chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle pain in back; fever; chills; red blotches; diarrhea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotches), DIARRHOEA (diarrhea), VOMITING (vomiting), MYALGIA (muscle pain in back) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced RASH MACULAR (red blotches), DIARRHOEA (diarrhea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills). On 23-Feb-2021, the patient experienced MYALGIA (muscle pain in back). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 25-Feb-2021, MYALGIA (muscle pain in back) had resolved. At the time of the report, RASH MACULAR (red blotches), DIARRHOEA (diarrhea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.   This case was linked to MOD-2021-024801 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of convulsions in a 10-year-old male patient who received Tdap vaccine. On an unknown date, the patient received Tdap vaccine. On an unknown date, an unknown time after receiving Tdap vaccine, the patient experienced convulsions (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the convulsions was unknown. It was unknown if the reporter considered the convulsions to be related to Tdap vaccine. Additional details were provided as follows: The reporter stated that, on an unknown date, a male patient received one dose of a vaccine indicated for Tetanus and experienced convulsions, for which he was hospitalized. As treatment the patient was placed in a cold water bath. The reporter was unsure if the suspect vaccine was BOOSTRIX, if the vaccine was a Tdap vaccine or if it was a Tetanus vaccine. All other information was unavailable, as the reported events occurred when the patient was 10 years old and was unknown to the reporter.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 24-Jan-2021, PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking Diabetes medication.   This case was linked to MOD-2021-297898 (Patient Link).
fever; headache; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL#246) second dose, via an unspecified route of administration on 08Jan2021 12:00 at single dose at right arm for COVID-19 immunisation. Medical history was none. No known allergies. Historical vaccine included bnt162b2 first dose on 18Dec2020 18:00 at single dose on left arm for COVID-19 immunisation. Concomitant medication included ascorbic acid (VITAMIN C).  The patient experienced tiredness started on 08Jan2021 at 15:00, headache on 09Jan2021 at 14:00, fever on 09Jan2021 at 20:00. Patient received treatment ibuprofen for the events. Outcome of the events was resolving.
PERSISTENT HEADACHE PAIN; AUDIBLY DISTRESSED; This spontaneous report received from a patient concerned a female 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 was not reported, administered on 12-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient experienced audibly distressed. On 18-AUG-2021, the patient experienced persistent headache pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent headache pain, and the outcome of audibly distressed was not reported. This report was non-serious.
Irregular menstrual cycle and blood clots. Menstrual cycle has been irregular, lasted longer than ever before in life or absent
Muscle pain, shivering, headache and sinus pain during night of 12/3/21 and early morning of 12/4/21, plus nausea at 9 pm on 12/3/21. Took one 325 mg acetaminophen tablet at 7:30 am on 12/4/21, and it eliminated all negative side effects within 10 minutes.
Tdap shot was given in right arm, flu shot in left which resolved in 6 days.  The Tdap shot caused greater swelling in lymph nodes under arm, but severe redness kept getting worse, not better, esp. after 4-5 days (hot to touch). Area was swollen, the day I went in to urgent care at the nurse's recommendation it was more swollen and I could see the redness moving down my arm (like an armband around both sides) so went in. The urgent care Rx gave me an antibiotic due to cellulitis at the shot site. After 2 days of antibiotics it is resolving.  The red swollen area was 8"x6"x3". My arm bothered me the last 2 days with itching and felt "heavy".
No additional adverse effect reported; a female patient received improperly stored VAQTA; Expiration date: 25-MAY-2019; This spontaneous report was received from a medical assistant referring to a 18 month old female patient. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On 04-NOV-2019, the patient received an improperly stored hepatitis a vaccine, inactivated (VAQTA)25/0.5 (units not reported) (Lot No. S009562 has been verified to be a valid lot number for hepatitis a vaccine, inactivated, expiration date reported as 26-JUL-2020, but upon internal validation established as 25-MAY-2019) (expired product administered) for prophylaxis (dose, dose number, route of administration and anatomical injection site were not reported).     It was reported that on an unknown date, the vaccine was exposed to a temperature excursion above 47 Fahrenheit (F) degrees (52.09 F degrees) for 1.39 hours. There was a previous temperature excursion above 47 F degrees (64.83 F degrees) for 13.35 hours. The call was placed because of a Digital Data logger report. No adverse effects were reported.
body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches) and PYREXIA (fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches) and PYREXIA (fever). At the time of the report, PAIN (body aches) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous report was received from a male patient of unknown age, who was also a pharmacist and refers to himself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided). Other suspect therapies included sterile diluent (manufacturer unknown). On an unknown date, the patient experienced 2 inch diameter (or little less) of hive or welt around the injection site. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not provided. Additional information is not expected as there was no consent for contact with the physician.
Myalgia, Arthralgia, Fever, NauseaVomiting, pain Narrative:
Cramping; Spotting; Not supposed to start period for another week; This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Sep2021 at 10:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included human immunodeficiency virus syndrome (HIV). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included emtricitabine, tenofovir disoproxil fumarate, rilpivirine hydrochloride (COMPLERA) for an unknown indication from an unknown date and unknown if ongoing. On 12Sep2021 at 09:00, the patient was not supposed to start period for another week, however she had uncomfortable cramping and spotting which were still ongoing two days after. The patient never had these symptoms before. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events cramping, spotting and not supposed to start period for another week were not resolved at the time of this report.
Patient received a sub-optimal COVID-19 vaccine due to a storage and handling error. Vaccine was stored in a regular freezer prior to being refrigerated and then administered. The Maine CDC requested that a VAERS form be submitted for this patient.
Vaccines received at 1:15PM. Felt slightly feverish and worn out at bedtime. Woke up next morning  to a fever of 102.4 - and achy, exhausted, and stiff, presenting with headache, slight productive cough, and mild congestion. Lymph nodes under armpit (on arm that was injected) so inflamed that cannot raise arm above head without sending shooting pains down side and into breast. Proceeded to treat fever with a lukewarm bath as needed, and alternating tylenol and advil along keeping hydrated. All day, fever never went away or below 100. The following night, it went up to 103. Same symptoms, treated same way. The next day, at 6pm, temp dipped below 100 for the first time ever, and began to feel a little hopeful. The next morning, however, nausea and vomiting set it. Fever has remained low grade, but nausea, headache, body aches, congestion, coughing, and exhaustion as well as excruciatingly painful lymph nodes remain.
The company told me to get the vaccine, and on the 17th (Friday), I will be vaccinated with #Pfizer. Within an hour after that, my neck, shoulders, and arms started to hurt, and at night (during work) I sometimes felt pain in my heart. Before going to bed at night, I suddenly had a headache, abdominal pain, nausea, and dizziness, and even rushed to the bathroom and fainted. Dyspnea continues in the toilet and faints I have had shoulder and arm pain, heart pain, and chest pain.  I don't have a insurance, so that I couldn't go hospital.
Headache, vomiting, fever (101.2), chills, sleepiness, achiness, fatigue; symptoms mostly gone after 36 hours
more symptoms with booster dose than first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (more symptoms with booster dose than first dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (more symptoms with booster dose than first dose). At the time of the report, VACCINATION COMPLICATION (more symptoms with booster dose than first dose) outcome was unknown.            Concomitant medications was not provided by the reporter Treatment information was not provided   This case was linked to MOD-2021-373949 (Patient Link).
Got the shot, got shingles / Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot, got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-APR-2023 This case was reported by a patient via interactive digital media. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This is a spontaneous report from a contactable physician (a pediatrician). A 26-year-old female patient received the first dose of TRUMENBA (Lot R56655, Expiration date Jan2019), via an unspecified route of administration on 02Jun2017 at 0.5 ml, single for immunisation. Medical history was none. There were no concomitant medications. No other vaccines were administered on the same day. The patient experienced 103 degree fever after vaccination. The outcome was recovered on unspecified date. The second dose of meningococcal group b rlp2086 was not yet given.
This case was received from a health care professional on 28 July 2009. A 70-year-old female patient, with a history of Bell's Palsy one year ago, received an intramuscular left deltoid injection of DECAVAC (lot number U2346AA) on 07 May 2009. According to the reporter, who was the patient's daughter, the patient had received many previous doses. In July 2009, approximately two months post-vaccination, the patient complained that both arms became painful and difficult to lift. The patient had been seen by her physician; no additional information was available. Follow-up information received on 17 August 2009 from a health care professional, who is the patient's daughter. The patient had no concurrent illnesses at the time of vaccination on 07 May 2009; however she was taking "Anatriptaline" and multiple unknown herbal medications/vitamins at the time. Specific laboratory tests performed were unknown; however the patient had an x-ray of the shoulder, EMG and MRI of the neck (results not reported) and was diagnosed with PMR (polymyalgia rheumatica). The patient was treated with Prednisone. At the time of this report, the patient had not recovered and stated her "muscles are better, but joints still hurt." Contact information for treating physician was provided. Per this new information, this case meets seriousness criteria and is upgraded to serious.
I could hardly stand up I lost my balance and fell, I took blood pressure and it was 80/40. Once I took my blood pressure I called my doctor to let him know I had fallen. I had an emergency appointment for the following day where he ordered blood work. He took me off of all of my blood pressure related medications. I am now back to walking a mile and doing my normal daily activities.
GOT THE VACCINE AFTER IT HAD BEEN EXPIRED FOR 2 HOURS; This spontaneous report received from a health care professional concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced got the vaccine after it had been expired for 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got the vaccine after it had been expired for 2 hours was not reported. This report was non-serious.
I have small fiber neuropathy; I have other symptoms; it hurt really bad and I told him to take it out of my arm and he did, but I believe he hit a nerve or something in my arm; Pain in the ears; Headache; Pain you know the fire in my feet and my legs; Heart beats fast; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 51-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration and administered in left arm on 05Apr2021 (at the age of 51-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient took the Pfizer vaccine (COVID Vaccine) on 05Apr2021 and she went to the emergency room not long after that and then she went to ask a doctor not long after that and just went to a neurologist. She told that she had small fiber neuropathy (on an unspecified date in Apr2021) and called the Pharmacist at pharmacy where she had the vaccine and told them what had happened. When the man gave her the vaccine it hurt really bad (on an unspecified date in Apr2021). The patient told him to take it out of her arm and he did, but she believed he hit a nerve or something in her arm, pain in the ears, headache, pain you know the fire in her feet and legs, heart beats fast, shot in her left arm, it hurt really bad (on an unspecified date in Apr2021). The patient stated the patient did not take the second vaccine because of this problem. She did not have any of these problems until and after she took the vaccine, whole day 'without any side' effects. The patient was  taking medication, Gabapentin (treatment). She had to go back in two weeks. She did not know why all this was happening. The patient was fine until she took the vaccine. The patient underwent lab tests and procedures which included she took 5 or 6 vials of blood when reporter was there on Thursday, not sure what all she was testing with unknown result. Was in the hospital (further clarification unknown) in April they did do a CBC, Differential Metabolic Panel, Urinalysis, Drug screen, EKG, Chest x-ray. They did all sort of stuff. When reporter went to the (voice not clear) doctor they did an ultrasound on her legs and said that her veins were okay and then the neurologist said that the nerves (incomplete sentence). Therapeutic measures were taken as a result of events with gabapentin take 100 mg three times a day for a week and then (voice not clear) it up to more than that for the second week and more than that for the third week (further not clarified). The outcome of events was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021744526 similar report from same reporter
I go the vaccine A couple days later I had redness on my arm that went away 5 days later, a week later my arm  rash was more severe and hot to the touch, from shoulder down to my elbow, I contacted the Dr which thought it was a sterile abcess and prescribed ibuprofen and went away after another week
I felt exhausted after a couple hours of injection and needed an hour long nap. By the evening I was achy, feverish, and felt pin pricking sensations all over my body. I was unable to sleep that first night. The second day (Thursday 8/19/21) I was bed bound and had little appetite. Symptoms resembled similarities to flu. The next day Friday I awoke and felt remarkably better. Within a week I was short of breath and unable to exercise to my normal capacity. My heart fluttered as soon as I would meet any resistance with exercise. I have forced myself to walk everyday but do not have the same stamina due to exhaustion and labored breathing  and fluttering heart. I can feel my heart working harder than normal. Symptoms have not seized to exist even though it has been several weeks since the onset. I have met with my primary care doctor and she has referred me to a cardiologist. My appointment is 10/18/21.
Patient filled out consent form indicating that he was looking for a second dose of Moderna Covid vaccine. On processing forms at a later time it was found that his initial vaccination had been with Pfizer Covid-19 vaccine
Strong burning on administration. Red, swollen area size of a silver dollar. Severe aching of arm, somewhat relieved with ibuprofen. Slight fever and nausea.
Developed pink lump 4" below injection site from flu shot 24 hours after vaccination, by 36 hours there was a line growing from the first lump. At 48 hours, I had hives and the lump spread down my arm following the vasculatory system. There were 3 distinct splotchy areas with lines connecting them. All were large and red and growing and very warm to the touch. These were on the arm that had the flu shot. There was no evidence of an issue on the arm with the shingles shot. Both did have minor redness where the bandages had been placed but that is standard for me. The red rash/splotches and hives were an unusual/unexpected reaction. Benadryl had not slowed the progression. The pharmacist showed me both vials before the injections. They were current and not expired. Not expecting a reaction, I didn't make note of the dates.