chrisvoncsefalvay/vaers-outcomes huggingface dataset:
01/26/2005 8:05am phone call from mother and then return call to mom after talking further with RN. Mother gave conflicting information regarding whether Tylenol-Motrin-Advil was given, amount given, interval between doses. Mother finally decided she had given Advil. 0.4 mg every 6 hours round the clock initially. Sequence of events as follows: 09/21/2005 child felt warm but temp not checked. Child fussy (WT of child 18#) Advil? given. 09/22/2005 still had temp (felt warm) child taken to MD temp 98.6 there but around 3:00 pm temp 102.6 (at home). child crying constantly. Dime to nickel size lump in RT. 09/23/2005 call to health dept. Received reporting temp 103 on 09/22/2005. Dime size red welt, fussy, screamed, decreased breast feeding. Baby ok today. 09/26/2005 mother reported MD had done test 09/22/2005 child fine today except for lumping dime-nickel size in RT. 09/26/2005 PHN called MD office MD nurse stated they too had conflicting info from mother. Test done 09/22/2005 CBC and DIFF were negative. Nurse to call PHN back re: further Immunizations after talking with DR. 09/28/2005 Telephone message on PHN answering machine to continue with regular immunization regimen. Mother informed of same on 10/03/2005.
Left leg on thigh was sensitive to the touch. It wasn't muscular. It was on the surface of the skin (nerves). Wearing clothing was painful. NSAID did not help relieve this pain. Typical side affect of sore arm at injection site. No redness.  Day 2 following injection my right leg was achy. It was different than the nerve pain in left leg. No redness or swelling. I took a Tylenol which helped. Left leg improved. Lymph nodes under left armpit enlarged.  Day 3 no more leg pain.
Feels like my throat is falling asleep like when eat ginger; This is a spontaneous report from a contactable pharmacist. A 27-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via intramuscular route of administration in the right arm on 17Mar2021(at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes mellitus, and COVID 19. It was unknown if patient was pregnant at the time of vaccination. Concomitant medications included metformin hydrochloride (METFORMIN), lisinopril (MANUFACTURER UNKNOWN) and hydrochlorothiazide (HCTZ); all from unknown date and for unknown indication. The patient was allergic to ibuprofen (MOTRIN) and ginger. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received tetanus vaccine toxoid, diphtheria vaccine toxoid, pertussis vaccine acellular 3-component (BOOSTRIX) on 03Mar2021 within four weeks prior to the COVID vaccine. On 17Mar2021, the patient experienced throat felt asleep like when she ate ginger. Therapeutic measures were taken as a result of event and included treatment with BENADRYL 50mg capsule. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the event throat felt asleep when she ate ginger was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
No adverse event reported. The dose was given 1 hour after 6 hour expiration date listed
Arm red; Extremely sore; Itching; This spontaneous case was reported by a consumer and describes the occurrence of   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 (No reported medical history.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided  This case concerns a female of unknown age who experienced nonserious unexpected events of erythema, pruritus, and pain in extremity.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected events of erythema, pruritus, and pain in extremity.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Blood blister in mouth the day after vaccination. It popped that night while I was sleeping. No or very little pain.
no additional adverse event reported; The vaccine was reconstituted with normal saline sodium chloride (manufacturer unknown) rather than the Merck diluent and administered to the patient; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 09-APR-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (dosage, route of administration, lot number and expiration date were not provided) for prophylaxis. The vaccine was reconstituted with normal saline sodium chloride (manufacturer unknown) rather than the Merck diluent and administered to the patient.   No additional adverse events were reported.
administered an expired dose of Daptacel; Initial information received on 03-May-2019 regarding an unsolicited valid non-serious case received from a physician by phone.  This case involves a 18 months old female patient who was vaccinated with an expired 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5190AA and expiry date: 24-Apr-2019 and route of administration were not reported) in the left thigh on 03-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
pediatric moderna booster administer instead of adult  moderna bivalent boost. no adverse event. patient and dr being notified. patient being called back in to be administered adult  bivalent moderna booster
With previous two doses, was tired within a few hours of the vaccinations; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 51-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FH8020, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 04Mar2021 (at the age of 51-years-old) as Dose 1, Single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EP6955, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 25Mar2021 as Dose 2, Single for COVID-19 immunization. Medical history included ongoing Asthma was diagnosed 6-7 years ago on an unspecified date. The patient concomitant medications were not reported. On Mar2021, patient experienced with previous two doses, was tired within a few hours of the vaccinations. The event was reported as non-serious. The patient underwent lab tests and procedures which included BMI was high on an unspecified date. The outcome of the event was unknown.   Follow-up attempts were completed. No further information was expected.
Right upper arm swollen, red, and itching. Area hot to touch. Child is irritable. Patient given triamacinolone cream .1% to apply to area twice daily.
tested positive for COVID-19; tested positive for COVID-19; This is a solicited report from a contactable consumer (patient) and healthcare professional, based on the information received by Pfizer (manufacturer control number: 2021SA284825).   A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose on Mar2021 (lot number and expiration ate not reported) at dose 1, single, then second dose on Apr2021 (lot number and expiration date not reported) at dose 2, single; both via an unspecified route of administration at the age of 63-years-old for COVID-19 immunisation; and teriflunomide (AUBAGIO 14 mg coated tablet), via oral from 12Jul2021 and ongoing at 14 mg, four times a day (QD) for multiple sclerosis. Medical history included ongoing multiple sclerosis. The patient's concomitant medications were not reported. On 26Aug2021, the patient tested positive for COVID-19 (drug ineffective). It was stated that they wanted to start the patient on an intravenous medication Regen-COV and used Lexicomp for interactions and recommended to the physician. The patient was calling from her doctor's office as she tested positive for COVID-19 after she had her Pfizer COVID-19 vaccine. The patient was prescribed with antibiotics and some other unspecified medications as treatments for the events. The events were ongoing. The patient called to ask if it was okay to take the medications given by her doctor with teriflunomide. As of time of report, teriflunomide was continued. The patient underwent SARS-CoV-2 test on 26Aug2021 with positive result. No additional information at the time of report. The events resulted in physician office visit and therapeutic measures were given as a result of the events. The action taken in response to the events for teriflunomide was unknown. Outcome of the events was not recovered.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
9/10/03 Received MMR, Td in left deltoid . Shot was painful and site remained with pain for 1 week and tender for 2 months. The site also had a pea sized lump for 2 months and a pea size lump is still present. Patient complained of intermittent pain at injection site that radiates down approximately 3-4 inches and can be relieved with massage.
Information has been received from a physician, for the Pregnancy Registry for GARDASIL vaccine, concerning a 15 year old female with no relevant medical history or allergies who on 16-MAR-2007 was vaccinated with a first dose of GARDASIL vaccine (lot number, injection site and route not reported). On 13-OCT-2008 the patient was vaccinated intramuscularly with a second dose of GARDASIL vaccine (lot umber and injection site not reported). There was no concomitant medication. On 13-OCT-2008 the patient experienced trace vaginal spotting. On 31-OCT-2008 the patient was determined to be pregnant by urine pregnancy test. The patient's LMP was 27-SEP-2008. Unspecified medical attention was sought. The outcome of the patient's experiences was unknown. Additional information has been requested.
Significant chest pain and shortness of breath over a three day period.  Came on gradually and were significant for days number two and three, then subsided.  The ER ruled out heart attack and pulmonary embolisms.  My primary physician believes it was likely pericarditis.  A night after the symptoms subsided I dropped into continuous a-fib, which I had treated originally back in July.  The pericarditis symptoms are all gone, but I am still in a-fib and will have another cardiogram on 12/1/2022 to try to get me back in rhythm.
DTP/OPV/HIB #1 given 12SEP91-clinically well @ time; pt DOA @ Hosp 7OCT91; unresponsive to resuscitative efforts;
8 days after vaccination the patient's arm started getting red at injection site. The next morning the red area was bigger and the upper arm felt warm. Patient applied some Benadryl cream to area. Patient said it's not really painful, but feels like a heat rash.
Patient came to the pharmacy for a scheduled Bivalent booster. Entering technician did not verify stock. (We have been out of Bivalent sine 1/26) . We had administered a monovalent dose earlier in the day so there was a vail in the cooler. The administering technician did not reverify the vial before drawing and the pharmacist on duty did not review the vaccine before the tech left the pharmacy with it. When I returned to the pharmacy the technician let me know that they had pulled the last bivalent vial. Knowing that the vaccine was not in stock I then told the technician about their error.
Flu like symptoms. Fever of 101, chills, body aches, headache. Fever broke around 1:00 PM on 3/12/2021. Chills stopped at this time. No headache but slight body aches going into 3/13/2021. No doctor called. Bayer Back & Body taken every 4 hours.
extreme fatigue and whole body muscle ache. This person previously tested positive on 12/31/2020.  She recovered and was having no symptoms. She received the vaccine upon the  recommendation of her physician as she was recently diagnosed with cancer. With in 24 hours she reports that she was completely incapacitated with extreme fatigue and muscle pain "from her toes to her head". Injection occurred  3/6/21. Symptom onset 3/7/21. Date of contact by a case investigator was 3/22/21. Symptoms were still present and acute on 3/22/21.
Eyes swollen; Eyes puffy; Her arm got itchy after vaccination; This spontaneous case was reported by a patient and describes the occurrence of EYE SWELLING (Eyes swollen), PERIORBITAL SWELLING (Eyes puffy) and PRURITUS (Her arm got itchy after vaccination) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Patient had no allergies.     On 18-Sep-2022 at 12:45 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Sep-2022, the patient experienced EYE SWELLING (Eyes swollen), PERIORBITAL SWELLING (Eyes puffy) and PRURITUS (Her arm got itchy after vaccination). At the time of the report, EYE SWELLING (Eyes swollen), PERIORBITAL SWELLING (Eyes puffy) and PRURITUS (Her arm got itchy after vaccination) outcome was unknown.            No concomitant medication was provided.  On 18-Sep-2022, night after vaccination one of patient eyes swollen and it was puffy. On 19-Sep-2022, morning the same thing happened for both of her eyes. Treatment medication was not provided by the reporter. Reporter did not allow further contact.
After Shingrix first dose (3 MONTHS AGO), patient was blind on one eye.; This case was reported by a physician via call center representative and described the occurrence of unilateral blindness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced unilateral blindness (serious criteria GSK medically significant). On an unknown date, the outcome of the unilateral blindness was unknown.   It was unknown if the reporter considered the unilateral blindness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination were not reported but adult has been selected as age group according to the vaccine. The patient received 1st dose of Shingrix 3 months ago from reporting date and was blind on one eye. According to reporter emergency room visit was required. The reporter consented to follow up.
not able to walk without a cane; lower body pains; cannot bend over; vaccine might have aggravated the myelitis she had in 2009; vaccine might have aggravated the myelitis she had in 2009; had difficulty urinating; A spontaneous report was received from a consumer who was a 59-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not able to walk without a cane/gait disturbance, cannot bend over/movement disorder, difficulty urinating/dysuria, lower body pains/pain, and vaccine might have aggravated the myelitis that she had in 2009/myelitis and condition aggravated.  The patient's medical history included myelitis. Concomitant product use was not provided by the reporter.  On 16 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 16 Mar 2021, two hours after the vaccination, the patient experienced lower body pains, had difficulty urinating, was not able to walk without a cane and could not bend over.  She felt the vaccine may have aggravated the myelitis that she had in 2009.  Treatment information was not provided.  The reporter felt the events of cannot bend over, lower body pains, not able to walk without a cane, and vaccine might have aggravated the myelitis that she had in 2009 were disabling.      Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event of not able to walk without a cane, cannot bend over, difficulty urinating, lower body pains, and vaccine might have aggravated the myelitis that she had in 2009 was unknown at the time of this report.; Reporter's Comments: Very limited information regarding the rest of the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the rest of the event has been provided at this time. Further information has been requested.
74 year old female presents to the clinic for evaluation of mostly nontender lump in her right deltoid ever since her second Moderna COVID vaccine April 1st at Hospital.  She applied ice topically initially but has not done so lately.  No chest pain or shortness of breath.  No history of pulmonary embolism or deep vein thrombosis. Patient has not applied any creams topically.  She wanted to make sure this wasn't anything that she should be worried about.    I recommended topical Voltaren cream to right deltoid as needed, cool compresses, Extra-Strength Tylenol, and expectant management.
This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecifeid dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, joint swelling, possible nerve injury, possible autoimmune disease and activities of daily living impaired. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information received on 26 February 2009 via records from an interview between the subject and lawyers. The subject received the first, second, and third doses of LYMERIX ON 04 May 1999, 04 June 1999, and 30 June 2000. Between June 2000 and the winter of 2000, the subject developed achiness, joint pain and stiffness, fatigue, diminished alertness, and diminished memory. Diminished alertness was assessed to be medically significant by GSK. The subject noted that diminished alertness and diminished memory occurred when she was fatigued. In 2008, she experienced "popping" of the right knee. The subject reported hip pain that was attributed to a bone spur. Treatment included ibuprofen and glucosamine/chondroitin. The events were unresolved at the time of this report.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient with high blood pressure and high cholesterol, no drug reaction/allergies. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX (lot # J007211, exp. date: 20-SEP-2014), subcutaneous in the arm. No concomitant medication and no drug reaction were reported. On 13-JAN-2014, within a day of the administration, thea patient experienced an injection site reaction. The patient called the pharmacist. The pharmacist viewed a picture of the reaction and described it as being hot and bright pink at the injection site (1 inch wide by 3 inches long) and surrounding this the patient's skin is duller pink and swollen. The pharmacist noted the total injection site reaction is about 6 inches by 8 inches); from patient's deltoid (site of injection) down to patient's elbow and wrapped around her arm. Pharmacist recommended that patient draw a circle around the site with a black marker to see if the reaction gets any bigger. The treatment was not given for AE. Lab was not performed. The outcome of events was not recovered. Additional information has been requested.
Severe itching sensation all over the body that started around 1 hr after vaccination and swelling at the vaccination site
lots of pain on the site radiating from shoulder to hands; lots of pain on the site radiating from shoulder to hands; lots of pain on the site radiating from shoulder to hands; swelling; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced lots of pain on the site radiating from shoulder to hands and swelling on an unspecified date. The outcome of event was unknown. Information on the Lot/Batch number has been requested.
From initial information received on 24Jan05 from a RN registered an adverse event occurring, it was reported that a two month old female pt received her first dose of Daptacel, lot number C2104AA, administered in the left thigh, as well as her first doses of Acthib, Ipol, Prevnar, and Hep B vaccine, administered on 23Nov04. The lot number, routes and sites of administration for Acthib, Ipol, Prevnar and Hep B vaccine were not reported. Four to five hours later, the pt started to cry inconsolably for a duration of 45 minutes. She was given Tylenol by her mother, which gradually stopped the crying. Per the reporter, the pt recovered from this event.
Shot Given + 5 min after given, pt had LOC witnessed with jerky movement of extremities. Pt then stood + collapsed while walking. Remained dizzy after she was arousable.