chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THE PATIENT RECEIVED THE VACCINE AROUND 1PM AND BY 6PM SHE WAS EXPERIENCING RINGING IN THE EARS, A RACING PULSE (DESCRIBED TO BE AROUND 180). SHE SAID SHE NORMALLY GETS THE CHILLS AND A FEVER OVERNIGHT AFTER A FLU SHOT BUT THIS WAS FAR WORSE THAN SHE HAD EVER EXPERIENCED. SHE CONTINUED TO FEEL FUNKY OVERNIGHT BUT DIDN'T END UP TAKING ANYTHING. SHE CONSIDERED GOING TO THE ER BUT DECIDED TO WAIT IT OUT AND FINALLY WAS ABLE TO SLEEP AND SAID SHE STARTED TO FEEL BETTER AROUND 6AM THE FOLLOWING MORNING.  SHE SAID SHE WAS ILL FOR ABOUT A TOTAL OF 12 TO 24 HOURS.
Breakthrough case admission after 3 vaccines Moderna 3/2/21 Lot# 030L20A;  Moderna 3/30/21 Lot# 002B21A;  Moderna 11/17/21 Lot# 004F21A;
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 28-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L049314, expiration date 03-DEC-2017. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
1PM pt began to vomit & had a h/a; mom denies flu in family or friends & was feeling well prior to vax; ran fever for 3 days was as high as 105.5 on 2nd day - 101 3rd day - 99 on 4th day & very tired; arm sore;
This study case was received from the investigator on 13 February 2013. A male subject (birth date not reported) had received the ACAM2000 (lot number, route, and site of administration not reported) on 29 January 2013. The subject had also received the following vaccinations on 29 January 2013: anthrax vaccine (manufacturer, lot number, route and site not reported) and tetanus/diphtheria vaccine (manufacturer, lot number, route and site not reported). On 08 February 2013, 10 days post vaccination, the subject with benign past medical history was noted to have lab troponin = 0.26 ng/mL (rapid troponin normal). The subject denied any cardiac symptoms. The subject reported headache and "neck tension" for which he took TYLENOL 325 milligrams orally as needed. On 11 February 2013, the lab troponin was < 0.10 ng/mL. The electrocardiogram from 11 February 2013 was normal. The subject was referred for care but was unable to be reached for further information on care received. The subject's outcome was reported as recovered on 11 February 2013. According to the investigator, the event of elevated troponin was considered probably related to vaccination. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: none.
11/18/07 attempted to vaccinate pt with influenza vaccine. It appeared that vaccine was leaking from syringe. Not sure of how much vaccine may have been administered. Contacted CDC regarding situation. CDC did not return call. Called CDC again 11/19/07 and their recommendation was to re-vaccinate pt. Pt came in for re-vaccination 11/22/07. Pt had no complaints and was feeling well.
Still have red, warm injection site 10 days after received vaccine. It was warm and red at the injection site soon after receiving the vaccine, arm was tender the next day but thought I should report this since the site is still red, warm and slightly tender 10 days later. A 3x3 red warm area still slightly tender to touch & itches.
Trouble breathing; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included headache (the patient had all these headaches prior to the first injection and prior to yesterday second injection) from an unknown date and unknown if ongoing. The patient's concomitant medication was not reported. Historical vaccine included tetanus vaccine and a shingles vaccine in Oct2020. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced trouble breathing. The outcome of the event was unknown.  No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.
2d after vaccine: erythema, swelling & bulla around site of injection, fever last night but not today. No vomiting no trouble breathing positive diarrhea.
Immediately after injection, severe pain in upper left arm, loss of range of motion, that continued on for 3 weeks. Called the Pharmacy where I received the shot, they suggested I go to my doctor.  I went to my Doctor yesterday....Wed  Nov 7,2018 and received two Rx's :  MEDROL pack, FLEXERIL 5mg and Slow Mag. Dr. said to return to his office in 2 wks if not better.
No additional AE; an expired dose of RECOMBIVAX HB was administered; This spontaneous report was received from registered nurse concerning a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not provided.  On 02-NOV-2021, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # S022584, expiration date: 31-OCT-2021) (dose number, route of administration, and anatomical location were not reported) for prevention of hepatitis B (Expired product administered).  No additional adverse event was reported.  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA000945:
Child woke up at 2330 with hives and itching.  Hives mostly on arms and sides. Benadryl was given. Taken to the ED and given Decadron and Benadryl.  Improvement noted on 10/23/2009. 11/6/09 Medical records received for date 10/22/09. DX: Allergic reaction acute. Chief c/o generalized uticaria with itching. Received H1N1 vax 1 day previous. Assessment: hives on legs, arms, chest. Rash generalized. Pt. dc home rash resolved after tx.
about 430-5Pm itching all over body, scalp;DPh helped but was cont for 1wk;
30 minutes after vaccination an area of the patient's LEFT elbow began to swell to about the size of an egg. The patient reported the spot felt "like a bruise". The patient was more panicked than in pain. The pharmacist drew a circle around the swollen area with a marker and instructed the patient to go to urgent care to be examined.
Delayed injection site reaction; Injection site hard/Injection site induration; Injection site itchy; Injection site hivethe size of a miniature orange; Injection site swelled; Joint aches; Muscle aches/Myalgias; Injection site redness; A spontaneous report was received from a physician concerning a 45 years old, female patient who experienced delayed injection site reaction/delayed skin reaction, injection site hard, injection site induration/vaccination site induration, injection site itchy/vaccination site pruritus, injection site hive the size of a miniature orange/vaccination site urticaria, injection site swelled/vaccination site swelling, joint pain/arthralgia, muscle aches, myalgias/myalgia and injection site redness/vaccination site erythema.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 24 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:39K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient experienced delayed injection site reaction, injection site hard, injection site induration, injection site itchy, joint pain, muscle aches, myalgias.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The events, injection site hard, injection site induration, injection site itchy, injection site swelled, joint pain, muscle aches and myalgias were resolved o 03 Jan 2021.  The outcome of the events delayed injection site reaction, injection site hives the size of a miniature orange, injection site swelled, and injection site redness were unknown.
Reddened, tender,  raised lesion approx 3in in diameter to injection site
RASH NEAR INJECTION SITE THAT BEGAN 9 DAYS POST ADMINISTRATION
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old male patient who was vaccinated with 0.5 ml PENTACEL (batch number: C5506AA, expiration date: 05-Sep-2019, route: intramuscular and site of administration: right thigh) but only the HIB portion was administered to the child, on 29-Aug-2018. The patient's medical history was not reported. Concomitant medications included PREVNAR 13, PEDIARIX, ROTARIX on 29-Aug-2018. It was an actual medication error due to inappropriate reconstitution technique. The patient had no adverse event. 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 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. List of documents held by sender: none.
On 4/14/21 patient reported a splotchy, itchy rash on the trunk of his body that started about 5-6 hours post vaccination.  On 5/3/21 the patient called and said he was still struggling with the same symptoms.  On 5/21/21 the patient stopped by the pharmacy and showed the pharmacist the splotches on his torso.  The pharmacist suggested he seek medical attention which he did and returned with a prescription for prednisone taper.  On 6/15/21 the pharmacist followed up with patient.  He said it symptoms were nearly resolved.  He will complete another course of prednisone.
Chills, fever of 102, body aches and pains, nauseousness, dizziness, loss of appetite, night sweats, increase in blood pressure.
Moderna COVID 19 vaccine EUA Not a big deal but I?m surprised to have redness, swelling and minor discomfort at the vaccination site 8 days after vaccine received. Literature says 2-3 days is normal.
Information has been received from a physician concerning a 9 year old female who in 1996 was vaccinated with a dose of varicella virus vaccine live. On 28Jun04 the physician reported that in Jan 2004, the pt had a mild case of chicken pox breakthrough and she has a mild case of chickenpox now. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Given MMR left thigh on 9/25/06.  Erythema and swelling left thigh 9/26/06.  Some oozing by site 9/27/06----->AUGMENTIN  syrups.  Clear 9/29/06.
I was getting at home treatments and I was using a lot of medications because I could not get my head to stop hurting. I called my neurologist to schedule and appt. I was having IVIG treatments and the headaches became uncontrollable. I saw Dr. and he advised to continue my medicine and to schedule a f/u. He noticed I developed a rash and he said he thinks it was an autoimmune reaction and I would have to let it run it's course. I received a shot of Torodol and it helped. It aborted the cycle that I was in. I finally felt like I was able to get everything under control. Overall, my joints still hurt, but I feel that I can manage. My days seems to end early because of extreme fatigue.
Expired booster shot of moderna vaccine administered to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired booster shot of moderna vaccine administered to a patient) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer on 15-Apr-2021 and Pfizer on 08-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired booster shot of moderna vaccine administered to a patient). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired booster shot of moderna vaccine administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.  Vaccine was given to a patient on 17 Dec 2021 after it was expired on 16 Dec 2021. The vial was initially stored in the refrigerator on 14 Dec 2021 and it was first punctured on 16 Dec 2021 at 10am PST and administered on 17 Dec 2021 at 10am PST.
No pain at time of or day of injection-next day shoulder pain radiating to neck and pectoral area. Called our office 12/15/16 with symptoms. Still having pain relieved by high dose of MORTIN-suggested next 3xday 15 mins continue NSAID call MD if not better 12/20/16 - not much relief can't see MD until 1/19/17, still pain Deltoid muscle hard.
Fever 103F, pain of left upper arm, redness, induration 8.5cm x 6.5cm. Treatment with Ancef, Bactrim, Flagyl. The pt developed diarrhea. 2nd day of admission cellulitis started decreasing, decreased WBC, CT scan chronic sinusitis. D/C med: Augmentin, Flagyl, Bactrim, Advair, Flonase. 11/18/05 Per review of d/c summary cellulitis secondary to Pneumovax immunization was confirmed as final diagnosis.
covid arm; a rash; it itches; a little swollen; This spontaneous case was reported by a patient and describes the occurrence of SKIN REACTION (covid arm), RASH (a rash), PRURITUS (it itches) and PERIPHERAL SWELLING (a little swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced SKIN REACTION (covid arm), RASH (a rash) and PRURITUS (it itches). 11-Feb-2021, the patient experienced PERIPHERAL SWELLING (a little swollen). At the time of the report, SKIN REACTION (covid arm), RASH (a rash), PRURITUS (it itches) and PERIPHERAL SWELLING (a little swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021:
Injection reaction. Red, sore, left arm.  Size of a baseball. I was also given flu booster but called pharmacy to confirm which one was given in left arm.
Patient is 12 years old and received the pediatric dose of 0.2 ml.  Patient should have received 0.3 ml of adult dose
Patient was admitted to the hospital for 2 days. Admitting diagnoses were weakness, SIRS, and Sepsis without acute organ dysfunction due to unspecified organism. Final diagnosis on discharge were: Final Diagnosis: 1.)  SIRS, though no infection found, this is likely due to the flu injection 2.)  Pulmonary fibrosis, on chronic mycophenolate 3.)  Mild NIDDM, stable 4.)  Cor pulmonale secondary to his lung disease, on aggressive diuretics at home 5.)  CKD, stage 3, stable 6.)  AFIB, on rivaroxaban 7.)  History of alcoholic cirrhosis, stable
dry eyes; ocular rosacea; hard bumps; hard bumps; acne; This non-serious case was reported by a consumer via call center representative and described the occurrence of eye dryness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received one Shingles injection before on an unknown date from different manufacturer).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced eye dryness (Verbatim: dry eyes), ocular rosacea (Verbatim: ocular rosacea), local swelling (Verbatim: hard bumps), induration (Verbatim: hard bumps) and acne (Verbatim: acne). The patient was treated with doxycycline. Shingrix was discontinued. The outcome of the eye dryness, ocular rosacea, local swelling, induration and acne were unknown.   It was unknown if the reporter considered the eye dryness, ocular rosacea, local swelling, induration and acne to be related to Shingrix.     It was unknown if the company considered the eye dryness, ocular rosacea, local swelling, induration and acne to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-OCT-2023 The patient self-reported this case. The patient reported that, she had one injection of the Shingrix and then experienced the noted issues. She had dry eyes, ocular rosacea, hard bumps and acne, this happened about 3 to 5 months ago in 2023 (from the date of reporting), she really not sure about the timeline. She further stated she had seen eye doctor and dermatologist.  She was receiving Doxycycline for her eyes. She did not receive the second dose of Shingrix.  The patient stated these events were still occurring on and off. They resolve then reappear. The reporter did not consent to follow-up.
I started vomitting on and off afternoon receiving the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the arm left on 20May2021 at 16:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history included soy allergy. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the arm left on 27Apr2021 at 16:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Prior to the 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 vaccination. On 20May2021 at 19:00, the patient started vomiting on and off afternoon receiving the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event vomiting was resolved on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Administered MMR Vaccine following Negative result for Rubella IgG Titer on 6/27/2005.  Received 2nd Hepatitis B Vaccine on July 6, 2005. Began to experience fever, headache, mucsle soreness and neck stiffness on July 9 and 10.  Notified Clinic on 7/11/2005 at 5Pm  Advised to take Tylenol for fever and pain and come to clinic in Am.  Today feeling much improved with resolving neck stiffness.
The morning of 4/25/01 the pt noticed redness and swelling of right upper arm at the injection site. Area approximately 6 x 4 inches, slightly warm to the touch and tender.
Redness 10 cm, swelling, mild pain, mild tenderness at injection site of right arm. Left arm - normal.
Pt presented to Hospital on 10/31/2009. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome and was treated with IVIG.
tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Subsequently post vax, the pt's lab values indicated that the pt failed to seroconvert.
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unspecified dates, improperly stored doses of ROTATEQ orally (dose, lot # and expiration date were not reported) were administered to the patients. The vaccine was stored in the temperature between 46 and 77 degrees Fahrenheit for 15 minutes and between 32 and 36 degrees Fahrenheit for 18 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports received from the same source. Additional information is not expected as no consent for contact with the reporter was given. Sender's Comments: US-009507513-1702USA006676: US-009507513-1702USA006711: US-009507513-1702USA006712: US-009507513-1702USA006714.
Patient fainted within a few minutes after injection, patient was sitting on exam table while medical assistant and patient's aunt were scheduling the patient's follow up visit, patient fell forward onto the floor, patient landed on her face and broke off part of her two front teeth.
Fever, chills, nausea, Muscle hurt all over, Arm swelled and was hard around the injection site, Pain radiated under arm, redness for days and hardness. Sick even today 12/19/2016 intradermal flu vaccine.
had some swelling in that area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACICNE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "had some swelling in that area".  Additional information: The report was received from a Pfizer sponsored program. The patient also received the 2nd dose on an unspecified date and they angled the needle and it entered into her deltoid and she wanted to know about the efficacy of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.