chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels truly awful; severe congestion; cough; sore throat; body aches; This spontaneous report was received from a Dietician concerning a 50-year-old, female patient who received Moderna's COVID-19 Vaccine, and experienced the events severe congestion, cough, body aches, sore throat and feels truly awful.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received her first of two planned doses of mRNA-1273 on 26-Dec-2020 intramuscularly for prophylaxis of COVID-19 infection.   On 26-Dec-2020, the date of injection, caller reported that patient had severe congestion, cough, body aches, sore throat and the symptoms of Covid-19.  The patient was tested for Covid-19 on an undisclosed date.  Test results were pending at the time report was received.  By 28-Dec-2020, caller reported that the patient stated she felt truly awful. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided  The outcome of the events severe congestion, cough, body aches, sore throat and feels truly awful were unknown.; Reporter's Comments: This case concerns a 50-year-old, female patient, who experienced  non-serious unexpected events of Nasal congestion, Cough, Oropharyngeal pain, Malaise and non-serious expected event of Myalgia . The events of Nasal congestion, Cough, Oropharyngeal pain and Myalgia occurred 1 day (same day) after the first dose of mRNA-1273, COVID-19 vaccine. The event of Malaise occurred 2 days  after the first dose of mRNA-1273, COVID-19 vaccine. Based on the current available information and temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.
No adverse event came from this vaccination. The patient was given an adult dose of the Bivalent Pfizer vaccine and she was given this dose before her first two primary series of mRNA vaccine. She has had no symptoms or adverse reactions as a result of this vaccination.
This spontaneous report as received from a pharmacist refers to a pediatric patient. The pharmacist reported that the patient received an adult dose of VAQTA (strength, dose, frequency and lot # not reported) on 29-JAN-2014. No adverse symptoms were reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
fever 99 at home, runny nose, chills, headache, sinus congestion, cough. starting on 11/15/21
Patient reported approximately 3 to 4 weeks after first booster, a rash appeared like bug bites affecting hands, feet, legs and trunk for about 2 months. She did not relate this to the first booster. Patient reported approximately two weeks after second booster, a rash/hives of increased severity appeared in varying areas of trunk and arms for a few hours. They were red and raised after possibly itching, then disappeared and reappeared in different places.
Information has been received from a nurse practitioner concerning a female patient who on unspecified dates in 2007 was vaccinated with the first two doses of GARDASIL, 0.5ml, intramuscularly in the buttocks and in December, 2007 was vaccinated with the third dose of GARDASIL, 0.5ml, intramuscularly in the left arm. The nurse practitioner reported that when the patient was seen in December, 2007, there was an indentation in her buttocks about the size of half dollar and the skin was "caved in". There was no inflammation. The patient was seen again that week. The area on her buttock has increased in severity. The indentation remained. The area was blue-purple in color and tender to touch. At the reporting time, the patient had not recovered. The patient sought medical attention through an office visit. Additional information has been requested.
I had severe pain in my abdominal and back. I was diagnosed with a pulmonary embolism. This lasted for about a week.
Localized erythema, induration within 1 hour started with redness & itching. (L) deltoid 3.5 x 4.0 cm - welt.
experiencing nosebleed; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiry dates were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient reported that she experienced nosebleed and wanted to know if this was a normal side effect. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
This case was reported by a pharmacist via sales rep and described the occurrence of corneal graft rejection in a elderly male patient who received SHINGRIX for prophylaxis. Co-suspect products included ZOSTAVAX for prophylaxis. The patient's past medical history included corneal transplant. Concurrent medical conditions included Fuchs' Disease. On an unknown date, the patient received the 1st dose of SHINGRIX and ZOSTAVAX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced corneal graft rejection (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and adverse reaction. SHINGRIX was discontinued. On an unknown date, the outcome of the corneal graft rejection, ophthalmic herpes zoster and adverse reaction were unknown. The reporter considered the corneal graft rejection to be related to SHINGRIX. It was unknown if the reporter considered the ophthalmic herpes zoster and adverse reaction to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife who was also a pharmacist. The age at vaccination was not reported. He was about 70 years old at the time of reporting. Previous to the receipt of ZOSTAVAX (ZVL), the patient a corneal transplant. The patient's wife reported that, the patient experienced severe reaction and rejection of transplant (no timeline given post dose). The patient's treating physician stated that, the SHINGRIX had caused transplant rejection. The patient required another transplant, hence the patient would not receive 2nd dose of SHINGRIX. The patient's wife was counseling patients or friends to not get the vaccine if they previously received ZOSTAVAX as she felt that was somehow related. The patient's wife was suggesting perhaps a herpes ophthalmicus relationship.
Severe peripheral cyanosis; difficulty stridor; laryngospasm; loss of muscle tone. One hour and 15 minutes after injection she was symptomatic. Maintained on SA O2 over 97% room air. Asymptomatic approx. 30 minutes after onset without treatment.
Received vaccine on 12/30/2020: Experienced 5-7 Days of neuropathy, itching.  Six hours after injection, I woke up with extreme flushing, but no fever. Worst part was, I had like a tingling and burning sensation that radiated to my extremities legs and feet. Sweating in feet that came in waves. I felt like my skin was on fire, like I was too close to a heater. Waves of numbness and tingling that was constant that lasted for approximated 5 days. Bad taste in mouth like a metallic taste. Blood pressure was extremely high. Worse at night. I went to ER on 1/3/21, because I was still having waves of burning and discomfort that was raising my blood pressure. I thought after 72 hours I would be better and it did not so this is why I went to ER.  Day 5, I had lost of taste, runny nose, light nausea. By day 6, the cough turned into itchy throat discomfort. Day 7 low grade fever. Day 8, everything started to subside.
Several hrs p/vax pt became fussy, whining, fever 101.3 @ 1130PM; @ 230AM fever of 103.7, slept only 20min, not drinking; Taken to ER w/fever 102;
This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 25-OCT-2012 03:40, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
C/O "feeling bad" at bedtime. During the night developed fever at 101.5 degrees F oral with chills, sweating, cough, vomiting. On 10/23 took child to physician who told mother that it was a reaction to the flu shot. Fever has resolved but child continues to cough and occasionally vomit.  Mother called as she is concerned about getting dose #2 of flu.
Back pain, neck and shoulder pain, intense headaches, jaw tightening, vision problems and swelling of both temples
severe itchy rash covering upper torso, neck & scalp;rx Hydrocortisone & Mycolog creas by pvt MD;
Shortly after leaving office patients cheeks turned bright red and patient became lethargic and spacey. Became very fussy and ran temperature around 102 throughout evening and night. Vomited once around midnight 2/11/04. Right arm site red and blotchy. No trouble breathing noted.
Patient presented with substernal chest pain and was found to have an elevated troponin. He was taken for coronary angiography which showed no obstructive CAD. A subsequent cardiac MRI was consistent with subacute/resolving myocarditis.
devel hives & itching 22OCt97 11PM took/DPH @ 655AM 23OCT97;pt contacted p/hr c/o swelling, itching face, throat tight;no SOB;chest hurting, tight;
Initial and follow up information has been received from a registered nurse concerning a 12 month old white female, with no pertinent medical history, drug reactions or allergies, who on 14-JUN-2007 at 10:50 was vaccinated subcutaneously in the left thigh with a 0.5 ml first dose of varicella virus vaccine live (Oka/Merck) ( lot # 656823/0305U). Concomitant therapy included a fourth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (TRIPEDIA) (lot # C2569AA) given in left thigh, a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) given in the left thigh. Additional suspect vaccinations include a third dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (MSD) (Lot#654537/0500F) given in the right thigh and a first dose of measles virus vaccine live (Enders-Edmonston) (-) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot#655270/1409F) given in the right thigh. Illness at the time of vaccination included bilateral serous otitis. On the morning of 28-JUN-2007 the patient's mother discovered "rashes" on the patient. The patient developed a red area, that was approximately 1.5 cm in diameter (previously reported as bigger than a nickel but smaller than a quarter) on her left thigh (at or near the injection site). There were 3 fluid filled vesicles within this red area. The patient also had morbilliform (previously reported as billiform) rash over the upper trunk extending into the diaper area (sparing the rest of the body). Medical attention was sought. There were no lab studies performed. At the time of the initial report the patient had not recovered. In follow up it was noted that the patient's status was unknown. Additional information is not expected
At 1:30 PM, developed itching, swelling at waist, crotch and under bra; took shower before itching. 8:00 PM, took Benadryl; slept until 4 AM. Awoke and had hive like areas on left side and back. 4:30 AM Took another Benadryl. No rash today; no itch.
Information has been received from a physician, via a company representative, concerning a 14 year old female patient, who on 11-JAN-2007 was vaccinated with the first dose, 0.5ml, of Gardasil, with no adverse events reported, and on 08-MAR-2007 was vaccinated with the second dose, 0.5ml, of Gardasil. There was no concomitant medication. On 08-APR-2007, the patient had experienced "extreme leg and back pain" and was diagnosed with acute transverse myelitis; she was hospitalized. The duration of hospitalization was not known. At the time of this report, the patient had not recovered from the acute transverse myelitis. Additional information has been requested.  6/19/07 Received PCP medical records which included vax records w/lot & dose #s.  VAERS database updated w/same. ALso included was hospital d/c summary which reveals patient admitted 4/17-4/20/07 with severe LE pain which had progressively worsened.  Seen by PCP who sent to neurologist prior to admit .   Admitted for high dose steroids & close observation.  Improved dramatically & d/c to home w/PCP & neuro f/u.  Seen by neuro in f/u on 4/23/07 being transported by ambulance on a gurney due to total paralysis of both LEs.  Also had severe depression.  5/18/07 w/only partial recovery.  Continued to have severe low back & LE pain despite fentanyl patch & PT. Was unable to ambulate & was w/c bound.  Exam revealed severe flaccid hypotonic muscle weakness of LEs w/hyperreflexia.  Bladder & bowel function were intact. Patch increased & was to continue PT.  7/3/07 Received hospital medical records which reveal patient experienced severe LE pain which had progressively worsened.  Admitted 4/17-4/20/07 for IV steroids & pain management.  Patient had URI w/sore throat & fever approx 3-4 wks prior to admit treated w/antibiotics.  Then developed back pain which worsened & LEs also became numb.  Seen by PCP who consulted neurosurgeon & MRI was done which was neg.  Patient continued to worsen & was seen by neurologist who dx w/transverse myelitis & admitted to hospital. FINAL DX: Transverse Myelitis.
Patient reports that three days after having varicella vaccine, she broke out in a rash on her shoulder and antecubital fossa area and two days after that, three bumps were on her back and two on the right side of her body.  She reports the bumps went away, but the rash did not.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 11-OCT-2012 the patient was vaccinated with PNEUMOVAX 23 (lot # 669579/0595AA) which had expired on 30-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
I received my 2nd booster shot on 05/13/2022 my adverse event started on 05/14/2022 in the morning at 8;00AM I had headache, and pain on the left arm where I got my shot. The pain was till Sunday. On Tuesday 05/17/2022 in the night 9:00PM I had cough, fever, headache, runny nose, and sore throat. When I woke up it was worse. I went to my doctor medication azithromycin 500mg for 5 days. He also gave me Claritin for 5 days. I am still taking the medicine. Today 05/19/2022 is my second day. I feel much better. I have little headache, and runny nose the other symptoms are gone.
I had vision problems (very hazy vision); This is a spontaneous report from a contactable Consumer (patient, self-reported). A patient of an unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiry date was not reported), via an unspecified route of administration, on an unknown date, as single dose for unknown indication. Patient's medical history and concomitant medications were not reported. On an unknown date, the patient had vision problems (very hazy vision). On an unknown date, next Friday, the patient will get the second dose. Patient mother and patient had vision problems after getting the vaccine. The patient deciding whether to get the second one, as the patient afraid to lose patient's vision. Need to decide quickly. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained. No further information is expected.
Administered vaccine in (R) deltoid. Went to push plunger and vaccine would not go in. I explained to patient I would need to stick her again and I changed site on (R) arm and then administered vaccine. No problem at that time. Pt unable to lift (R) arm.
I suffered pain, redness, and swelling of the injection site within a few hours after the shot, but I started feeling sick to my stomach and dizzy at around 11:00 AM the next day pretty suddenly. Within a couple of hour, my whole body was aching severely. I had a fever and was soaked with sweat from head to toe. I was extremely sick for about 24 hours then my fever broke and I felt better and was over it within 4 to 5 hours. It was scary.
Injection site itches; Rash at the injection site; Swelling at injection site; Redness around the shot area about the size of 4 quarters; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness around the shot area about the size of 4 quarters) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness around the shot area about the size of 4 quarters). At the time of the report, VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness around the shot area about the size of 4 quarters) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included an ice pack and an anti-histamine. No concomitant medications were provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Pink area the size of a baseball at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Pink area the size of a baseball at injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Pink area the size of a baseball at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Pink area the size of a baseball at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: NNI
Patient called and said her arm was itching, had redness and swelling and was warm. She was advised to go see a doctor and to monitor for allergic reaction.
Pt experience diarrhea vomiting and fever of 101 degrees after receiving 2 mo shots.
Patient tested positive to COVID-19 on 6/25/2021. His symptoms were just loss of taste and smell.
Information has been received from the authors in a published literature article regarding a child patient of unknown age and gender, who in 2007 received a complete vaccination regimen of 3 doses of ROTATEQ (dose and route were not reported). ROTATEQ is a pentavalent human bovine reassortant vaccine that contains 4 G types (G1, G2, G3, and G4; VP7 gene) plus the P[8] VP4 type on a bovine WC3 (G6P[5]) backbone. On an unknown date, in the child with acute gastroenteritis was identified an NSP2 gene ROTATEQ in an RVA with a DS-1 like genotype (adverse event). Although the child from whom the NSP2 reassortant specimen was obtained had been vaccinated with a complete regimen of 3 doses and no other rotavirus vaccine, ROTATEQ genes was detected in the fecal sample. Finally, the finding of strain RVA/human-wt/USA/2011729115/2011/G2P[4], a wild-type RVA with a vaccine-derived NSP2 gene, in a child with acute gastroenteritis highlights the need for continued rotavirus surveillance, domestically and internationally, after vaccine introduction. The outcome of gastroenteritis and NSP2 gene ROTATEQ in an RVA with a DS-1 like genotype was unknown. The reporter considered the events to be related to ROTATEQ. Additional information has been requested.
not feeling right with each Pfizer COVID vaccine; Sore arm; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL8982) at the age of 79 years, in left arm and on 09Feb2021 as dose 2, single (Lot number: EL9267), in left arm for covid-19 immunization. The patient's relevant medical history included: "Heart failure", start date: Aug2018 (unspecified if ongoing); "Asthma", start date: Aug2018 (unspecified if ongoing), notes: She does inhalers; "COPD", start date: Aug2018 (unspecified if ongoing), notes: She does inhalers; "scoliosis" (unspecified if ongoing), notes: She has had scoliosis for many years.; "Pacemaker placed", start date: 2018 (unspecified if ongoing). Concomitant medication(s) included: ENTRESTO; DIGOXIN; SPIRONOLACTONE. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovering", described as "not feeling right with each Pfizer COVID vaccine"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Sore arm"; PYREXIA (non-serious), outcome "recovering", described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No additional vaccines were administered on same date of the Pfizer suspect. No AE require a visit to Emergency Room and Physician Office. Patient did not take any prior vaccinations (within 4 weeks). Patient did not receive any medical treatment for events sore arm, low-grade fever and not feeling right with each Pfizer COVID vaccine and all improved within the 2nd day. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200756211 similar report from same reporter.
day of vax pt sudden onset of slight dizziness, cold chills (transient) difficulty reading, flushed feeling, deep breathing. temp 99.3
Vaccine given on 4/25/2000. On 05/02/2000, pt with erythema, edema, warmth in area 4" x 5" on right deltoid.