chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in 2015, the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in 2016, the patient was treated for a vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
Patient reported couple of hours later, she experienced fever/chills, nausea and vomited once. Patient felt dizzy. On Wednesday 9/28/16 8am (next day) patient felt ok.
Morning after flu vaccine, noticed rash on both thighs.  On Sunday am (10/6), face and hands were swollen.  Hives noticed on waking (legs, arms, stomach).  Took Benadryl on Sunday, Monday, Tuesday, and today (2 tablets three times daily).  Hives improving, however, remains itchy.  Face improved but still swollen...lips feel swollen.  Today (10/9/19) has symptoms of a cold (stuffy, cough x 1 week - prior to flu vaccine, itchy eyes - after vaccine).  No fever.  No shortness of breath.  Employee is encouraged to contact her private practitioner or go to ED for evaluation (prefers her private practitioner).
the patient received an improperly stored dose of PEDVAXHIB; This spontaneous report was received from a nurse and refers to a patient of an unknown age an gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-SEP-2020, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S036823, expiration date 31-MAR-2020 (dose and route of administration were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 72.8 Fahrenheit (F) for 4 hours. Data logger was involved. There were no previous excursions reported.
nausea, vertigo, stabbing pain in arm approx 30mins p/inj;felt ok next day;
Headache, Fever, NauseaVomiting, Injection site swelling Narrative:
Fever  Chills Body aches Shortness of breath Headache  Fatigue  Nausea  Vomiting  Dizzyness Loss of appetite  Body pain
My body is like blowing up like a balloon, like my dad used to take cortisone and prednisone his body will blow up; sometimes people who take contraception or birth control their body blows up; arm was swollen; The only normal side-effect I got in the area they shot it, I had little bit of pain for few days; This is a spontaneous report from a contactable consumer (patient). This is the first case out of two cases in which the reporter is reporting for himself.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 05Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient's body was like blowing up like a balloon and in the area, they shot it had little bit of pain for few days. Clinical course included: consumer stated that patient took the vaccine probably about a week or two ago (05Jun2021) and all of a sudden body seems to be like blowing up. Now, patient was not eating an overly amount, anything out of ordinary, but everything was getting tight on patient and cannot figure out why, except that the only difference was that the patient took the vaccine. It does not hurt or anything but wanted to know, was that a possible side effect, so it's more like body getting swelling. Like patient's dad took prednisone or cortisone and his body blew up and like sometimes women who takes contracepts or whatever, birth control, it happens to them too. So, patient do not understand like patient was trying to figure out why was patient body, why pants are getting tighter. Why did patient felt like body was getting swollen like blowing up and wanted to know if that was a possible side effect. The patient's arm was swollen and that was it, patient felt fine, but pants kept getting tighter and tighter (like way more tighter than usual and thinking of rest of the body, all clothes, why it was tightening) and felt like blowing up like a balloon and cannot figure it out, it was not like that patient eating any differently, patient just cannot figure it out. So, patient was just asking, was that a possible side effect that will go away. The only normal side-effect the patient got in the area they shot it, patient had little bit of pain for few days, but it was not all of this, so cannot understand why patient body was blowing up. The patient second dose was on the 26Jun2021. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Vaccine given Thursday morning. Symptoms started Friday (headache, chills, fatigue, body aches) continued through Saturday (today).
agitation; intermittent fever; altered mental status; difficulty walking; Initial information received on 28-Aug-2023 by health care professional regarding an unsolicited valid serious case issued from a literature article.  This case involves a 4 years old female patient who experienced agitation, intermittent fever (pyrexia), altered mental status (mental status changes) and difficulty walking (gait disturbance) while receiving vaccines VARICELLA ZOSTER VACCINE, MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE, POLIOMYELITIS VACCINE (INACTIVATED) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  A developmentally normal, ex-35-week, female presented at age 2 years with sudden onset encephalopathy and seizure activity in the absence of clinical triggers. A diagnosis of acute disseminated encephalomyelitis (ADEM) was made. After 5 days of IV (intravenous) methylprednisolone her condition improved, and seizures abated. The patient was back to her neurocognitive baseline after 7 days. After discharge, the patient's parents reported that her neurocognitive development slowed compared to other children. She was diagnosed with autism spectrum disorder (ASD) at age 3 years and family noted that with any acute illness or vaccination, the patient would have regression of her skills for 2-3 weeks before returning to her baseline. Specifically, the patient would become agitated, irritable, lose expressive language, and refuse to eat, walk, or participate in typical activities (e.g., brushing her teeth). These episodic symptoms are not uncommon in presentation of THMD5.   On an unknown date, two weeks after her 4-year vaccinations (DTap, IPV, MMR, and VAR) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as prophylactic vaccination, the patient began experiencing episodes of agitation, intermittent fever, altered mental status, and difficulty walking.   The patient was mildly encephalopathic and did have a wide-based gait although this improved without intervention over the subsequent 3 days of hospitalization.   Action taken: not applicable for all vaccines Corrective: unknown for all events Outcome: unknown for all events Seriousness criteria: hospitalization for all events Reporter Causality: Related for all events; Sender's Comments: Sanofi company comment dated 04-SEP-2023: This case involves a 4 years old female patient who experienced agitation, intermittent fever, altered mental status and difficulty walking while receiving vaccines POLIOMYELITIS VACCINE (INACTIVATED) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.. Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
Severe premenstrual dysphoric disorder: debilitating depression monthly for the weeks before and during menstruation. Lasted 3-4 cycles, needed to permanently increase anti depression medication dosage.
Arm pain; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and MYALGIA (Arm sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 48F21A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol. Concurrent medical conditions included Thyroiditis and Vaginal infection. Concomitant products included LEVOFLOXACIN HEMIHYDRATE (LEVOFLOXACIN [LEVOFLOXACIN HEMIHYDRATE]), IBUPROFEN and LEVOTHYROXINE for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain) and MYALGIA (Arm sore). At the time of the report, PAIN IN EXTREMITY (Arm pain) and MYALGIA (Arm sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  Atorvastatin 40 mg
Edema and erythema in left thigh after receiving injection there. At time if follow up, left thigh was 3 " larger in circumference than right.
After the second dose, she had a sore arm for a couple of days, but then she started having tangling in the arm the injection was given and then the entire arm went numb. There is no feeling in the left arm from shoulder to fingers. And the tingling and weakness is spreading to the left leg. She was completely fine before the shot.
On 4/5/21, 3 days after the vaccine, I developed a piercing headache behind my right eye. Shortly after the vision in the left eye started going in and out for a brief time. About 30 minutes later my left arm went completely numb, including my hand. This resolved after about 10 minutes, but then was intermittent for the next 2 hours. During this time, I also started having some mild and intermittent lower lip numbness. Speech felt different but was overall normal. The neurological symptoms were resolved by 11/12 that afternoon but headache lasted 48 hours.  At the time I was 17 weeks pregnant, due approx. September 11. 1 precious history without any complications.
Fever, rash and fatigue. Triamcinolone BID, Diphenhydramine.
headache, sore throat, nonproductive cough, fever, body aches, loss of taste, loss of smell, sinus congestion, nasal congestion, post nasal drainage, sneezing. starting 11/28/21
body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and HEADACHE (headaches) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2021.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced MYALGIA (body aches) and HEADACHE (headaches). On 28-Feb-2021, MYALGIA (body aches) and HEADACHE (headaches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015 09:32, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5 and 0.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
pt says that her arm was very sore after taking the vax but then she developed a fist size bruise at the injection site.  there is no fever or soreness any longer but the bruise has been there for almost 2 weeks.  She went to PCP Dr. on 4/12/2021 and she was told it was not a bruise and to contact the vax manufacturer since he wasn't sure what it was.
Extreme pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 14:00 at single dose for COVID-19 immunization. Medical history included atrial fibrillation. Concomitant medication included apixaban (ELIQUIS). The patient previously took iodine and experienced allergies to Iodine.  The patient experienced extreme pain at the injection site on 05Feb2021 14:00. No Treatment received for the event. The patient was not pregnant. The patient had no COVID prior vaccination. She had no COVID tested post vaccination. There was no other vaccine received in four weeks. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Vaccine received: 6/24/17. Reactions began: 6/26/17. Drowsiness, faint-feeling, tingling, lightheadedness, loss of appetite - taken to ER on 6/26/17.
Mom states after vaccines given 110/23/2002, child cried unconsolably >4 hours and right leg swelled up into groin area.  No treatment prescribed by MD.  I have attempted numerous times to contact mother to compete form without success.  No response to letter and telephone number wrong.
his first cup of coffee about killed him, it tasted so bad; dryness in the mouth; his voice has changed to raspy; his urine has a smell; lethargy; metallic taste in the mouth; This is a spontaneous report from a contactable consumer (patient) reported for herself that.  A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration administered in Arm Left on 08Jun2021 (age at vaccination 61-years) (Batch/Lot Number: EN0180) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient states coffee tastes strange/bad and this is ongoing but had improved some. Caller states starting out his taste was completely gone, his first cup of coffee about killed him, it tasted so bad. Caller states he has dryness in the mouth every day and he was drinking more water. Caller state he normally drinks a lot but this is more. Caller states his voice has changed to raspy most of the time and his urine has a smell. Caller states it was not like when he eats asparagus but another smell he hasn't had before. Caller states it started the morning after on 09Jun2021. Caller states his coffee is not back to normal taste yet, it still just tastes weird. Caller states he was also lethargic but that has improved some. Caller states he figured that out because he usually only has 1 cup of coffee and he was having 2-3 cups so he could stay focused and work, it was kind of weird. He also states he had a metallic taste in the mouth and for a while he had to brush his teeth 5 times a day. Outcome of the events was not recovered.
This case was reported by a other health professional via sales rep and described the occurrence of headache in a female patient who received SHINGRIX. On 3rd April 2018, the patient received the 1st dose of SHINGRIX. On 3rd April 2018, less than a day after receiving SHINGRIX, the patient experienced headache and pain in spine. On an unknown date, the outcome of the headache and pain in spine were unknown. It was unknown if the reporter considered the headache and pain in spine to be related to SHINGRIX. Additional details were reported as follows: The case was reported by a Clinic director. The age at vaccination was not reported. The patient was a provider in the office. The patient began experiencing a severe headache and spinal cord pain and she had called off work today.
10 minutes after vaccine was given, patient had onset of throat tightness, difficulty breathing, flushing, and rash.  Patient was immediately treated with 0.3 mg of epinephrine and within approximately 60 seconds began having improvement in her symptoms.  EMS was called and patient was taken to the ER via EMS for ongoing observation.  Patient was feeling improved but not back to baseline prior to leaving the clinic.
Pt developed a puffy eye, became irritable, had dyspnea; Taken to ER dx a cold; Had poor appetite, emesis, lethargy;
pt recvd vax & 5 1/2 hrs p/shot & 2nd 26 1/2 hrs p/shot pt pale, cyanotic, limp & unresponsive-felt cool; each event no prev episodes; exam p/2nd event normal;
shortness of breath; tightness in her chest; This is a spontaneous report from a contactable nurse (patient).  A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number: EL0140, expiry date: 19 Vaccine: Mar2021, via an unspecified route of administration in the left arm from 29Dec2020 16:00 to 29Dec2020 16:00 as SINGLE DOSE for COVID-19 immunisation.  Medical history included blood pressure abnormal (She has been on blood pressure med for 3 years).  Concomitant medication included labetalol oral 200 mg, 2x/day for Blood pressure. The patient reports since Sunday night, 03Jan2021, she noticed feeling a little tightness in her chest and shortness of breath but her O2 saturation is fine. Reports she tested it at 98% to 97%. Asking is this a side effect of the vaccine, has it been reported? Does it have anything to do with the expected effectiveness after a week of getting the first dose? She is scheduled for the second dose 18Jan2021. The outcome of the events was not recovered.
Very sore muscle for 4 day straight.  Could not touch it, it was so painful.  5 days after shot developed swollen supraclavicular lymph node and shoulder and neck pain.
A nurse reported that a 12 month old male received vaccines on 10/4/00 and on 10/13/00, the infant developed an injection site reaction characterized by redness, warmth, tenderness, swelling and blisters at the site of Prevnar administration. He was treated with Keflex and hot soaks.
Patient may have received first dose with a Pediatric (5 to 11 Y)  Pfizer vaccine
Given Varivax 5-7-07 L del SQ redness and swelling around inj site. Seen three days after vaccine - size of redness 11x9 cm with 3x2 182 cm induration in center of redness
for 2 1/2 half weeks after vax she had fever, nausea, dizzy, feeling weak, tried, rapid blinking, bruising and rash on injection arm  since she received vax her pulse rate and resting heart rate has gone up 25 points and hasnt gone down since she received vax
severe diverticulitis attack; bloody stool; diarrhea; fever; nausea; severe vertigo; difficulty breathing; profuse sweating; intense abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 28Jul2021 08:15 (batch/lot number EW0187 and expiry date unknown) at 43 years of age as dose 1, single for covid-19 immunization in an urgent care center. Medical history included asthma, hyperlipidemia, hypertension, chronic pain, GERD, diverticulitis. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included lisinopril, omeprazole, ibuprofen, ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN); all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that within 24 hours of vaccine being administered (approximately midnight on 29Jul2021), he had severe diverticulitis attack to include bloody stool and diarrhea, experienced fever, nausea, severe vertigo, difficulty breathing, profuse sweating, and intense abdominal pain. The patient informed that he required ER visit via paramedics. He had CT scan with dye contrast administered and was then admitted to the hospital for four days on high IV antibiotic regimen plus IV narcotic pain meds. The patient informed that the adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported serious as caused hospitalization (hospitalization not prolonged). The patient underwent lab tests and procedures which included covid test (nasal swab): negative on 29Jul2021. The outcome of the events was recovering.
Received flu vaccine Oct-2002 L DIM-client states in two days that pain and couldn't lift his arm.
Erythematous area extending from top of arm to mid humus area. Firmness around injection site about around 5 inches wide.
Pt recvd MMR vax & exp fever, austistic behaviors, encephalatic condition, began to tune out; sound sensitivity, hand-flapping, wheel-spinning; nightime sweats, appetite inc;
Joints, particularly knees, became inflamed, sore, and stiff.  Severe symptoms continued through to 03/24/2013 when all but the knee pain and inflammation diminished.  Knees are slowly improving but remain inflamed and painful through 03/26/2013.
I developed a red rash around my neck, down the sides of my torso, and upper back.
Client claims pneumonia shot given in "top" of right shoulder on 10/26/04 at flu clinic.  Describes nurse as "very young".  Student nurse giving pneumonia shots at that clinic.  Client presented at ER that evening with right arm pain and inability to raise right arm.  On 10/29/04 saw PCP who gave her Darvocet for pain.  Called HD 11/10/04 to report incident at husband's urging.  Has improved mobility of right arm from elbow to hand but remains restricted from shoulder to elbow, less pain now.  Says   who arm was originally numb.  Says reported no previous pneumonia shot when received but now feels she may have had one in past 5 years.