chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Master of Science in Dentistry and a Physician concerning herself, a 61 year old female patient with pre-osteoporosis and no know drug allergies, who on 09-JAN-2009 was vaccinated with a "single dose" of ZOSTER vaccine live (Oka/Merck) (lot # not provided).  Concomitant therapy included, vitamins (unspecified) and EVISTA.  On 24-JAN-2009 the patient developed a "shingles rash that is about 2 inches by 4 inches in the left hand side of the belly".  It was reported that the patient had received in November 2008 a shot of influenza virus vaccine (unspecified).  Patient sought medical attention by seeing her physician.  No lab diagnostic studies were performed.  At the time of this report the patient had not yet recovered.  Follow up information received on 29-JAN-2009.  Patient called back and reported that the "rash never developed into fluid-filled blisters but rather pimple-like".  The rash is improving and she is not experiencing severe pain or pruritis.  Follow up information was received from a physician who reported that the patient had a history of cholesterol and chickenpox when she was a child.  The patient had no recent exposure to chickenpox or herpes ZOSTER.  The patient was vaccinated with ZOSTER vaccine live (Oka/Merck) (Lot no. 663673/1710X) SC, 0.65 mL into the right arm.  The physician stated that the patient did not develop the event (shingles) at the site of the injection.  The patient had pain quantified as 0 in a 0-10 scale and did not present other systemic symptoms.  The patient recovered from the event.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  On 30-JAN-2009 the lesion sample was collected.  On 04-FEB-2009 the sample arrived to the laboratory and the DNA was amplified.  The PCR results confirmed that the VZV strain was related to a wild-type.  The specimen was adequate.  It is unknown the specific site where the sample was collected from.  A photo of the lesion was taken.  No further information is available.
RASH IN FOREARM AND EXTERMLYITCHY.  WHEN EXPOSED TO RUN THE IRRTATION INCREASE.
This spontaneous report was received from a physician refers to a 30 year old female patient. The patient pertinent medical history included asthma and allergic rhinitis. The patient had drug reaction or allergic history of BETADINE by using BETADINE, the patient developed a rash from topical use and patient had unspecified food allergies. On 10-JAN-2014 the patient was vaccinated with second dose of VARIVAX (merck) lot # J003709 (Expiry: 27-MAR-2015) (dose, route and frequency was not reported). On 05-FEB-2014, the patient experienced generalized hives, itching and swelling as well as generalized joint pain and chest pain. The patient sought medical attention and visited the physician office. The Physician thinks the patient might have serum sickness. The patient was treated with prednisone, hydroxyzine and ibuprofen. It was also reported that on 28-MAR-1985, the patient had received the first dose of VARIVAX (merck) (dose, route, lot number, expiry and frequency was not reported). The outcome of the events generalized hives, itching and swelling as well as generalized joint pain, chest pain and serum sickness was reported as not recovered. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Mild
Received 2nd dose of COVID vaccine on 3/23/21.  Pt with symptoms on 6/30/21 presenting to provider on 7/2/21.  Pt found to be COVID+  and received Regeneron on 7/2/21.
No adverse event; Instead of the adult dose, he got the pediatric dose. He received the Moderna COVID19 Vaccine for 6 months-11 years old, single dose vial, 0.25 ml.; Instead of the adult dose, he got the pediatric dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Instead of the adult dose, he got the pediatric dose. He received the Moderna COVID19 Vaccine for 6 months-11 years old, single dose vial, 0.25 ml.), INCORRECT DOSE ADMINISTERED (Instead of the adult dose, he got the pediatric dose) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU5509B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .25 milliliter. On 28-Sep-2023, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Instead of the adult dose, he got the pediatric dose. He received the Moderna COVID19 Vaccine for 6 months-11 years old, single dose vial, 0.25 ml.) and INCORRECT DOSE ADMINISTERED (Instead of the adult dose, he got the pediatric dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Instead of the adult dose, he got the pediatric dose. He received the Moderna COVID19 Vaccine for 6 months-11 years old, single dose vial, 0.25 ml.), INCORRECT DOSE ADMINISTERED (Instead of the adult dose, he got the pediatric dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Instead of the adult dose, he got the pediatric dose. He received the Moderna COVID19 Vaccine for 6 months-11 years old, single dose vial, 0.25 ml.) and INCORRECT DOSE ADMINISTERED (Instead of the adult dose, he got the pediatric dose).    Concomitant medication was not provided. Reporter stated that she had a customer that got a vaccination on morning of 28Sep2023. Instead of the adult dose, patient got the pediatric dose. He assumed he will need to be revaccinated in a couple of months. He received the Moderna COVID19 Vaccine for 6 months-11 years old, single dose vial, 0.25 ml. Treatment information was not reported.   Reporter did not allow further contact
7:30pm 1/20 - headache, body aches, fatigue, fever 6:15am 1/21 - temp 100.1, continued symptoms as 1/20 but more severe 11:45 1/21 - temp 100.9 7:45pm 1/21 - took ibuprofen 600mg  4.00am 1/22 - woke up drenched in sweat but aches improved 7:45am 1/22 - difficulty breathing, lungs ache with full inhalation - symptom still ongoing.  6:30pm 1/22 - neck and shoulder pain along with lung issue.
Face feels hot; Dizzy; Upset stomach; No appetite; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Face feels hot), DIZZINESS (Dizzy), ABDOMINAL DISCOMFORT (Upset stomach), DECREASED APPETITE (No appetite) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer and Breast cancer.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING HOT (Face feels hot), DIZZINESS (Dizzy), ABDOMINAL DISCOMFORT (Upset stomach), DECREASED APPETITE (No appetite) and HEADACHE (Headache). At the time of the report, FEELING HOT (Face feels hot), DIZZINESS (Dizzy), ABDOMINAL DISCOMFORT (Upset stomach), DECREASED APPETITE (No appetite) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment medication included Tylenol (paracetamol) and taking Tylenol was helping somewhat.
Have Hives on stomach and on hands; like three big bumps Hives; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 24Jun2021, as dose 1, single for COVID-19 immunization. The patient's concomitant medications and medical history were not reported. When probed for the concern, consumer stated that he/she received the first dose on 24Jun2021 and on an unknown date in 2021 (on 9th day) he/she had hives on stomach and on hands, consumer thought that hives were like mosquito bites, but they were not mosquito bite, they were like three big bumps hives. The consumer just wanted to know, which antibiotic cream should he/she put on. The second vaccination was due on 15Jul2021. The event outcome was unknown  Information about batch/lot number had been requested
This spontaneous report as received from a Registered Nurse refers to 2 patients of unknown demographics. The patient's medical history and current conditions are not reported. On 25-SEP-2014 the 2 patients were inadvertently administered improperly stored RECOMBIVAX HB injection (strength, dose and frequency not reported) (Lot # and expiry date not reported). No adverse effects reported. Product quality complaint was not involved. The outcome of the event was unknown. This is one of the several reports received from the same reporter and Linked to cases MARRS # (1410USA007243, 1410USA007242, 1410USA007240 and 1410USA000627). Additional information has been requested.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix on an unspecified date, and only experienced a sore arm. The reporter did not consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR241957, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR241957:same patient
Wrong dose of flu vaccine given to my son. The nurse administer the full adult dose 0.5 ml  instead of the pediatric 0.25 ml dose.
Body aches, joint aches, mild headache, no fever no rash, upper lip swollen with papules on upper lip, tired, shotty cervical nodes, no seizures, no neck pain.
Nauseous and feverish. Muscle aches and super tired with sore arm too
Pt had syncopal episode after vaccine. Patient instructed to lie recumbent, VS taken, given water and apple juice. VSS. Patient status improved, disposed home with mother.
Enlarged node, generalized achiness, fever, relief after aspirin, pain not worsening.
- loss of taste and smell *days 3-15 following vaccine - blurred vision in right eye & difficulty focusing - headache  - out of body / spacey sensation
chills; not feeling well; This is a spontaneous report from non-contactable nurse.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration and date at a SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported.  On an unknown date (the day after the vaccine), the patient had chills and not feeling well. Outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Arm Soreness, Sharp Headaches, Nausea and Vomiting, stuffy nose
Info has been received from a health professional concerning a male, "in grades 3-5", who was vaccinated with a dose of varicella virus vaccine live. "Recently", since November 2005, the pt experienced a chickenpox outbreak. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated at a healthcare facility/office with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2014, the patient was treated at the medical center/hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
think it was PHN / knew it was nerve related; could barely breath; pain was excruciating and similar in placement to the PHN diagram for people with shingles.; excruciating pain; This case was reported by a consumer and described the occurrence of post herpetic neuralgia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced post herpetic neuralgia, difficulty breathing, muscle spasm and pain. On an unknown date, the outcome of the post herpetic neuralgia, difficulty breathing and muscle spasm were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the post herpetic neuralgia, difficulty breathing, muscle spasm and pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient received Shingrix by the evening and experienced felt like a muscle spasm below the shoulder and wrapping around my upper waist. The pain was excruciating and similar in placement to the PHN diagram for people with shingles by the next morning. The patient stated it was so painful that patient wanted to go to the hospital. The patient stated that the pain tonight was less and at time of reporting quite manageable but for two days, patient could barely breath. The excruciating pain went away within 72 hours. The patient wanted to know if anyone else had the same response or reaction.
I woke up with sold symptoms on Monday. It was just a runny nose and headache. The next day I woke up with a bad cough, I was hacking and the cough was productive. I also had pain in my chest and my heart when I was coughing and it was making it hard to cough. I did a home test and was positive for COVID-19. I called my doctor and he got me on Paxlovid to treat me. I was able to recover but I was tired and had fatigue for a few weeks after recovering from COVID-19.
Facial rash, mildly itchy, slightly raised, scaly.  Gradually worsening since middle of  May, being treated by a dermatologist for psoriasiform dermatitis with a low dose steroid cream and now tacrolimus.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 3:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 3:34 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 64.51.  Concomitant products were not provided.  On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021..  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Vaccine underdose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Vaccine underdose) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Vaccine underdose) 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 assessment was provided for UNDERDOSE (Vaccine underdose).    Concomitant medication was not provided. 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Non-Significant follow up : Age group updated.
Chest pain developed 36 hrs after 2nd dose of Phizer vaccine. Elevated troponin to 2900. Admitted to hospital for Cards eval
Both doses were given at the same time in the same arm to the pt, she had no lymph nodes in the other arm, pharmacist meant to do accelerated vaccination schedule but missed the 6-8 week spacing notation--pt had extreme fatigue, soreness, just shouldn't have gone together so we are reporting.
Approximately one week post vax, pt experienced a severe case of chickenpox. Pt was then diagnosed one week later with pneumonia.
Tingling on left side  -  then 2 days later shingles rash appeared.
Large rash, warm to touch, covering entire upper left arm radiating out from site of vaccination.
Significant insomnia after Gardisil vaccine. Spoke with Dr. and advised to start melatonin to help correct disruption.
Moderna COVID-19 Vaccine EUA Red rash at injection site approximately 5 cm in diameter, increased soreness beginning day 7 or 8. Increasing through day 10 at the time of this report. Photographs available
Very tired and lethargic immediately after the shot but 104 fever presented first Wednesday afternoon. The high fever lasted 4 full days. Very lethargic. Very sore throat and headache and stomach ache still ongoing.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, injection (route, dose, lot number and exp. date not provided). Other suspect vaccine administered in the same day included an unspecified flu vaccine (manufacturer unknown), injection (route, dose, lot number and exp. date not provided). On an unspecified date the patient had developed Bell's palsy. The outcome of event was unknown. Additional information has been requested.
Redness traveled down arm Injection site sore and hard for 2 days. Pain that traveled to shoulder. Became sick for 2 days
Patient reports after his first (2 doses in series) dose of the Pfizer vaccine, fairly soon after he got an erection that as of yesterday was still present.  I advised him to go to the ER immediately.
Pain in arm, moving into shoulder, back and armpit, February 1, 2021,  till now.
severe headache, dizziness, nausea, light-headedness, fatigue, and muscle weakness lasting more than 10 days after injection.