chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fainted twice; hypotensive; head injury; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted twice) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autism.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainted twice) (seriousness criterion medically significant), HYPOTENSION (hypotensive) and HEAD INJURY (head injury). At the time of the report, SYNCOPE (fainted twice), HYPOTENSION (hypotensive) and HEAD INJURY (head injury) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Further information has been requested.
patient received only the DTaP-IPV portion of Pentacel, no advesre event; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown demographic patient who was vaccinated with a dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot number not reported via unknown route in unknown administration site on an unknown date. The patient received only the DTaP-IPV portion of Pentacel.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate reconstitution technique.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a edical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Patient received first dose Pfizer and second dose Pfizer, but was given Moderna for 3rd dose.
Medication error, pt given Pfizer Pediatric dose for second dose, should have been given Pfizer for 12+ age.  Grandmother notified that patient will need to return  after 12-24-21 for Pfizer for 12+ age for second dose.  Pt had no adverse outcome from medication error.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-DEC-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours, the lowest recorded temperature was 34 Fahrenheit degree and the type of excursion was refrigerator (R). The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
got hte shingles from the shot/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient actually got the shingles from the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
I had 2 Moderna's in 2/21 & 3/21. No issues. Then had booster in 11/21. No immediate issues, but about a month or so later I got a bad sore on my genitals. Then a month later, a bad canker sore in my mouth. And now a terrible fever blister. These are not normal, though I had a fever blister 40 years ago (contracted in college from my "little sister". I do get the occasional canker sore in my mouth, but nothing like the severity of this one in late Jan, early Feb. And this week I've had a really bad fever blister which I haven't had in 40 years. This is not at all normal for me and I think there is an association with the Pfizer booster.
I started with headaches, and a small rash lower arm (I felt like I had a cold) woke up today (8/13) with a large painful rash at the injection site on my left arm. Also, today's fingertips feel harsh (dry, peeling). Continually to have headaches.
Patient complained of tenderness with increasing erythema at injection site with signs of allergy presentation (itching). Eventually saw physician and prescribed an antibiotic.
Pediatric Pfizer was drawn from vial without first being diluted with saline solution. Patient was given 0.2mL of undiluted vaccine. Patient waited the 15 minutes in observation with no adverse reaction. Patient's guardian was notified at 4:30pm of the error and told to monitor for any adverse reaction and advised to seek immediate emergency treatment for any extreme reactions (high fever, excessive vomiting, etc). Parent understood the error and understood aftercare; she was put in contact with vaccine site lead and clinical liaison for any further questions.
Tingling and loss of feeling in face, hand/arm, and foot/leg. Comes and goes but is still an ongoing issue 6 months later. Predominantly on left side.
24 hours after vaccination some redness and swelling noticed. Seen 48 hours, later in office, swollen red, painful, warm to touch (L) deltoid. Temp if ofc. 100. 4" in diameter. Treated with KEFLEX 250 mg/5ml 10 ml po BID x 10 days.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prevention. Concurrent medical conditions included hypothyroidism (problem with processing calcium) and hypertension (high blood pressure). Concomitant products included amlodipine besylate, calcium carbonate (Calcium), fluticasone propionate (Fluticasone), calcitriol and hydralazine. On 3rd April 2018, the patient received the 1st dose of SHINGRIX. On 3rd April 2018, 2 hrs after receiving SHINGRIX, the patient experienced pain in arm, tingling and numbness. On an unknown date, the outcome of the pain in arm, tingling and numbness were not recovered/not resolved. The reporter considered the pain in arm, tingling and numbness to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received Allergy pill as concomitant medication. At 5:00 hours, the patient received SHINGRIX on the left arm. The patient felt like a deep sharp pain in her arm. The pain was so strong and severe that it would cause her to wake up when it happened if she was not already awake.  The pain initially lasted every day for about 10 days after injection. The patient continued to have pain in her arm but now it comes and goes and was not continuous. The patient said that, there was no swelling or redness of the skin at the injection site. The patient had not spoken to her physician about this, nor did the physician recommend to get the vaccine. The patient decided at her age, she said, that it was probably a good idea to go ahead and get the vaccine. The patient was due to receive the 2nd dose in July 2018. The reported lot number (324KL) for SHINGRIX did not exist and was updated to 3Z4KL, according to sales database.
Patient female 37 years old reports on 7 September to the vaccination center to get her second dose Moderna and reports that two weeks after getting her first dose she had a reaction on the left upper extremity were the vaccine was adminitered, the area was inflamed, lymph node and breast
Patient received vaccine, after a minute she felt dizzy and lightheaded, and started having a seizure for about 30 seconds . After it was over she still felt lightheaded and had vision problems so we laid her down. After a few minutes she started feeling better and at that point the ambulance and EMTs arrived in store to assess her. She was taken to the hospital to receive further treatment.
A report was received on 2/28/02, concerning a 73 year old male pt who was hospitalized for pneumonia, 1 month after receiving Fluvirin vaccine, on 11/12/98. The event was considered serious. The causality was stated to be possibly related. No further information was provided.
I have had a persistent cough; I have had a persistent hoarseness.; This spontaneous case was reported by a patient and describes the occurrence of COUGH (I have had a persistent cough) and DYSPHONIA (I have had a persistent hoarseness.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (I have had a persistent cough) and DYSPHONIA (I have had a persistent hoarseness.). At the time of the report, COUGH (I have had a persistent cough) and DYSPHONIA (I have had a persistent hoarseness.) outcome was unknown.            No concomitant medications reported. No treatment reported.
Patient fainted after shot. She was out for several seconds before opening her eyes. She recovered shortly after awakening and returned home with parents - follow-up Monday -> father reported patient was fine.
Initial report received from healthcare professional on 15 December 2013. A patient whose age, gender, medical history and concomitant medications were not reported, received ACTHIB (lot number, expiration date, route and site of administration were unknown) on 04 December 2013. On 4 December 2013, patient received a dose of that was reconstituted with Merck's sterile diluent. Documents held by sender: none.
R09.02 HYPOXIA 7/12/2023 TRAUMATIC SUBDURAL HEMORRHAGE W LOC STATUS UNKNOWN, INIT
urticarial rash started the day after the vaccinations and worsened the second day after. On the arms, legs and abdomen. Seen in the office on 6/11/2021, 2 days following vaccination. No other parent reported signs of illness or other changes that could have resulted in the rash.
Information has been received from a woman concerning a male who on 02/28/2003 was vaccinatd with pneumococcal vaccine 23 polyvalent.  The woman reported that in March 2003, her husband developed a sore throat, fatigue and flu-like symptoms.  The reporter felt that the sore throat, fatigue and flu-like symptoms were related to the pneumococcal vaccine 23 polyvalent vaccine.  At the time of this report, the outcome was unknown and the patient had not sought medical attention.  The woman also reported that her daughter also developed a sore throat, fatigue and flu-like symptoms after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES # 0303USA00342).  No further information is available.
Last year I had a very severe case of shingles and have PHN. About 24 hrs after vaccine my neuralgia became very intense and painful around the waist area - I had not had this level of pain in over 6 mos. This lasted about 2 1/2 days.
Patient developed  allergic reaction from Pfizer Covid vaccine  Received his Pfizer covid vaccine at a round 1600 5 to 10 minutes after the vaccination, he developed numbness of the right side of his tongue At 1621 He is having numbness of his whole tongue, scratchy sensation at the back of his tongue  He is stable with normal respiration and not in distress. No difficulty of breathing  Benadryl 25 mg po.  given at 1621 Benadryl 25 mg po.  given at 1635 The scratchiness of his tongue resolved at around 1700.  He has no respiratory difficulty, Vital signs stable Ambulance services is called at around 1630:  Evaluated the patient, take vital signs  Observe the patient for 15 minutes and told to be back at the Covid vaccine line to be observed closely  The scratchiness of his tongue resolved at around 1700.  He has no respiratory difficulty, Vital signs stable He was discharged at 1745. Told to take 50 mg Benadryl tonight. Follow-up in the clinic tomorrow.
ARM WAS EXTREMELY PAINFUL, COULD NOT LIFT ELBOW OVER SHOULDER ON 9/24. TODAY 9/25 LARGE RED AREA NEAR SITE OF INJECTION THAT MEASURES 7 INCHES LONG AND 3-4INCHES WIDE, FEELS HOT TO TOUCH IN THAT AREA.
Diagnosed with phlebitis due to pneumococcal injection. Per doctor, injection given to low on arm (4" from shoulder).
PFIZER-BIONTECH COVID-19 VACCINE EUA.  Vaccination occurred between 6:30am to 10am.  Adverse event noted at 5:30pm included seizure activity followed by lethargy/unresponsiveness lasting a few minutes (approx 15 min unresponsive).  VS 138/82, 76,16. Blood sugar 105.  O2 sat 98% on room air.  MD visited and ordered labs.  Subsequently treated for UTI with Rocephin IM x 5days.
High fever..lasting approximately 2-3 days after vaccination, runny nose and congestion, feeling really tired, occassional rapid heartbeating.
Sore Arm since influenza vaccine on 11-1-07. Has been seen by her HCP and was told she has a "lump under muscle" at injection site. She states that she cannot raise arm above shoulder or take her arm out of coat sleeve. Reports arm was fine prior to flu shot. Did not remark about any other symptoms except arm soreness during next 1-2 days.
Pt recv vax on 9/11/98; on 9/12/98 pt exp macular papular rash on face, trunk &proximal extremities (<48 hrs).  Pt had pharyngitis.
12/04:  Body aches and malaise;  soreness at injection site. 12/05  Injection site is warm and largely inflamed.
On 7/12/21 patient came to healthcare center with parent to obtain Covid Vaccination. Patient was given 1st dose.  Patient did not exhibit or complain of any adverse symptoms during observation period.   On 7/22/2012, back office identified that recipient's birth date is 12/07/2006.  This makes the recipient only 14yrs and 7 months old; ineligible for Moderna vaccination for which minimum age is 18 years.    Phone call placed to legal guardian (Father) on 07/23/2021 to inform. He stated that patient has not experienced adverse reaction to date, but that he will monitor. Discussed with Mr. the CDC guidelines for Moderna and Pfizer vaccines, including wait time between doses and wait time for
Severe body aches, headache, body temperature of 103F, and confusion lasting several days after vaccination.
Intense back pain for 3 weeks, ears ringing, heartburn daily (tums and bland diet did not help), tingling in arms legs and head. Hot flashes. Swollen lymph node developed on base of neck on left side that has not gone away yet 5 weeks later. Tender sore underarm and breasts for 5 weeks. Dizzy, lightheaded immediately after and for weeks after.
she noticed her arm was "slightly slightly" swollen; arm "sore" and it's given her a "little bit of pain".; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "she noticed her arm was "slightly slightly" swollen"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm "sore" and it's given her a "little bit of pain".".  Additional information: It was reported that she slept on that side mostly it could have made her arm "sore" and it's given her a "little bit of pain". She asked if she could exercise this arm and for treatment recommendations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain in right arm, swelling gradually radiated to fingers. Back at doctor's by 3:30 pm; was given antihistamines condition did not improve overnight back to the doctor's by morning: was given Ibuprofen for pain and fever. Couldn't raise arm for a while. Feeling better by first week of November, today is back to normal.
4 days post vax the pt developed viral respiratory symptoms treated with Hydrocodone nitrate, Tylenol and Motrin. Symptoms resolved 12 days post onset. The following day pt returned to the clinic complaining of conjunctivitis and a persistent cough. 19 days post vax, the pt developed a fever and cough with shaking chills and 20 days post vax pt was diagnosed with pneumonia. Pt was hospitalized the following day and on admission a chest x-ray revealed peribronchial thickening in perihilar regions which was compatible with tracheobronchitis. Pt was treated for presumptive bacterial pneumonia in hospital . The event resolved after 18 days.
35-year-old female presenting to the emergency department complaining of palpitations, dyspnea, headache. Started approximately 10 minutes after receiving her first dose of Pfizer COVID vaccine. Headache is described as diffuse, denies difficulty with vision with the exception of "burning" when looking at light. In the ED symptoms resolved after giving ibuprofen and fluids  Patient came back to the ER a week after with headache, myalgia, sensation of difficulty breathing and chest tightness. Patient states she had similar symptoms one week ago after getting her first Covid vaccine. She came to our emergency room and had a full workup here including CT PE, basic labs, thyroid testing. She reports improvement in symptoms after that with recrudescence a few days ago. Fluids and Ativan was given during the ER visit. Symptoms resolved and patient was discharged.   Other: tachycardia, Other Cardiovascular Outcome attributed to the adverse event- Other Specify: ER Visit. Was it an ADA? Yes  If yes, please indicate the type of event: X- Continuing action/reaction, persisting for longer than expected time period. X- Idiosyncratic response not expected from normal pharmacological mode of action. Specify type of idiosyncratic response: dyspnea, palpitation, tachycardia and shortness of breath If yes, what was the strength of causality between the drug and ADR? - Possible Case assessment:  35F presenting with persistent headache and resolved dyspnea and palpitations 10 minutes after receiving the first dose of Pfizer COVID vaccine. Persistent low-grade tachycardia. Further evaluation at the ED revealed Normal HsTn value. Low concern ACS, aortic syndrome. Reassuring neurovascular exam. No infectious symptoms. A CT-PA is negative. The patient came back to the ED one week later complains headache, tachycardia 100-120 BPM. sensation of difficulty breathing and chest tightness. Patient states she had similar symptoms one week ago after getting her first Covid vaccine. In the ED patient was treated with fluids for tachycardia and Ativan. Patient symptoms improved and was discharged. Given the timing of the onset of symptoms this maybe caused by the vaccine.
This spontaneous report as received from a certified medical assistant refers to a male patient of unknown age who on 12-AUG-2011, was vaccinated with the first dose of GARDASIL (route and lot# not reported). On 05-SEP-2012, the patient was vaccinated with the second dose of GARDASIL (route and lot# not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Pt. returned to pharmacy approximately 12 hours after receiving PNEUMOVAX 23 injection in left deltoid. Pt. complained of severe pain waking him up crying in the middle of night. I observed no redness or visible evidence of exact inj. site, but muscle was warm and swollen. Pt. winced in pain when I had him move his shirt sleeve up. He was wanting to go to doctor to have it evaluated. Stated he believed we had injured his rotator cuff.
Went to sleep around 11pm, woke up at 2am shivering cold, despite being under heavy blankets. Felt pain in chest and kidney area. Heart racing. Headache. Got up to get Ibuprofen, but felt dizzy, weak, and too cold to get down the stairs. Felt confusion, fear. Condition worsened over the next hour. Considered calling 911 but feared related expenses. Again went to get ibuprofen. Getting back into bed I felt out of breath, like there was no air in the room/high altitude. Noticed my hands felt like ice upon my chest.. Fell back asleep around 5am, awoke the next day with a headache, neck ache, malaise and weakness. Slept most of day, headache resolved by 8pm with continued use of Ibuprofen. Malaise and weakness persist until time of writing.
15DEC92 in clinic states might have had reaction 1hr p/vax; sx like disoriented, tingling of extremities; 15DEC92 15 mins p/vax exp tightness of chest, SOB, numbness, intoxication like sxs;  tx w/DPH; sxs returned to hosp;
Experienced Bell's Palsy on right side of face.  Noticeable when smiling.