chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Re: Moderna Covid-19 Vaccine EUA   I was extremely fatigued within 30 minutes of the injection for 48 hours, then ok, terrible pain at injection site the second day, the next day it was fine. No other side effects.
Information has been received from a nurse practitioner concerning her 18 year old daughter with drug reactions/allergies and medical history reported as unspecified who in approximately 2007 was vaccinated with second dose of Gardasil (yeast) (lot # not reported) 0.5 ml intramuscularly. Concomitant medication was unspecified. In approximately 2007, after the second dose of Gardasil (yeast), the patient experienced dizziness, and stomach upset. They were flu-like symptoms. The patient sought medical attention. At the time of reporting, the patient had recovered. No additional information was available at the time of reporting. Additional has been requested.  This is in follow-up to report (s) previously submitted on 2/14/2007. Information has been received from a nurse practitioner (NP) concerning her 18 year old daughter with drug reactions/allergies and medical history reported as unspecified who on 24-OCT-2006 was vaccinated with first dose of GARDASIL vaccine (lot # not reported) 0.5 ml intramuscularly in the deltoid. Concomitant medications was unspecified. On 24-OCT-2006, the patient experienced body aches and nausea. The outcome of the events was not reported. In approximately 2006, the patient received second dose of GARDASIL vaccine (lot # not reported 0.5 ml IM. Subsequently, the patient experienced dizziness, and stomach upset. They were flu-like symptoms. The patient sought medical attention. At the time of reporting, the patient had recovered. No additional information was available at the time of reporting. No other information is expected.
My heart started racing (not irractic, just rapid). It kept me awake most of the nightand continued until almost noon the following day (4/28/2021).
pt recvd vax & devel redness, a wheal, swelling of the arm of inject;
Initial information received on 11-Dec-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves a 30 years old female patient who experienced neuropathy on her arm, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine, lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious neuropathy on her arm (neuropathy peripheral) 2 weeks following the administration of Influenza Quadrivalent Recombinant Vaccine. This event was assessed as medically significant. (Other relevant tests included no lab data.) Final diagnosis was neuropathy on her arm. It was not reported if the patient received a corrective treatment. The patient outcome was unknown for neuropathy on her arm. List of documents held by sender: none. Sender's Comments: This case concerns a 30 years old female patient who developed neuropathy on her arm 2 weeks after vaccination with FLUBLOK QIV. The time to onset is compatible. However, there is no information regarding patient's past medical history, medical condition at time of vaccination and lab tests ruling out alternate etiologies, particularly nutritional and neurologic. Based upon the reported information, the role of the vaccine cannot be assessed.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 16-FEB-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (lot # L030587, expiration date 10-FEB-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Dose administered to patient after improper storage and handling; Vaccine thawed then freezed then thawed then gven to the patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Vaccine thawed then freezed then thawed then gven to the patient) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS since 02-Aug-2021 and Post-traumatic stress disorder since 21-Jul-2021. Concomitant products included VENLAFAXINE from 14-Jul-2021 to an unknown date and OLANZAPINE (ZYPREXA) from 21-Jul-2021 to an unknown date for Mental disorder.    On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Vaccine thawed then freezed then thawed then gven to the patient). On 26-Aug-2021, PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Vaccine thawed then freezed then thawed then gven to the patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD21-136361 (E2B Linked Report). This case was linked to MOD-2021-299985 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Patient details updated. Patient's relevant history updated. Vaccine information and vaccination facility information included. Concomitant medications included. New event- Expired vaccine used added.; Sender's Comments:  MOD21-136361:
This is to report significant side effects from the series of 2 Japanese encephalitis travel vaccinations I received. Shot 1 February 5 - about three days later woke up with severe vertigo (couldn't stand or walk unsupported), nausea, malaise. BP normal. Rested/slept all morning, vomited, OK by noon. Next day normal. Shot 2 March 4 (recommended 28 day interval) - next morning woke up with slight vertigo lasting 1 hour. Second day woke up with worse vertigo, nausea, malaise. Rested/slept all morning, OK by afternoon. Third day normal. I did not connect the first reaction with the shot because it was delayed by days and I am used to shots with no issues. I guessed I had food poisoning! The second shot & reaction changed that.
Hospitilization, weakness, malaise, body aches, fatigue, diarrhea, unknown onset of symptoms
Injection site is swollen, red, and hurts to the touch. 9:00am 2/06/2021. Headache and nausea 4:00pm 2/06/2021.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L015415, expiration date: 01-AUG-2016. No adverse effect was reported. Administered dose of vaccine experienced the temperature excursion of -9.7 degrees Celsius for 45 minutes. Data logger was involved. There was previous excursion -11.9 degrees Celsius for 30 minutes. Additional information has been requested.
Shooting pain from shoulder to fingers on both arms/Shooting pain from shoulder to fingers on both arms; Extreme pain 12/10.; Arms got hotter than rest of body; Hives; This is a spontaneous report from a contactable other health professional(patient). A 32-year-old non-pregnant female patient received first dose of BNT162B2(PFIZER BIONTECH COVID19 vaccine, Solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration, administered in Arm Left on 24Mar2021 10:00 (At the age of 32-year-old) as single dose for COVID-19 immunisation. Medical history included food allergy, hypersensitivity to drywall, mok orange, allergy to arthropod bite, iodine allergy,allergy to animal, allergy to arthropod sting, seasonal allergy from an unknown date. Concomitant medications included clarithromycin (MACROBID) taken for an unspecified indication, start and stop date were not reported.The patient didn ot received any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 03:00 the patient experienced shooting pain from shoulder to fingers on both arms/shooting pain from shoulder to fingers on both arms, extreme pain 12/10, arms got hotter than rest of body and hives on 29Mar2021 20:00. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from the authors of the article, and refers to a 63 year old female patient who was seen for a rash on the left arm that had been present for 6 weeks. At the time of presentation, she reported no pain or pruritus. The patient reported an initial development of extremely pruritic red bumps from her left shoulder to her hand, which appeared 2 weeks after receiving an intramuscular hepatitis B vaccination (manufacturer unknown) in the left deltoid (date of vaccination unspecified). Her past medical history was unremarkable. The patient was not taking any medications at the time the rash developed. She was receiving the hepatitis B immunization series owing to negative hepatitis B core and surface antibodies. On physical exam, she had violaceous papules and both hyperpigmented and hypopigmented macules along Blaschko lines. The lesions started on the left lateral shoulder and continued down the medial forearm to the dorsal hand. A punch biopsy was performed on a violaceous papule on the distal forearm for hematoxylin and eosin (H&E) staining. Histologically, the H&E-stained sections were notable for lymphocytic infiltrate and pigment incontinence in the upper dermis and in a perieccrine distribution, consistent with the diagnosis of lichen striatus (LS). Given her lack of symptoms at the time of presentation, treatment was deferred. The authors stated that the patient was administered the second hepatitis B vaccine (manufacturer unknown) in the right deltoid without similar findings. Three months after initial onset, all lesions had resolved with only residual hyperpigmentation remaining. The authors considered LS to be related to hepatitis B vaccine (manufacturer unknown).
Pain started in my upper and lower abdomen for the first  three days. The following days the pain grew to an excruciating stabbing pain radiating throughout my stomach to my lower abdomen. The excruciating and debilitating pain has left me without the ability to walk or maintain my home.
Patient states on 10/17/14 he felt cold, freezing, and achy. Had a fever of 101.7. No appetite. Same symptoms on 10/18/2014. Went to emergency room on 10/19/14. Was admitted and given IV fluids and antibiotics. He states he was not given a diagnosis. Was discharged on 10/21/14.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (violently sick), INJECTION SITE MASS (golfball sized lump on her arm at the injection site) and HYPERSENSITIVITY (allergic reaction) 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 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 MALAISE (violently sick), INJECTION SITE MASS (golfball sized lump on her arm at the injection site) and HYPERSENSITIVITY (allergic reaction). At the time of the report, MALAISE (violently sick), INJECTION SITE MASS (golfball sized lump on her arm at the injection site) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medicines were not reported
Flu-like symptoms for 24 hours after vaccination; swollen lips, numbness; red puffy eyes
Patient develops nausea, vomiting, fever, muscle aches, and a swollen and red shoulder and arm several days after AVA and SPV vaccinations. Joint pain isolated start 02/06/2007 pain in left shoulder inability to lift the left arm for several. Erythema start 02/06/2007 end 02/10/2007 patient reported redness over the entire left shoulder and down to the middle left bicep as well as into the axilla and the upper outer left pectoral. Fever start 02/06/2007 end 02/09/2007 initially as high as 101F but has been declining since her last ED visit. Nausea w/vomiting start 02/07/2007 end 02/10/2007 the vomiting was recurrent and caused the patient to present to the emergency department on 2/7 and 2/9/2007. Tenderness start 02/06/2007 noted in the left axilla. The pain was previously more intense but has declined over the weekend. Tachycardia started 02/07/2007 end 02/09/2007 patient reported a racing and pounding heartbeat after several episodes vomiting. Resolved since ED treatment with IV fluids on 2/9/07.
massive arm pain, massive shivering, massive muscle aches and weakness. took acetaminophen and ibuprofin. on 3rd day, still weak and aching  but far less severe than previous days.
On November1, 2022 I was feeling a little fatigued and tested positive for COVID-19.  I had a bit of congestion and scratchy throat.  I became more fatigued the following day.  I developed a fever. I spoke with my doctor on November 2nd and was prescribed Molmueriavir.  Within 24 hours I was feeling better.  I tested negative on November 7th and I thought my symptoms were gone.  However, in December, about the 13th, I suddenly had heart palpitations.  I spoke to my doctor and wore a heart monitor for a while, and they found nothing.
Shingles on penis.  Appears to be minor (two bright red bumps with a bit of swelling under skin); This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 06May2021 at 11:30 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. On 11May2021 at 11:00, the patient experienced shingles on penis (two bright red bumps with a bit of swelling under skin). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event shingles on penis (two bright red bumps with a bit of swelling under skin) was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
When I first received the shot I felt dizzy after the 15 minutes I waited after it was injected. When I left the urgent care my arm was sore which I was told was common. When I got home I noticed my arm was starting to itch. I took off the bandaid and noticed that around the injection site my skin started turning red, and was about the size of a dime. Later that evening I started sweating profusely, I took my temperature, and it was at 101.6. I started taking Advil to help with the flu like symptoms I was having. I noticed my arm was itching so much at this point I also could not touch it with out physically holding my breath. When I woke up the next day and went to work I could barely lift my arm to a 90 degree angle or bare weight on it. I still had a constant fever and the itch on my arm started to spread up my shoulder. Later that evening I checked my injecting site in the mirror and noticed that the size of the red patch had grown from a dime to a three inch diameter across the center of the patch. At this point I had been taking benedryl to try to stop the itching as well as using hydrocortisone ream with no help. By Saturday the itching was uncontrollable all the way to my fingers and down the left side of my back. On Saturday two new  symptoms started to develop.  My throat felt swollen and has physically hurt to swallow anything. I checked my throat for any sign of spots or sores, it was bright red and looked inflamed. My right ear was the other symptom that developed, all noises seem to make my ear  worse. The rash has not gone away and neither have the other symptoms.
Pt. states that after receiving the 2nd dose of Moderna 01/27/2021, started experiencing symptoms that evening of heart palpations, fatigue, flu-like symptoms, chest heaviness, high heart rate (lasting 2 months). Heart monitor recommendation, 04/2021 Covid = Positive, 02/2021 developed rash in facial area (extremely dry patches with pain), subsided 09/2021. Primary visit confirmation of Shingles 2 months after 2nd dose 01/27/2021.
Localized rash spreading to neck and chest. BPs 150/101 (pulse 110), 137/89 (pulse 87). Benadryl 25 mg PO given.
Dizziness, Weakness, Shaky, Excessive sweating, Low heart rate and low blood pressure,
Shaking chills, fever to 101, muscle aches, joint pain, headache. Symptoms started 12:30 AM and lasted till 11:00 PM. Fever responded to Acetaminophen 1000 mg.
This case was reported by a nurse via call center representative and described the occurrence of fever in a 19-year-old female patient who received BEXSERO (batch number 16B101, expiry date 28th February 2019). On 11th August 2017 11:30, the patient received the 2nd dose of BEXSERO. On 11th August 2017 16:00, 4 hrs 30 min after receiving BEXSERO, the patient experienced fever, feelings of weakness, headache, lower extremities weakness of, heaviness in limbs, felt faint, fatigue and feeling unwell. The patient was treated with MOTRIN. On an unknown date, the outcome of the fever, feelings of weakness, headache, lower extremities weakness of, heaviness in limbs, felt faint, fatigue and feeling unwell were not recovered/not resolved. It was unknown if the reporter considered the fever, feelings of weakness, headache, lower extremities weakness of, heaviness in limbs, felt fatigue and feeling unwell to be related to BEXSERO. Additional details were provided as follows: Around 4 pm, the patient did not feel well described as, developed a fever of 101 degrees, her legs felt heavy and weak along with fatigue, an extreme headache, felt weak, and even felt faint while driving. The patient returned the office to be seen and was given MOTRIN as treatment. The healthcare professional did not believe the symptoms were disabling, or life threatening.
Within 20 minutes of receiving vaccine patient reported dizziness, lip tingling, metallic taste in mouth, swelling to eyes, and difficulty swallowing. Patient was assessed by provider at 1500. She received oxygen 2 L via nasal cannula, Epinephrine 0.3 mg IM, followed by diphenhydramine 25 mg IM for allergic reaction. EMS was called and patient transported to Hospital Emergency room at 1530
Excursion took place 15Dec2022 through 27Dec2022; No adverse event; First time excursion started on 15-Dec-2022. HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15-Dec-2022. HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, 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 19-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15-Dec-2022. HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15-Dec-2022. HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022) 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 POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15-Dec-2022. HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022).    No concomitant medications were reported.   It was reported that, excursion took place on 15-Dec-2022 through 27-Dec-2022 and maximum temperature reached was 46.5F. Excursion cumulative duration was 19.3 hours. First time excursion started on 15-Dec-2022. HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022 and then following that the vaccines were marked to not use. HCP informed that no reports of side effects had been reported to them.  No treatment details were reported.