chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm twitching where the vaccine was given; Swelling of arm; Pain in extremity; Vaccine exposure during Pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy), MUSCLE TWITCHING (Arm twitching where the vaccine was given), PERIPHERAL SWELLING (Swelling of arm) and PAIN IN EXTREMITY (Pain in extremity) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy). On an unknown date, the patient experienced MUSCLE TWITCHING (Arm twitching where the vaccine was given), PERIPHERAL SWELLING (Swelling of arm) and PAIN IN EXTREMITY (Pain in extremity). On 26-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) had resolved. At the time of the report, MUSCLE TWITCHING (Arm twitching where the vaccine was given), PERIPHERAL SWELLING (Swelling of arm) and PAIN IN EXTREMITY (Pain in extremity) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Company Comment   This is a case of product exposure during pregnancy with  associated AEs of pain in extremity, peripheral swelling and muscle twitching  for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The event of exposure during pregnancy is assessed as not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events of pain in extremity, peripheral swelling, and muscle twitching, a causal relationship cannot be excluded.; Sender's Comments: This is a case of product exposure during pregnancy with  associated AEs of pain in extremity, peripheral swelling and muscle twitching  for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The event of exposure during pregnancy is assessed as not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events of pain in extremity, peripheral swelling, and muscle twitching, a causal relationship cannot be excluded.
Dose 1 given 2/4/2021 lot # EM9809 Patient died form Covid 19 at Medical Center
MD ordered Tdap. Mistakenly given Dtap. No adverse reactions noted after administration. Immunization coordinator, MD made aware of event. Followed appropriate procedure for error.
Patient called approximately 2 hours post injection to complain of soreness, swelling and itching at injection site. Called Tuesday (day after) complaining that there was now 2 holes in her arm and the redness and itching was extending down to her elbow. Pharmacist on duty advised patient to visit physician or clinic to diagnose. On her way to clinic, patient was involved in a motor vehicle accident being struck by an intoxicated driver. I followed up with the hospital to resolve vaccine issue, they had no record of complaint due to vaccination.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 33-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Single), for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "experienced fainting upon exertion"; PALPITATIONS (non-serious), outcome "unknown", described as "reoccurring symptoms of heart palpitations". The patient underwent the following laboratory tests and procedures: Cardiac imaging procedure: abnormal left side, notes: Recent heart imaging has shown abnormal left side; normal, notes: previous heart imaging was normal. Patient received the primary series vaccine. Since receiving the vaccine, he has developed reoccurring symptoms of heart palpitations and has experienced fainting upon exertion. Recent heart imaging had shown abnormal left side and previous heart imaging was normal. Patient was unsure if his condition was related or unrelated to the vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Tasted median, throat swelling, knot, itching, sick/aches, eyes matted shut by 11/30/15, legs heavy.
About 12 hours afterwards, nauseated and passed out (fainted), fever 100, extreme diarrhea, clammy,  headache, then the aches began - every single muscle in body hurt, every joint ached, back was so tender.   Could not sleep I was so miserable and twitching muscles for the next 6 hours.  Every time I ate something for the next 24 hours had stomach cramps.  The aches and fever have continued (on day 3).  Arm where shot was given is extremely tender to the touch, but no rash.
Rash over right deltoid area, intense, deep itching interfering with sleep.  Follow-up - symptoms resolved 3/20/07.
Patient received first dose of Pfizer COVID vaccine at a local pharmacy (Pharmacy).  He did not report symptoms experienced to that pharmacy, although he waited the requested 15 minutes there after vaccination.  Several weeks later, he reported post vaccination symptoms during an unrelated visit to the Co. Health Department.  He described sensations of chest tightness, facial and chest flushing, mild nausea and numbness in both hands which started ten minutes after vaccine administration.  He left the pharmacy without reporting these symptoms and reports they resolved without any intervention or medication, by two hours after receiving the vaccine.  During his subsequent visit to the Health Department he asked if he could complete vaccination for COVID.
Glazed over stare 7 to 19 days 5 days after vaccination.
Patient got inj. 12/17/12. Came back to the pharmacy 12/27/12 with rash all over left side of body. Stated she should contact her MD which she did. Called back later in day. Put on anti-viral med.
patient due for DTaP and polio vaccine.  Kinrix was administered in error,  age recommendation on box was over looked.  I spoke with mom and she said he done well yesterday after injections. He did sleep most of the afternoon.  No noticeable adverse reactions.
Redness and swelling of arm extending from shoulder down through elbow- child complains of tenderness and itching.
policeman called MD to tell that pt awoke @ 830AM was red put back to bed and found dead @ 1030AM;
First 2 days after vaccine I had the expected slight sore arm, some minor headache, some muscle aches. Nothing major that kept me from working or sleeping. Some time after, maybe 3rd or 4th day, I noticed a shortness of breath. This I did not expect since it's not a listed side effect for the vaccine but it is one for Covid. I notice it everyday while sitting/working. It does not keep me from being active (running/yard work) but I notice I'm not 100% healthy feeling. It feels like  the shortness of breath is closer to the top of the chest/throat area if that makes any sense. If I breathe deeply it feels like I may want to cough although I don't usually cough from doing so. It's mostly just a constant feeling of a very slight shortness of breath.
Father stated "Hives on face" 30 min. after vaccinated. Child had no resp. problems."Hives on buttocks today".
Pt was admitted on 12/12 after presenting to the ECC after a witnessed cardiac arrest.  The patient lived in an group home and was noted to stand up from the dinner table and suddenly collapsed.  CPR was started by staff. Arrival of EMS noted a PEA arrest.  Two rounds of CPR and 2 mg of epi were administered prior to ROSC.  Upon arrival to the ECC, he was noted to have minimal neurologic response with no gag reflex, no corneal reflex, and pupils fixed and dilated.  He also had a witnessed seizure of 15-30 seconds in the ECC and received Ativan with termination of the seizure activity.  CT of the head was performed which resulted as negative.  Lab work showed no leukocytosis, hemoglobin 12.5, platelets normal, potassium 3.3, creatinine 1.4, troponin negative, lactic acid 6.3, negative procalcitonin, UA negative, urine tox screen negative, COVID-19 positive.  Cardiology was consulted.  Patient was admitted to the ICU.   12/13-12/14 patient remained intubated and sedated on propofol.  Receiving Jevity 30. Noted to have myoclonic jerks and intermittent episodes of severe hacking and coughing.  Neurology consulted.  EEG reported to be severely abnormal consistent with post-anoxic mild clonus status epilepticus after cardiac arrest/severe diffuse anoxic ischemic brain injury and with an extremely poor prognosis for survival. 12/16:  Remained intubated, off infusions, unresponsive,  myoclonic jerks and seizure-like activity was noted.  Episodes of emesis. 12/17:  Patient was extubated to BiPAP.  Remained unresponsive.  GCS 3. Continued myoclonic jerks.  Neurology resumed home medications of Klonopin.  Depakote added. 12/18:  Early a.m., patient was noted to have episodes of desaturation of 83-87% on 6 L O2.  He was transitioned back to BiPAP.  Patient remained in significant distress in spite of multiple doses of morphine. Patient was continued on BiPAP/Ativan/morphine for comfort. The evening of 12/18, patient was found to have marginal blood pressures.  He continued on BiPAP with high settings.  Guardian was contacted again-requested no escalation of care.    12/19:  Patient remained on supportive care .  He developed significant bradycardia with decreasing SpO2.  Clergy was called in for bedside prayer.  The patient developed asystole with no breath sounds or respirations noted at 0220 hr with a five-minute confirmation.   Discharge Diagnoses:  PEA cardiac arrest, acute hypoxic respiratory failure, anoxic brain injury, COVID-19 pneumonia, AKI, death.
Injection site where vaccine given became red/swollen-about the size of a baseball. Pt states itchy, too.
Previous mild tinnitus 2-3 worse (louder) since 2nd vaccine shot.
2/12:High fever and shortness of breath.  Low oxygen. Went to emergency room.  Discharged from ER with meds for pneumonia 2/27: Extreme SOB, respiratory distress.  Went by ambulance to hospital.   Admitted for 3 days at hospital
Information has been receive from a pharmacist regarding a 5 year old male patient who on an unknown date the patient was vaccinated with dose 1 of VARIVAX (Merck) (dose not reported). The pharmacist reported that her grandson on an unknown date experienced varicella like rash "afterwards". The reporter stated that she "believe his mom probably took him to the doctor", but she did not have any details, except that the patient got the rash. She also stated that her grandson on an unknown date (reported as "just") received his second dose of VARIVAX (Merck). No adverse event reported with the second dose. On an unknown date the patient recovered from varicella like rash. Relationship between varicella like rash and vaccination with VARIVAX (Merck) was not reported. Additional information is not expected.
The vaccine that was given was past its beyond use date of 31 days after placing into the fridge (it was given on day 32 ). After calling the manufacturer (pfizer), the medical team explained that there was off label data supporting the stability of the vaccine for an additional 15 days after. However, they told me it was still considered a vaccine error and needed to be reported. Have not been  able to reach out to the patient yet, but we will continue to call. We have only been able to leave a voicemail for patient to call us back.
feel horrible, Missed a day of work; fever, Missed a day of work; chills, Missed a day of work; body ache, Missed a day of work; headache, Missed a day of work; Missed a day of work; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful, fever, chills, general body pain, headache and activities of daily living impaired. On an unknown date, the outcome of the feels awful was recovered/resolved and the outcome of the fever, chills, general body pain, headache and activities of daily living impaired were unknown.   It was unknown if the reporter considered the feels awful, fever, chills, general body pain, headache and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient glad that he/she got the vaccine, but it made the patient feel horrible for a couple days. The patient also experienced fever, chills, body aches, headache. The patient missed a day of work.  The patient was scared to go get the second one.
Arm sore and patient states she is not able to lift her arm high or lift anything with her arm. Symptoms are still occurring a month later. Patient states she is going to see MD tomorrow.
a metallic taste in their mouth; His lips also feel dry; This is a spontaneous report from a contactable other hcp.A male patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN,SINGLE for covid-19 immunisation.The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date,the patient experienced a metallic taste in their mouth and his lips also feel dry.He does not have any tingling in his lips and she (nurse) suggested to stay hydrated. He took a Tylenol about an hour ago. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received Moderna for his first dose of COVID vaccine on 02/03/2021 and received Pfizer for his 2nd dose of COVID vaccine on 04/13/2021. Patient reports no adverse effects at this time.
Patient woke up the morning after Dose #2 with lower body allodynia, up to the pubic bone. Pain with clothing or bedding being in contact with skin on legs/buttocks bilaterally. Patient took 5-325 oxycodone/acetaminophen and could only tolerate bed rest for the next 8-12 hours. Condition had completely resolved by 36 hours after vaccination
A little bit of a sore arm; Fever; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (A little bit of a sore arm) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (Bactrim allergy), Allergy to antibiotic (Allergy to gentamycin eye drop), Osteoporosis and Atrophic vaginitis. Concomitant products included ESTRADIOL (VAGIFEM) for Atrophic vaginitis, CALCIUM, COLECALCIFEROL (CALCIUM D [CALCIUM;COLECALCIFEROL]) for Osteoporosis, MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation.On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (A little bit of a sore arm) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (A little bit of a sore arm) and PYREXIA (Fever) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (A little bit of a sore arm) and PYREXIA (Fever) to be related. No treatment medications were provided.This case was linked to MOD-2021-387064 (Patient Link).Most recent FOLLOW-UP information incorporated above includes:On 16-Nov-2021: Added patient demographics, Allergies, Medical history, Updated Vaccine start date of dose 2, Added Concomitant medications, Event fever, Event outcome and causality.
Patient was given Flublok that should have only been given to patient 18 years old and older.  No adverse reaction noted.
Patient said she feels very dizzy and she felt really cold and  had tremor  little later.  Her condition of shaking got worse over period of time and she complained about shortness of breath and she was gasping for air . I asked her if she had or experienced the allergic reaction in the past and she got the prescription EPIPEN from md but didn't have it with her. I injected EpiPen 0.3mg IM.  After5-10 minutes later, she complained about numbness on her extremities and tingling sensation on her finger and she still experiencing tremors.  We had to call the ambulance and they arrived within 5-7 minutes.
tennivac vaccine was administered to a patient accidently as the patient was supposed to receive the tdap with no reported adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient and it was reported diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine was administered to a patient accidently as the patient was supposed to receive the tdap with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine VLP RL1 4V (yeast) (Gardasil) and meningococcal vaccine A/C/Y/W CONJ (CRM197) (Menveo) both for Prophylactic vaccination.  On 05-Apr-2023, diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine suspension for injection (batch/lot number: U7189AA; expiry date: 30-Sep-2023; strength: standard; dose:0.5 mL) was administered to the patient accidently via intramuscular route in the right deltoid for immunization as the patient was supposed to receive the tdap with no reported adverse event (wrong product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 01-NOV-2012 06:55, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Additional information was received from a healthcare professional, which medically confirmed the case and also provided medical history, laboratory results and event details resulting in an additional event.  Information regarding PREVNAR was received from a consumer and later confirmed by a healthcare professional regarding a 7-month-old patient who received a dose of PREVNAR that was not shaken prior to administration, was fussy and crying, his head would flop over periodically and when trying to crawl, he would fall down flat.  The patient additionally experienced eye blinking.  At 7 months of age, the patient received the third dose on 11-Nov-2009.  On 11-Nov-2009, the patient's mother reported that her son received a dose of PREVNAR that was not shaken prior to administration and indicated the product was "crystal clear".  On the same day, the patient was fussy and crying, his head would flop over periodically and when trying to crawl, he would fall down flat.  The mother expressed concern that the product was not "safe" since it was not administered according to the package insert.  On 17-Nov-2009, at a follow-up visit to the physician, the parents reported that the child was blinking his eyes.  An EEG was ordered, but as of 17-Dec-2009, had not been performed.  The patient's outcome was not reported.  See related case (s): US-WYE-H12200209 (medication error without and ae, non-expedited) and US-WYE-H12200309 (medication error without and ae, non-expedited).  No additional information was available at the time of this report.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product were reported No treatment medication was provided   This case was linked to MOD-2021-395985 (Patient Link).