, all of a sudden within that same week I ended up with varicose veins, she always looking at legs never had them like that. Again, she rather have varicose veins than have Covid. The report was related to a study or programme. The reason for no lot number of Covid vaccine Caller did not know where her Covid vaccine card to provide those numbers. She declined date of birth, height and weight. Originally caller also declined ethnicity but later in the call she provided that. She had either the booster or the 2nd dose, but it must of been the 2nd dose, felt it very strong. The caller felt that the 2nd was stronger than the 1st but she feels the booster more intense. She takes thyroid medication but she did not think that was relevant. She will say that after getting the Pfizer vaccine that she noticed that her varicose veins got worse and that's weird because they have never stuck out the way they stick out now. She noticed this after the 2nd dose, not the 1st dose, so that's something that she needs to keep an eye on. She think that her 2nd dose was possibly, she can't remember exactly, but she thinks that it was maybe in late Apr2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Swelling of face and eye area began on 1/15/21 until 1/20/21 Itchy bumps on face,neck,shoulder, waist, arms, hands and legs began on 1/13. It started on face and began to spread. Itchiness still persists.
Went to give an ob pt. Pfizer covid vaccine. Drew up 0.3mL. Gave pt vaccine. Pt had no reaction while in clinic. Pt is 19 weeks pregnant. When giving the vaccine diluent was not mixed in with it. Gave vaccine without diluent. Coworker notified me. Next step I filled an incident report
My heart was weakened according to my Cardiology PA at local Hospital. It caused me to have serious breathing problems, which ultimately landed me in the ER at local Hospital. The problems are ongoing and the hospital says it might never go away. I have been told not to exercise or exert myself in any way.
had fever that was never higher than 100 w/APAP for 2 days; leg was swollen, bruised & had a knot which is still present; 21SEP 1 wk following vax; had grand mal sz; MD was notified by phone; 25SEP 2 wks following vax had 3 grand mal sz's;
Had fever and body aches after 1st and 2nd dose; Had fever and body aches after 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had fever and body aches after 1st and 2nd dose) and MYALGIA (Had fever and body aches after 1st and 2nd dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bipolar disorder. Concomitant products included LAMOTRIGINE (LAMICTAL) and ASENAPINE MALEATE (SAPHRIS) for Bipolar disorder, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Had fever and body aches after 1st and 2nd dose) and MYALGIA (Had fever and body aches after 1st and 2nd dose). At the time of the report, PYREXIA (Had fever and body aches after 1st and 2nd dose) and MYALGIA (Had fever and body aches after 1st and 2nd dose) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-386573, MOD-2021-386555 (Patient Link).
mom called states pt c/o h/a; n/v p/vax given approx 4PM;pt feeling ill;advised to seek emergency care to determine vax rxn & tx;mom states child was left overnight in hosp for observation states MD documented poss vax rxn;
3/18/21 ER Triage Nurse Note: "To er via EMS for eval of weakness and dizziness. States he started with sore throat and head congestion last week. Seen PCP Monday 03-15-21. Started amoxil. Took it for 2 days and became dizzy so he quit taking it. Dizziness got worse and came to  ER." 3/18/21 ER HPI: 76 y.o. male who presents with c/o weakness cough and fever for the past seven days.  Pt report sx are mod better with rest and worse with movement.   Transferred to Hospital,  dx: pneumonia dt covid-19 virus
Felt like lumps developed in throat that hurt, started wheezing, and slight nasal congestion.  2 hours after that my eyes swelled, had green discharge from them, throat continued to hurt and congestion worsened.  Felt extremely fatigues, went to bed and slept for 3 hours, woke up with eyes partially closed and red, sore throat went away and had slight congestion.  Went back to bed and slept for another 7 hours.  Got up and went to work.  Starting feeling dizzy, stomach got upset 2 hours afterwards, started vomiting.  There was only 1 incident of vomiting.  Drove back home and slept another 3 hours.  Felt queasy the rest of the day.  Went to bed and felt much better on Sunday morning as I'm typing this.
the first, second doses were administered to the patient on 13-FEB-2014, and 05-SEP-2017 respectively (timeframe of 3years and 6 months); This spontaneous report was received from a nurse and refers to a 5-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported. Patient historical vaccines included: influenza vaccine; Hepatitis B Vaccine (Recombinant) (manufacturer unknown); polio vaccine; measles vaccine, mumps vaccine, rubella vaccine (manufacturer unknown); diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5),tetanus vaccine toxoid (PENTACEL); pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), rotavirus vaccine live reassort oral 5v (ROTATEQ), and varicella vaccine inact (manufacturer unknown).  On 13-FEB-2014, the patient was vaccinated with dose 1 of hepatitis a vaccine, inactivated (manufacturer unknown) intramuscular injection, then on 05-SEP-2017, was vaccinated with the second dose (Inappropriate schedule of vaccine administered), both doses administered for prophylaxis (strengths, lot #s, expiry dates, anatomical locations, and routes of administration were not provided).  Other vaccination included: hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP).    This is one of several cases of the same patient.; Sender's Comments:  US-009507513-2307USA010345: US-009507513-2307USA009835:
09/20/22 presents to ED for "abdominal pain". PMHx of alcohol induced pancreatitis with described hemorrhagic pancreatic pseudocyst status post partial gastrectomy, distal pancreatectomy and splenectomy, and left gastric artery pseudoaneurysm status post gelfoam embolization"
Difficulty breathing within 10-15 min of receiving the vaccine. BENADRYL (50mg) admin. IM. Pt transported by emergency service to ER.
4 y/o female due to site reaction from immunizations she rec'd yesterday. It was red and swollen will treat with antibiotic ordered, cephalexin 10mg. Mother concerned because a similar thing happened the last time she received immunization, stated she had to take child to the ED where she was given antibiotic for skin infection.
RIGHT ARM IS RED, HOT AND SWOLLEN.  IT HAS BEGUN TO DEVELOP BLISTERS.  SHE HAS A HEADACHE, NAUSEA AND BODY ACHES.
4X6 inch area of redness surrounding injection site between shoulder and elbow with marked swelling and turgor.   Shivering and chills, extremely weak with difficulty walking 2 blocks to vehicle (was attending an opera at time of onset).  On following day temp was 100.7.  Increased induration and severe malaise on day following injection.  Symptoms gradually decreased over next 3 days.  No respiratory problems tachycardia nor swelling of face or throat.
Shortness of breath and calf pains that began about 3 weeks after the second Covid vaccine that turned out to be a DVT and Pulmonary Embolism
This spontaneous report was received from a physician referring to a 4 weeks old male patient. Information about the patient's medical history and concurrent conditions was not provided. On 19-MAY-2009, the patient was vaccinated with his first dose of RECOMBIVAX HB, then on 21-JUL-2009 he received the second dose of the series and on 07-DEC-2009 the third one (administration routes, lot numbers and expiration dates were not provided). No concomitant therapies were reported. This is one of two reports from the same reporter. Additional information has been requested.
Swollen lymph nodes for two weeks after second dose Tonsil stones developed after two weeks
Malaise, progressed to deep lt flank pain within one week.  Dermal tenderness/itching soon after. ER visit 11/29/2009 R/O kidney stone.  Characteristic rash appeared 12/02/2009.  Confirmed Dx 12/04/2009.
Two hours after vaccine on 11/13/21, I started having distorted OCD thoughts. My usual calming techniques became less and less effective and I started having major panic attacks the next day. Every day during the next week, I was having 3-10 panic attacks a day. On 11/21/21, I had to go to a mental health crisis receiving center and it was recommended that I speak with my prescriber about adjusting my medications. The next day, I tried to contact the psychiatric nurse practitioner, so I contacted a doctor and let him know what was happening.  My Lexapro was increased to 10mg. I was hesitant to inform my doctor that it started after my vaccine.
Lost control of the leg and fell down; Headaches; Chills; A Spontaneous report was received from a consumer concerning a male patient of 74 years who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of control of legs, headache, and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 024M20A) for prophylaxis of COVID-19 infection.   On 24 Feb 2021, the patient reports she experienced headaches, chills, lost control of the leg and fell down. The event loss of control of legs was deemed medically significant.  Laboratory details were not provided. Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, headache, chills, and lost control of leg was unknown.; Reporter'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.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX. Concomitant products included Losartan, vitamin D, AMBIEN, PLAQUENIL and SYNTHROID. On 28th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm, head pressure, foggy feeling in head and tiredness. The patient was treated with ADVIL. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the head pressure, foggy feeling in head and tiredness were not recovered/not resolved. The reporter considered the pain in arm, head pressure, foggy feeling in head and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The patient received SHINGRIX in the left arm. The patient developed arm soreness after the shot and that it had improved some but was not totally resolved till the time of reporting. The patient had treated this with ADVIL. The patient also experienced pressure in her head and fogginess in her head. The patient had not notified her physician and had not treated these events. The patient declined to provide her address and requested to not be contacted for follow up. The patient had denied permission to contact their physician. The patient was unable to provide full demographics for the pharmacy and only provided the first name of the pharmacist that administered the dose.
Nausa, headache, back pain and knot on ear lob, feeling of something is stuck in her throat
Patient reports mild swelling around both eyes, as well as itching and irritation. No other areas affected, no trouble breathing, no other symptoms. She has been taking Benadryl since symptoms started. Patient says after 20 hours, symptoms have not resolved. She will continue to monitor. She hasn't tried any new makeup or food recently but she was gardening on 8/12 and forgot to wear gloves.
This spontaneous report was received from a physician refers to a 33 year old male patient. No drug allergies were reported. The patient's medical history included appendectomy for which he was hospitalized on an unspecified date. Upon discharge from the hospital on 09-NOV-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date and dose were not reported) in the left arm. No concomitant medications were reported. The patient returned to the hospital the next day on 10-NOV-2013 (exact time frame development was unspecified) and was admitted on same day for the injection site reaction (cellulitis, redness and warmth), headache and fever(fever of 103F). The patient was currently hospitalized (patient sought medical attention). The patient received symptomatic treatment and unspecified antibiotic were prescribed for the adverse events. No laboratory tests were performed. The outcome of the reported events was not recovered. The reporter considered the events injection site reaction (cellulitis, redness and warmth), headache and fever to be significant disability. Additional information is not expected.
about 5 minutes after patient received shot , he came to pharmacy counter to say he felt light headed, as I ( the pharmacist) headed out to have him sit down, dropped to a sitting position on the floor, I was able to get him up to a chair and was fanning him and we got him some water.  he the passed out and his lead lobbed backwards, I got behind him so he did not hit his head and he went into a mini seizure which only lasted about 5 seconds and then he came out of, he was in sweats and we called 911. He declined to go to hospital and his mom came and picked him up
This spontaneous report as received from a registered nurse refers to a "either 12 or 13 years old" male patient. The patient did not have pertinent medical history. On an unknown date the patient was vaccinated with a dose of GARDASIL. Lot #, dose # and administration route were unspecified. On the same date, after the GARDASIL was administered, the patient became "rigid and stiff for 30 seconds". The patient recovered after those 30 seconds. No lab test was done. Patient was seen by a physician assistant. Additional information has been requested.
Patient stated that about 1/2 hour after vaccination she started "itching all over" and had a red rash on her chest. She states that her legs are also very itchy and red from scratching them.
A report has been received from a Health Professional concerning a 50 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 26-Sep-2013. Lab manager reported that they have inadvertently given FLUMIST quadrivalent to a 50 year old employee of clinic. She had not reported any adverse effects. FLUMIST quadrivalent (intranasal) was discontinued on 26-Sep-2013. The outcome of the event of inadvertently gave FLUMIST quadrivalent to a 50 year old patient is unknown. The report was considered to be non-serious.
Fever 102 for 2-3 days. Redness, edema. 6" x 4" erythematous, pruritic wheal left thigh surrounding DTaP site.
pt recv vax 24JUN98 @ 3PM & mom returned w/child 330PM stating child was developing a skin rash on face, arms & trunk;as instructed by MD mom gave DPH for itching;
vertigo/started spinning last night; a little dizzy / super dizzy; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo/started spinning last night) and DIZZINESS (a little dizzy / super dizzy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 01-Apr-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 22-Apr-2021, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to at an unspecified dose. On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced DIZZINESS (a little dizzy / super dizzy). On 14-Nov-2021, the patient experienced VERTIGO (vertigo/started spinning last night). At the time of the report, VERTIGO (vertigo/started spinning last night) and DIZZINESS (a little dizzy / super dizzy) outcome was unknown.            No Concomitant medications were provided. No treatment medications were provided.
fever, swollen eyes, rash over trunk & limbs; non on face actions atypical;
Intense soreness and pain at injection site.  Pain in finger joints of the hand on that side.  Headache, slight dizziness.  More than one day, continuing.
No adverse event; Vaccine was expired on 07-JUN-2023 and was utilized to administer with patient on 15-JUN-2023; Adult patient was administred with Moderna covid-19 vaccine,bivalent as primary series dose instead of Spikevax; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-JUN-2023 and was utilized to administer with patient on 15-JUN-2023), WRONG PRODUCT ADMINISTERED (Adult patient was administred with Moderna covid-19 vaccine,bivalent as primary series dose instead of Spikevax) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PCV 20. Past adverse reactions to the above products included No adverse event with PCV 20.    On 15-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-JUN-2023 and was utilized to administer with patient on 15-JUN-2023) and WRONG PRODUCT ADMINISTERED (Adult patient was administred with Moderna covid-19 vaccine,bivalent as primary series dose instead of Spikevax). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-JUN-2023 and was utilized to administer with patient on 15-JUN-2023), WRONG PRODUCT ADMINISTERED (Adult patient was administred with Moderna covid-19 vaccine,bivalent as primary series dose instead of Spikevax) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-JUN-2023 and was utilized to administer with patient on 15-JUN-2023) and WRONG PRODUCT ADMINISTERED (Adult patient was administred with Moderna covid-19 vaccine,bivalent as primary series dose instead of Spikevax).    Patient have received other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown patient have any relevant medical history/conditions, allergy, concomitant diseases and risk factor.  No concomitant medication was reported.  No additional AE details reported No treatment information was reported.
7 days after vaccine, injection site red, warm and itchy. Symptoms resolved on own after 3 days.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 12 months old. The patient demographics were updated. On 12-JUN-15 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.