chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got COVID after both doses of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID after both doses of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID after both doses of the vaccine). At the time of the report, COVID-19 (got COVID after both doses of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.         No concomitant medications were provided. No treatment medications were provided.
Patient reported the next morning that her arm was warm to touch and had about 2-3 cm. of redness around injection site. It lasted until 9/23/2017
foggy in head; flushed feeling but not fever; tired; very sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of FEELING ABNORMAL (foggy in head), FLUSHING (flushed feeling but not fever), FATIGUE (tired) and PAIN IN EXTREMITY (very sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MAGNESIUM for Magnesium supplementation, CALCIUM and CURCUMIN (TURMERIC MERIVA) for Supplementation therapy, BUPROPION HYDROCHLORIDE (WELLBUTRIN), AMLODIPINE, HYDROCHLOROTHIAZIDE, ROSUVASTATIN CALCIUM (CRESTOR) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING ABNORMAL (foggy in head), FLUSHING (flushed feeling but not fever), FATIGUE (tired) and PAIN IN EXTREMITY (very sore arm). In March 2021, FEELING ABNORMAL (foggy in head), FLUSHING (flushed feeling but not fever), FATIGUE (tired) and PAIN IN EXTREMITY (very sore arm) had resolved.            Concomitant medications included probiotics Action taken with mRNA-1273 in response to the events was not applicable.  No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD-2021-075617 (Patient Link).
Admitted for UTI and infected decub, found to be COVID+. Received vit-c and zinc. Did not require O2 or other targeted therapies. DC to LTAC for wound care needs on RA.
Pt recvd vax on 18MAR92 & exp pain in the rt thigh, scoliosis, narrowing of the L2, L3 intervertebral disc space w/mod sized osteophytes; calcifications of aorta; pain; degenerative disc disease, synovitis, bronchitis, laryngitis, poss neop
Admitted on 6/5 with nausea, diarrhea and abdominal pain for several days. CT showed left hemiocolonic colitis with ileus, acalcuous cholecystitis, cholangitis, papillitis, possible cystitis. Surgery consulted and started on antibiotics.  Symptom improvement but persistnet abdominal pain. Covid + 6/6.  Underwent HIDA on 6/7 with lap choly scheduled on 6/8 but cancelled due to wrsening clinical status. signs of septic shock and had celiac artery stent graft placement and superior mesenteric arter stent placement.Was on heparin drip and had NG tube for decompression. Pallative care consutled due to poor clinical status and comorbidities. Patient and family decided no further agressive treatmetn and proceeded with comfort care on 6/22. Supported for his pain, anxiety, feedings and control of diarrhea.
Patient has not had an adverse event.  Submitting for to report vaccine error.  Patient received pedi pfizer vaccine dose which was not diluted, resulting in a higher concentration than prescribed.  I contacted CDC and Pfizer to report incident and receive any info I could pass on to the parent about the erroneous dose.  I contacted the parent and informed them of the error and passed on information collected from CDC and Pfizer representative.  Parent understood and will be monitoring child for any adverse events.
I had hives and 'bumps' on my legs.  The 'bumps' are along with shin bones in particular.  Antihistamine, such as Clairton and Benadryl took care of them.
Patient was admitted to hospital for thrombocytopenia, treated with transfusions. Upon discharging  pt tested + for covid asymptomatic.
I began coughing the Wednesday after the 1st shot in April.  The cough continued. Just before 2nd shot I asked facility if I should get 2nd shot since I was coughing and they said yes. I had been concerned about family having MG and myself possibly too.  I got 2nd shot 5/7/21. I continued to feel ill. About 10 days ago diagnosed w/ pneumonia.  Took 1 round of antibiotics. Now on 2nd taking 2 antibiotics at the same time.
She came in today for her second shot and said her arm turned red and was hot to touch. She said it was 2x4 inches big.
Serious flu-like symptoms about 10 hours after injection (body aches, chills, fever, nausea, fatigue) which lasted approx. 72 hours. Stomach pain was on-and-off, radiating, and localized to lower left abdomen. Symptoms went away after rest. Uncontrollable eye-twitching began 24 hours after vaccine but has not gone away.
Nausea; Vomiting; Diarrhea; Chills; Sweats; Severe pain in left arm; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: ep6955), via an unspecified route of administration in the left arm on 23Mar2021 at 11:00 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included ethinyl estradiol; norgestimate (TRI-PREVIFEM) for an unspecified indication from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 20:00, the patient experienced nausea, vomiting, diarrhoea, chills, sweats and severe pain in left arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events nausea, vomiting, diarrhoea, chills, sweats, and severe pain in left arm were unknown.  No follow-up attempts are needed. No further information is expected.
Upper arm pain (at site of injection), headache, chills, nausea, body aches. Started on the morning after injection, continuing through the day.
no adverse events reported; he received his first dose of GARDASIL 9 in June of 2020 and received his second dose 05MAR2021; he is unsure of the valency of Fall 2019 HPV vaccination; This spontaneous report has been received from a 28 year old male patient, reporting on himself. The patient was not sexually active so he considered himself as human papillomavirus (HPV) naive. No other information regarding the patient's concurrent conditions, concomitant medications or medical history were not reported.   In fall 2019, the patient was vaccinate with his first dose of an unknown valency of human papillomavirus (HPV) (manufacturer unknown) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The patient "recently" graduated from medical school and had decided to become sexually active. In June 2020, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported) and on 05-MAR-2021, received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis  (dose, route of administration, lot number and expiration date were not reported). Due to the interruption in schedule the patient wanted to know if he should restart the series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No adverse event was reported.
no adverse event  Dose 2 given at day 23 after dose 1 (12/30/2020)
Very sore injection site, chills, sweats, serious headache, systemic joint pain with swelling, 102.5 F fever. Severity peaking 19-20 hours after injection, treated with acetaminophen and ibuprofen, mostly resolved by 48 hours after injection.
Patient passed out after receiving her 2nd dose of the Pfizer COVID19 vaccine. Patient was sitting in waiting area after receiving the dose when she passed out and her mother was holding on to her. Patient came back after a few seconds and was laid to the ground. Her BP read at 107/68 and then later at 101/71. Mom stated that patient has history of passing out before. She stayed with us until she felt better until her mom took her home.
Saturday Morning experienced disorientation like dizziness; real bad vision as well last Saturday Morning; Yesterday patient  was still sick on the couch all day until around 6-7o'clock; Fever 103F; Chills; Violently shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Violently shaking), DISORIENTATION (Saturday Morning experienced disorientation like dizziness), VISION BLURRED (real bad vision as well last Saturday Morning), ILLNESS (Yesterday patient  was still sick on the couch all day until around 6-7o'clock) and PYREXIA (Fever 103F) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS], ASCORBIC ACID (VITAMIN C ACID), VITAMIN D NOS and SIMVASTATIN for an unknown indication.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced TREMOR (Violently shaking), PYREXIA (Fever 103F) and CHILLS (Chills). On 20-Aug-2021, the patient experienced ILLNESS (Yesterday patient  was still sick on the couch all day until around 6-7o'clock). On 21-Aug-2021, the patient experienced DISORIENTATION (Saturday Morning experienced disorientation like dizziness) and VISION BLURRED (real bad vision as well last Saturday Morning). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (Violently shaking), DISORIENTATION (Saturday Morning experienced disorientation like dizziness), VISION BLURRED (real bad vision as well last Saturday Morning) and CHILLS (Chills) had not resolved, ILLNESS (Yesterday patient  was still sick on the couch all day until around 6-7o'clock) outcome was unknown and PYREXIA (Fever 103F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, Body temperature: 103 (High) had fever at 103 F all night.         Patient was advised to take Tylenol and hydrate.   This case was linked to MOD-2021-293388 (Patient Link).
Immediately  felt faint and dizzy,vasovagal  reaction exacerbated, I get menopausal  hot flashes this was intensified 10 x and immediate pain top head,B/p went up,felt numb face extremities, cancelled 2nd injection and B/p still up currently still feel dizzy and pain top head
Red, swollen, very sore, hot nickel size welt at injection point 24 hours after injection. It grew to the size of a half dollar, still swollen and sore. Lymph nodes were swollen and sore at armpit. Now 48 hours symptoms are nearly subsided. Just thought you'd like to know.
PPSV23 in (R) deltoid-developed pain, redness warmth at site followed by diarrhea and headache.
4/8 - Nurse received phone call from pt's spouse stated pt woke up with a high fever and chills. Sat 4/6 ached all over. Pt still running fever on 4/8 still aching. RN encouraged spouse so take pt to provider.
From initial information received on 08/13/2004 from another manufacturer from information reported to them by a physician regarding an adverse event occurring in the USA, it was reported that a 58 year old female patient received a tetanus booster, lot number SH1278A, route and site of administration not reported, on an unspecified date.  On 07/17/2004 the patient developed induration, swelling and extreme warmth at the injection site.  She was treated with prednisone, penicillin and Levaquin.  The patient improved after drug therapy and is recovering from these events.  From additional information received on 10/11/2004 from a physician, the patient's date of birth was provided.  According to the date of birth provided, the patient was 57 years old at the time of this event.  The patient received a 0.5ml dose of TD ADS Adult, lot number U1278AA, administered in the right arm on 07/16/2004 due to left facial abrasion and contusion.  The amount of previous doses was reported as unknown.  The patient has no known drug allergies.  Her pre-existing medical conditions include hypertension, which is treated with Diovan and Norvasc.  Per the reporter, the information has been reviewed and no further information is available at this time.
Patient reports an egg size swelling around site of injection around 12 noon and swelling increased by evening. Pt visits Emergency Centre. Per pt she was given prednisone injection. Reported today swelling decreased.
rash on body 3 wks p/vax; rash w/in 24 hrs neck area, wrists etc; MD had said OK to receive 2nd dose;
no adverse effect; administered improperly stored vaccines; This spontaneous report as received from a medical assistant  referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 24-MAY-2019, the patient was vaccinated with inadvertently administered doses of varicella virus vaccine live (Oka/Merck)(VARIVAX) that were improperly stored (Dosing details, route, frequency and indication were unknown) lot number R034394 and expiry date 27-NOV-2020 and R030614 and expiry date 23-OCT-2020 (product storage error). Concomitant therapies included sterile diluent. All lots of varicella virus vaccine live (Oka/Merck)(VARIVAX) was reconstituted with properly stored diluent. No adverse effects were reported(No adverse event). There was no previous temperature excursion. The temperature was - 10 degree Celsius and time frame was 3 hours. No further information was provided.  This is one of the three reports received from the same reporter.
Headache, Sedation, Myalgia, Arthralgia, Fever, Redness/Swelling @ injection site Narrrative:
Large reddened area around site, painful, warm to touch per patient; body aches and fever.
Within 13 hours of receiving the second dose, I developed severe chills, migraine, fever and extreme nausea.  I proceeded to vomit for the next 16 hours until I was able to reach my physcian who prescribed Zofran.  I was advised to take Tylenol but could not keep anything in my stomach.  At hour 18 I finally stopped vomiting and was able to take Excedrin Migraine, which dulled the headached but did not stop it.  The first 24 hours after the injection, I was able to sleep off and on.  The second 24 hours after the injection up until today, I have not be able to sleep more than a couple of hours at a time and continue to have stomach cramps.
develop floaters in the vitreous of my right eye; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (develop floaters in the vitreous of my right eye) 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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VITREOUS FLOATERS (develop floaters in the vitreous of my right eye). At the time of the report, VITREOUS FLOATERS (develop floaters in the vitreous of my right eye) outcome was unknown.            No concomitant medication provided. No treatment information provided.   Reporter did not allow further contact
8/22 after injection, mild headache. 8/24 migraine. 8/25 headache. 8/26 at 12:00 PM migraine. 8/27 migraine, nausea and fatigue. 8/28 saw doctor and prescribed Ferenal for headache. Diagnosis was adverse reaction to Hepatitis B vaccine. Patient called immunization clinic who told her the components in the vaccine could cause reaction.
Headache, severe pain and redness from slightly above to 5 inches below shot area.
This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. On 23-FEB-2015 the patient was inadvertently administered an expired dose of GARDASIL (lot # H010649 and expiry date: 20-FEB-2015). No adverse effect reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
No pain the day of the shot. Pain started that night in the lower part of the arm by the elbow. Pain continued to get worse and now can hardly move arm up in the air. Can't put on jacket. Hurts with use of arm...takes breath away and flinch. Ibuprofen does not touch the pain.
Home: Pale, limp, listless, not responding to stimuli. ED: intermittent periods of tonic activity of upper and lower extremities with clonus noted in the left lower extremity.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 23-OCT-2013 at 17:30, ZOSTAVAX lot # J004268 was exposed to -14C for an estimated total time out of range of 10.0 hours. On 25-OCT-2013 at 18:30, ZOSTAVAX lot # J004268 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 19-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Spontaneous onset of racing heart (between 90 and 119 bpm).  Continuous anxiety and panic attacks (no previous history). Anxiety not responsive to SSRI.  Heart racing subsided after one week.  Anxiety / panic attacks have been on and off for six weeks thus far.
Left arm hot to the touch, redness and sore.  Mother stated child had temperautre 10/08/2003, gave temperature resolved.  No temperature 10/09/2003.  10/09/2003.  Mother stated my child had reaction to shots had some fever on 10/08/2003.  I gave  Tylenol temperature has resolved.  No temperature today.  Only has redness to left upper arm and soreness.  He is Ok today.  He has been playing.  Left deltoid redness, hot to touch, size 3 inch by 5 inch, no temperature, no shortness of breath.  Instructed mother to place cool compress to site for x per day till redness gone and comfort.  Instructed mother to give children tylenol over the counter and to give as directed in bottle.  Instructed other to buy OTC Benadryl for child.  give as directed in bottle or container.  Instructed mother if redness and soreness worse and envolved, more OT left extremity, to seek medical care for child via own MD.  If no MD, call ER.  Nurse will assist with appontment.
temperature reached 55 F and the total excursion lasted 188.5 hours for ADACEL and was administered to a patient post excursion, with no reported adverse event; Initial information received on 25-Jan-2022 regarding an unsolicited valid non-serious case was received from the healthcare professional.  This case is linked to case 2022SA029938.  This case involves a 40 years old male patient who had product temperature excursion issue as the temperature reached 55 f and the total excursion lasted 188.5 hours for DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and was administered to a patient post excursion, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 03-Jan-2022, the patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml total (strength, form: not provided; lot number: C5863AA and expiry date: 13-Apr-2023) via intramuscular route in unknown administration site for immunization.  On 03-JAN-2022, the patient developed a non-serious event 'temperature reached 55 f and the total excursion lasted 188.5 hours for adacel and was administered to a patient post excursion, with no reported adverse event' (product temperature excursion issue) (latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "Caller reported a temperature excursion earlier today. The highest temperature reached 55 F and the total excursion lasted 188.5 hours. The ADACEL was administered to a patient post excursion. However, the caller did not have patient specific information available when they reported the excursion earlier. They called back to provide the patient information. Caller requested clarification on the Stability and Storage information, as well as the Administration Post Excursion information. The caller requested that the Stability and Storage information be emailed and faxed again. The caller was not aware of any treatment required post administration. "  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event (temperature reached 55 f and the total excursion lasted 188.5 hours for adacel and was administered to a patient post excursion, with no reported adverse event).  No further information was provided by the reporter.
100.3 fever; Minor lethargy; Occasional chills; Minor headache; This is a spontaneous report from a contactable consumer (Patient).  A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL3247), dose 2 via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included finasteride, 1mg daily for several years. The patient previously took first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. On 13Apr2021 the patient experienced 100.3 F fever, occasional chills, minor headache, and minor lethargy after 2nd dose of Pfizer vaccination. symptoms started approximately 20 hrs after vaccination. Patient stated that it was just his body immune response. He no underlying conditions, borderline obese and no significant allergies.  No follow-up attempts are needed. No further information is expected.
Soreness at injection site starting later in the day,  then severe chills, body aches, small headache, shortness of breath (used Albuterol and Icruse Elipta, and Advil for headache), gastrointestinal upset, low grade fever. This lasted all night, and subsided the next day except for gastrointestinal upset and continued redness (lessening as days go by)at injection site that has continued through March 5.
8 days after receiving first dose, right arm became itchy, swollen and hot/red at injection site