chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant concerning a 77 year old female with diabetes mellitus, hyperlipidaemia, hypertension, allergy injections weekly or once a month, and history of gastrointestinal bleeding who on 19-DEC-2006 was vaccinated intramuscularly in the left upper arm with a 0.5ml dose of Pneumovax 23 (lot 655289/0958P). Concomitant therapy included PRILOSEC, ezetimibe (+) simvastatin, GLUCOPHAGE IX, LUNESTA, MAXZIDE, ALLEGRA and aspirin. On 20-DEC-2006, the patient's whole upper left arm became red and inflamed that went down to her elbow. The area almost looked bruised. The patient had no fever. The patient was treated with DDVIL. By the next morning there was significant improvement. The patient recovered approximately 24 to 48 hours after the reaction occurred. The medical assistant mentioned that the first time the patient received pneumococcal 23v polysaccharide vaccine, the patient did not have a reaction. The reporter felt that the patient's inflammation and erythema were serious as other important medical events. This is one of two cases reported by the same source. Additional information has been requested.
12/7/2022 at about 4:00 PM I noticed more coughing and discomfort in chest. Participant was recovering from bronchitis. 12/8 Televisit where doctor advised to treat symptomatically. Tested positive with at home COVID-19 test. This got slightly worse, experiencing fatigue and nasal drainage. Felt better 12/10, but 12/11/and 12/12 were especially bad as the symptoms flared up. Participant experienced body aches in hip and back these days. These lasted about 3 days. Dizzy spell on 12/22, lasting about a half hour accompanied with a sharp headache near temporal lobe. Experienced slight dizzy spells since then no more frequently than once a day, but not every day and they are very minor. Fatigue lingers. Cough is greatly diminished.
itchy egg size lump on her right arm at the injection site; itchy egg size lump on her right arm at the injection site; feeling bad; fever; nausea; This case was reported by a consumer and described the occurrence of feeling bad in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling bad, fever, nausea, injection site lump and injection site itching. On an unknown date, the outcome of the feeling bad, fever, nausea, injection site lump and injection site itching were recovered/resolved.   It was unknown if the reporter considered the feeling bad, fever and nausea to be related to Shingrix. The reporter considered the injection site lump and injection site itching to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported the case for herself. The first dose was given in fall of 2018 in right arm.  The patient felt bad and reported nausea, fever that resolved one day after the injection.  The reporter also reported an egg size lump on her right arm at the injection site that lasted for several weeks before resolving.  More than 2 years after vaccination the patient experienced injection site lump and injection site itching. No other information was available. The reporter did not consent to follow-up and declined to contact health care professional.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 4:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 4:35 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 51.79. Concomitant products were not provided. On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
numbness is coming back to his foot; headaches; About 10-14 days after the vaccine he was out walking and started to regain the feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "automobile accident", start date: 2012 (unspecified if ongoing), notes: loss the feeling in his big toe down to the arch of his foot; "He loss the feeling in his big toe down to the arch of his foot" (unspecified if ongoing), notes: loss the feeling in his big toe down to the arch of his foot; "Surgery on his foot", start date: 2014 (unspecified if ongoing), notes: foot surgery back in 2014 & 2017,regaining feeling for about 45 minutes 1-2 weeks after 2nd surgery. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First Dose, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "About 10-14 days after the vaccine he was out walking and started to regain the feeling"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "numbness is coming back to his foot"; HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: Patient reported at first it was unbearable and it started to go numb again. Like when you go to the dentist and they numb you and it feels heavy, but you can feel after touching your jaw. He did different was take the covid vaccine and occasionally takes Aleve for headaches.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient had a syncopal episode while sitting in chair, fell backward striking back of head on ground, pt. states he did not eat breakfast
MUSCLE SORENESS IN NECK, ARM, SHOULDERS STOMACH PAIN ABDOMINAL CRAMPS RECTAL BLEEDING BLOOD IN STOOL
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided. HCP states that some patients had reported flu-like symptoms after receiving the vaccination.
patient inadvertently received an expired dose of MENACTRA, with no AE; Initial information received on 11-May-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (reference number ).  This case involves a patient (unknown gender and age) who inadvertently received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (total, 1x, lot number not reported and expiration date: 23-Feb-2021) via unknown route in an unknown administration site for prophylactic vaccination on 04-May-2021 (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error due to expired vaccine used (same day latency).  It was also reported that smart scripts was not completed as caller had limited data available to report. Caller was advised to call back to provide patient and vaccine data. Caller was with the question on the safety and efficacy of the expired dose.   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.  There will be no information on the batch number for this case.
10/18/02 flu vaccine administered. 10/19/02 site red, itchy and hot at injection site. Site was marked around area of swelling redness. 10/21/02 swelling s/s all gone.
Patient presents the ED with shortness of breath, low oxygen saturation, generalized weakness, fatigue and body aches. He was found to be COVID positive.  He was admitted for further management. He was discharged 5 days later in stable condition.
Large reddened and swollen area around injection site, Headache, numbness and tingling
Moderate soreness at site of injection. Fatigue, aches, chills, fever 101.5 treated with Tylenol and Ibuprofen. Symptoms mostly alleviated after 24 hours.
24 hours after immunization mother states pt whining, agitated, anorexia, Temp 99 degrees (A) on 7/8/13 at 9:00 pm mother gave pt 1 teasp Children's ADVIL. 7/10/13 WCC at PCP - it was noted: (1) Left arm anterior deltoid hypererythema (not endurated) measured 10cm x 9 cm (2) Left arm more distal hypererythemia with discrete in duration measured 1.5 cm x 1.5 cm.
In the days following her shot she began to have mini seizures her Doctor referred to as "drop episodes". Patient ran a fever for days and whenever she'd gently bump her head (standing up under a table or walking into a door) her eyes would roll back in her head and she would fall over. Then act very dizzy as she tried to stand up, crying. 6 days after vaccine she was seen for fever and headaches. 14 days after vaccine I called about the seizures.  2 days later we met with her Doctor and she prescribed an EEG. EEG scheduled for 5/13/13. The results came back normal, but with Interpretation that "Normal EEGs do not rule out seizures".
Urticarial rash began about 24 hours after vaccines were given patient also had bloodwork drawn after receiving her vaccine. Patient returned to office 2 days after vaccine was given; rash improved with Benadryl somewhat completely improved with Atarax.
Patient stated she had a 101 fever and her arm swelled and felt like it was on fire.
On December 26 at 10 am received the ZOSTAVAX vaccine; about 10pm had a terrible headache and took 2 ADVIL. On 27 at 2 am woke up with chills and 101 fever. On the 28 woke up throwing up and fever was 102 during all day Sunday. On Monday the 29 at 2:30pm nausea and fever did not go away, patient called her Dr. Fever was 103.8. She Prescribed to take ADVIL and a medication for the nausea. Patient stayed taking medications until Tuesday the 30. On the same day she woke up covered with HIVES from head to toes, like pimples and hives in the entire body. Contacted her doctor again and the patient was prescribed BENADRYL, and VALTREX then the fever started going down. On Wednesday 31 the temperature was normal but hives still there. On Thursday 1st. Temperature was normal hives disappearing. 2 hives and pimples almost disappeared, little achy and tired.
Redness at injection Site w/swelling. Feverish. Small raised red bumps on upper back and torso. Steroid injection administered 7/13/2020 Kenalog & Decadron
Pt began to exp inc warmth & pain @ area of inject llt; Began swelling at site 22MAY91 on 23MAY91 seen by Md 3 1/2 x 4" area of induration; PO temp 100.4; no joint pain or edema; no s/s abscess or immobility;
Received 0.5mL for booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5mL for booster dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 038K20A and 039A21A) for COVID-19 vaccination.     The patient's past medical history included GERD. Concurrent medical conditions included Type 2 diabetes mellitus (Type-2 diabetes), Hyperlipidemia and Drug dependence (nicotine dependent). Concomitant products included METFORMIN, ATORVASTATIN, SILDENAFIL CITRATE (VIAGRA), SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), OMEPRAZOLE, VARENICLINE TARTRATE (CHANTIX) and MONTELUKAST for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5mL for booster dose). On 08-Nov-2021, ACCIDENTAL OVERDOSE (Received 0.5mL for booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Nicotine replacement was taken as concomitant medication. No treatment medications were reported.  Confirmed with caller no adverse effect was observed with all 3 doses. The patient was observed for 30 minutes after the booster dose, no abnormalities observed during the observation period.
This spontaneous report as received from a Healthcare worker refers to herself as a 45 year old female patient. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (lot, dose and route not reported). Concomitant medication was not reported. On an unknown date, the patient experienced vaccinated with a not stored properly VARIVAX (Merck). No adverse effect reported. Additional information has been requested.
Shortly after administration, patient complained of pain in left arm. Overnight swelling and redness appeared and patient reported that she was unable to move her arm.
Pt reported itching and then burning at injection site on Wednesday 9/27/17. After scratching, a white line appeared and she was bleeding. Pt. went to urgent care and was prescribed SSD 1% cream.
Information has been received from a physician concerning a 4 month old patient who on 23-MAY-2011, was vaccinated with the first dose of ROTATEQ (dose, route and lot number not reported). There were no adverse events to report. The patient did not seek medical attention. Additional information has been requested.
Mother   stated  baby   started throwing up  last night and she gave Pedialyte,  Infant  started having  a fever this morning.  Infant had 2 loose stool and vomited 3 times since this morning . Mother continued to give Pedialyte . Mother claimed  there are 2 other babies that are sick living in the   shelter.   Advise mother to go see  PMD.
Left arm sore with a red bumpy rash that extended down the arm. Patient states that rash lasted for one month. Did not call our office to report adverse reaction. Immunization administered was Gardasil #2.
Patient came in on 02/27/2022 and states that since the second covid shot, she has been having a hard time stretching her arm and it feels like she has been Charlie horse at the injection site. She is unsure if a nerve was hit during the shot or if something else happened. She states she is going to see the doctor today and will let me know the outcome after the appointment.
bursitis in right elbow, right heal, and left foot. about 1-2 weeks apart; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Feb2021(at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and heart attack in 2017. The patient previously had almonds and experienced allergy to nuts. The patient previously had beer and experienced alcohol intolerance. The patient previously took cefuroxime axetil [CEFTIN] for unknown indication and experienced drug allergy. Concomitant medications taken within two weeks of vaccination included apixaban (ELIQUIS) and metoprolol (MANUFACTURER UNKNOWN) both from unknown date for unknown indication. 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 an unknown date in Feb2021, the patient experienced bursitis in right elbow, right heal, and  left foot about one-two weeks apart. The event resulted in doctor or other healthcare professional office/clinic visit. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of bursitis in right elbow, right heal, and  left foot, about one-two weeks apart and included treatment with prednisone. The clinical outcome of the event bursitis in right elbow, right heal, and  left foot about one-two weeks apart. was resolved with sequelae on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist and the patient's husband referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as Pneumococcal vaccine) (dose, route, lot # and expiration date unknown) for prophylaxis. On an unknown date, the patient died after getting the vaccine. The cause of death was not reported. It was unknown if the autopsy was done. The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. Reported Cause(s) of Death: Cause of Death: Unknown by reporter.
Very painful arm. Red, swollen, radiating pain into neck. Chills, aches. Could not use arm x 3 days. Today-sxs resolved.
No side effects to dose #1.  Recd dose #2 of Moderna on Tuesday, March 16.  No side effects until Sunday, March  21.   Upper arm at injection site began to itch.  Area was about the side of a quarter.  Red.  No bumps.  Slightly warm.  By Monday morning, the red area was about three inches wide and four inches long on my upper right arm.   Still itchy.  No pain.  The red area was slightly warm.  Otherwise, no side effects.    By Tuesday morning (one week after the injection),  the redness had spread almost down to my elbow.   Less itchy.  No pain.  The redness got less and less over the next three days, and was gone by Sunday, March 28.
Tested positive for COVID after first dose; Second dose administered almost 90 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Second dose administered almost 90 days after first dose) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced OFF LABEL USE (Second dose administered almost 90 days after first dose). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first dose). At the time of the report, OFF LABEL USE (Second dose administered almost 90 days after first dose) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first dose) outcome was unknown. Not Provided          No Concomitant medications were provided No Treatment information provided    This case was linked to MOD-2021-098874 (Patient Link).
pt recv vax 4JUL97 & 2hr later c/o wheezing & some signs & sx of lower lip being swollen;event lasted approx 4-5 hr & then resolved;pt was given pedialyte poss dehydration;
Sporadic Racing heartbeat, still since June 5 second shot. Also, heart seems to skip beats - have to cough to bring it back in rhythm.  Not been to doctor yet.  Shooting pain up the back of my neck to crown of head, frequent within first week of 2nd vaccination, rare but still occurring. Headaches- never had headaches before.
Spotting between period, period heavier than normal, cramps hurting longer and contracting harder than usual
Flu-like symptoms beginning approximately 12 hours after the shot:  feverish, nauseated, sore all over (particularly head and neck)
ADEM secondary to agency from administration of live virus flu vaccine to patient following interferon confusion, fever, coma, death. Contact hospital doctor for details.
Heavy vaginal bleeding for 6+ days with blood clots 3-4 inches long/ wide with disorientation, dizziness, pain radiating from right hip to the back of right knee, lower back pain, abdominal cramps. Treatment: progesterone medication Outcome: vaccine reaction
Generalized rash faint lacey erythematous plaque. There was a tactile temperature. 24 hours after Rabies and tetanus vaccination. No other symptoms. Rapid strep is negative. Benadryl per oral at night.
A circular area about 2 inches in diameter appeared red this morning. It hot to the touch and felt itchy when touched. This was a new symptom that I did not have after getting the vaccine. The day I got the vaccine, I had pain in my arm that lasted several days, but this had already resolved when the new symptom developed.