chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; Arm Pain, tenderness; Headache; Swelling near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VACCINATION SITE PAIN (Arm Pain, tenderness), HEADACHE (Headache) and VACCINATION SITE SWELLING (Swelling near Injection Site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced DIZZINESS (Dizziness), VACCINATION SITE PAIN (Arm Pain, tenderness), HEADACHE (Headache) and VACCINATION SITE SWELLING (Swelling near Injection Site). On 05-Feb-2021, DIZZINESS (Dizziness), VACCINATION SITE PAIN (Arm Pain, tenderness), HEADACHE (Headache) and VACCINATION SITE SWELLING (Swelling near Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Febrile sx in the evening of inject; 4th DTP, no prior problems; No family hx of convuls;
NO ADVERSE EFFECTS, PT RECIEVED THE HD FLU SHOT WHEN NOT QUITE 65 YEARS OLD
lt arm swelling w/involvement down to the elbow noted w/in next day; pt admitted 2 days later to r/o septic elbow due to immunocomprimised state;
Information has been received from a physician concerning a 16 year old female with no pertinent medical history and no history of drug reactions or allergies who on 18-JUN-2007 was vaccinated with the first dose of GARDASIL and on 10-JUN-2008 was vaccinated with the second dose of GARDASIL.  On 10-JUN-2008 the patient was also given MENACTRA.  Ten days after the second dose of GARDASIL (on 20-JUN-2008) the patient experienced joint pain and fatigue.  Seventeen days after the second dose of GARDASIL (on 27-JUN-2008) the patient had a seizure.  No adverse events reported after the first dose of GARDASIL was given.  The patient sought medical attention by calling the physician's office.  The physician reported that she noticed that patients who are given GARDASIL and MENACTRA usually have more side effects.  She further stated she would not be administering the two vaccines together from now on.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested. 8/12/08-records received for DOS 6/27/08-Syncope. Presented after 1 episode found on floor with legs shaking. Vision blurred. Now continues with fatigue and dizziness. Impression: syncopal event induced seizures due to orthostatic hypotension.
Classic "COVID arm": Red patch on skin - very itchy and slightly painful to the touch. Started out about 3'' across with well defined rim.  Ultimately grew to ~6 inches long.  Today is the first day that all symptoms are gone.
dizziness; nausea; pain all over the body; severe headache; excessive flatulence; Fever 40 Degree C/severe fever; pain in knees, ankles and foot the first day; pain in knees, ankles and foot the first day; administration date= 04Jan2021, dose number=2/administration date=18Dec2020, dose number=1; This is a spontaneous report from a contactable healthcare professional. A 35-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ES1686), intramuscular on 04Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 (first dose). The patient experienced fever 40 Degree C, pain in knees, ankles and foot the first day (on 04Jan2021 21:00); second day (05Jan2021) dizziness, nausea, severe fever, pain all over the body, severe headache, excessive flatulence. Symptoms lasted a week. Treatment included Panadol every 4 hours. The patient went for an emergency visit for the events. The outcome of the event was recovered in Jan2021.
Information has been received from a physician concerning an 19 year old male patient who on 27-MAY-1992 was vaccinated with the first dose of MMR II (route, site, dose and lot number not reported). On 14-OCT-1997, the patient was vaccinated with the second dose of MMR II (route, site, dose and lot number not reported). On 30-NOV-2009 the patient experienced mumps (date diagnosed was reported as 03-DEC-2009). The patient was afebrile and had parotitis. On 03-DEC-2009, the laboratory tests showed IgM <1:10, IgG 4.29 and serum amylase 273. The outcome for mumps was not reported. Follow up information has been received from the physician who reported that the 15 year old patient at symptoms onset date experienced mumps on 22-NOV-2009 (previously reported as 30-NOV-2009). The date diagnosed was reported as 23-NOV-2009 (previously reported as 03-DEC-2009). The patient was afebrile and had bilateral parotitis. On 23-Nov-2009, the blood work test showed IgM <1:10, IgG 3.94 and serum amylase 190. At the time of the report the patient's outcome was unknown. This is one of several reports from the same source. No further information is available.
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.  Reporter stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
She started itching and developed nausea and vomiting, chills,fever.   Woke up with eyes swollen and big blister under each eye on cheek bone.  General  malaise
The pt developed rash in the groin areas, abdomen and chest. Treated with Benadryl.
a patient who received the vaccine and got ill; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer reported for a female patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that a patient who received the vaccine and got ill on an unspecified date in 2021. It was reported that caller was the consumer, wanted to know the exact percentage of each ingredient of the Pfizer COVID 19 vaccine. She believed that the vaccine caused cardiac arrest, DVT and other cardio related diseases. Caller was very upset with Pfizer since she believed that there was more ingredients in the vaccine that was not publicized. She also mentioned that the fact sheet provided for the recipients does not include the percentage of each ingredients. Even the pharmacists and doctors cannot provide her information. She wanted to have the full list of the mRNA vaccine. Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]- N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol),0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. Insisted to speak with higher position, she believed that someone would have an answer for her. She wanted to speak with the next level since she believed that there were still more information available with the specialist II. Outcome of the event was reported as Unknown.   Information on the Batch/lot number has been requested
Throbbing/severe pain in left big toe (which had been injured about  7 months prior)  Pain resolved next day after taking ibuprofen. Redness and swelling continued for about 1 week.
Narrative: Pt is a 86y.o. male who died on 05/14/2021 w/ h/o colon cancer resected in 2010, COPD, HTN, CAD s/p PCI 8-10 years ago, CHF (EF 46% on echo in 5/2019), and and recent pleural effusion with thoracentesis 2 weeks ago. Notable "smoker since age 5 1/2." Recently smoked 3 cigs/day (04/29/2021). Pt received Moderna Covid-19 Vaccination 2/2 on 03/25/2021. Pt presented to ED on 04/29/2021after two episodes at home of facial flushing and shortness of breath. Pt diagnosed w/ Multifactorial Dyspnea, Acute on chronic anemia, Recurrent Pleural Effusion, Tachycardia, COPD Exacerbation and admitted on 05/01/2021. Pt consented to life-sustaining treatment on 05/05/2021. Discharged to outpatient hospice on 05/12/2021. Unlikely that Moderna Covid-19 vaccine caused/contributed to pt death.
Temp 103 degrees, stiff neck, passed out, nausea, chills, muscle aches, joint aches.
Redness and swelling of the left thigh. Left thigh circumference 35 cm. Red area 15 cm x 12 cm.
Brother w/ chicken pox 2 wks prior. Pt febrile 102. Areas of red fluid filled pockets about dime size.
Weak; Sick/Illness; Dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), ILLNESS (Sick/Illness) and DEHYDRATION (Dehydrated) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Stent insertion NOS (Has 2 stents.). Concurrent medical conditions included Fish allergy and Diabetes. Concomitant products included ATORVASTATIN, METOPROLOL and VITAMIN D NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ASTHENIA (Weak), ILLNESS (Sick/Illness) and DEHYDRATION (Dehydrated). At the time of the report, ASTHENIA (Weak), ILLNESS (Sick/Illness) and DEHYDRATION (Dehydrated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also mentioned diabetes medication NOS. Treatment information provided was fluids.
she was very very tired; sleepy and weak; sleepy and weak; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in arm on an unspecified date in 2021 (at the age of 40-years-old) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received Tylenol for an unspecified indication and had allergy. On an unspecified date in 2021, after receiving first dose of vaccination, the patient was very very tired, sleepy and weak was hesitant about getting the second shot because of what happened the first time. Patient states that the only reason she got the shot was because her baby has asthma. Reportedly, the first shot patient got the day after her birthday and she was tired and weak and even the patient's baby noticed that the patient was sleepy and then she got scared. Patient reports that she just turned 40, and she was a medical assistant, so she knows her body and knows what she was talking about. The outcome of the she was very very tired, sleepy and weak were unknown.  Information on Lot/Batch number has been requested.
w/in about 1min of receiving MMR vax pt exp mild grand mal sz w/loss of consciousness & tonic-clonic movements lasting aobut 20 seconds;
Headache, Myalgia, Arthralgia, Fever, Fatigue, chills, injection site pain/swelling Narrative:
Fever up to 103.4 ax starting the evening vaccines were given. Lasted 6 days rash blotchy in axilla, neck, elbows and ankles also slight swelling of ankles for 5 days.
11 days after being injected with the Moderna COVID-19 booster shot, I have developed symptoms of Bell's Palsy on the right side of my face.  The symptoms have been facial paralysis of the right side of my face.  Difficulty squinting of right eye, cannot move right lips; cannot frown, nor smile completely.  Have lost facial movement to the right side of my face, which began on January 25, 2022, 11 days after being injected.  I do not have any other pre-existing conditions, and am healthy with NO diseases.  I was also healthy at the time of inoculation injection.
Breakthrough case admission after 5 vaccines Pfizer 1/28/21 Lot# El9265;  Pfizer 2/18/21 Lot# En6200;  Pfizer 10/6/21 Lot# 301358A;  Pfizer 4/24/22 Lot# FK9893;  Moderna 11/9/22 Lot# 020H22a
Vaccine administered prior to 6 month recommendation of CDC.  Elapsed time between last dose and booster = approx. 5 months
This is an instance of breakthrough COVID-19 disease after which death occurred.   This individudal was a resident of a group home type facility for individuals with disabilities.   The individual was vaccinated with the Moderna product on 02/05/2021 and 03/04/2021. The individual presented to emergency dept on 11/24/2021 for hypoxia and tested positive same day. She was admitted 11/24/2022 and transferred to an out-of -state hospital for higher level of care on 11/30/2021. They remained hospitalized at this out-of-state hospital until their death on 12/07/2021.
Dizziness, Myalgia, HYPOtension, weakness,rigor Narrative:
Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. The pharmacist reported that on unknown dates the patients "might" have received doses of improperly stored ZOSTAVAX (lot#, dose and route were unknown). Concomitant medications were not provided. No adverse effects were reported. This is one of three reports received from the same reporter (other linked case # 1511USA009275 and 1511USA009326). Additional information has been requested.
Atrial fibrillation on and off for 4 days, high inflammatory markers, fatigue, chest pain
My left side lymph node at my collar bone was swollen. These is still ongoing. I also have developed severe panic attacks as well. I had locate site swollen for 2 weeks. I also have been diagnosed with IBS. I have never has an issue before the vaccine. I have been the doctor about these symptoms. She has prescribed me medicine for it. I had blood work done, normal results.
Information has been received from a Nurse Practitioner (N.P.) concerning an 18 year old female patient who was vaccinated with a dose of Gardasil and fainted after receiving the injection. Unspecified medical attention was sought. On 29-MAR-2007 the patient recovered. Additional information has been requested.
Tight throat, tingly, difficult swallowing.  Benadryl 25mg IM given.
Noticed lump forming on right ankle on May 12. It continued growing, becoming hot and painful. Swelling began. Additional nodules in both legs. Swelling eventually included my entire foot, ankle and up to my knees. Night sweats and ankle joint pain. Was unable to walk due to swelling and pain. Advil, Icing, elevation,  and compression socks suggested. Swelling considerably subsided by May 25th- yellow bruising. By May 27th swelling was minimal.
Patient states approximately 3 weeks following influenza immunization her entire upper arm become swollen and sore and remained that way for 3 days. The swelling then went down, but the arm remained sore and a golf ball sized nodule appeared mid-upper arm. Was seen at a clinic and no treatment was prescribed.
Received vaccine on 8/29/2021. Pregnancy detected on 12/24/2021. COVID + on  1/18/2022. Started bleeding vaginally on 1/21/2022. Confirmed pregnancy on 1/21/2022 to be 6 weeks 6 days with no fetal heartbeat. Vaginal bleeding continued. On 1/24/2022, complete miscarriage confirmed. Continued bleeding for 9 days.
On 01/25/2022, at the COVID-19 vaccine clinic, Patient, age 17, was given a booster dose of Moderna COVID-19 vaccine indicated for persons 18 years of age and older. Patient, age 17 should have received a booster dose of Pfizer gray cap, indicated for persons 12 years and older.
24hr p/MMR inj-rash from elbows (both arms) down; Rx DPH X2;
No additional AE/; HCP called to report inadvertent administration of expired PNEUMOVAX 23 to a patient. Product expired on 08/21/2023 and was administered on 08/28/2023. No additional AE/PQC.; This spontaneous report was received from Other Health Professional and refers to a 77-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 28-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, expiration date: 21-AUG-2023, administered for prophylaxis (strength, dose, lot #, anatomical site of administration and route of administration were not provided) (expired vaccine used). No additional AE (no adverse event).
pt recvd 3 doses of Engerix-B & antibody titer was due to be checked on 22MAY92; 18MAY92 pt devel a vaginal yeast infection; awoke on 19MAY92 w/dry mouth & devel a huge ulcer on rt roof of mouth which lasted a wk; ear & rt side of head hurt
An itchy lump on the arm; Ache on the arm; Redness on the left arm which spread to the neck , of approximated 3 inches.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (An itchy lump on the arm), PAIN IN EXTREMITY (Ache on the arm) and ERYTHEMA (Redness on the left arm which spread to the neck , of approximated 3 inches.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (An itchy lump on the arm), PAIN IN EXTREMITY (Ache on the arm) and ERYTHEMA (Redness on the left arm which spread to the neck , of approximated 3 inches.). At the time of the report, PRURITUS (An itchy lump on the arm), PAIN IN EXTREMITY (Ache on the arm) and ERYTHEMA (Redness on the left arm which spread to the neck , of approximated 3 inches.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
syncope; POTS; headache; dizziness; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 15-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2011, the pt experienced Postural orthostatic tachycardia syndrome (POTS), syncope, dizziness, and headache. The outcome of all the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946:
(L) upper arms swell to 4 inches. Slight raise & arm redness itching. BENADRYL/topical hydrocortisone/ TYLENOL.
shivering/chills; pain; fever; This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering, pain and fever. On an unknown date, the outcome of the shivering, pain and fever were unknown.   It was unknown if the reporter considered the shivering, pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever, pain, chills, and shivering that her niece reported to the pharmacist.   The pharmacist had no other details of the aunt's experience at time of report. The reporter consented to follow up. This case linked with US2020AMR167887 and US2020167477, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR167887:same reporter US-GLAXOSMITHKLINE-US2020167477:same reporter
injection arm is swollen; injection arm is swollen and extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (injection arm is swollen) and VACCINATION SITE PRURITUS (injection arm is swollen and extremely itchy) in a male 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.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced INJECTION SITE SWELLING (injection arm is swollen) and VACCINATION SITE PRURITUS (injection arm is swollen and extremely itchy). At the time of the report, INJECTION SITE SWELLING (injection arm is swollen) and VACCINATION SITE PRURITUS (injection arm is swollen and extremely itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.
Patient's blood pressure dropped while sitting in the waiting room. We immidiately helpled to get his legs elevated and checked his BP. EMS arrived and took over after that.
4-6 hours post vaccination, patient developed left leg (groin to knee) swelling, redness, hot to touch, irritability. Treated with cool compresses and Tylenol.
BNP- 1280, muscle pain, joint pain, severe headache - went to ER.
Per mother, pt had swollen right deltoid and some fever. Mother also, left the bandaids on for several days, had swelling under them.