chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning himself an 82 year old male with prostate cancer and that spread to bone and had had for 3 years and taking LUPRON which seemed to helping it and no drug reactions/allergies, who "3-4 years ago" (in approximately 2007) was vaccinated subcutaneously with the "full dose" of ZOSTAVAX (Merck) (LOT# not reported). Concomitant therapy included ZOCOR. There was no lab diagnostics studies performed. The patient received ZOSTAVAX (Merck) injection and in the last 6 months (In approximately 2007) had had 4 or 5 episodes of having tender, itchy rashes in certain spots. It was noted that in the past, the physician was able to self treat with ZOVIRAX cream or FAMVIR that would clear the rashes. Physician remembered one time about one year ago (in approximately August 2009), he had gotten a patch of rash and used ZOVIRAX ointment which took care of it. Currently, the physician had 3 spots (spots were patches of rash) on the one side of the body and couple of spots on the other side of his body. Physician just started FAMVIR. At this time of reporting, the patient was not recovered. Additional information has been requested.
Neighbors are getting sick after having the shot and tested positive with the virus; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Neighbors are getting sick after having the shot and tested positive with the virus) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Neighbors are getting sick after having the shot and tested positive with the virus). At the time of the report, ILLNESS (Neighbors are getting sick after having the shot and tested positive with the virus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No treatment medications were provided.
Sister in law died w/i 24 hrs of her first Moderna; This spontaneous case was reported by a non-health professional and describes the occurrence of DEATH (Sister in law died w/i 24 hrs of her first Moderna) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  This fatal spontaneous case concerns an unknown-year-old female patient with no medical history reported who experienced the unexpected seriousness criteria death event unknown days after the 1st. dose of the mRNA-1273. No further details were provided regarding the events. The reported cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This fatal spontaneous case concerns an unknown-year-old female patient with no medical history reported who experienced the unexpected seriousness criteria death event unknown days after the 1st. dose of the mRNA-1273. No further details were provided regarding the events. The reported cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Sister in law died w/i 24 hrs of her first Moderna
Initial report received on 07/Dec/2005 from a health care professional. A 40 year old female with no significant medical history, had received an intra-muscular injection of Fluzone SV '2005-'2006 USP, lot number U1775AA, in the right deltoid and an intra-dermal injection of TUBERSOL 5 TU, lot number C2079AA, in the right arm on 07/Dec/2005. Fifteen minutes later, the patient had a large red area at the injection site (side was not identified), difficulty breathing, chest tightness and weakness in her legs. She was transferred in a wheel chair to the nurse office and was given oxygen. An electrocardiogram was done and she was transferred to the hospital. It is unknown if the patient recovered from these events at the time of this report.
Serious Rashes that are getting worse; Welts; Does not sleep well; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Serious Rashes that are getting worse), URTICARIA (Welts) and INSOMNIA (Does not sleep well) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M02A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-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 RASH (Serious Rashes that are getting worse), URTICARIA (Welts) and INSOMNIA (Does not sleep well).   At the time of the report, RASH (Serious Rashes that are getting worse), URTICARIA (Welts) and INSOMNIA (Does not sleep well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On November 1, 2022, I woke up with a sore throat and cold symptoms. I couldn't test until the 5th. I tested positive COVID-19. I continued to test positive for another 5 days. I had mild cold symptoms, nasal congestion, cough and mild body aches until November 19th. On November 24th, after my son and wife were diagnosed with the flu, I had extreme headache and fever of 103. I had severe body aches. I also had chills and a non-productive cough. Those symptoms lasted through November 28th. I still have a lingering cough since November 24th.
Sore throat scalp sweating, chills, chest and sinus congestion, sneezing, cough, headaches, aches (flu shot seemed to damage my immune system).
Father completed form for daughter, and indicated (12 years old).  Before administering the shot, I verified with daughter her age, which she confirmed was 12 years old.  I discovered that she may be under 12 years old when I tried to process the vaccine through where her profile indicated she was born in 2010 and insurance stated she was underage.  I called father and left a message to call back to verify date of birth.  Father called back and said it was his mistake but "doesn't remember date of birth or age" since he was 4 kids and "doesn't see them much."  I asked the father why the daughter confirmed she was 12 years old, and he didn't have anything to say and kept repeating that he made a mistake.  I informed him that since she was under 12 years old daughter  cannot receive 2nd dose until authorized to do so.
Felt tired; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date:31-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that patient felt tired after the first one but not sick now waiting for the second one. The follow-up could not be possible as no contact details were available.
Patient was given the MMR vaccine at the age of 3 months without authorization from any doctor and without any concern from the nurse administering the shot. Hives have been prevalent since the shot, which may have also been from the PCV shot which was given 4 days earlier. No obvious other signs have been apparent.
Chills; terrible migraine; achey entire body; couldn't sleep; arm tender; clenched jaw for several hours; lack of energy; couldn't relax; no appetite; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0151), via an unspecified route of administration in the left arm on 09Apr2021 at 10:00 (at the age of 34 years old) as single dose for COVID-19 immunisation. The patient had no reported medical history. Concomitant medications included prenatal & OTC allergy meds from an unknown date and for unknown indication. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6208), via an unspecified route of administration in the left arm on 19MAr2021 at 11:15 as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had not been tested for COVID-19. On 09Apr2021 at 21:00, patient experienced chills, terrible migraine, ache entire body, couldn't sleep, arm tender, clenched jaw for several hours couldn't relax, lack of energy and no appetite. The patient did not receive any treatment for the reported events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event chills, terrible migraine, ache entire body, couldn't sleep, arm tender, clenched jaw for several hours couldn't relax, lack of energy and no appetite were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt recvd vax;40 days later exp minor rash on face & neck;sister had pos strep test on 30aug95
Pain with injection all the way down my arm into my fingers. Arm felt very heavy. Sharp pain in left chest area Lightheaded  Tired
On March 25th I got my Johnson and Johnson vaccine.  Since I got the vaccine, I've been getting headaches, dizziness, nausea and hot flashes on my face.   On April 8th, I saw my primary. He believes it's related to my perimenopause changes. I also went to the ER had blood work and an MRI. No explanation of the results just that everything was ok.  My concern are the headaches. It feels  like pressure in my head. I never had these types of headaches prior to taking the vaccine.
This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL 9, intramuscularly (strength, site of administration, lot # and expiry date were not reported). On an unknown date, the patient experienced a strange feeling, like being out of it after the vaccination which lasted approximately 48 hours. The outcome of the event was reported by the physician as recovered. It was also reported that therapy was not discontinued and the event did not reappear after reintroduction. The relatedness between the event of the strange feeling, like being out of it and therapy with GARDASIL 9 was not provided. Additional information has been requested.
Local swelling, redness, pain, warmth (around injection site). Treated at approx 24 hrs post with ice and Tylenol. Reaction began about 2 hrs after injection. MD gave medrol cortico pack. Arm returned to normal over several days.
Area was itchy, red, developed rash then blisters. Went to Dr's office who prescribed BACTRIM DS to prevent further infection. On 3/8/14 patient came to pharmacy. Area looked clear.
Patient's left arm became achy and a rash appeared the evening of vaccination.  She experienced extreme fatigue, nausea, and muscle weakness in the left arm the same evening, lasting into the following day.  Symptoms decreased and were resolve by the 3rd day post vaccination.  Patient did not seek tx from a health care provider.
A few hours after injection, I noticed pain in my right arm at injection site with redness. Also a bit of nausea, and chills. I also experienced headache and congestion.  The following day I had a very strong headache and very strong pain at injection site as well as swollen lymph nodes. On the third day I still have headache and pain in my arms as well as a swollen lymph nodes
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from an other care health professional. This case involves a 6 months old female patient who was vaccinated with a 0.5 ml dose of PENTACEL via unknown route in the left thigh on 05-Oct-2018. It was reported that, Vial: Lot# C5427BA, Exp date: 13-Oct-19 NDC 49281-560-05. Lypholized powder: Lot# C5573AA Exp date: 13-Oct-19 NDC 49281-545-15. Box: Lot# C5573AA, exp date: 13-Oct-19. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN); PREVNAR 13 and ROTATEQ for Immunization. The patient's medical history was not reported. It was an actual medication error due to inappropriate reconstitution technique. (gave Pentacel liquid vial (DTaP and IPV) but did not give the ActHib lypholized powder vial to a 6 months old female.) No information reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Within minutes of receiving my first dose injection, my mouth and tongue began to itch and my tongue began to swell.  I also had a headache and felt nauseous.  Over time, I also had some difficulty breathing
Patient was give an expired dose of vaccine. No symptoms reported.  Patient was called back to get active dose less than 12 hours later.  Again, NO symptoms reported from either vaccine administration.  Second shot was given in opposite arm.
Dose administered was less than recommended volume. Patient received less than half of dose in left deltoid.  Dose was repeated in right deltoid arm immediately. Patient was monitored and displayed no immediate adverse effects.
Swelling under armpit of injection arm 12 hours later lasting 5 days, aches, chills and cold sweat 24 hours after injection lasting 1 day, fatigue and weakness lasting 5 days starting 24 hours after injection, itchy skin all over and rashes under both armits and inner thighs on both sides appearing after 5 days of injection so far for two weeks and worsening.
12 hours after shots, his right leg was painful. He had chills, shaking and tremors. he was unable to walk due to pain in r. leg.   Sat 6/5 thru Wed 6/9 No fever, no rash, no vomiting, no diarrhea -Give Tylenol/ibuprofen, ice it, ace wrap, rest #18  Patient was nervous and struggling with mom and staff.         Staff held patients legs while injections were given.         Legs were tense.
ITCHING ALL OVER; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced itching all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itching all over was not reported. This report was non-serious.
granuloma annulare on hands; Bump at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 at 12:00 as dose 3 (booster), single (Lot number: Ff2593) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PTSD" (unspecified if ongoing); "liver and gallbladder disease" (unspecified if ongoing); "liver and gallbladder disease" (unspecified if ongoing). Concomitant medication(s) included: BUSPAR; WELLBUTRIN; XANAX. Past drug history included: Flagyl, reaction(s): "Known allergies: Sensitivity to flagyl"; Cipro, reaction(s): "Known allergies: Cipro". Vaccination history included: BNT162b2 (Dose 2, Single, Batch/Lot No: En8727, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 06Apr2021, when the patient was 50-year-old, for Covid-19 immunization; BNT162b2 (Dose 1, Single, Batch/Lot No: En6205, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 19Mar2021, when the patient was 50-year-old, for Covid-19 immunization. The following information was reported: GRANULOMA ANNULARE (hospitalization), outcome "recovered with sequelae", described as "granuloma annulare on hands"; VACCINATION SITE MASS (hospitalization), outcome "recovered with sequelae", described as "Bump at injection site". The events "granuloma annulare on hands" and "bump at injection site" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of granuloma annulare, vaccination site mass.  Clinical course: No other vaccine in four weeks.
Patient was dizzy and nauseous.  She felt heaviness in her head.  Her vitals WNL.  She had not yet eaten and was given Coke and a snack.  Patient's symptoms resolved within 15 minutes.
Vaccine not working as intended; COVID-19; This is a spontaneous report from a non-contactable consumer or other non hcp. A 74-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Mar2021(age at vaccination: 74-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that vaccine not working as intended on an unspecified date. The outcome of the events was unknown.  No further information was reported.   No follow-up attempts are possible. No further information is expected.
Patient's email report, 10 days after vaccinations:  "First of all, the pharmacist used me for dart practice instead of an injection. I had blood running down my arm from the flu shot (she must have hit a vein?). Still bruised. Secondly, I have had incredible pain in my joints (now easing up). I think the worst pain was in my joint replacements of metal. It seems every other day, I nap for 2 hours after sleeping 10 or 11 hours each night. My energy level has been really low. I've literally been stumbling a bit with my left foot, but better today. My left thumb has been numb for 3 days after tingling and numbness in hands sporadically."  She wrote again on 10/19/20: "I just want to connect to let you know I am still having symptoms following the 2 vaccines. Today, I researched the effects of receiving the flu vaccine and Gulliane-Barre is listed. It completely describes how I am feeling with my odd gait, weakness, and numbness in my left thumb and forefinger. On my morning walk with a friend, I mentioned my gait, and the weakness. She had noticed my foot dragging off and on. It finally caused me to research and the information said it can last several weeks or even months.  I also told last week that I felt like I had an autoimmune situation going on.  It all makes sense. It is very frustrating, but empowering to know that it won't last forever. You would think I have had a stroke to watch me walk. Yet, I knew the traveling pains in different joints over this 3 and a half week period had been an issue from the injections"
High blood pressure of 149/72 when pressure was 107/77 three weeks prior; Rash on chest area
macular papular rash over entire body with the exception of the soles of the feet and the palms of the hand. Severe itching.
Pt developed large swollen area on lateral aspect of left thigh on 6/20/01. The swelling was soft peripherally but firm centrally. On 6/22/01 pt had cellulitis of left thigh.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-JAN-2017, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 27-JAN-2017, the patient was treated by a physician at a hospital for stroke. The patient was diagnosed with shingles and or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered.  Causality assessment was related. Upon internal review, stroke was determined to be a medically significant event. Additional information has been requested.
Suddenly at about 4:50 pm on Saturday night I got very cold, my whole body ached, including my head. My temperature was 100.5. I took 3) 200 mg ibuprofen and went to bed. I slept for 11 hours. I felt better on Sunday. I did not have a fever on Sunday. I did have flashes of headaches and nausea though.
This spontaneous report was received from a medical assistant refers to patient of unknown age and gender. On 23-JUL-2014, the patient were vaccinated with GARDASIL (0.5 ml, lot#J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.