chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in chest -continued and on 1/19/2010 it continued and in addition I have a rash/hives in on breasts, back, hips, around an old incision scar, belly button, another old scar, and the place where the bandaid covered the H1N1 shot site is outlined in red
This case was reported by a other health professional via sales rep and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced shingles, tingling and rash. On an unknown date, the outcome of the shingles, tingling and rash were unknown. It was unknown if the reporter considered the shingles, tingling and rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a physician assistant. The age at vaccination was not reported. The patient developed tingling 24 hours after receiving a dose of SHINGRIX, which escalated to full rash and shingles.
Information has been received from a registered nurse concerning an over 50 year old male with a history of hepatitis c who 2 years ago, was vaccinated with the first dose of PNEUMOVAX 23, and on 27-OCT-2009 received the second dose by intradermal route. On 27-OCT-2009 the patient had a local reaction at injection site. It was red, swollen and hot to touch. Patient also received a tuberculin skin test referred to as PPD skin test on 27-OCT-2009. The patient was seen in office. At the time of the report, the patient had not recovered. Additional information has been requested.
Received on 03/07/05 Pediatrix, Hib, PCV 7. Developed pink pimply rash 3/8/05. 3/11/05 reported rash worse-brighter red spread to back, stomach, neck. Tx: Hydrocortisone cream 1%, Benadryl PRN, F/U MD.
Had an exhausting 24 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Had an exhausting 24 hours) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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 experienced FATIGUE (Had an exhausting 24 hours). On 01-Sep-2021, FATIGUE (Had an exhausting 24 hours) had resolved. Not Provided          No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.   This case was linked to MOD-2021-304655 (Patient Link).
4 patients administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine) in a 97-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2022 at 8:23 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 08-Feb-2022 at 8:23 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine). On 08-Feb-2022 at 8:23 AM, EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.
'seizes'/seizure; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 31Mar2021 at 13:00 (at the age of 54-years-old) as 1st dose, single (Batch/Lot Number: ER8732), via an unspecified route of administration, administered in arm left for COVID-19 immunisation. Medical history included coconut allergy from an unknown date and unknown if ongoing. Concomitant medications included topiramate and triamterene, both taken for an unspecified indication, start and stop dates were not reported. Between 31Mar2021 and 21Apr2021 (reported as Apr2021), the patient had a total of 10 'seizes'/seizure. Before, he had 2 to 4 'seizes' within a three months' time. The patient received the second dose of BNT162B2 on 21Apr2021 at 13:00 (Batch/Lot Number: EW0151), via an unspecified route of administration, administered in arm left for COVID-19 immunisation. There was no treatment received for the event. The outcome of the event was unknown.    Information about lot/ batch number has been requested.
child received too many vaccines. The infant was scheduled to receive VAXELIS, PREVNAR 13, and ROTARIX. However, the infant also received MMR, VARICELLA, and a Flu shot which were not scheduled with no reported adverse event.; age: 2 months; This spontaneous report has been received from a consumer via Sanofi referring to a 2-month-old female patient. Information of concurrent conditions, medical history, family history, concomitant medications and drug reactions/allergies was not reported.  On 12-DEC-2022 (also reported as on an unknown date, conflict information), the patient received too many vaccines. The infant was scheduled to receive a dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) injection, pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (formulation was unknown) and rotavirus vaccine live oral 1v (ROTARIX) (formulation was unknown) (all strength, dose, lot#, expiration date, anatomical location and route of administration were unknown) for prophylaxis. However, the infant also received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, and influenza vaccine (formulation was unknown) (all strength, dose, lot#, expiration date, anatomical location and route of administration were unknown) for prophylaxis which were not scheduled with no reported adverse event (inappropriate schedule of product administration, product administered to patient of inappropriate age).
Hospitalized (11.14.21-11.17.21; COVID-19 positive (11.10.21); fully vaccinated PLUS Booster  HISTORY OF PRESENT ILLNESS: Patient is a 58 y.o. male who presented to the ED today with generalized weakness that has been progressive since November 6th. He was evaluated in the ED on November 10th and was found to be positive for COVID 19. He continued to feel poorly with generalized weakness, poor orally intake, nonproductive cough and shortness of breath.  He reports oral intake has been poor.  He was taking Tylenol for symptom management.  He was having difficulty ambulating due to generalized weakness and left hip pain with negative x-rays so PT and OT evaluated patient with recommendations for Sar placement.  His remained on room air without significant respiratory symptoms.  Because of need for placement he required admission and no beds available at Hospital so he was transferred to Campus HOSPITAL COURSE:   58 yo x3 vaccinated man with:   Left lateral buttock pain w/ radiation to posterior mid-thigh Challenging to localize such a dermatome but S1 possible given posterior location Generalized weakness Inability to ambulate Began 1-2 weeks PTA His chiropractor suggested he was suffering from sciatica No recalled injury and no falls No numb/tingling at leg/foot Could consider MRI L-spine and sacrum PT/OT SAR advised   Covid positive, no PNA Sore throat 11/9/21 HS Covid + 11/10/21 No SOB, hypoxia, and not on O2 CRP: 49.5 D-dimer: 990 Monoclonal antibodies provided   CKD stage IV Nephrotic syndrome with membranous glomerular nephritis Cr 3.64 -> 2.88 Undergoing workup in Ann Arbor for renal transplant Avoid nephrotoxic agents and renal dose meds   Hyperkalemia, mild Likely related to decreased renal function Provide information on potassium restricting diet   Hypertension No med in use for this condition   Hyperlipidemia No med in use for this condition   Hypothyroidism, TSH 1.14 11/14/21 L-thyroxine 112 daily continued   VTE ppx: Lovenox 30 SQ d given decreased renal function Diet: General  Full code   Dispo: Home w/ OP PT
The day of the application I didn't feel anything. The second day I started with lots of  tiredness, chills, extreme fatigue, pain in my bones.  I haven't been able to function this 2 days.
Redness and swelling appeared about 30 minutes after vaccine. Still red and swollen 5 days later. No tenderness, not hot to touch.
Myalgia, Fever, Diarrhea, NauseaVomiting, malaise Narrative:
Pt had erythema, increased in warmth noted on left thigh less than 1 minute after vaccines. Benadryl given po.
Flushed and face was warm. Gave water to drink and checked every 10 minutes by RN. Remained at site for observation for two hours. Stable when left site.
DVT in Peroneal vein in left leg. diagnosed 05/24/2021. Went to ER with pain in left Calf. Pain onset was 5 days prior to ER visit (05/19/2021).
I started feeling pressure in my chest, and also my heart started palpitating, it makes me feel like I cannot breath.  I have had this off and on and am still having them but not as much.  This is my first COVID shot and I am worried to take the 2nd one because I heard the 2nd shot is worse.  I had Covid back in December. My husband is a PA and has me taking ibuprophen.
No symptoms; patient received improperly stored VARIVAX; This spontaneous report as received from a medical assistant refers to an 16-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 12-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M025867 with expiry date on 24-MAY-2018; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1701USA000675: US-009507513-1610USA004609: US-009507513-1701USA000677: US-009507513-1701USA000678: US-009507513-1701USA000679: US-009507513-1701USA000680: US-009507513-1701USA000681: US-009507513-1701USA000682: US-009507513-1701USA000683: US-009507513-1701USA000684: US-009507513-1701USA000685: US-009507513-1701USA000686: US-009507513-1701USA000687: US-009507513-1701USA000688: US-009507513-1701USA000689: US-009507513-1701USA000690: US-009507513-1701USA000691: US-009507513-1701USA000692: US-009507513-1701USA000693: US-009507513-1701USA000694: US-009507513-1701USA000695: US-009507513-1701USA000696: US-009507513-1701USA000697: US-009507513-1701USA000698: US-009507513-1701USA000699: US-009507513-1701USA000700.
Swelling at injection site;  Swelling around entire upper arm, swelling in arm pit and down rib cage.  Tenderness and discomfort associated with swelling.
L arm red and warm to touch. Area approx size of "golf ball" noted in the inner aspect of L arm above elbow area.
Awoke with redness, warmth and mild tenderness on left upper arm.  That arm had Varicella lot 1000Z administered the day before.  Raised redness 1 1/4 inch in diameter, surrounded by additional redness.  Total reaction diameter 2 1/4 inch.
Within a few days after completing the second dose, I started experiencing continuous tinnitus in both ears. The levels I am experiencing have not abated since I first noticed it. Before the vaccinations, I would just occasionally experience tinnitus, but those were very brief events that self resolved. The current symptoms are different than what I was experiencing previously.
Patient potentially received higher than the recommended 0.3ml dose of the Pfizer vaccine. As of Sunday 4/4, patient only complaint is mild arm soreness.
Bruise; This is a spontaneous report received from a Pfizer sponsored program. This consumer reported for her husband (patient) that a male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on unknown date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter (patient's wife) stated that, after my husband had his 1st vaccine he started to bruise (Contusion) it finally got better. 2 weeks ago, it began to bruise again for no reason. He had been to 2 different doctors. She thought if anyone else has had this issue. The outcome of the event bruise was not recovered.  No follow-up attempts are needed. No further information was expected.
positive COVID-19 antigen test with symptoms (ache, cough, fever); positive COVID-19 antigen test with symptoms (ache, cough, fever); This is a spontaneous report from a contactable physician (patient). A 51-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration on 17Dec2020 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included borderline diabetes, ongoing hypertension, ongoing hyperlipidemia, ongoing rhinitis allergic, and currently ill. Concomitant medication included ongoing fexofenadine hydrochloride (ALLEGRA, strength: 180 mg) at 180mg once daily by mouth for Rhinitis allergic taking for years, ongoing lisinopril (strength: 40 mg) at 40 mg once daily by mouth for hypertension taking for two or three years, ongoing atorvastatin (strength: 40 mg) at 40 mg once daily by mouth for hyperlipidemia taking for a year. The patient experienced positive covid-19 antigen test with symptoms (ache, cough, fever) from 19Dec2020. Event details: The patient received the COVID 19 Vaccine on 17Dec2020 10:30AM in the left arm. Tested for COVID 19 with the antigen test, on 20Dec2020 and his result was positive, he experienced ache and cough on 19Dec2020. Clarified he started having symptoms in the evening (19Dec2020) and then tested in the morning (20Dec2020). He experienced the low grade fever on 20Dec2020. His maximum temperature was 100.4 fahrenheit. He had only been treated with over the counter products. No further information provided for the over the counter products. He was not hospitalized. He will take the second dose of the COVID 19 vaccine on 07Jan2021. The patient didn't have SARS-CoV2 antibodies at diagnosis. The patient was not admitted to an Intensive Care Unit. The patient didn't display clinical signs at rest indicative of severe systemic illness. The patient didn't require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient didn't have any pre-existing diseases worsened during the SARS-CoV2 infection. The patient was not treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The outcome of all his symptoms was resolving.; Sender's Comments: The reported events drug ineffective and COVID-19 are likely intercurrent and are unrelated to suspect drug BNT162B2 based on short temporal relation between vaccination and onset of events.
10 hours after receiving vaccine I started to feel very weak and had very bad body aches. It was in the 90's outside, but I was freezing, so I took a hot bath and laid down. I was shivering uncontrollably and my fever spiked to 102 degrees. I took 2 ADVIL PM around 9 PM and went to sleep. I woke up at 3 AM in a pool of sweat and felt very weak and nauseous. Re-checked temperature at 9 AM the next day and it had returned to normal, though I still felt very weak, so I stayed home from work to rest that day. I had also received my weekly allergy shots that same day at 4:30 PM, but they said it was okay to do my allergy shots on the same day I had my flu vaccine.
Experienced blurred vision and felt faint around 2:30 pm on 07/02. Very tired and developed dark circles around eyes . Slept on/off for 2-3 days. Started feeling better in the afternoon of 07/04. Never experienced any SOB, difficulty breathing, or difficulty swallowing. No fevers. No signs/symptoms at injection sites. No redness, tenderness, swelling, bruising, or warmth. Mother contacted Pediatrician as soon as patient started experiencing the blurred vision and feel faint.
Within a month after receiving this shot I was starting to experience Left eye blindness. I later got an MRI done and was told it was due to a low grade glioma optic nerve tumor. This vaccine caused a brain tumor. I had pressure on my eye, pain from the pressure, headaches, blindness, fainting and dizziness. Got a brain biopsy surgery done to figure out what kind of tumor it was to get treatment. I later received radiation treatments to my brain from 8/1/22 to 9/12/22.
Sore arm days 1-3 Hot red mark appeared at day 9, is continuing to grow through now (day 11)
Dizziness and dysphoria that started day after vaccine and has faded over the subsequent week
SkinRash, Rash, Red circular area approx. 5cm that first appeared on 12/28/2020, she also reports itching at site.
VERY SORE AND SWOLLEN ARM AND FELT UNWELL THE FOLLOWING DAY
Soreness at injection site, hot and swollen at injection site, numbness in arm down through wrist. Only last about 48 hours. Started 8 days after vaccination.
p/vax pt exp cellulitis;rt arm was swollen, red, & hot to touch;pt sought unspecified medical attention 7 was treated w/cephalexin;pt recovered from cellulitis;
Seizure, with moving the head side to side. Second seizure occurred on 3/19, with moving the head and arms in rhythmic fashion.
after administration, patient comes up with severe allergic reaction redness and  rashes starting  from left lower arm spreading  all the way to the neck and swelling with patient itching and patient acknowledge and started saying he is having severe reaction. Epipen was administered and after about 4 to 5 minutes of administration of epipen all those reactions stopped and patient said he felt better and thank me for the care. I was going to call 911 but patient said he was ok and there is no need . Patient waited  for another 25 to 30 minutes after the administration of epipen in the pharamacy area  to observe the patient .  Patient left after about 30 minutes with no further reaction
Left arm was hurting just before bedtime on 01/07/15 but she didn't get up and look at it in the mirror. Next day couldn't get bp reading at dr office, nurse & doctor documented problem.
ipol excursion was for 3 hours to a maximum temperature of 12.6°C with no reported adverse event; received ipol after the punctured vial was exposed to the excursion with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA239251 and 2023SA239621(CLUSTER).  This case involves a 11 years old male patient who received ipol after the punctured vial was exposed to the excursion for 3 hours to a maximum temperature of 12.6°c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Jun-2023, 0.5 ml(TOTAL) dose of suspect IPV (VERO), Suspension for injection lot W1A101M expiry date- 10-Feb-2025 via unknown route in unknown administration site for Immunization (strength: unknown), patient received ipol after the punctured vial was exposed to the excursion with no reported adverse event (poor quality product administered) (latency same day).  On an unknown date ipol excursion was for 3 hours to a maximum temperature of 12.6°c with no reported adverse event (product storage error) (latency unknown).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product storage error and poor quality product administered.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical 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.
Day 1 of shot: headache 10 hours after Day 2: headache, fatigue, joint pain Day 3: headache. Fatigue, joint pain  Day 4: headache, fatigue, joint pain and low grade fever, diaphoresis Day 5: worsening headache, fatigue, joint pain  Tylenol was obtained per bottle recommendation for pain on all days.
Low titers after first series / as a child; First dose March 4 2021 / Second dose March 18 2021; This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 25-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis and HBV (Engerix B) (batch number 74em4, expiry date 20th December 2022) for prophylaxis.   Concomitant products included HBV (Engerix B).   On an unknown date, the patient received Engerix B and hepatitis B vaccine pre-filled syringe device. On 18th March 2021, the patient received the 2nd dose of Engerix B. On 18th March 2021, not applicable after receiving Engerix B and hepatitis B vaccine pre-filled syringe device, unknown after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased and drug dose administration interval too short 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 details were provided as follows: The age at vaccination was not reported. The patient as a child had low titers after receiving the first series of Engerix-b, which led to therapeutic response decreased. Now patient started with second series of Engerix B and received 1st dose on 4th March 2021. The patient received 2nd dose earlier than recommended schedule, which led to shortening of vaccination schedule. No known side effect was reported. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021173207:Same reporter
Got my shot at 3p. but 340p became short of breath, throat felt tight/itchy.  woke up at 2am shaking, later that day  developed at headache, felt warm but couldn't stop shaking. Headache became too unbearable  I've been developing a headache every day since the shot.
vaccine  at Health Clinic 12/23/2020, 1/13/2021.   pt tested positive for COVID at Pharmacy 7/27/2021 Mild symptoms.
Extremely sore and painful injection site beginning around seven hours post injection. Painful to touch and movement. Sx lasted approx. 36hrs.