chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart palpitations 3 to 4 days after second dose; aches; tiredness; fever; chills; This spontaneous case was reported by a pharmacist and describes the occurrence of PALPITATIONS (heart palpitations 3 to 4 days after second dose), PAIN (aches), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 29-Jan-2021. Previously administered products included for COVID-19: Proair and Flovent. Past adverse reactions to the above products included Product used for unknown indication with Flovent and Proair. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and DESOGESTREL, ETHINYLESTRADIOL (ISIBLOOM) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PALPITATIONS (heart palpitations 3 to 4 days after second dose), PAIN (aches), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills). In April 2021, PALPITATIONS (heart palpitations 3 to 4 days after second dose), PAIN (aches), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was reported.
PATIENT WAS SEATED AFTER VACCINATION FOR OBSERVATION PERIOD. PATIENT FAINTED IN HER CHAIR ABOUT 10 MINUTES AFTER VACCINE. SHE CAME TO AFTER ABOUT A MINUTE OR LESS. SHE LOOKED PALE, SHE WAS GIVEN ICE PACKS, WATER, AND ORANGE JUICE. 911 WAS CALLED, PATIENT WAS TAKEN AWAY VIA AMBULANCE ON A STRETCHER.
swelling & redness w/in a day or so of inject; soft tissue injury which was debilitating; no systemic sx;
Patient states that patient was experiencing body aches and headaches the evening after vaccine administration of second dose of the Pfizer series. Three days later, patient still experiencing headaches, but body aches had resolved.  Patient took Advil on 10/6/2021, but he was not sure if he had memory loss prior to taking Advil. In the first 3 weeks after vaccine administration, patient states that short term memory is being impacted the most, but it is now affecting long term memory. Patient is having a difficult time recalling things. Patient is seen for memory issues on 12/8/2021 and awaiting test results.
I took a COVID-19 PCR test on 12/22/2022 and it was negative. Starting around midnight on 12/26/2022, I got a sore throat and a dull pain in my right ear. I went to touch it and I would get a sharp pain. I was unable to sleep due to the ear pain. I went to urgent care the next day and was diagnosed with 2 types of flu: A and B. I was having headaches and, after that, I developed fever and chills. My fever never went higher than 100.5. The PCR test at urgent care came back positive for COVID-19 but the antigen test was negative for COVID-19. I treated myself with TYLENOL and congestion meds. My fever broke on 12/30/2022. After that, I had headaches and congestion still. I had a sore throat during all of this. Also, I had some dizziness and weakened sense of balance over that weekend. On 01/04/2022, I felt my vision fading slightly and I had an event of vision disruption for about 5 min then resolved. I am still having slight congestion to this day.
Swelling if lymph node in left armpit. Armpit is swollen and tender. It is still currently swollen as of march 28th
DT given outside of recommended age. Pt should have received per representative at manufacturer, no need to revaccinate with Td.
Fever of 103, lethargic, went to urgent care, was sent to the hospital to monitor fever. Was sick for 2 weeks. Received another flu vaccine on 1/10/2013 and similar reaction occurred. Nothing was done by medical staff, other than monitoring.
acute hepatitis; transaminitis; Nausea; Vomiting; Belly pain; This is a spontaneous report from a contactable physician. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. 3 days after the Pfizer covid 19 vaccine, patient developed acute hepatitis with transaminitis. She was symptomatic, but was improving. She had profound transaminitis with nausea, vomiting, and belly pain. She had a surgical workup and emergency room workup and everything was negative and physician was calling to see if this had been described previously. What physician was seeing was elevated AST and ALT as seen following drug induced injury. Emergency room visited for the events. The outcome of events acute hepatitis and transaminitis was recovering. The outcome of rest events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Hepatitis acute, Transaminases increased, nausea, vomiting and abdominal pain cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
T104.6, 2 convuls, treated for ear infect when seen @ Hosp ER;
This spontaneous report as received from a medical assistant refers to a 9 year old patient of unknown gender. The patient's pertinent medical history and concomitant medications were not reported. On 18-JUL-2016, the patient was inadvertently vaccinated with expired dose of VARIVAX (lot # K007975, expiry date 03-JUN-2016, dose and route of administration not reported). No adverse effects were reported. Additional information has been requested.
Initial information regarding unsolicited case received from Pharmacist on 08-Oct-2013: This case involves a 57-year-old patient (gender unknown). The patient's past medical history hypertension and hypothyroid. Concomitant medications were not reported. On 04-Sep-2013, the patient received FLUZONE (dose and indication were not reported) (Lot# UH909AA and expiration date unknown) at left deltoid site. The patient also received PNEUMOVAX (Lot # H014196) at left deltoid site and TWINRIX (Lot # AHABB276AB) at right deltoid site on 05-Sep-2013. On 05-Sep-2013, the patient woke up the morning after the vaccine was administered and felt lethargic, had difficulty lifting her head, neck stiffness, body aches. No fever reported. The outcomes of the events were recovered. No further information provided. List of documents held by sender: none.
had COVID in Jul2022; had COVID in Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8733), on 19Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "known allergies: Alcohol" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "had COVID in Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (12Jun2023) Negative, notes: Blood test; (03Jul2023) Negative, notes: Blood test; (12Jun2023) Negative, notes: Blood test; (03Jul2023) Negative, notes: Blood test. Clinical course included that patient had also received BNT162b2 (BNT162B2), on 25Oct2022 as dose 4 (booster), single (Lot number: GH9703) in left arm, on 09May2023 as dose 5 (booster), single (Lot number: FJ4991), in left arm for COVID- 19 immunisation.
Extreme dizziness that turned into vertigo with nausea and vomiting.  Had to be prescribed anti nausea.  Happened with both the first and second shot. The negative reaction came quicker with the second shot.
For about a week, small red area at vaccination site, about 1/2 inch in diameter, tender to touch. Then it subsided after a week,  and CAME BACK 10 days after vaccination on  01/25/2021, but larger (now about 1 1/2 inch diameter).
Starting approximately 3hrs after vaccine administration pt began to experience significant diarrhea. Mom states pt has not had any fevers, sick contacts, difficulty breathing, decreased level of activity, or increased sleep. Pt experienced ~30 diarrhea stools after vaccination before presentation to ED. ~30 hours persistent diarrhea & dry mucus membranes, tachycardic, concerning for dehydration. Pt given 20ml/kg NS bolus, electrolytes wnl, pt improved clinically, had wet diaper w/o diarrhea during stay. Pt brother required hospitalization for same after he received his rotavirus vaccination several years ago.
T104F, & agitated; MD called; Instructed to give APAP; delirious, speaking but not making sense; No LOC; Lt arm swollen by 3PM; inc temp & agitation duration 3 days; 20JUN91, child broke out in chicken pox-like rash;Lt side lymphadenopathy;
tired; sleepy; This case was reported by a pharmacist via other manufacturer and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced tiredness and sleepiness. In January 2020, the outcome of the tiredness and sleepiness were recovered/resolved.   It was unknown if the reporter considered the tiredness and sleepiness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient was tired and sleepy after vaccination. No further information were provided.
Weak, nausea, stomach pain, blurred vision, arm pain Phenergan for nausea.
Immediately dizzy, diaphoretic, cold, clammy, blurred vision, pale, BP 60/86, pulse thready, Epi 0.5 given per RN, pulse better 86. Receipts and all information regarding Flu shot given to pt before transport to ER, Police arrive, then EMS arrived took to ER alert, orientated and feeling better. Cold pack followed and appropriate at time of administration of vaccine.
do experience some  increased fatigue at intervals.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (do experience some  increased fatigue at intervals.) 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.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, 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 FATIGUE (do experience some  increased fatigue at intervals.). At the time of the report, FATIGUE (do experience some  increased fatigue at intervals.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: low (Low) Mid forties to low fifties beats per minute and 38 (Low) At rest patient have recorded it at 38 beats per minute at times.         No concomitant medications were reported.  Treatment information was not provided. Patient received 2 doses of Moderna in March. Since then, the heart rate has lowered from seventies to the mid forties and low fifties. At rest patient have recorded it at 38 beats per minute at times.
approx 1 & 1/2 wk post vax pt noticed generalized malaise, lymph node swelling of rt axillary area, rt groin & lateral anterior cervical nodes on the neck, joint aches, fever & body aches lasted 48-72hr;
Twelve Moderna vaccines were given in office .Only 11 were drawn up this morning and the 12th dose was, most likely, a left over dose from yesterday. After incident was discovered, Moderna manufacturer was contacted per CDC recommendation. Quality was also notified.   Patient notified with The Moderna Vaccine received may have been outside of the 6 hour thaw recommendation. We contacted the Moderna manufacturer and CDC. At this time, there are no recommendations for revaccination. Pt will still receive your 2nd dose as previously scheduled. Titers will be available at no cost in 2-3 months after your second vaccine.
She got the vaccine, started out with fatigue and a headache about 19 hours later . Between 19-24 hours started getting nausea and vomiting and then developed cramping in her stomach, diarrhea, chills which lasted 24 hours.   She had pain in her arm at the injection site ,which were normal  She swears she will not go back for another vaccine.  The sore throat and throwing up were horrible.   She took for the diarrhea some Pepto and lasted about 24 hours and raw from that, so she decided to take something to stop it.  The cramping in the abdomen was the worst.   The symptoms lasted until the afternoon of the 25th.   She is due for her 2nd vaccine today, 4/13/21.
Fever, respiratory paralysis, etc. Admitted for about 2 wks. Under care of neurologists including automatic respirator.
This case was reported by a nurse via call center representative and described the occurrence of attention concentration difficulty in a 60-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. Co-suspect products included Hepatitis A vaccine for prophylaxis and DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. Concomitant products included clindamycin (Clindamycin Gel), estradiol (Estradiol Vaginal) and colecalciferol (Vitamin D3). On 21st May 2018, the patient received the 1st dose of SHINGRIX, Hepatitis A vaccine and dTpa vaccine. On 21st May 2018, less than a day after receiving SHINGRIX, Hepatitis A vaccine and dTpa vaccine, the patient experienced attention concentration difficulty. On 22nd May 2018, the patient experienced chills, sweating, injection site rash and injection site pain. On an unknown date, the outcome of the attention concentration difficulty, chills, sweating, injection site rash and injection site pain were recovered/resolved. The reporter considered the attention concentration difficulty, chills, sweating, injection site rash and injection site pain to be possibly related to SHINGRIX. It was unknown if the reporter considered the attention concentration difficulty, chills, sweating, injection site rash and injection site pain to be related to Hepatitis A vaccine and dTpa vaccine. Additional details were reported as follows: The patient received SHINGRIX in the right deltoid. On the day of vaccination, later that evening, the patient had difficulty in focusing while watching the television. The patient stated, she knew she was watching television but could not focus or did not know what she was watching and that this felt weird. The next day after receiving SHINGRIX, the patient experienced chills, sweats, rash around the arm injection site and pain at the injection site. The manufacturer of concomitant vaccines were not asked during the phone consultation.
pt recv vax & devel temp104;pt taken to MD adm to hosp for suspected sepsis workup;@ hosp t103.6 & irritable & fussy;LP showed 361 white cells w/31 red cells;protein was 50;dx aseptic meningitis
Initial report received from a consumer on 22 November 2011. This is a non valid case as contact information is missing. An 86-year-old female patient received an injection (route and site not reported) of INFLUENZA VACCINE, manufacturer and lot number not reported, on 18 November 2011. The patient experienced, a few hours after influenza vaccine, extreme tiredness and pain all over, abdominal pain and feeling of not with it. The patient could not wake up and was seen in the Emergency Room (ER). The patient required hospitalization. The patient was discharged from the hospital but was still very tired and "not right". The patient only wanted information on how to reverse the shot effects and terminated the call. No contact information was provided. The outcome was reported as unknown. Documents held by sender: None.
Pfizer-BioNTech COVID-19 Vaccine EUA  On my right hand, I noticed a small red spot, which has progressed into a larger red spot with a darker interior. It has minor soreness when touched. Showed to my husband (a physician) who thinks that it is erythema multiforme. Diameter of the spot is about 1 inch.
3 Feb 2021:  Around  14:00 the patient received her Vaccine Dose. Soon after while sitting in observation, the patient began to experience "hot" red ears and alerted Medic Staff, who observed redness spread down the neck and onto the chest.  The patient stated that she was not experiencing any itching or shortness of breath at that time. She was observed by medic staff who took medical history and observed the patient for escalation of symptoms. She was given 50mg of diphenhydramine at 14:44 following post vaccine anaphylactic protocol. She still reported zero itching and swelling or SOB. 14:53  BP recorded at 238/146 HR 108  pulse ox: 96%.   EMS was called and arrived on scene and was turned over to their care at 15:15.
Decrease Energy and appetite, redness and swelling at injection site, persistent cough, dry heaving, constipation, fever.
Patient returned to clinic 45 minutes after immunization was administered with erythematous macular papular rash diffusely all over. No throat swelling, wheezing, or SOB noted. Child was playing and acting normal.
I felt unwell Thursday night. The next morning felt worse and took a COVID-19 test and it was positive right away. I went to the COVID-19 clinic and was given PAXLOVID for the 5 days, it didn't make symptoms any worse or better. I had a severe headache at first achiness, runny nose, slight cough, nausea. I was extremely tired after the PAXLOVID for quite a while. Now I'm ok.
Urticaria on face, itching, but he was alert awake, after 30 minutes of the vaccines. He was given BENADRYL 17.5 mg by mouth, he was referred to the ER for observation where he stayed 3 hours then d/c home.
It was reported post vaccine's pt developed scattered areas of pink/red lesions on lower extremities.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of PEDVAXHIB (lot#, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. Follow up information has been received from an other reporter on 07-JUL-2015 and refers to a 9 weeks old patient of unknown gender. On 04-JUN-2015, the patient was vaccinated with a dose of PEDVAXHIB lot # K016965, expiration date 20-JUL-2017. This is one of several reports received from the same source. Additional information has been requested.
t107 & sz 27NOV or 28NOV96 to ER via ambulance;sl temp earlier in day-teething but spiked in PM;IV 6hr & wrapped in towels;ER MD felt rxn to MMR vax;no other hlth problems @ that time;recovered;
On 10/19/01 at 01:00, had severe pain in right arm. She called the doctor and he told her to take Benadryl and ibuprofen. Her arm was swollen between her elbow and her should and was red but no itching. She had red blotchy areas and was hot to touch. On 10/20/01 AM, she had increased swelling down toward her wrist and under her armpit. Her temperature was 101.4F. Nausea started and she went to ER.
Narrative: Patient's daughter called 4/15/21 stating Patient is c/o of both of his arms hurting "from the Johnson and Johnson vaccination". She said he thinks he "has a blood clot". Patient received Vaccine MARCH 18th in Rt Deltoid. Notified PCP. Patient advised to go to ER if he believes he is having a blood clot. Verbalized understanding. On 4/19: Message left for Patient to monitor for the following symptoms over the course of three weeks after the vaccination. * A headache that occurs 6 days or more after vaccination * A headache that is different from other headaches you have had * Confusion or trouble thinking clearly * Visual changes, such as blurry vision * Weakness, numbness, or trouble moving one or more parts of your body of your body, trouble speaking or seizures * Tiny spots under the skin away from the area where you had the infection (this is a sign of low platelets) Patient instructed to contact their health care provider if one or more of these symptoms develop. If symptoms are sever, seek immediate medical attention at the closet emergency department of call 9-1-1
Breakthrough. Tested positive for Covid on 9 May 2021. The test was saliva  My husband, who received shots of Moderna on 4/12 and 5/10 also tested positive for Covid on 5/12/21. His test was also saliva .
This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Inflammation of sinus cavity), FATIGUE (Really tired), MYALGIA (Arm was not that sore) and HEADACHE (Headache worsened) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00321A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Pollen allergy.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced FATIGUE (Really tired) and MYALGIA (Arm was not that sore). On 01-May-2021, the patient experienced HEADACHE (Headache worsened). On 06-May-2021, the patient experienced SINUSITIS (Inflammation of sinus cavity). At the time of the report, SINUSITIS (Inflammation of sinus cavity), FATIGUE (Really tired), MYALGIA (Arm was not that sore) and HEADACHE (Headache worsened) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: Inflammation of sinus cavity.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Rizatriptan, Flonase, Claritin, Nasacort, Aleve and Advil   This case was linked to US-MODERNATX, INC.-MOD-2021-114194 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114194: