chrisvoncsefalvay/vaers-outcomes huggingface dataset:
delay in second vaccine dose; feeling cold; "not feeling good"; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold), MALAISE ("not feeling good"), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in second vaccine dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING COLD (feeling cold), MALAISE ("not feeling good") and HEADACHE (headache). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in second vaccine dose). At the time of the report, FEELING COLD (feeling cold), MALAISE ("not feeling good"), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in second vaccine dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient called to ask questions about travelling to state and timing of second dose Patient is scheduled for second dose on 31Mar2021 but wants to travel to state on 29Mar2021.  Patient asked Customer Care if it was ok to delay second dose until her return.  Patient confirmed with Customer Care agent that her HCP at the vaccine facility already okayed her to delay her second dose. Patient hung up during transfer. Patient was called back and there was no answer; patient does not have voicemail set up. Consent was not obtained.     This case was linked to MOD21-075365 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up- patient answered wanted to inquire at day 43 could she still get second dose added. Patient consented to be contacted if needed- updated; Sender's Comments:  MOD21-075365:
States she was out to dinner and felt faint, tinnitus and vomited. Went home, felt cold, went to bed with 4 blankets. Next morning had a Headache and some nausea.
Called later the same day of vaccination reporting swelling from shoulder to elbow of arm of administration. Did not improve following day. Pt seeking medical attention.
COVID-19; A spontaneous report was received from a physician concerning a female patient (Unspecified age) who experienced COVID-19.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number: Unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient undergone COVID-19 test and was diagnosed with COVID-19.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event COVID-19 was unknown.  Based on MSA comment, MAH causality updated to Not applicable
Initial unsolicited report received from a healthcare professional on 18 March 2015. A 65-year -old male patient, whose medical history and concomitant medications were not reported, had received a dose of DIPHTHERIA AND TETANUS TOXOIDS (batch number, dose, dose number, expiry date and site of administration were not reported) via Intra Muscular route on unspecified date. It was reported that the Patent had a large reaction in childhood to horse serum and patient can't take tetanus or tetanus containing products." No information about prior exposure to vaccine was not reported. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient outcome was recovered. Documents held by sender: none.
Fever (101.2), sweats, chills, confusion. 12/24/2014 cellulitis at injection site started.
This was vaccination #2 Redness, swelling, itching, heat to injection site beginning hours after injection. Site continues to be  hot to touch, swollen and itchy but redness is gone. Cool compress helps. Fever between 100.4 and 102.2 for aprox. 40 hours ( beginning 12 hours after injection) Pain meds taken for headache helped fever. Tachycardia and intermittent tingling feeling in chest on day after injection ( has resolved) Nausea, lightheaded for two days following injection, mostly resolved. Fatigue beginning day after injection, not resolved. Headache beginning day after injection, currently being managed with Exedrin migraine, will see if it persists today. Not the worst headache I have ever had, but definitely uncomfortable at times.
fatigue; long hour sleep; sore arms; headache; swelling at injection site; inflammation; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received second dose of BNT162B2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 23Feb2021 as single dose for COVID-19 immunisation. The patient previously received the first dose on an unspecified date. Medical history and concomitant medications were not reported. The patient was experiencing adverse events after the second dose of the vaccine given on 23Feb2021. On Feb2021, adverse events experienced by the patient were fatigue, long hour sleep, sore arms, headache, swelling at injection site, and inflammation. She was asking if these are normal. Outcome of events was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
patient receiving dose 1. But after the safety needle retraction mechanism was activated, majority of the vaccine came back out of the patient's arm. Per  guidelines, Patient to be revaccinated . Parents consented and tolerated without  issues.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD subcutaneously, lot # N020615, expiration date 22-JAN-2019, albumin status rHA; and lot # N010246, expiration date 25-SEP-2018; (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018 (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008780, 1712USA008781, 1712USA008782, 1712USA008783, 1712USA008784, 1712USA008785, 1712USA008787.). Sender's Comments: US-009507513-1712USA008050.
Developed facial droop and had a hard time doing her job. She could not recall specifics. Her co-workers brought her to the ER. She later confirmed to have a stroke.
Initial report received from a Consumer (the patient) on 28 September 2014. A female patient, whose age, medical history and concomitant medication was not reported, had received a dose of INFLUENZA VACCINE (manufacturer unknown, batch number, dose in series, route and site of vaccination not reported) on an unspecified date. On an unspecified date, the patients experienced swelling, redness, fever, headache, and soreness at the injection site. Laboratory details were not reported. The patient received some treatment (unspecified). At the time of this report, the outcome was unknown. Documents held by sender: none.
This case was reported by a physician and described the occurrence of shortness of breath in a 52-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included chronic obstructive pulmonary disease, diabetes, heart disease, high cholesterol, hypertension and obesity. Concurrent medications included Nitroglycerine, Aspirin, Lisinopril, ZOCOR, SPIRIVA, FLEXERIL, NOVOLOG, Metoprolol, BYDUREON and RENAX. On 4 October 2012 at 10:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 4 October 2012, approximately 2 hours after vaccination with FLULAVAL, the subject experienced shortness of breath, dizziness and heart pounding. One hour later, the events had resolved. The physician considered the events were disabling and life threatening. On 4 October 2012, the events were resolved. The physician considered the events were probably related to vaccination with FLULAVAL.
Altered mental status (agitation, repetitive words, fussy, active) for more than 12 hours, started "out of the blue" on 10/21 while at the grocery store with Mom. Went to ER and had full workup. Symptoms improved without spontaneously within 24 hours.
Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Sleep problem and Acid reflux (oesophageal). Concomitant products included FAMOTIDINE for Acid reflux (oesophageal), LORATADINE for Asthma, ZOLPIDEM for Sleep problem, LEVOTHYROXINE for Thyroid disorder, APIXABAN, PAROXETINE, VITAMIN D [VITAMIN D NOS], MELATONIN, CLOZAPINE and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-211414 (Patient Link).
Gave HPV injection. Patient immediately passed out, had small seizure (10 - 15 seconds), became pale, got nauseous. We laid him down and called in his PCP.
Local erythema, induration at site. Right upper extremity SQ. Malaise, sub, fever and headache.
6 x 6 raised, warm red area left upper arm. Keflex 2500 1-step tid for 7-10 days.
Onset nausea. increase myalgia, fever. Now difficult ambulating did to myalgia and arthralgia. Fever 101.7 and headache with fatigue
This spontaneous report as received from a healthcare worker refers to a 17 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 11-AUG-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT HAS HIVES ON LEFT UPPER AND LEFT LOWER ARM,  LEFT HAND, UPPER CHEST/BREAST AREA AND C/O OF BEING ITCHY.  PRESCRIBED BENADRYL 50 MG BID. HIVES AND ITCHYNESS HAVE RESOLVED.
On evening following receiving vaccine, patient reports itching on both arms and legs which continued to get worse.  Appointment to see MD on 05/21/2003.  Saw MD who gave medication for itching and told her it was a reaction to the Hep B vaccine.
Moderna booster was administered to patient after manufacturer provided expiration date. No adverse reactions reported by the patient. Moderna notified and is performing a lot assessment to determine activity level of the vaccine on date of administration.
Day 7 after vaccine developed 14 cm indurated, red and itchy area at site.  It started the morning of Day 7 and increased over the day.
Shortly after receiving vaccination the patient reported feeling "on fire" and that they might pass out.  It was observed that the patient appeared flush in the face.  Requested the patient to stay for observation, however, after a few moments they left without notice.
A mother reported that her 8 month old daughter received her 2nd dose of Prevnar on 11/14/00. That afternoon, her eyes began rolling around and she was sleepy. Between 21:00 on 11/14/00 and 04:30 on 11/15/00, she vomited 8 times. She was taken to the hospital; she had a fever of 102.5F and an ear infection. She was treated with azithromycin, acetaminophen and IV fluids. She was released from the hospital at 09:30 on 11/15/00. The fever resolved by 11/17/00. This child developed a fever, vomiting and an ear infection following a previous dose of Prevnar. See MCN HQ4086327NOV2000.
Immediate leg cramping after shot was given and following 24 hours; This is a spontaneous report from non-contactable consumer  representative. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced immediate leg cramping after shot was given and following 24 hours on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
During waiting period after receiving vaccine patient stated that "somethings not right". chest pressure/felt like elephant on his chest, left arm tingling, sweating, increased BP at 8:02 am. Healthcare personal called 911 for ambulance and stayed with patient until ambulance arrived. Patient remained conscious and reported no change in symptoms. Ambulance arrived and performed EKG at site with probable a fib at 8:22 am. Pt taken to hospital ER 8/13/2021.
Patient complains of not being able to elevate her arm and tingling in her fingers. I referred her to see the prescribing physician. Physician not sure if related to vaccine or if some other cause.
Sleep paralysis.  Woke up unable to speak for a couple of minutes after taking a nap the day of my vaccination. The rest of my body was fine, my mouth and throat felt fine, just couldn't get my brain to make my voice speak.  Googled it and seems to be similar to flu shot reaction so just wanted to let you know so other people won't be alarmed if it happens to them.
One day after second dose of moderna , had bad chills, body aches, joint pain, sore throat, headache, fever.  Lasted 2 days.   Took repeated doses of excedrin migraine, Advil, and liquid cold medicine.  Two days after vaccine, developed patchy, slightly raised, itchy red rash extending approximately 5 inches below the injection site.  No rash on rest of body.  Rash still visible 4 days after injection but not as severe.
No adverse reaction, this was a immunization error.  Vaccine expired on 05-23-2021 and was given to this child.  Advised mother of error and recommendation  to repeat this dose.  No other funded DTAP was available in the clinic at the time of administration.
SUSPECTED COVID-19; FLU; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: sensitive to new products, and other pre-existing medical conditions included: The patient had no heart problem with other vaccines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19, and flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu, and the outcome of suspected covid-19 was not reported. This report was non-serious. This case was associated with a product quality complaint: 90000217339. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. Based on the PQC evaluation/investigation performed.  Version created to amend previously reported information on 24-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
1 of 2 pts immunized from same DTAP vial who exp a rxn @ DTAP site; 5yo pt devel swollen & painful arm (erythematous & hot); MD visit-tx w/Motrin; recovered; recvd Monovax in opposite arm & OPV; prev had 4 doses DTP w/no adverse event;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-JUN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L040460, expiration date 27-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 80 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 51-year-old male patient who received ENGERIX B adult (batch number 4T4GJ, expiry date 4th NOVEMBER 2017). Concomitant products included Atorvastatin and enalapril. On 8th NOVEMBER 2015, the patient received the 1st dose of ENGERIX B adult (intramuscular) 1 ml. On 9th NOVEMBER 2015, 1 day after receiving ENGERIX B adult, the patient experienced hives. On an unknown date, the outcome of the hives was recovering/resolving. The reporter considered the hives to be possibly related to ENGERIX B adult. Additional results provided were as follows.  On 8th NOVEMBER 2015, at 13:00 PM, the patient received his 1st dose of ENGERIX B adult in left deltoid. On 9th NOVEMBER 2015, 1 day after vaccination, the patient experienced hives on the right elbow and on the both hands near the knuckles.
Patient received immunization after confirming he never had any severe reactions previously.  Patient ended up fainting minutes after receiving the immunization, but became conscious soon after. He then stated he had this happen before some years back.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 46.38.  Batch number 044B21A underwent temperature excursion on 15-April-2021 with temperature  34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 06-April-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-April-2021 Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported. No concomitant medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Fever 103.2 (Rectal), WBC 19.9. Treated for possible bacteremia/fever without source. B Cx negative.
Sleeplessness; This case was reported by a other health professional via call center representative and described the occurrence of sleeplessness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 10th November 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 10th November 2019, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced sleeplessness. On an unknown date, the outcome of the sleeplessness was unknown.   It was unknown if the reporter considered the sleeplessness to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced sleeplessness after vaccination with Shingrix and unspecified flu vaccine. The healthcare professional who reached out to Medical Information via chat function declined to provide any contact information and wishes to remain anonymous. The brand of flu vaccine was known, healthcare professional provided that it is the flu vaccine for patients over 65. No further details were provided. The reporter did not consent to follow up.
fever, anorexia, & generalized tonic clonic seizure 48 hrs p/vax administered;