chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "known allergies: Mango" (unspecified if ongoing); "known allergies: seasonal pollens" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 30Jan2023 to 03Feb2023.
urticaria, rash, redness, swelling, nausea, dizziness, all over body itching
After receiving the new shingles vaccine, ZOSTAVAX, I had an outbreak of herpes, type 1. I had not had an incident of an outbreak of herpes, type 1 for over two years. I feel that getting the live vaccine might have being the reason for the outbreak.
Case number PHEH2015US004139 is an initial spontaneous report received from medical assistant on 27 Feb 2015: This case refers to a 09 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch numbers: U5036CA, U501BAA, U5018AA, UI173AB, UI207AB, UI2O7AB, 14511F) at a dose of 0.5 ml intramuscularly on 24 Feb 2015, which reached 31 F for two hours. No adverse event was reported following this administration error.
nose bleeds on and off 2 days, headaches 4 days,  neck pain current , left shoulder  and arm pain current ,  muscle pain, lost feeling in my left shoulder to fingers for over 12 hours, tingling feeling and numberless over 12 hours , rash 4 days  treatment took a muscle relaxer and bendryl.
Information has been received from a medical assistant reporting on her mother in law a 73 year old female patient who in September 2010 "a year ago", was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not provided). It was reported that the patient sought medical attention by seeing the physician who performed physical examination. The medical assistant stated that after her mother-in-law received the ZOSTAVAX (Merck) she suffered a case of shingles (date unspecified) which caused her to be admitted in the hospital. The medical assistant mentioned that she was not certain how long her mother-in-law was in the hospital, but her mother-in-law had recovered completely on an unspecified date. Additional information has been requested.
Patient made it home, then became dizzy and passed out on the floor. She was in and out of consciousness for 48 hours. She can barely eat and remains dizzy
passed out; Fall; knee got banged up pretty bad; Got dizzy; weak; A spontaneous report was received from a consumer who was also an 81-year-old, female patient that received Moderna's COVID-19 Vaccine (mRNA-1273) and passed out/ loss of consciousness, fall, knee got banged up pretty bad/ joint injury, dizzy/ dizziness, and weak/ asthenia.  The patient's medical history included knee replacement, COVID-19 in Nov 2020, and pneumonia. Concomitant product use was not provided by the reporter.  On 01 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013h21a or 013E21a) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Mar 2021, the patient got dizzy. The patient was weak and passed out. She was sitting on toilet cover and was getting ready for a shower but the next thing she knew was that, she found herself laying in the shower stall. The patient did not know for how long she was passed out for. Treatment for the events included 2 Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of events, loss of consciousness, fall, joint injury, dizziness, and asthenia, were considered as unknown.; Reporter's Comments: Very limited information regarding these even/s has been provided at this time.  Further information has been requested.
Patient presented to the emergency department with pain at the site of a tetanus shot 5 days ago. Exam is very benign. She has no cellulitis, crepitus, edema. Does have some mild axillary adenopathy. She had an MRI that showed some nonspecific fluid around her deltoid. The radiologist had commented that this could be cellulitis versus myositis. However, provider did not think patient has either of these conditions. She has no fever, no elevation of her CK, no elevation of her WBC, no erythema, no warmth, no redness. Her fluid collection may be a nonspecific reaction to her vaccine. It could also be a small amount of blood. Patient reported she felt much better after a dose of IV TORADOL. Patient was discharged and instructed to follow up with PCP or the emergency department if condition didn't improve.
Left side delt arm redness, swelling, and tenderness 45 ml x 50 ml side not painful no other symptoms.
This spontaneous report was recevied from a nurse and refers to a patient of unknown age and gender. No information about concomitant medication, pertinent medical history and drug reactions was provided. On 10-OCT-2014 the patient was vaccinated with the first dose of GARDASIL (dose, frequency, lot# and expiration date not reported). On 04-MAR-2015 the patient was vaccinated with the second dose of GARDASIL (dose, frequency, lot# and expiration date not reported). On 21-MAY-2015, the patient was vaccinated with the third dose of GARDASIL (dose, frequency, lot# and expiration date not reported). No adverse effects were reported. Additional information has been requested.
Within a week of receiving the vaccine, I got several small bullous on my ankles.  These were itchy, but went away.  Approximately 1 month after receiving vaccine got blisters on my head that started weeping and a few small blisters that opened on would not heal.  These were on my back and front torso.  These flat blisters slowly spread while doctors initially tried treating as skin infections.  Eventually referred to a dermatologist, was tested, and diagnosed with pemphigus foliaceus.
Pt received her shot around 11:10 am about 5 min later pt began to feel dizzy, light headed. Pt is taken to EMS vitals are taken all vitals normal Range 125/61 R65 spoz 98% B6, 135. Pt wish to have a rescue advised by the Doc. Transferred ->ER via EMS
No adverse events. Will need to re-vaccinate because unsure of efficacy (see enclosed).
AKI (acute kidney injury); Decreased oral intake; Hypercalcemia; Nausea vomiting and diarrhea; COVID-19 infection
Extremely swollen and painful lymph node swelling under arm. Pain in breast, shoulder, and collarbone. Lasted approximately 1 weeks. Abnormal menstrual bleeding began 12/3. Daily spotting and menstrual bleeding until the day of this report 1/1. Varying levels of bleeding ranging from extremely heavy to light spotting.
Blood Pressure immediately dropped to below 80. Injection caused me to pass out. Monitored me for 30 minutes and Blood Pressure would not rise above 80. Nurse took me to the ER where they started an IV.  It took about 4 hours for my Blood Pressure to rise above 100.
pt recv vax & 2 days post vax pt became ill w/serious multi-systems illness requiring a 2wk hosp;pt was found to have angioimmunoblastic lymphadenopathy;pt recovered;
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On unspecified dates, the patient were vaccinated with MMR II (dose, frequency unknown). No concomitant medication was reported. The healthcare worker reported patients received less than recommended dose of MMR II due to incorrect reconstitution methods. Healthcare worker reported that the full amount of diluent was being drawn up to reconstitute the product but then only 0.5 milliltre of reconstituted product was being administered to the patients. No adverse effects were reported. No product quality complaint was reported. The outcome of events was unknown. This case is related to 1407USA008555, 1407USA008556, 1407USA008557, 1407USA008558 and 1407USA008559 via same reporter link. Additional information has been requested.
This spontaneous report received from a pharmacist concerned a 53 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: 19-SEP-2021) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-OCT-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000203761. This case, from the same reporter is linked to 20211151967.
On 06/14/2022 I woke up and felt my sinus were full. I took a home test 06/17/2022 and it was positive. The next day I went to urgent care and had a PCR test that also showed positive. I had drainage, cough, sore throat and fatigue. It was too late to start any medications but I did take a steroid. As of today I am only having a lingering cough that does continue to get better and less frequent.
The worst period I had to years. I got my period a week and a half early , it started the morning after I got my vaccine. I was bleeding through plus tampons in 2 hours. I went off north control 1 year ago and have no other hormones in my body.
Slight swelling around injection sire, red itchy bump at injection site, sore and stiff arm lasting for about 24 hours, slight fever
Around 9-10pm the day of our vaccinations, both my husband and I experienced extreme reactions to the j&j vaccine. We had fever, chills, elevated heart rates, nausea, vomiting, splitting headaches, all for approximately 6 hours.
2 weeks after vaccination, patient developed swelling in legs and feet, shortness of breath, left pleural effusion, ground glass opacity on imaging of lung
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant products were not provided. Treatment medication were not reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
14:40: Large local noted right arm at injection site. 14:45: Patient complained of nasal congestion.  Unusual throat sensation. 14:50: Benadryl 25mg (2) per mouth given.  Patient began coughing.  Hives noted on neck and face. 14:52: Spl 0.3mL given SQ left arm.  Health officer notified. 15:00: Hives, coughing, tightness in chest and throat up. 15:05: epx given SQ left arm. 15:06: 911 called 15:10 911 called again.  15:15 patient to ER.
Pt received Moderna vaccine at pharmacy and started with fever Tmax 102 F.  2 days after her vaccine, she started with non-transient hives along her L side that spread around her chest/abdomen/back and bilateral cheeks and lower legs.  Swelling  of the face and bilateral fingers of the hands noted in clinic.
This spontaneous report was received from a office manager referring to the currently 70 year old female patient. Patient's Medical History and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a single dose vial of PNEUMOVAX23, (lot # L008664, expiry date 03-NOV-2016). On an unknown date the patient experienced pain in the arm of injection of PNEUMOVAX23. The outcome of injection site pain was unknown. This is one of several reports from the same reporter sources (MARRS# linked case 1510USA006230). Additional information has been requested.
Pt. states that after receiving the 3rd Booster of Moderna 10/28/2021, started experiencing symptoms that evening of nausea, loose stool, dizziness, weakness, light headedness, and fatigue. No noted Primary visit/communications. 10/29/2021 weakness, headache, and sweatiness still continue.
Abnormally long menstruation beginning after first shot. First vaccine short received on 04/12/21 and menstruation lasted from 04/14/21 through 04/27/221. Second shot received on 05/12/21 and menstruation lasted from 05/17/21 through 05/28/21. Menstruation began again on 06/16/21 and has not stopped as on 07/20/21. Menstruation had never previously exceeded 7 days.
Patient reported heart palpitations on Friday 12-9-16 but was gone the next day. Patient then reported a rash at injection site Saturday 12-10-16, but rash has not changed, worsened or spread as of 12-11-16.
Patient under 65 received Fluad QIV; Hot and red knot; Hot and red knot; Swollen arm; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04816) and concerned a 58-year-old, female patient.   The patient's medical history included hypothyroidism. The patient's concomitant medications were not reprorted.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influneza prophylaxis. The batch number reported was 286592.  On an unspecified date in 2020, unknown time after receiving Fluad Quadrivalent, the patient developed hot and red knot, swollen arm. The patient was treated with Tylenol (paracetamol).  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 58-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed peripheral swelling, nodule and feeling hot (hot and red knot). With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 58-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed peripheral swelling, nodule and feeling hot (hot and red knot). With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Information has been received from a physician concerning a 4 year old male patient, with no pertinent medical history and no drug reactions or allergies, who on 22-OCT-2010 was vaccinated with a dose of VARIVAX (Merck), (lot # 666917/0550Z, expire date not reported), 0.5 ml, subcutaneously. Concomitant therapy included PREVNAR. On 24-OCT-2010 the patient developed an injection site reaction. The patient received the VARIVAX on his thigh and it became red and swollen. The red and swollen area was about 37 cm in diameter. It was not tender. There were no laboratory diagnostics performed. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Severe chest pain and shortness of breath lasting two-three days. Symptoms resolved spontaneously, no treatment received
This spontaneous report was received from a nurse via company representative refers to a male patient of unknown age. The medical history, concurrent conditions and concomitant medications were unknown. On APR-2016 (reported as beginning of April), the patient was vaccinated with GARDASIL 9 dose 2, intramuscular. On an unknown date, the patient developed an unspecified red rash before he left the examination room. The rash got larger as time went on. The rash was also reported to be lacy. The nurse explained that the rash was unlike anything they had seen before. The patient had no issues after the fist injection. The outcome of the event was unknown. Additional information has been requested.
Felt some irritation near the upper middle of my back my spouse checked it out and it is hard to see.What I can see and my spouse is a 7x7 inch bumps spread across area.Some pain not much itching .I'm postive it's a reaction to shot first time iv ever had this happen.Im very healthy good skin no new products in used.Im feel like it's a reaction.Keeping Close eye on it.Useing hydrocortisone cream at this time.Thank you .I was asked by My local Health Dept to Contact you.
My asthma was getting worse I noticed I had to do more treatments, I have had to go to the walk in.  I just recently went to the walk in because I have been having chest pain on my right side and at night wheezing and using my inhaler daily I feel tired anxious,  I am also forgetting things.
Slight swelling and soreness next day. The next day day after that, swelling increased to size of 16 x 7 cm, raised, hot. Arm very sore and hard to use.
Inflammation of the heart. Borderline enlarged. Hard to breathe, light headed easily. This started between getting the first and second shot. I was not informed this was a possible side effect and was allowed to get the second vaccine.
Patient said she noticed the reaction this morning (9/21/17), she said it is red, swollen and itchy. She showed me the rash and it looks about the size of 2-3 quarters, and it is on the back of her right arm at the site of the zoster injection. When asked if she's taken anything for it yet she said no. When suggested she could take some Benadryl for it, she said she can't take it yet because she has work today and Benadryl makes her too sleepy.
5 minutes following the shot in my left arm, the left side of my throat, tongue and face (from underneath eye, down to  mandible, across from ear to nose) went numb.  Feeling was similar to that of being frozen for a dental procedure.  It lasted 48 hours.   My left hand and foot also went numb and remain mildly numb. Similar to feeling I had when my spinal court tumor was discovered 15 years ago. Post resection, it subsided as pressure on nerves was alleviated.   Very scary. I won?t return for a second shot.
4 hours after vaccine -pt had severe strider - received EPONEPHRINE and ambulance transport to ED. Dx spasmoodic croup  10/23/2009 records from PCP and ED visit date 10/15/2009 received. Patient presented post vaccination with c/o's croupy cough, difficulty breathing, loud stridor, vomiting and tachypnea. Tx'd with O2, racemic Epinephrine neb, and oral Decadron with resolution of sx> DC Dx: Acute Croup
Immediately upon receiving the flu vaccine (and having my left ear irrigated) on 11/19/07, I immediately felt dizzy to the point where I had to lie in my physicians office for about an hour.  Upon going home I continued to experience dizziness and nausea. On 11/21/07 I called my doctor to inform her that I was still having dizziness and nausea symptoms.  The physician stated that it was probably due to the ear irrigation and that I should just take it easy and the dizziness and nausea would eventually go away.  On 11/24/07 I talked to a pharmacist who suggested that I take Dramamine and follow up with my physician.  On 11/26/07 I went back to my doctor and informed her that I was still having dizziness and nausea.  She stated that ther was nothing that she could do and I that just needed to wait it out and that it would go away and that I could continue to take Dramamine.  To date I continue to have dizziness and nausea.
Swelling of right thign 2 1/2 x size of left thigh.
Generalized seizures - brief - 4 times over 8 hours time starting about 24 hours after vaccinations below. Treated with anti-seizure medicine for 5 days only (Ativan). Medical Records received on 2/7/2005 states pt was stiff, shaking and fussy. Followup 02/07/05: Neurologist diagnosed as afebril seizure (new onset), with possilbe precepitation by immunization. Main symptoms were siffening and shaking, starting 26 hours after immunization. No prior seizures.