chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Loss of taste; Headache; Feeling tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), FATIGUE (Feeling tired) and AGEUSIA (Loss of taste) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Feeling tired). On 18-Mar-2021, the patient experienced AGEUSIA (Loss of taste). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), FATIGUE (Feeling tired) and AGEUSIA (Loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Fever and headache are consistent with the known safety profile of the vaccine.
My 2 does were 1 year apart.; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 1 year apart from the 2nd dose ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. The patient asked did this provide immunity.
Extreme cramping and heavier than normal bleeding during periods. Not being able to function due to pain much worse than normal. Almost like labor pain.
On 4/11/2021 I noticed on my vaccine site it was hot to the touch. hard, it was swollen it was like a golf ball size lump. I had a telehealth appointment and they told me to take Zyrtec but it has not resolved.
she woke up with the flu; This is a spontaneous report from a non-contactable consumer. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient informed that she was supposed to receive the 2nd dose of the Pfizer-BioNTech Covid-19 vaccine. However, she woke up with the flu. The patient wanted to know if she is allowed to receive the 2nd dose even if she has the flu. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Axillary lymph node swelling (left arm), painful lymph nodes, some numbness in left elbow and fingers of left hand.
Pt. started having unexplained chest pains, shortness of breath, and abdominal issues 3 days after the first dose of the vaccine. They got so bad that he was taken to the ER twice, one of those times was after we had to call 911 because we were very concerned he was having a heart attack
Developed dermatographia. Physical hives that itch when  the skin is rubbed or scratched. The scratch line will become puffy and red and will go away after a few minutes if not touched or scratched further.  Symptoms are finally subsiding after about 2 months.
About 12 hours after receiving the vaccine I had a fever, and chills. My fever was 101.5-102. I took Tylenol to reduce my fever and it didn't help much.  My symptoms last for about 36-48 hours. After that I felt fine.
Patient presented to my office for a routine visit (as her family doctor) the very next day after she started noticing symptoms. First it started with some numbness of her tongue on the left and accompanying decrease in taste. The next morning (day of my appointment with her) she woke up with left side facial drooping involving the entire left face. I diagnosed her with Bell's Palsy today and discussed the case with a neurologist at the academic center nearby and started treatment of prednisone  for 7 days. Also instructed other conservative measures such as eye wetting drops and eye patch.
Case number PHEH2013US023964 is an initial spontaneous report received from a pharmacist on 12 NOV 2013. This report refers to a 6-months-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number: boy vomited 2-3 times after the flu shot was administered) intramuscularly on 12 NOV 2013. It was reported that he vomited two to three times after the flu shot was administered. The outcome of the event was unknown. No further information was provided.
Pt recv vax on 12/9/98; on 12/19/98 pt exp hives; tx=Benadryl
Injection site swelling and pain. Unable to move or lift left arm without pain. Unable to sleep on left side. Tenderness to left arm.
I95.9 HYPOTENSION 1/19/2023 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 1/19/2023 ATRIAL FIBRILLATION, PAROXYSMAL I95.9 HYPOTENSION 1/19/2023 ATRIAL FIBRILLATION, PAROXYSMAL I95.9 HYPOTENSION 1/19/2023 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 1/19/2023 FEVER I95.9 HYPOTENSION 1/19/2023 FEVER
DL got "hot" after HPV vaccine injection; dizzy Did not Lose consciousness "Always feels this way when blood drawn"
Patient received a flu shot at around 11:15 AM and called pharmacy at 12:00 PM stating that he was having an itchy feeling all over and swelling of face. I advised him to take Benadryl as soon as possible and get to urgent care to be evaluated. No difficulty breathing or mouth swelling at the time of speaking to him
Information has been received from a physician concerning a 15 year old female patient, with a history of rhinitis and sinusitis and no drug reactions or allergies reported, who on 01-APR-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot #: 665300/1314Y, Exp: 08-may-2011), 0.5 ml, intramuscularly. There were no concomitant medications reported. The physician reported that on 02-APR-2011, after receiving PNEUMOVAX 23, the patient was admitted to the hospital. She had fever and localized swelling. The patient was given antibiotics in the hospital as treatment for the event. Blood cultures and spinal tap were performed (Results not provided). Physician would like a lot check for this product. A lot check has been initiated. At the time of the report, the patient's outcome was recovering. This is one of several reports from the same source. Additional information has been requested.
Case number PHEH2012US022172 is an initial spontaneous report received from a physician on 06 Nov 2012: This report refers to multiple patients. They were vaccinated with MENVEO (batch number: unknown) intramuscularly on undetermined dates in Jul 2012 and Aug 2012. The un-reconstituted vaccine had reached 31 to 32 degree Fahrenheit temperature multiple times in Jul 2012 and Aug 2012. The vaccine was not frozen. No adverse event was reported.
Hep A dose #2 due 10/29/21.  Given 6/8/21 in error.  No immediate adverse effects noted.
Patient had previously received the Pfizer COVID vaccine for doses #1 and #2. The patient requested to receive the Pfizer COVID vaccine for her booster dose today as well (dose #3). The pharmacist administered a booster dose (0.25 ML) of Moderna to the patient, thinking the patient wanted Moderna (not Pfizer) for her booster dose. No adverse events or symptoms developed during the observation period and unaware of any that have developed since. The patient's primary care doctor was contacted and informed of the situation.
SLEEP APNEA 11/22/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Bruising (quarter size); Missed menstrual period 7 days late (ongoing); This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 09Apr2021 at 09:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021, the patient experienced bruising (quarter size) for 7 days. The patient missed her menstrual period which was 7 days late and was ongoing. The patient reported that she rarely if ever was late and had been regular the entire duration of the pandemic, neither any dietary changes nor any lifestyle changes that can be attributed to irregularity. 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 bruising (quarter size)  was resolved on 23Apr2021 with the duration of 7 days; while that of the event menstrual period which was 7 days late was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sore arm (started on 2nd day and continued for 2 days after), mild fatigue (started after 1 day, continued for 5 days), nausea (mild 2 times), explosive diarrhea (started 2 days after and still having) taking antidiarreal medicine that is helping somewhat but not totally.
Painful rash beginning on the hands and outside of feet B.  Traveling up arms to elbow, up legs and onto belly as it progresses.  Ongoing issue.  No fever, no enlarged glands, no soar throat
Significant increase in Tinnitus - bilateral - higher in left ear no perceived hearing loss. Always had tinnitus previously but not to this extent.  Also had Tinnitus after the first 3 pfizer Covid-19 vaccine does.  It subsided a week or two later in all cases.
- Arm pain (sharp and severe with movement in upper arm, constant and aching down through fingers), worsened on days 2-3 and then taped off on 4th day after shot - Chest pain/discomfort (worse when lying down flat or on right side), worst on 2nd day, present on 3rd day, mostly gone by 4th day - Low grade fever - Fatigue - Headache - Nausea
A dime-sized knot developed under injection site immediately upon needle withdrawal, extending to the left within 5 minutes, knot had dissipated to small pinpoint.
Sore arm after Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047T21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Sore arm after Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided. for mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessment.    This case was linked to MOD-2021-261602 (Patient Link).
Patient left the clinic after receiving the Moderna booster but returned about 5-8 minutes later stating that she feels "weird". She stated that she felt "hot and dizzy with wobbly legs". Patient was assessed and vitals are as follows: 138/88, 78bpm, 98.8 temp 98% O2 on RA, and 20rr. all vitals were per the patient. patient was given fluids and allowed to rest a little longer. patient was advised to remove the 2 coats she was wearing to allow her body to cool. before leaving patient stated that she felt back to normal and would like to go home. patient's BP was assessed while standing to assess for orthostatic hypotension, which was negative. Patient was escorted to her car by this writer and accompanied by her husband who was the driver. patient was able to walk to the car without further incidence.
THE PATIENT STATED SHE WAS FEELING SHARP PAIN AROUND THE INJECTION SITE AND SHE COULDN'T MOVE HER ARM OF INJECTION.
Irregular heart beat. Heavy heart beat. Headache. Shortness of breath. Knee pain.
Narrative: 75 yo with ADENOCARCINOMA LUNG treated outside facility died in hospice care (outside facility) on 11/24/2021. Pt had received covid vaccines on 2/23/2021 & 3/23/2021. This death was caused by lung cancer, not related to covid vaccines.
My tongue became immediatley swollen , i had bad sensations going through-out my body. I felt very ill and tired after the first shot. I became very irratble. The symptons went away after about 3 days. Once i got the second shot i went down hill. I have been very tired, stressed, having suicidal thoughts, mental health breakdowns, face burning, and terrible sensitations throughout my body. My mental health has been affect severely.
The pt complained of left arm being limp, unable to use without increased pain. He had swelling in his left hand. He came to the clinic and was seen on 11/28/01. Ordered Benadryl  3tsp q 4-6 hours. Return to clinic if unresolved. Pt didn't return for visit or return phone calls to him.
Red round rash on arm near injection site.  Pronounced itchiness and some soreness.
Nausea and Vomiting, muscle aches, and mid-grade fever at time of onset and continuing through submission of VAERS report.  Only treatment is pain/fever reducer/NSAID.
Pt awoke with 9/10 bilateral thigh pain that made ambulation difficult. Over the course of day 0, he became more fatigued, and developed bilateral forearm pain, finger joint pain, nausea, decreased appetite. Difficulty sleeping that night d/t pain and some perceived fever, though no temp taken. Seen the next morning at sick call by the author - patient afebrile, mild tachycardia. Significant bilateral quadriceps pain on palpation, with 4/5 strength d/t pain. Remainder of neuro exam normal. Lab w/u pending. Pt given 2 days off work, NSAIDS for systemic reaction to rabies vaccine.
reaction to the booster and big swelling on their right arm; swelling on their neck; face is hurting; jaw is hurting; headache.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (reaction to the booster and big swelling on their right arm), SWELLING (swelling on their neck), FACIAL PAIN (face is hurting), PAIN IN JAW (jaw is hurting) and HEADACHE (headache.) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (reaction to the booster and big swelling on their right arm), SWELLING (swelling on their neck), FACIAL PAIN (face is hurting), PAIN IN JAW (jaw is hurting) and HEADACHE (headache.). At the time of the report, VACCINATION SITE SWELLING (reaction to the booster and big swelling on their right arm), SWELLING (swelling on their neck), FACIAL PAIN (face is hurting), PAIN IN JAW (jaw is hurting) and HEADACHE (headache.) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
Sudden loss of energy during afternoon walk about 1.5 hrs. after shot - was walking only about 10-15 when occured Tired in evening 2:30 am - feeling washed out, stomach pains, nausea, very slight headache, sore arm, redness at shot site Feeling fatigued right now: 12:30 pm 09/28/2021 Not much of an appetite Otherwise improving
Period began a week earlier than usual and thus far as been very heavy with additional clotting. So far I am on day 3 of this period and had to change my cup 4 times throughout the night where I usually only need to change it once or twice. As I am very anemic this is concerning.
Numbness and tingling in feet and legs. Walking becoming challenging. Speech requires greater focus. Hands are becoming less nimble. I had guillon barré syndrome October 2010 and recovered. Symptoms are reoccurring.
Patient started coughing immediately after getting injection, hives to face, scratching arms. LVN notified MD, gave BENADRYL and EPI, observed for 2 hours. Patient slept for 1-1/2 hrs. Discharged by MD.
First vaccine no issues.  Second Vaccine, low grade fever, body aches, chills, light headache.  About 48 hours Third Vaccine, ( after about 5-6 hours and for the next almost 48 hours ) Significant headache ( I thought I was going to have a stroke ), more significant body aches, uncontrollable chills, numbness left arm, my chest/upper body from shoulder to shoulder was tight.  These kind of reactions are not normal for me after taking medications/vaccines etc. Prior to Vaccine 1 & 2 I had no history COVIS 19 however, between dose two and three I was diagnosed with and experienced symptoms of COVID but any symptoms were still less than what I experienced with the 3rd vaccine.
She came down with a virus on August 30, 2021 (27 days after Pfizer dose #1) which presented with fever, congestion, fatigue, sore throat and swollen glands through September 3rd. September 4-5 she seemed to be better, but then developed severe Urticaria on her feet, legs, torso and hands on September 6, 2021. Her feet, fingers and hands swelled and her fever returned. She developed dizziness and  shortness of breath so I took her to the ED on September 7, 2021. They sent us home with instructions for Benadryl, Ibuprofen and Oatmeal Baths which we'd already been doing, but this did nothing and she got progressively worse. She was unable to walk, eat or sleep. I took her back to the ED on September 8, 2021. This time they gave her prednisone and a stronger antihistamine and she was finally able to sleep. She was on a 6 day course of prednisone and her immune system finally calmed down and cleared the Urticaria, swelling and fever. We were told that it was a response to the virus she had, but she has never had anything like this happen before. The only variable was the Pfizer vaccine less than a month prior. Her immune system acted very differently and couldn't clear the histamines. She has never been that sick.
had a relapse was sick for weeks; took the flu shot got the flu; Initial information regarding this unsolicited valid non-serious media case was received from a consumer (patient) and transmitted to Sanofi on 17-Dec-2020.  This case involved a patient with unknown demographics who got the flu (influenza), had a relapse was sick (illness), while the patient received the flu shot (INFLUENZA VACCINE).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), had a relapse was sick (illness), unknown latency following the administration of INFLUENZA VACCINE.   Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Pt. was given expired PREVNAR 13 vaccine. Pt will be revaccinated with appro dose in December 2015.
patient received both doses of COVID-19 vaccines and tested positive for COVID-19; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EH9899/expiration date: unknown), via unknown route of administration, on 22Dec2020 13:00 PM (at the age of 43 years old) as a single dose on right arm and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284/expiration date: unknown), via unknown route of administration, on 11Jan2021 09:30 AM (at the age of 43 years old) as a single dose on left arm, for COVID-19 immunisation at a hospital. Relevant medical history included exposure to COVID-19 on 15Jan2021 because her oldest son tested COVID positive on Tuesday with a rapid COVID test and she had dinner with her son on Friday (15Jan2021). Historical vaccine included flu shot in Oct2020. Relevant concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received both doses of COVID-19 vaccines and tested positive for COVID-19 via COVID PCR test on 20Jan2021. The patient reported that she was asymptomatic and was at home quarantining. The patient would like inquire for information on volunteering in any post-vaccination research trials as she would be a candidate for it. Laboratory test included COVID PCR (polymerase chain reaction) test on 20Jan2021 with positive result. The outcome of the events "patient received both doses of COVID-19 vaccines and tested positive for COVID-19 via COVID PCR test" was unknown. It was also reported that the sample of product was not available to be returned.
Small amount of swelling at injection site, headache, severe body aches, body weakness, nausea, fever, chills, injection site tenderness, and fatigue. All symptoms started the night of 4/29. It has lasted up until 5/01 afternoon with the use of tylenol. Currently 24 weeks pregnant, due august 23rd.
About 2 week after the vaccine I developed soreness, redness and swelling in my lower legs with peticia and edema associated as well.  I reached out to my PCP who order various bloodwork and refered me to a dermatologist who confirmed it could be an immune response to the vaccine and prescribed compression sock and a topical steroid cream and after about almost 2 weeks all symptoms subsided.
Pt had received Tdap, Varivax #2, HPV #1, Hep A #1.  That night, Varivax site became red and pruritic.  Also had shortness of breath she thought might be her asthma.  SOB resolved without treatment.  Came to clinic on 10/8/10, varicella site now 6.5x4cm tumor, pruritic and red.
Narrative: Error only. No ADR. Pt received 3 doses if Pfizer vaccine. 2 were received at Clinic (02/19, 03/20) and 1 at another facility (05/04)
Hives, rash, lethargy. Onset less than 4 hours after injection. Hives and rash on arms, chest, back, and neck.
Covid ' arm"  injection site swelling, redness, tenderness about 3 inches wide by 3 inches long.
09/09/21 - encephalopathy (admitted to hospital and d/c on 9/10) 09/10/21 - rigors, chills, fever, altered mental status (admitted) 09/12/21 - hypoxic respiratory failure (received Lasix) and bicytopenia noted, systolic CHF with exacerbation due to IV fluids (IV Lasix given)
Chills, Fever (103 degrees), body aches, exhaustion, intense headache