chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hard of hearing; joint pain in his left leg (knee); This is a spontaneous report from a contactable consumer (the patient). A 98-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number was not provided), via an unspecified route of administration on 16Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated he got his first COVID vaccine on 16Jan2021, and 3 days later (19Jan2021), he developed joint pain in his left leg (knee).  He has put an arthritis ointment on it and a heating pad, and it felt a little better. The patient asked if this was normal and should he see his doctor. He stated he was hard of hearing (unspecified date). The clinical outcome of joint pain in his left leg (knee) was recovering. The clinical outcome of hard of hearing was unknown.  Information on the lot/batch number has been requested.
tongue swelling starting 7 am 2/14 requiring epinephrine and steroids
At home, when I was cooking dinner I had arm pain. The next day I started feeling chills, and the symptoms progressed to body aches, fatigue and loss of smell and taste.  No fever. Had cough.
1st shot no symptoms, 2nd shot Glaxo Smith Cline Shingrix 50 mcg, NCD:58160-0823-11, 9 weeks later adverse symptoms: 2.5" x 5" red swelling at site of injection for 5+ days, severe shaking/chills starting ~12 hr after shot lasting ~18 hr, headache, muscle aches 3 days.  Stayed in bed 3 days, low grade fever. weak after 3 days.  Nausea starting as ~12 hr-~30+ hr  Symptoms are beginning to repeat on 1/30/22. COVID-19 negative test.
Left arm swollen, red, warm to touch at injection site. Checked by MD, can administer Benadryl, Tylenol, watch signs/symptoms of infection.
tiredness(like previous 2 shots); soreness in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Jan2021 12:00 (Lot number: EI3248) as dose 1, single and intramuscular, administered in arm left, administration date 20Feb2021 12:00 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Celiac disease", start date: 1949 (ongoing), notes: On gluten free diet for many years; "GERD" (ongoing), notes: Had 2 endoscopies to dilate esophagus(past year); "Antiphospholipid syndrome" (ongoing), notes: Aspirin (Excedrine everyday 1/2-1 tablet), in my 40s; "SIBOS" (ongoing), notes: Onset date: discovered about 10 years ago; "DVT", start date: 29Sep2021 (ongoing); "prevent migraine and arrythmia" (unspecified if ongoing); "arrhythmia" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "prevent headache antiphospholipid syndrome" (unspecified if ongoing). Family history included: "Heart disease" (unspecified if ongoing). Concomitant medication(s) included: INDERAL taken for migraine, arrhythmia (ongoing); EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE] taken for headache, antiphospholipid syndrome (ongoing); TUMS 500 CALCIUM taken for gastrooesophageal reflux disease (ongoing). The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tiredness(like previous 2 shots)"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was not received any prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Patient present to clinic for an appointment, he did not think he had received any covid-19 vaccines. Vaccines were reconciled in his chart this morning and showed no covid vaccines received either. upon completion of vaccine patient mentioned he did have on done before. It was then found that the patients name was spelt different in the State Immunization System then in local chart. Patient in fact did receive three monovalent Pfizer Vaccines.
On 2/22/03, 26 days after vaccination, I was doing some hard physical labor and I felt faint and tired. I took my pulse - it was irregularly irregular and I suspected atrial fibrillation. EKG confirmed this diagnosis. I converted to RSR in ER over 3-4 hours after receiving IV diltiazem and Digoxin that slowed my heart rate. Troponin was negative. I have excellent lipid profile, don't smoke and no family hx of cardiac disease. I have had no recurrence of AF and take atenolol and other meds for hypertension. Atenolol was started after my incident of atrial fibrillation.
Possible adverse event started on 09/14/22 at about 2:30 am. When stood up had severe stabbing pain unilaterally on back right side of head.  Standing, tilting, or turning the head caused the sharp stabbing pain. Also head pain when yawning. Acetaminophen did not relieve the pain. Head pain on 09/15/22 was mild. Pain on 09/16/22 was moderate to severe again and went to primary care provider for evaluation on 09/16/22. Primary care provider stated there were no alarm symptoms and to continue watching. Head pain on 09/17 was mild, but now unilaterally on the left side instead. Minimal to no head pain on 09/17 and 09/18. Moderate head pain today, unilaterally on left side middle. Head pain unrelieved by naproxen. Current outcome is still dealing with this possible adverse event.
From 4/15/2021 to current have numbness on left side of face from bottom of eye going down neck. Both sides of lips are numb on top and bottom.
pediatric patient received adult dose of Havrix; pediatric patient received adult dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 13-year-old male patient who received HAV (Havrix 1440 adult) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 31-OCT-2023, the patient received the 1st dose of Havrix 1440 adult. On 31-OCT-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: pediatric patient received adult dose of Havrix) and adult product administered to child (Verbatim: pediatric patient received adult dose of Havrix). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-NOV-2023 It was reported that male pediatric patient received adult dose of Havrix which led to overdose and adult product administered to child. The reporter consented to follow up. This case is linked to US2023152355, same reporter.; Sender's Comments:  US-GSK-US2023152355:Same reporter
Information has been received from a 66 year old female patient who on 09-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot number 667915/1111Z). On 09-FEB-2011 the patient experienced swelling, sores and welts on her arm after receiving a PNEUMOVAX 23 injection. The patient sought unspecified medical attention. It was unspecified if any treatment was given for the adverse events or if any lab diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. Follow up information was received which indicated that the patient was not hospitalized but was treated just back and forth to the doctor 2 or 3 times. Additional information has been requested.
COVID TEST POSITIVE; This spontaneous report received from a patient concerned a 30 year old male. 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: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced covid test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000195707.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Day 1 (started about 5 minutes post-inoculation) lightheadedness (Short-lived, about 5')  Day 1 (A few hours later): lightheadedness headache Low energy Arm pain & Hand pain (same arm as where inoculation took place)  Day 2: headache not persistent Low energy Arm pain  (same arm as where inoculation took place)  Day 3: headache not persistent generally tired Upper Arm pain  (same arm as where inoculation took place)
SOMNOLENCE; NOT FEELING RIGHT; HEADACHE; WEAKNESS; This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced somnolence, not feeling right, headache, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, somnolence, weakness and not feeling right was not reported. This report was non-serious.
My son was not sick at all. No cold, runny nose or any other sign of sickness. Just a little cranky.  Put him down for a nap at 2:00 PM and he had no fever. Woke him at 4:15 PM and he had a 104 fever. Gave him Infant Motrin at 4:30 and at 5:15 he had a seizure that lasted 2 minutes.  Took him to the hospital and his fever had gone up to 104.5.  They gave him a higher dose of Tylenol and brought the fever down.  He then spiked a fever again in the middle of the night to 104.2. That day he was asleep and had no fever and then within a couple minutes he developed another fever of 102.8 and was having spasms while he was sleeping.  I woke him gave him Tylenol and then the fever went down. The Dr. advised to continue giving him Tylenol and Motrin alternating every three hours.  He woke up today, (2/9/2010) with a 101 fever.
Patient reported feeling extremely fatigued and nauseated.  Described flu-like symptoms and body aches.
Contracted Covid 19, recovered 9 days later. Symptoms started day after injection, tested positive for Covid 4 days later.
Symptoms are not unusual, but THE DURATION IS VERY UNUSUAL. Starting from 4-6 hours after the vaccine and still persist THREE WEEKS later!  Lightheadedness/dizziness, mild nausea, some intermittent jitteriness , periodic extreme fatigue. This has been going on every day for THREE WEEKS. Symptoms have faded some, but still persist. Will delay or cancel second shot.  If these effects are permanent, then I will have great difficulty doing my job.
No adverse symptoms reported.; A nurse states that on 12/17/2019 a patient was administered an expired dose of VAQTA; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 17-DEC-2019, the patient was administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R032910, expiration date of 18-NOV-2019 (route of administration and frequency were not reported).  No adverse symptoms were reported.
CLIENT RECEIVED PEDIATRIC PFIZER FORMULATION OF 0.2ML AT 12YO. CLIENT SHOULD'VE RECEIVED PFIZER GRAY-CAP FORMULATION OF 0.3ML.
I had inability to balance properly, leg cramps, significant exasperation in peripheral neuropathy, and severe pain in my lower extremities. I had urinary problems as well and the symptoms similar to transfer myelitis. So, I contacted my PCP on 12/14/2021 for proper diagnosis and they haven't been able to successfully diagnose me either, so I was referred to a neurologist who I will be seeing this Thursday, 12/31/2021 to properly diagnose me. My PCP conducted an MRI on me and forwarded my results to my neurologist.
he fainted at school for no apparent reason; This case was reported by a consumer and described the occurrence of fainting in a 10-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th October 2022, 1 days after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced fainting (serious criteria GSK medically significant and clinically significant/intervention required). On 14th December 2022, the outcome of the fainting was recovered/resolved.   It was unknown if the reporter considered the fainting to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's comments: The reporter was patient's parent. The reporter had stated that the patient had received flu vaccine from GSK (influenza, injectable quadrivalent pf, Flulaval 6 months or elder). The following day, he had fainted at school for no apparent reason. He had never fainted before or since. Because of the fainting event, he was taken to see the physician, which had resulted in medical bills, for which the reporter would like to receive a reimbursement from GlaxoSmithKline (GSK).  The reporter had consented to follow-up. Additional supportive information: This case was linked with US2023AMR009365 which was reported by same reporter. The dose description was mentioned as 1 vaccination. The outcome was captured as recovered/resolved conservatively as the event end date was provided and AI was raised to confirm the same.; Sender's Comments:  US-GSK-US2023AMR009365:same reporter - reporter case
Pt recv vax on 11/24/98; on 12/4/98 pt exp sore throat, runny nose, fever &chills, dizzy, weak, nasal congestion; tx=allergy tablets
vomiting; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), NAUSEA (nausea) and VOMITING (vomiting) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (nausea). On 07-Mar-2021, the patient experienced VOMITING (vomiting). On 07-Mar-2021, VOMITING (vomiting) had resolved. On 09-Mar-2021, DIZZINESS (dizziness) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were not provided by reporter.
Shortly after receiving vaccine patient fainted in waiting area. Ran to check on patient and she got up on her own accord. Helped patient and mom to a bench in the waiting area, had pharmacy technician grab some orange juice while pharmacist waited with patient and parents to monitor for other signs of reaction.
Diarrhea; nausea; headache; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route administration in right arm on 19Mar2021 at 16:00 (at the age of 54-years-old) as a single dose, for COVID-19 immunisation. Medical history was reported as none. The patient had unspecified allergies to food, medications, or other products. The patient received unspecified medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 20Mar2021 at 02:00, the patient experienced diarrhea, nausea and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken for the reported events. The clinical outcome of the events diarrhea, nausea and headache were not recovered at the time of this report.   No follow-up attempts are needed. No further information was expected.
I got the 2nd dose vaccine and had flu like symptoms including high fever and chills which lasted for 12 hours and resolved.  About a week later, I started dragging my foot and had left leg weakness and pain in my left leg. I also noticed I was developing slurred speech and decreased hearing.  I was diagnosed with ALS on 2/17/2021.    My lung function is now at 50%, I am unable to write legibly, and I cannot feed myself.  I have a feeding tube and I now have to use a wheelchair.  I have to use bipap at night for my breathing.  I was diagnosed with rapidly progessive ALS and have given the diagnosis of 1 year to live.  Up until the 1st vaccine, I was working as a physician/doctor treating covid patients in the Urgent Care.  I am now confined to a wheelchair.
Fever & chills Nausea & Vomiting Uncontrollable yawning/stretching Trouble breathing Swelling and pain on injection site on right arm Pain on entire right side of body (injection side) Trouble sleeping
Starting about a week or two after injection I started getting sick. I was vomiting all the time. I was having severe headaches. I was fatigued and my body felt like it was shutting down. Since 2022 I have been fighting to find someone to help me when I found a doctor who finally has gotten me on the path to getting answers. Since the vaccine I now have gastroparesis, liver disease, I have had my appendix removed and now seeing a colon surgeon and a neurologist..
After getting shot I started experiencing PMS symptoms earlier than normal but my period never arrived.  I still have not gotten my period and estimate I am now two weeks behind my normal schedule.  I have tested negative on a pregnancy test.  The past approximate two weeks my breasts have felt swollen, tender, and somewhat painful.
Dad called to report area around injection site is red, hot and feels right, about 3 inches in diameter.
Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little sore arm) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unk) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Little sore arm). At the time of the report, PAIN IN EXTREMITY (Little sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included 2 Advil before the shot, 2 Tylenol.
sore arm; red spot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and erythema. On an unknown date, the outcome of the pain in arm and erythema were unknown.   It was unknown if the reporter considered the pain in arm and erythema to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient just got his/her second shingles shot. The patient only had a sore arm and a red spot as a reaction.
Presented with CP, anxiety, SOB, nonproductive cough; + Covid-19 in ED; admitted to ICU with hypotension, bradycardia, Covid-19 PNA, AKI; treated with O2, remdesivir, steroids, zinc; TX to tele 9/14. DC home.
After vaccinations given, patient complained of dizziness, became pale and diaphoretic, and vomited.  He was placed in a reclined position in a recliner and cold pack was placed on back of his neck.  Patient began to return to normal skin color and he denied any nausea or dizziness after 15 minutes of recovery in the recliner.  Patient was placed in the sitting position for 5 minutes without any dizziness or nausea.  He was able to stand and ambulate out of clinic without difficulty.
About an hour after receiving the flu shot, my left arm started aching a little different than I ever remembered.  After a while the pain was started to get worse to the point my arm was getting heavy.  I reported back to the person that administered the injection and she noticed my arm visibly swollen.  She recommended that I apply a cold pack to the arm for a few hours and then apply heat.  Also recommended an anti imflammatory.  The following day (Friday) I started feeling a little sweaty.  Later that day, I started feeling nauscious, headache, diarrhea.  I have had those symptoms along with drowsiness (fatigue), ever since.
Patient received the second dose of SHINGRIX series on 5/26/18. She called today (5/29/18) and reported that she felt nausea on the day of the vaccination and developed redness and warmth the next day. She said her right hand up to her elbow was red and warm; and the right side of her chest was red and warm. She denied any redness or swelling at or around the site of injection. She did not report any problems breathing, chest tightness, or abnormal heart rate.
Approx. 1 wk after immunization back of arm (L) sore, hot to touch, slightly itchy. Symptoms progressed to front of arm with 4 blisters. Areas hot and painful. Reaction occurred when pt out of state on vacation. Pt seen today by Dr. Better now per pt. ZPAK ordered by Dr.
The patient is a 72 y male presenting to the ED with complaints of chills, fever, and myalgias since he received the first dose of the vaccine on 02/23/2021. He reports he developed a cough the 2nd or 3rd day following the vaccine, which was productive of a light colored phlegm, but he states this morning he coughed up blood and when he blew his nose blood came out. The patient states he first developed pain at the injection spot which resolved after a couple of days, and then the chills and myalgias onset. He reports loss of taste and eye pain bilaterally. Patient was given bamlanivimab on 3/1/21 in the ED and was discharged home. Returned to ED on  3/3/21 for worsening symptoms and inability to maintain O2 sats above 90%. Admitted to hospital for 6 days.
Same night as injection; sleepness night, following morning, feeling very sick as if I had Covid or the flu. Very weak and listless; unable to perform daily tasks.  Took a Xanax to go to sleep and slept soundly, feeling much better today (9/20).  Although very unpleasant, not life threatening just unexpected since I didn't have any reactions to all the previous injections. Just a note: have only received the Maderna Covid vaccines.