chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain on top of the mouth; infection; swelling of her lips and gums; Swollen Face; painful gums; like someone gave her a hundred needles to her gums; pain on her front teeth from top to bottom part, pain in teeth, couldn't bite or eat; when she bites and eats she has tremendous pain; swelling of her lips and gums; This is a spontaneous report received from a contactable consumer (patient). A 62-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158), via an unspecified route on 07Apr2021 at 15:00 (at the age of 61-years) as dose 1, single for covid-19 immunisation. The patient medical history included anxiety, panic attacks started 15 years ago, heart beat and high blood pressure, high cholesterol started 10 years ago and had root canal with last year. The patient concomitant medications included losartan hydrochlorothiazide /day(50/1250mg once a day)(10 Years Ago) for high blood pressure, rosuvastatin calcium (CRESTOR) 10 mg, 1x/day for High cholesterol, nebivolol hydrochloride (BYSTOLIC) 5 mg, 1x/day(Started 10 Years Ago) for heart beat and blood pressure, venlafaxine hydrochloride (EFFEXOR) 150 mg, 1x/day(15 Years Ago) for anxiety and panic attacks from an unknown date and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced extreme pain on her front teeth from top to bottom part, also pain on top of the mouth and on 09Apr2021 some swelling of her lips and gums, pain in teeth, couldn't bite or eat; when she bites and eats she has tremendous pain, swollen face, painful gums; like someone gave her a hundred needles to her gums. She started having pain in the front of her teeth and she couldn't bite or eat. States she thought maybe she had an infection so she called her dentist and he gave her a prescription for an antibiotic. Patient states her lips got very swollen and all of her teeth are up and down and painful and her gums have pain, like when the insert a needle during gum surgery. States she has a lot of pain in her mouth. Patient stated that it was good she didn't go to the Dr. she had her root canal with last year, he was really expensive. She has no fever, she checked a few times. Took Salt and Water and washed her mouth with it a few times, and it made it a little better. States she used mouthwash and it also made it better. States later she was going to get some Coca-Cola because it kills every virus in the body. States she was thinking to take Benadryl but she had to ask her doctor because she was on an antibiotic now because she thought she had an infection. States she was taking amoxicillin 500mg three a day, but it hadn't made any change. Patient did not visited to Emergency Room or Physician Office. The outcome of the events was swollen face, swelling of her lips and gums was resolving, pain in teeth, couldn't bite or eat; when she bites and eats she has tremendous pain was not recovered and other events was unknown.  Information on Lot/Batch number was available. No further information is expected.
Red based excoriated lesions- 5-6 on abdomen, right wrist with vesicles forming on thigh; sore throat this morning, felt warm to touch last night; received varicella and MMR vacines on 08/21/2006; no treatment at this time.
fever 100.7; body aches, sore arm w/mild edema w/dec ROM;tender lt side lymph node since 9PM 16JUL96;
Chills, teeth chattering, body aches, and swelling/redness in injection arm lasting 24 hours. Two days later hives under right arm, extending from armpit to midway down torso on right side. I was put on oral prednisone and Benadryl.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported. She stated that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and could not administer the Moderna COVID-19 vaccine to patients until an assessment by the State was made. There was no power outages that would have impacted the Moderna vaccine. However, she reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download were for the months of  DEC 2021, JAN 2022, and FEB2 022. She said that they were filling out a temperature excursion assessment with the State at  this time and she was calling in to report the same. Caller states that she did not have any questions and that she simply  wants to report this to Moderna. Upon further questioning by agent, caller confirms that patients had been administered doses while the temperature excursion assessment was ongoing. Caller did not have details on how many patients were impacted or any information on the patients. She did state that no adverse reactions were reported by any patients.
Information has been received from a pharmacist reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 13-OCT-2017, the patient received an improperly stored dose of ZOSTAVAX lot # M040146, expiration date 26-DEC-2017, 0.65 ml for prophylaxis (dose number, anatomical location and route of administration were not reported), reconstituted with properly stored sterile diluent (STERILE DILUENT). On 05-OCT-2017, the administered vaccine was exposed to a temperature between 15 Fahrenheit degrees and 46 Fahrenheit degrees for 22 hours and 44 minutes. On 04-SEP-2017, the administered vaccine was exposed to a temperature between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 15 hours and 45 minutes. On 28-SEP-2017, the administered vaccine was exposed to a temperature between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 8 hours and 15 minutes. The pharmacist reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA016231:
NAUSEA,VOMITTED 3 TIMES POST INJECTION .BP 138/109,TEMP 97.8,PULSE 94. BP 134/90 PULSE 92.(REPEATED 10MINS) SKIN WARM ,DRY,NO SOB,NO DIZZINESS. DRANK 2 BOTTLES OF WATER(NO VOMITTING)
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Hyperventilation-Severe, Systemic: Shakiness-Severe, Additional Details: PT reports to pharmacy that she had an adverse reaction the night of recieving her flu shot. By the third day she was feeling too dizzy and fell down the stairs which prompted her to visit the ER. At the ER they found that she had a slight irregular rhythm. She was discharged that day after the symptoms subsided and they have not returned. She has followed up with a cardiologist. Noteworthy, she has had covid August of 2022 and she is still having symptoms of hair loss from that.
After the Pfizer vaccine I experienced irregular spotting and cramping; After the Pfizer vaccine I experienced irregular spotting and cramping; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 11:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had regular periods her entire life, she knew what day and what time of day it will arrive and for how long. After the Pfizer vaccine, she experienced irregular spotting and cramping on an unspecified date in Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events after the Pfizer vaccine she experienced irregular spotting and cramping was resolved on an unspecified date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness in right arm after Prevnar injection, mom states child would not use arm to hold anything. Mom stated daughter was cranky, tired and vomited.
Initial report received from a health care professional on 18/Jul/2005.  A 27-year-old female patient had received a subcutaneous injection of DECAVAC, lot number U1219DA, in error on 28/Jun/2005.  Immediately after injection, the patient had irritation at the site of administration.  Two days later there was a 6 cm area of redness, pain, warmth and a palpable knot at the injection site.  At the time of this report, the patient had not recovered from these events.  Follow-up information received on 07/Nov/2005 from a health care professional.  Per the reporter, the route of administration of the DECAVAC was administered in error intradermally instead of subcutaneously as previously reported.  It was also reported that the patient experienced right forearm cellulitis and a six centimeter erythema area around the site that was warm to the touch and painful.  The patient completely recovered from these events at the time of this report.
Patient had a rash on her back at time of injection. Patient reports that the rash had been there for a couple weeks. After the injection, the patient perceived that the rash increased in severity and wondered if the vaccine could have caused the intensification. Pharmacist on staff told patient that because there was no reaction at the injection site that spread to the back that her concern was not likely to be true, however, if the rash continued to get worse or did not get better, then she needed to report to her physician for a checkup.
Inability to abduct (L) arm secondary pain. Moderate swelling, PROM painful. Put in sling, given NSAIDS, lidoderm patch and physical therapy to increase motion in (L) arm.
Initial report received from a healthcare professional on 11 September 2013. A 77-year-old female patient had received first dose of FLUZONE HIGH-DOSE (lot number U4715AA, route of administration was not reported) in left deltoid on 10 September 2013. The patient had no illness at the time of vaccination. The patient's pre-existing allergies and medical conditions include PCN, AVALOX, fluoroquinolone allergy and rash. On 11 September 2013, one day after vaccination, the patient developed palm sized red area, itchy and hot to touch without any other symptoms. Laboratory details and corrective medications were not reported. The patient outcome was not recovered. Follow up information was received from a healthcare professional on 31 October 2013. Based on the f/up information received on 31 October 2013, this case initially considered as non-serious was upgraded to serious. The patient had hypertension, COPD and sarcoidosis at the time of vaccination and was receiving SYMBICORT inhaler, PROAIR inhaler and ALTACE 10 QD as concomitant medication. On 11 September 2013, the patient was seen by physician and treated for left deltoid cellulitis. The patient was examined and given Doxycycline as corrective treatments. As of 13 September 2013, the patient was recovering from events. Documents held by sender: none.
Pain at injection site began approx. 16 hours after injection (resolved in one day);  Low grade fever (99.1) began approx. 24 hours after injection (resolved by next day); Buzzing/high pitch tone in both ears began approx. 16 hours after injection (still not resolved); Severe dizziness to the point of nausea began on 3/31/21 (still not totally resolved but not as severe)
Post vax, this pt developed bacteremia and cellulitis due to "vax failure." Lab tests were performed and pt was dxed as having Haemophilus type B.
Information has been received from a health professional concerning a female who on 03-JAN-2007 was vaccinated with MMR II. Concomitant therapy included Varivax. Other concomitant therapy included RECOMBIVAX on 26-Dec-2006. On approximately 17-JAN-2007 the patient experienced a fine itchy maculopapular rash on her left forearm. As of 02-Feb-2007, the patient had not recovered from the rash. Treatment has been over the counter hydrocortisone and cold compresses. Medical attention was sought. Additional information has been requested.
Information has been received from a registered nurse (R.N.) concerning a female who on 27-MAY-2009 was vaccinated with a dose of GARDASIL (LOT# not reported). It was unknown which dose in the series the patient received. On 27-MAY-2009, since vaccination, the patient fainted after receiving the vaccination. The nurse did not think the fainting was related to the vaccine and stated, "thought the patient was nervous and skittish about shots". It was reported that the patient sought medical attention in the office. The patient's outcome was unknown. Follow-up information has been received from via a phone call from the registered nurse (R.N.) concerning a female who on months ago was vaccinated with the first dose of GARDASIL (LOT# not reported). The registered nurse said the patient was fine. The mother reported that the patient usually dose this when she gives blood or gets shots. The registered nurse (R.N.) contacted during telephone follow-up could not supply the following information: patient name, date of birth, lot number, date of event and recovery status. No further information is available at this time.
Rash starting in RT. Arm then quickly spread to left arm then both leg . is most severe in RT. leg with blisters approx. the size of a kidney bean.
After 2nd injection low grade fever, severe chills, muscle pain, headache, weakness, tiredness, nausea, hands tremor, body shaking  started, and repeated every week / every 10 days for 7 months. All COVID tests ordered by physicians returned negative.  After 7 months symptoms improved except left hand tremor.
1. Hallucinating behavior at night (described to me by my wife), after receiving a Moderna booster shot on 11/2/21 2. Excessive pain along the upper section of my left hand caused by a Moderna booster shot. 3. Heavy breathing/gasping for air on November 2nd and 3rd
Patient developed body aches, chills, and a severe headache about 12 hours after receiving vaccine. Severe headache accompanied by blurred vision lasted until late night of 4-22-15. Patient states symptoms resolved, though still very red and sore at injection site.
This spontaneous report as received from a certified medical assistant (CMA) refers to an approximately 20 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On 09-OCT-2008, the patient was vaccinated with the first dose of GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported). It was reported that the patient received the second dose of GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported) in the human papillomavirus (HPV) vaccines series on 29-OCT-2015 (inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter reported for her uncle. The age at the vaccination was not reported. The patient received Shingrix and experienced flu like symptoms. The reporter consented to follow up. Limited information was provided by the caller about her patient. This case linked with US2020075688 and US2020075686, reported by same reporter.
2 days after receiving the 2nd dose Of  vaccine, redness, itchiness, and tiny blisters were noted about 1inch around the injection site.
Another clinic had written on the vaccination card that their next vaccine was on 5/11/21.  However the first dose on 4/20/21 and should have said 5/18 instead of 5/11.
ADMINISTRATION OF VACCINE STORED OUTSIDE OF 6 HOURS TIME FRAME THE VIAL WAS REFRIGERATED FOR 46 HOURS; VIAL PUNCTURED AND REFRIGERATED 46 HOURS PRIOR TO DOSE DRAWN FROM VAIL; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced administration of vaccine stored outside of 6 hours time frame the vial was refrigerated for 46 hours, and vial punctured and refrigerated 46 hours prior to dose drawn from vail. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial punctured and refrigerated 46 hours prior to dose drawn from vail and administration of vaccine stored outside of 6 hours time frame the vial was refrigerated for 46 hours was not reported. This report was non-serious.
it was given one month after the supposed expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received HAV (Havrix) (batch number GP75A, expiry date 04-OCT-2018) for prophylaxis.   On 20-NOV-2018, the patient received Havrix. On 20-NOV-2018, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: it was given one month after the supposed expiration date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-JUN-2023 The reporter reported expiration of a vaccine lot number and stated that it was given one month after the supposed expiration date.  It was reported that the lot number was searched for in system but no information appeared. Information about the vaccine, event and patient were collected. The Vaccine Administration Facility is the same as Primary Reporter. Havrix was given one month after the supposed expiration date which led to expired vaccine used. The reporter consented to follow up.
Uncontrollable shaking/chills and slight breathing difficulty at the same time.  I couldn't hold a full glass of water without having the water shake out of the glass.  I am in good health, was fully hydrated and exercise on a regular basis.    This symptom is not listed on the published symptom list and I had no idea this could possibly be the outcome of the vaccine.
This spontaneous report as received from a consumer reporting on herself, a 69 years old female patient with no drug reactions or allergies. In July 2008, the patient was vaccinated with ZOSTAVAX (dose and lot # not provided). There was no concomitant medications. The consumer stated that, in July 2008 she received ZOSTAVAX vaccine from her local clinic. In August 2012, the consumer broke out with skin rash that was shingles. She stated that, she had a rash all around her trunk with severe pain. No lab test were performed. The rash has cleared but she still had the nerve pain and the impacted skin felt was very different. She did not go to see her physician and she did not received medication. At the time of the report, the patient was recovering. Additional information has been requested.
About 48 hours following my first dose of Moderna, I experienced a prolonged and almost-unbreakable episode of supraventricular tachycardia. I was able to break the irregular heart rhythm while en route to the Emergency Room for medically-assisted treatment. I have not experienced a prolonged episode of SVT in over four years and feel strongly that the Moderna vaccination I received was responsible for the episode in question.
Information has been received from a physician concerning a 67 year old male who on 11-OCT-2007 was vaccinated with PNEUMOVAX 23 (lot# unknown) 0.5mL IM. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot# unknown) at a different site. On an unspecified date, the patient developed pain, swelling and redness at injection site. Medical attention was sought. On an unspecified date the patient recovered from pain, swelling and redness at injection site. No other symptoms were noted. Additional information has been requested.
Administration of vaccine was given about 3 inches too low, not sure if it went into muscle or subcutaneous but I did end up with an injection site reaction 2 days later to include a 2x3 inch red, itchy, raised, hot to the touch welt.  Also had extreme dizziness, nausea, headache 2 days after injection.  Dizziness, nausea, headache subsided after 24hrs however injection site reaction will go away and come back randomly.  Seems to coincide with getting sick?  Was fine up until 12/29 when I did end up getting sick to include headache, body aches, chills.  I went to go get covid tested which was negative.  I ultimately had a sinus/ear infection.  However injection site reaction had gone away UNTIL I got sick on 12/29 then it showed up again and still have it as of today.
Swelling of right thigh 9 cm x 10 cm slightly red, swollen and tight. Cetirizine 5mg/5ml oral Triamcinolone acetonide topically.