chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEART PROBLEMS; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart problems was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Information has been received from a physician concerning a male patient who was vaccinated, "within the last few days", with ZOSTAVAX (Oka/Merck) (Lot # was not available). The physician reported that "within the last few days", the patient experienced a significant adverse reaction. The patient's throat started to tighten and he had a birthmark on his face and during the reaction, it was noticed that there was blood flowing on the blood vessels on the birthmark on his face. The physician noted that the patient was hospitalized (hospital demographics unspecified) but did not specify if the patient was admitted or not. At the time of the report, the patient was recovering. The patient sought medical attention and saw the physician. Additional information has been requested.
Confirmed with customer that no other AE occurred; PROQUAD was administered after experiencing a temperature excursion; Information has been received from a nurse concerning a patient of unknown age or gender. Information of concurrent condition, medical history and concomitant therapy was not provided.    On 27-APR-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant human albumin (rHA)) (strength, route, lot# T005404 and expiration date expiration date reported as 24-MAR-2022, but upon internal validation established as 12-AUG-2021) for prophylaxis. This vaccine experienced a temperature excursion (incorrect product storage). The vaccine was stored in 37.2 Fahrenheit degrees (F) for 3 hours. There was no previous temperature excursion reported. Digital data logger was involved. The reporter confirmed no other adverse event (AE) occurred.
The third dose was administered before completing the 4 months required by the department of health and the patient only had 3 months.
Patient was given a pediatric dose of Pfizer vaccine for her 4th shot. The error was immediately figured out and then patient was brought back and received the Adult Pfizer 4th dose.
Severe, ulcerative rash on face and neck and upper back, lesions spread to hands and feet. Strange scarring from rash especially prominent on face and neck. Extreme nausea as well, spider veins and broken vessels in ankles and feet, chilblains. This lasted for about three weeks, onset was about 2.5 days out and continued in severity for two weeks, began to taper off at the third week. At about week four, healing began to pick up, and nausea mostly went away. Still  having occasional itchy spells, though mostly resolved. Rash has left some scars. No new products were used or consumed at this time. Doctor was totally confused and said it was some kind of contact dermatitis, prescribed oral antifungal, prescription steroid cream, and recommended Zyrtec.  Treatments bore limited efficacy, though the topical steroid helped with some of the itchiness. Nausea was not treated.
No just a very hurt arm at injection site and its swollen a little; No just a very hurt arm at injection site and its swollen a little; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (No just a very hurt arm at injection site and its swollen a little) and VACCINATION SITE SWELLING (No just a very hurt arm at injection site and its swollen a little) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (No just a very hurt arm at injection site and its swollen a little) and VACCINATION SITE SWELLING (No just a very hurt arm at injection site and its swollen a little). At the time of the report, VACCINATION SITE PAIN (No just a very hurt arm at injection site and its swollen a little) and VACCINATION SITE SWELLING (No just a very hurt arm at injection site and its swollen a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        .
Shoulder pain that started 3 weeks ago, hurts when I sleep and now my right fingers the bones are also hurting a little bit/ his shoulders on the joint are hurting; Shoulder pain that started 3 weeks ago, hurts when I sleep and now my right fingers the bones are also hurting a little bit/ He can barely move his arms and it hurts; Shoulder pain that started 3 weeks ago, hurts when I sleep and now my right fingers the bones are also hurting a little bit; Having a hard time moving his arms; This is a spontaneous report from a contactable consumer (patient, self-reported). A 73-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 19Apr2021, as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included atorvastatin (has been taking this for years and it was recommended by his doctor). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 29Mar2021, as a single dose for COVID-19 immunization and no reaction on previous exposure to drug. The patient stated he had bilateral shoulder pain/ shoulders on the joint were hurting that started 3 weeks ago, hurts when he sleep and now his right fingers the bones were also hurting a little bit and asked was this a normal side effect. He stated he just went to (withheld) hospital a month ago where he got his first shot and three weeks later got his second shot and now his elbows, not his elbows, his shoulders started hurting. He stated he had a hard time moving his arms. He tried to call his doctor and his doctor was retiring. He was moving on and trying to get another doctor at (withheld). He stated he was taking Advil (Exp: Aug2022) and aspirin when it comes on. It went away but it came back. He wanted to know what to do. His doctor was telling him to get another doctor at (withheld). He was rubbing some cream on it and it went away and came back. The name of the cream was Therageist. He could barely move his arms and it hurts. He stated everything else was fine on his body. It was not getting worse, but it was not going away either. He stated he needed to call to make an appointment for a new doctor as (withheld) but he thought he will go to (withheld) instead to get in their system and fill out the paperwork. He stated he wanted to tell them his story. He stated he really just wanted to know when this will go away, as he thought it would go away after and has not. The adverse events did not require a visit to emergency room or physician office. There was a product complaint. Outcome of the event arthralgia was not recovered and for all other events, it was unknown.
headache; Hands were cold; Nauseous; Swollen face; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution.  A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Eke199), via an unspecified route of administration, administered in right arm on 12Mar2021 as single dose for covid-19 immunization at the age of 61-years old.  Medical history included drug allergy to salidine from an unknown date and thyroid removal 2008/cancer from an unknown date. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 (Sofia 2) on an unspecified date with unknown results. The patient's concomitant medications included levothyroxine sodium (SYNTHROID), route of administration, start and stop date, were not reported for an unspecified indication taken within two weeks of vaccination.  The patient experienced headache, hands were cold, nauseous and swollen face on 12Mar2021, at 16:15.  The events were reported as after receiving the vaccine, headache for 2 days, swollen face 1 day; hands were cold for 2 days, and she was nauseous 3 days.  No treatment was received for the adverse events. The patient underwent lab tests and procedures which included negative nasal swab on 02Feb2021. The outcome of events were as follow: headache recovered on 13Mar2021, hands were cold recovered on 14Mar2021, nauseous recovered on 15Mar2021 and swollen face recovered on 13Mar2021.
pt recvd vax 29JUL93 & devel t104 which fluctuated, would not eat, had ulcer on rt upper lip; had in injected pharynx; 9AUG93 devel a macular rash on face & trunk; MD described rash a mild measles rash; lab eval revealed WBC 4100;
2/20/15: DTaP to left arm. 2/21/15: Injection site pink, with increase in intensity over the next several days. 2/25/15 (evening): ulcerated area noted, with large area of erythema some itching earlier in the day, with some soreness, and report of pain if asked directly. 2/26/15 (after 2 doses KEFLEX): healed approximately 3 mm healed ulcer, with 8x7cm zone of demarcation with surrounding small crusts and no redness, warmth, tenderness induration or fluctuance.
12/5 in afternoon started with pain in shoulder Rt and Rt neck could not. Pain and weakness were worse on 12/6. On 12/7 saw PCP and was given a injection for pain. Was sent for MRI of neck and was referred to Neurologist at the Hospital. Doctor reported case today to agency after EMG results and she made this diagnosis of immune mediated right brachial plexopathy. Patient has less pain but still significant weakness in Rt shoulder/arm.
On 12/18/22 I started having a stuffy head and headache, it progressed to congestion and coughing that hurt, runny nose I went in to see the doctor and I was prescribed steroids, Z-PAK and something to help with the cough. I still have a slight cough and a bit of a runny nose, but I am feeling better.
2 weeks after receiving the Zostavax vaccine I developed tinnitus and experiencing some loss of hearing in my right ear. Presently been treated with Prednisone and the Dr. Other brain MRI.
A big red patch on her upper arm, left arm, near the injection site; Very, very red and itchy; Felt very hot and warm to the touch; Like a skin reaction; Uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (A big red patch on her upper arm, left arm, near the injection site), PRURITUS (Very, very red and itchy), FEELING HOT (Felt very hot and warm to the touch), SKIN REACTION (Like a skin reaction) and DISCOMFORT (Uncomfortable) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.    Co-suspect product included non-company product cream for an unknown indication.    No medical history is provided and concomitant drugs are provided.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started cream (unknown route) at an unspecified dose. On an unknown date, the patient experienced ERYTHEMA (A big red patch on her upper arm, left arm, near the injection site), PRURITUS (Very, very red and itchy), FEELING HOT (Felt very hot and warm to the touch), SKIN REACTION (Like a skin reaction) and DISCOMFORT (Uncomfortable). At the time of the report, ERYTHEMA (A big red patch on her upper arm, left arm, near the injection site), PRURITUS (Very, very red and itchy), FEELING HOT (Felt very hot and warm to the touch), SKIN REACTION (Like a skin reaction) and DISCOMFORT (Uncomfortable) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Additional Information-NNI
12 hours after injection: tiredness/fatigue and severely sensitive nipples. I am 12 months postpartum and breastfeeding. 4 days after vaccine started menstration  (period) which was unexpected as I have not had a period the entire time I have been breastfeeding.
This spontaneous report as received from a nurse refers to a currently 51 year old female patient. There was none pertinent medical history and drug reactions or allergies. On 16-MAY-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J010396, expiration date: 16-FEB-2015, 1 single shot, subcutaneous for the prevention of pneumococcal disease (strength, dose and dose number were not reported). There were no concomitant medications. On an unknown date in 2014, after receiving PNEUMOVAX 23, the patient developed bicipital tendonitis. The patient sought medical attention. No treatment was given for the adverse event. No laboratory diagnostic studies were performed. The outcome of bicipital tendonitis was reported as recovering. The causality between PNEUNOMOVAX 23 and the bicipital tendonitis was not reported. Additional information has been requested.
Deep shoulder pain; sensation of shoulder being dislocated; radiating pain w/ tingling down through arm; muscle soreness in forearm & deltoid; weakness when lifting above shoulder level.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose, frequency, route of administration, lot# and expiry date unspecified) which were improperly stored. No concomitant medication was reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
First let me start with the fact that I did have the Covid-19 virus beginning the last week in September, 2020.  For three days before I had the usual symptoms, I had a very significant, itchy rash on both legs that sp   read to my torso and continued for at least a week.  I then developed a cough, loss of taste (actually everything I ate tasted horrible, I lost 12 pounds), fatigue, no temperature or chills.  Had a sight headache.  A few days before a knee replacement on November 23, 2020 I still tested positive for Covid 19. I had the 1st vaccine shot on March3, 2021.  My right arm was tender until March 8.  During the night after the vaccine I had a bad headache that lasted through most of the next day. I also had bad chills, fatigue, but most important to me is that I had both legs go numb until I was able to get up from bed and begin to walk. That scared me the most. Later that day I spoke to a nurse from wound care services that shared with me that one of her friends has a numb face after taking the 2nd shot; and another close friend of hers is in the hospital after the 2nd shot with 1/2 her body, right side is completely numb. So, I'm considering not taking the 2nd dose Please give me an opinion of your stuff, etc. of what my choices are.
Headache, Myalgia, Arthralgia, Fever, chills/fatigue Narrative:
4 hrs after injection began to notice redness and tenderness at injection site. 4/21/16 at 8:00 PM went to acute care with same complaints, noted to have diffuse swelling and redness to elbow and into left axilla, sent to ER for treatment, treated with IV fluids BENADRYL, prednisone and TORADOL with immediate improvement.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. Since on an unknown date in March 2015, the unspecified patients were vaccinated with improperly stored, oral, ROTATEQ (lot# K007246 and expiry date: 17-MAR-2016) (dose and frequency were not reported) for an unknown indication. No adverse effects were reported. No product quality complaint was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Progrerssively worsening systemic inflammatory response with severe all-over itching, exhaustion, inability to sleep, neurological shocks and twitches
12 hours after receiving vaccination -- chills, sweats, headache.  lasted for about 7-8 hours and resolved itself.  tylenol helped with headache.
HBP reported pregnant patient received GARDSIL 9.; No additional AE; This spontaneous report was received from office manager (also reported as healthcare business partner (HBP)), referring to a 9 weeks pregnant female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-SEP-2023, the pregnant patient was vaccinated with 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #W011266, expiration date: 05-SEP-2024, strength and route were unknown) for prophylaxis (Exposure during pregnancy). The last menstrual period (LMP) was estimated to be 25-JUL-2023 and the estimated date of delivery (EDD) was estimated to be 30-APR-2024 The pregnancy outcome was pending. The fetal outcome was unknown. The operator of the device was a nurse/healthcare professional. No additional adverse event (AE) or product quality Complaints (PQC).
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On unknown dates the patient was vaccinated with GARDASIL dose 1 and 2. Lot number, expiry date, route of administration and anatomical location were not reported for the doses. On an unknown date the patient received a 3rd dose of GARDASIL at 10 weeks an 2 day after the second dose. Route of administration, anatomical location, lot number and expiry date  were not reported. No adverse event was reported. Additional information has been requested.
Pt "fainted" few seconds approx 40-60min p/immun; mom noticed dec in resp; shook pt to arouse-no sz noted; pt aroused cried normally then fell asleep 2 hrs; fussy, crying as if ill 7PM-1030PM, ?fever, leg area red, swollen, painful;
pt recv vax & 2 days post vax pt devel a caudate infarction & was subsequently hospitalized for 6 days;pt was discharged & was doing well,& sx were resolving;addtl info is being sought
LEFT UPPER ARM BECAME RED, SWOLLEN AND HOT.  THE REDNESS WAS AN AREA ABOUT 6INCHES LONG BY 3 INCHES WIDE OVER THE BICEP AREA.   PATIENT APPLIED ICE FOR RELIEF FROM HEAT AND SWELLING.   REDNESS IS GONE.  TENDERNESS REMAINS.
Woke from nap Saturday afternoon not feeling well.; felt very cold.  Daughter insisted on taking temperature.  Ran fever with high of 101.4.  Tired and lower fever Sunday.  Woke during Sunday night with chills, completely soaked in sweat, returned to sleep but same thing happened about 2 hors hater-4:30AM.  Next morning felt good and temperature seemed to be normal.  Had an active day Monday but seemed unusually exhaused as retired Monday night.  Again awakened with chills and sweat twice during the night althougn not as bad as previous night.  Again on Tuesday daytime feel okay. Tem at 4PM 96.6.
8 days p/vax t104 & mild rash, fussy behavior-no intervention x/APAP
2 days later, itchy, red, hoyt to touch.  round, 21/2-3 inch diameter, omewhat puffy.
1330 got immunization at clinic; 1500 began to have arm and chest pain, back pain, headache. Exam noted tenderness and swelling. Examined in ED. Discharged 1900 from ED.
Day 2 after shot -> fever, chills, HA. Day 3 after shot - chest pain, SOB, (R) arm swelling, increased pulse.
Darkening of vision, loss of appetite, bad taste in mouth, weakness in arms and legs, unable to walk or write name, diminished hearing, loss 70 pounds.
Local reaction, fever 103F, edema and infiltrate. Pt has a case of salmonella about 1 month ago, redness on shot area, on R leg, had diarrhea was seen by doctor and given tylenol.
Metallic taste immediately after injection.  Loss of taste and smell 5 minutes after injection.
her daughter tested positive for covid; This is a spontaneous report from a non-contactable consumer (patient's mother). A female patient (daughter) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on Apr2021 as first dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller stated that she and her daughter got the first dose of the Pfizer covid 19 vaccine three weeks ago. Caller stated that three days after getting the shot, her daughter tested positive for covid on Apr2021. Caller stated she tested positive for covid also. Caller asked if they do not have symptoms were they able to get the second shot. Caller stated she has no symptoms and completed isolation. Caller stated she did not consider this an AE, stating that she just got exposed to a relative. The patient underwent lab tests and procedures which included covid test: positive on Apr2021. The outcome of event was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Information has been received from a physician concerning a female who on 09, Mar 2007 was vaccinated with a dose of ZOSTAVAX vaccine (Merck). Subsequently the patient's arm became swollen and red and blisters developed at the injection site. Medical attention was sought. The patient's outcome was not reported. The product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Follow up information has been received from a physician concerning a 60 year old house wife with no known history or allergies who on 08-MAR-2007 was vaccinated subcutaneously with a first dose of ZOSTAVAX vaccine (Merck) (lot # 656394/0162U). There was no illness at the time of vaccination. Subsequently on 09-MAR-2007, the patient developed a vsicular painful rasth at the site of injection and her arm became swollen and red. Medical attentionwas sough. Subswequently the patient recovered. No product complaint was involved. Additional information is not expected.