chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart was beating a little heavier than usual, racing heart skips a beat; memory issues; arm sore; warm in her chest and back and up through her neck and the back of her head; trouble talking; A spontaneous report was received from a consumer concerning an 82-year-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hot, warm in her chest and back and up through her neck and the back of her head, trouble talking, heart beating a little heavier, arm aches, arm sore, heart condition-racing heart-skips a beat, memory issues.  The patient's medical history included transient ischemic attacks (TIAs), vertigo, and heart condition-racing heart-skips a beat since she was 36 years old.  Concomitant medications reported were clopidogrel, levothyroxine, atorvastatin for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 029A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 04 Mar 2021, the patient experienced the event(s) hot, warm in her chest and back and up through her neck and the back of her head, trouble talking, heart beating a little heavier. On 05 Mar 2021, the patient experienced the event(s) arm aches. arm sore. On an unknown date, the patient experienced the event(s) heart condition-racing heart-skips a beat. 2 TIA's, vertigo, memory issues.  Treatment details included  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), hot was unknown, warm in her chest and back and up through her neck and the back of her headtrouble talkingheart beating a little heavier arm achesarm sore heart condition-racing heart-skips a beat2 tia's vertigo memory issues was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
THREE DAYS AFTER GETTING HIS 2ND DOSE OF MODERNA THE PATIENT DEVELOPED SOB AND WAS FOUND TOP HAVE BILATERAL PULMONARY EMBOLISM AND DVT
ear infection; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events ear infection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) ear infection.  Treatment details included She was given a 10 day regimen of cefdinir by her primary care physician for an ear infection on, 09FEB2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), ear infection,  was unknown.
Information has been received from a RN concerning a 6 year old white female with no pre existing allergies, birth defects or medical conditions who on 10/09/1998 was vaccinated SQ with a 0.5ml first dose of varicella virus vaccine live. There were no illness at  the time of vaccination. Concomitant medications included a first dose of MMR virus vaccine live administered SQ on 09/07/2004, the pt developed 20 lesions. The MD told the pt to take Benadryl for itching. Unspecified medical attention was sought. Ther ewas no product quality compalint. Follow up infomration receivedd from a RN indicated that on 09/04/04 the pt developed a varicella rash with 20-50 lesions that lasted for 1.5 weels/ The outcome was reported as recovered on approximatiely 09/15/2004. There were no relevant diagnostic tests or lab data.
Swollen eyes, swollen cheek, swollen throat, sore throat, small rash on various parts of body.
Member received smallpox vaccine 05Apr2012. Began with right facial paralysis on 20Apr2012. Went to ER 23Apr2012, Diagnosis: Bell's Palsy/Released on Prednisone and VALTREX.
Pt walked in clinic w/ father c/o the R upper arm swelling, redness, tender to touch. Pt received Tdap and Menveo on R arm. Skin intact and T- 99.8. Advised of local reaction, ice, home treatment, and monitor for increased pain and swelling. Advised to seek MD care if worse. Parent agreed w/ plan.
swelling in her arm (on the injection); This is a spontaneous report from a Pfizer-sponsored program  from contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) via an unspecified route of administration on 19Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Previously patient took first dose of BNT162B2 on 29Mar2021 for COVID-19 immunization. In 2021, she was calling to inquire how long the swelling in her arm (on the injection) would last. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Relative has a bladder infection; This is a spontaneous report received from a contactable consumer for her relative via Pfizer sponsored program.   A  female patient of unspecified age  received BNT162B2 (BNT162B2, formulation: solution for injection, lot no: unknown ), via an unspecified route of administration on 21-MAR-2021 as SINGLE DOSE for covid-19 immunisation. Medical history and Concomitant medication were not reported. on unspecified date, the patient experienced bladder infection and she was prescribed Cipro. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Notice hive like 1 cm raised area 1 inch from injection site R arm where varicella was given SQ. Notified M.D. via phone. He ordered BENADRYL liquid PO be given. BENADRYL given, VS WNL lungs clear. All three injection sites clear. Child observed until 1113. Area had resolved - Notified M.D. who gave OK to release pt, Mom notified us in person on 3-12-09 that no further difficulties.
Nerve palsy in right eye causing double vision.  Cat scan no results yet.  Prism on glasses to correct vision.
Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 2:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  The patient did not have any adverse events and did not require any medical attention after receiving the dose.
Patient's injection site started swelling up shortly after injection. Patient was given 50 mg diphenhydramine injection in opposite arm, and the affected injection site was iced.
This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion), CHILLS (Chills), FATIGUE (Severe fatigue), PYREXIA (Fever) and MYALGIA (body aches) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (nasal congestion), CHILLS (Chills), FATIGUE (Severe fatigue), PYREXIA (Fever) and MYALGIA (body aches). At the time of the report, NASAL CONGESTION (nasal congestion), CHILLS (Chills), FATIGUE (Severe fatigue), PYREXIA (Fever) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information provided.
Per MD's note on patient's chart on 2/26/21: Spoke with both the patient's mother and father today. Patient is 16 and received Moderna vaccine. Both state's current guidance and my correspondence with CDC indicate that she should receive 2nd dose of Moderna and not change to Pfizer. Patient does have a history of Rett Syndrome (rare neurologic genetic defect). Parents report 1 week after receiving Moderna vaccination, she experience her first seizure and was transported and treated at Hospital. Seizures can be a feature of this disorder but the patient had not experienced one in the past. Her parents report that her Neurologist does not believe the seizure to be related to vaccination. I informed parents I would search the VAERS system for similar reports. They were not enrolled in V-Safe, but I encouraged them to do so and gave them a link to the CDC site for registration. Correspondence with CDC (via email): "If the Moderna vaccine is inadvertently administered to patients 16 or 17 years old instead of Pfizer-BioNTech as the first dose, CDC currently recommends that the Moderna vaccine may be administered as the second dose (as off-label use). The second dose should be administered as close to the recommended interval as possible, 28 days for the Moderna vaccine. Additional information regarding administration errors and deviations can be found in CDC?s current interim clinical considerations regarding mRNA COVID-19 vaccines.
mom w/child for vax 12MAR93 states pt became pale & limp w/in 24 hrs following 1st shots; also vomiting; mom took pt to PMD; MD recommended pt not get pertussis on next shots;
I started to have a head ache, back ache, and neck ache. I started to run a low grade fever the night of 05/21/10. By Saturday 05/22/10 I began to run a fever around 100 degrees. By Saturday night I ran a high fever of 103 with severe body pain and ache, which could not be resolved with over the counter meds. The site where I received the pneumonia vaccine was a hard, red, hot knot. I could barely move my arm and it is still sore. I continue to run a temp today, Monday 05/24/10. I have no illness symptoms except for body ache and fever.
Fever and chills within 24 hours of dose that lasted for about 12 hours.  I have had various other things that may or may not be related to the vaccine but they are unusual for me.  I have ran a low grade fever of 99. to 100.2 about 50% of the time since my booster.  I have experienced ringing in my ears since around the time of the booster.  My level of inflammation has increased and made my regular activities more difficult.  I have had spuratic periods of heart palpitations.
My vaccine was 12/22/2020. I ended up with a sinus infection that required antibiotics. I didn't get tested because my symptoms carried on until 1/5/2021 (stuffy nose, fatigue).
This case is part of 2 cluster cases and is linked with 2013SA098949 (same reporter and same product lot number). Initial report received from a healthcare professional on 18 September 2013. An adult patient (gender not reported) had received 0.5 ml subcutaneous dose of FLUZONE vaccine in the deltoid region on 16 September 2013 (lot number: UH905AB). The patient did not have any medical history and details of concomitant medications were not reported. It was reported that the patient received FLUZONE SC instead of IM and from an hour after vaccination to 48 hours after, the patient had pain, redness and swelling at site. The patient was treated with TYLENOL. The patient also reported to have dizziness. The laboratory details were not reported. At the time of this report, the outcome was not reported. List of documents held by sender: None.
Information has been received from a physician concerning his daughter, a 27-month-old female who in July 2006, was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck). It was unknown if the vaccination was given with a single dose vial or pre-filled syringe. On 01-AUG-2007 the patient developed "papular lesions all over her body" which progressed to "exfoliating bullae and punched out ulcers," that could best be described as "full blown chicken pox." The patient was treated with antibiotics in case of secondary infections. On an unspecified date the patient recovered. No product quality complaint was involved. Additional information is not expected.
Menactra was grabbed as mistake and administered to the patient, 12 yo patient who was given a second dose of Menactra. The first dose was given at age 11 with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient by whom Menactra was grabbed as mistake and administered to the patient, 12 yo patient who was given a second dose of Menactra. The first dose was given at age 11 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml (once) dose of suspect Meningococcal A-C-Y-135 (D Conj) Vaccine (lot U7273BB, expiry date; 24-Apr-2023, formulation, strength: unknown) via intramuscular route at administration site left (unspecified) for immunization or Tuberculin skin test.  On an unknown onset and latency, It was reported Menactra was grabbed as mistake and administered to the patient, 12 yo patient who was given a second dose of Menactra. The first dose was given at age 11 with no reported adverse event (wrong product administered).  Action taken: Not applicable.  Outcome: Unknown   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 guidelines. 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.
I was given a TB test with the wrong medication it was tetanus instead of Tuberculin.  I developed a raised red rash with warmth around the area that is still growing.
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II (lot # M011666 [expiration date 08-MAR-2018] and lot# M040558 [expiration date 03-OCT-2018]) (dose and route unknown) for prophylaxis (incorrect product storage). Concomitant therapies included sterile diluent (manufacturer unknown). The nurse confirmed that sterile diluent (manufacturer unknown) was properly stored. No adverse effects were reported. The temperature excursion was between 47 degrees Fahrenheit (F) to 77.4 degrees F (66.4 degrees F) for a time frame of 3 hours and 22 minutes. There was no previous temperature excursion. This report was because of data logger. This is one of several reports from the same reporter (1708USA002328, 1708USA002361 and 1708USA002362).; Sender's Comments: US-009507513-1708USA002361: US-009507513-1708USA002328: US-009507513-1708USA002362:
Fatigue and headache initially followed by nasal congestion and sore throat, dry cough. However, loose stools about 6 times a day have occurred since the second dose of Moderna on 3/31/2021. She has not been able to form a solid firm stool ever since (more than 6 weeks later). Energy levels have also been low ever since.
Patient was to received their first bivalent booster dose (4th dose total.  Primary series completed.).  Patient instead received the Pfizer monovalent vaccine by error.
Severe stomach cramps, vomiting, diarrhea, dehydration, muscles locked up
Near-syncopal episode. Weakness, dizziness, diaphoresis, headache, body aches.
pt developed rash-Hives approximately 5 hours following vaccination. Approx. 36 hours following vaccination rash progressed and pt developed swelling of face and hands. Rash resolved day 5 following vaccination. Tx w/Benadryl
Heavy menstrual bleeding starting a few days after date of vaccination. (Normal period ended just before vaccination) Heavy menstrual bleeding for almost 28 days straight and counting.  Passing abnormally large clots everyday and soaking through both a super tampon and super pad together in about an hour.
Metal taste in his mouth after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-2021547682 (Pfizer).  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 05May2021 (Lot number: EW0171) at the age of 32 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 05May2021, outcome "unknown", described as "Metal taste in his mouth after receiving the vaccine". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: Caller states Someone caller know received the Pfizer COVID-19 Vaccine on 05May2021 and reported metallic taste. Caller wants to know if this has been reported with the vaccine. Response received as spoke from the attached document. Informed caller metal taste post vaccination has not been reported with the vaccine. However these may not be all the possible side effects of the Pfizer-BioNTech COVID-19. Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19. Vaccine was still being studied in clinical trials. Please speak to your HCP for more information. Treatment: reporter stated, No, he hasn't. Patient History, Other Products and Investigation Assessment was reported as no.  No follow-up attempts are possible. No further information is expected.
peripheral neuropathy; swelling; This is a spontaneous report from a contactable consumer (patient). This male patient of unspecified age received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on Dec2017 at single dose for immunization. Medical history and concomitant medications were unknown. In Apr2018, the patient experienced initial signs of swelling, a problem later pinpointed as peripheral neuropathy. He was supposed to "receive part A" (first dose of pneumococcal 13-val conj vac (dipht crm197 protein)) in Dec2017 and "part B" (a second dose) a year later, but he didn't because of the neuropathy issue. The patient said during trials to complete the study or during the trial process for drugs approved for the general population, there should have been results three to five months later, and information may be available about side effects after receiving the product. Patient said that on some government agencies websites he had seen peripheral neuropathy listed as a side effect for the vaccine, but not on Pfizer websites. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Around 8:05am, patient began to feel r arm parasthesia,  nausea, and lightheadedness which lead to a syncopal episode with dyspnea. Within 30 minutes started having a tremor that subsided within 2 hours
Pt feels hot and faint; no headache, CP  or pressure. Also feels as if she will pass out sweaty.  Heat in face in ascending pattern from chest to top of head. quick onset. Resolve after 5min and cool water.
lost appetite; severe body aches; slept like in a coma; chills; sore arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), DECREASED APPETITE (lost appetite), PAIN (severe body aches), HYPERSOMNIA (slept like in a coma) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Hospitalized for 6 days) in November 2020.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 14-Jan-2021, the patient experienced DECREASED APPETITE (lost appetite), PAIN (severe body aches), HYPERSOMNIA (slept like in a coma) and CHILLS (chills). On 15-Jan-2021, DECREASED APPETITE (lost appetite) had resolved. On 16-Jan-2021, PAIN IN EXTREMITY (sore arm), PAIN (severe body aches), HYPERSOMNIA (slept like in a coma) and CHILLS (chills) had resolved.        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.   No concomitant medications were provided Treatment Motrin 600
Loss of head control, could not hold up head on her own, screaming herself to sleep and inconsolable. Refusal to eat and high fever. Shaky.
This spontaneous report as received from a registered nurse refers to 3 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 16-JAN-2014, the patient was vaccinated with ROTATEQ lot # J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
dizziness, light headedness, fainting (loss of consciousness for a few seconds) 5 hours after receiving the first dose of Moderna
No symptoms. Pfizer booster administered at 3 mos (instead of the 5mos - recommendation at time of administration).
Client was given the dose for a child of 6-11-year-old. Pharmacist mistakenly open and prepared the wrong dose thinking it was the one for 6m-5years Moderna. Vaccine was then administered to client. The parents were informed on the situation once it was discovered.