chrisvoncsefalvay/vaers-outcomes huggingface dataset:
- Pain at injection site (RT arm) and tightness in right side of neck and jaw - from time of injection through approx 8 Oct. (23 days). - Tightness in chest approx 72 hrs after injection and slowly subsiding through 15 days after - Dry cough, hard to take a deep breath from approx 72 hrs after injection through 7 days after - Exhaustion and brain fog approx 72 hrs after and subsiding through 7 days after
I did not feel good after receiving the Moderna vaccine/feel like shit afterwards; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I did not feel good after receiving the Moderna vaccine/feel like shit afterwards) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I did not feel good after receiving the Moderna vaccine/feel like shit afterwards). At the time of the report, FEELING ABNORMAL (I did not feel good after receiving the Moderna vaccine/feel like shit afterwards) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient had 4 or 5 covid shots. No traumatic things.  Treatment information was not reported.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 3 Patients in the exposed cohort experienced, poisoning unspecified while 2 of the unexposed cohort experienced poisoning unspecified. Of the 3 exposed patients Age Group: 3 were in the 19-24 age group: Sex: 1 Female, 2 male. Of the 2 unexposed patients 2 were in age group 19-24. Sex: 1 female; 1 male.
Patient requested a first dose Pfizer Monovalent as he told staff that he never received a COVID-19 vaccine before. Staff was not able to login in to look up his record.  Staff administered Pfizer monovalent 0.3ml in his right arm.  Patient did not report any adverse reactions during his time in observation. Staff was able to login in later that day. His record showed that he completed his primary series on 3/25/22.
I woke up with severe Number 10 pain in my right knee, front , back and side. It was red, tender and swollen. The pain moved down to my right ankle and foot with severe muscle spasms pulling my right foot inwards toward my left foot. I could not walk to bathroom without screeming. Then it moved to my right hip area with muscle spasms across my lower back.  I am still experiencing pain and muscle spasms (not as severe) today at this writing. It seems to be attacking my body where I have old injuries.
Fatigue starting 6 hours after receiving vaccine, followed by vomiting and diarrhera that continuing until 1:00AM. Fatigue continued through the following day.
This spontaneous report was received from a pharmacist refers to a 60 years old female patient without drug reactions and allergies. On 31-AUG-2014 the patient was vaccinated with ZOSTAVAX lot # K003598, expiration date: 13-MAR-2015 (dose and route of administration were not reported). Concomitant therapies included SYNTHROID, Losartan potassium (manufacturer unknown), PREMARIN, PERCOCET, TOPAMAX, XANAX, trazodone hydrochloride, pravastatin sodium, NEXIUM, Vitamin D3, DILANTIN, hydrochlorothiazide (manufacturer unknown), PROAIR, FLUVIRIN and unspecified numbing mouthwash. In 2014 the patient experienced localized redness, itching and swelling after receiving ZOSTAVAX. The patient sought medical attention. She did not receive any treatment for the adverse events. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Rcv'd 2nd shot on 1/3/03 with slight burning upon entry into body. 1/4/03 exp. moderate bruise around injection site with slight swelling and numbness through out arms. Could not raise arm above head. No fever reported. Some tingling in finger tips.
patient was given shot and fainted several minutes later after receiving. He remained seated in the store and managers and staff were checking on him for  about 45 minutes and no sign or nausea/vomiting and said he felt fine and there was no swelling on knots on his head per his mother
Quarter-sized soreness at injection site for two days following the shot. Some swelling on the third day, and by the 4th, physical therapist thought the area looked infected. It was hot to the touch, and roughly 10cmx10cm. Recommended seeing a doctor immediately. Family physician later that day prescribed Cephalexin.
Experienced stabbing pain starting the day of receiving vaccination. Reports pain today, almost 1 week after receiving shot. Has not tried any pain reliving options yet so I recommended using an Ice Pack and taking over the counter Tylenol for pain relief until he can see a doctor tomorrow.
recurrent fainting starting on 11/15 (about 1 moth post vaccination) Metabolic changes, weight loss episodes of lightheadedness warmth
Patient feeling faint. Pt states he has issues with getting injections,"turns pale.' Recorded. Seen by EMS. Pt. discharged home at 16:00 p.m.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. Since 26-JAN-2015, doses of GARDASIL (lot#, expiry date, dose, route and dose number were not provided), which were exposed to temperatures outside of the recommended range, had been administered to the unspecified patients  (dates unspecified). No adverse effect had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
11/5/09 H1N1 UT014AA (IM); 11/9/09 difficult walking. Mother took child to chiropractor-walking improved by 11/15/09 child would "cross" eye involuntarily for several days. 11/24 lost speech-appeared to have seizure. 11/25 went to urgent care at hospital to see doctor.
painful/burning; broke out in hives; hives around my neck; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 66-year-old female 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 injection site pain, injection site hives and hives. On an unknown date, the outcome of the injection site pain, injection site hives and hives were recovered/resolved.   The reporter considered the injection site pain, injection site hives and hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After Shingrix vaccination the patient's injection site was very burning painful, broke out in hives at the injection and around her neck. This case has been linked with case US2019AMR226335, reported by same reporter.
fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was receiving his second dose on the day same as his surgery (unspecified). Patient was going to postpone his second shot because he had fever after receiving the first shot on an unknown date. The patient wanted to know the maximal interval between doses. The events were reported as non-serious. The outcome of the event fever was unknown.   Information about batch/lot number has been requested.
12:30am 3-27-07 child screaming, shivering and burning up-temp was 103.2F-gave 2tsp of Motrin-fever came down at 3:00am to 101F-3:30am gave Tylenol 160mg-child slept to 6:30am repeated Motrin at 6:30-went to doctor 7:05am told to just control fever, other symptoms-headache, dizziness and nausea. left upper deltoid with erythema and swelling. increase pain at site of Dtap injection.
Vomiting and lethargy, intussusception, required surgery for resection at necrotic bowel.
Patient had brief (appx 10-15 seconds) vasovagal episode approximately 5 minutes after vaccine was given.  He was seated in a chair and observed by NP during the episode.  HR 50s. BP stable.  No injuries.  Recovered quickly.  Stated afterwards that he has this reaction with needle sticks.  discharged home
Severe jaw pain; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN, age at vaccination: 24years) via an unspecified route of administration on an unknown date as DOSE 2, SINGLE, for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced severe jaw pain for five days after second dose of Pfizer vaccine. The patient did not receive any treatment for the event. The clinical outcome of the event severe jaw pain was recovering at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated patient data and suspect dose data.
Sore arm, minor headache, body ache, tiredness, fever that lasted a few hours. (Nothing serious, just reporting for data collection.)
Evening following vaccine, pt experienced prolonged vomiting with round of hives within 2 days recurring one week later. Pt saw physician and treated with prednisone and supportive care.
pt reported rash on face & chest 2 days p/vax;rash itched & was red;
Started around 1 p.m. with flu-like symptoms, i.e., fatigue, body aches, neck pain, headache.  Around 3-4 p.m., developed facial rash, face redness.  Flu symptoms dissipated the next day, but facial rash appears to be morphing to hives.    Other note - I had COVID-19 in February 2020.
Patient hospitalized with COVID-19 on 12/16/2021.  Currently hospitalized.
Client here for ZOSTAVAX - Screened for Td - Agreed to receive Td also. Once secretaries entered shot received was seen that it received TDAP 4/2009. No adverse event noted at this time.
Acute hearing loss unilaterally (right ear) beginning D7 after dose 1, peaking at D10-13 after dose 1 with moderate recovery by D15.  Again, acute hearing loss after second vaccine (R>L) beginning on D7, peaking on D11-16.  Today is D16 with no recovery whatsoever.
SWEATING; INCREASED BLOOD PRESSURE; EXTREME THIRST; SHAKINESS; CONFUSION; MILD HEADACHE; DRY MOUTH; CLAMMINESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 100 pounds, and height was not reported. The patient's pre-existing medical conditions included normally had low blood pressure was at 170/92. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced dry mouth. On APR-2021, the subject experienced clamminess. Laboratory data included: Blood pressure (NR: not provided) stabilized. On 18-APR-2021, the subject experienced extreme thirst. On 18-APR-2021, the subject experienced shakiness. On 18-APR-2021, the subject experienced confusion. On 18-APR-2021, the subject experienced mild headache. On 19-APR-2021, the subject experienced sweating. On 19-APR-2021, the subject experienced increased blood pressure. Laboratory data included: Blood pressure (NR: not provided) 170/92 mmHg. Treatment medications (dates unspecified) included: atenolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased blood pressure, and the outcome of extreme thirst, shakiness, confusion, mild headache, sweating, dry mouth and clamminess was not reported. This report was non-serious.
swelling & redness to lt deltoid;dx as local allergic rxn w/diffuse hives;
Information has been received from a male consumer, who was vaccinated with hepatitis B virus vaccine rHBsAg (yeast).  The caller reported he received three hepatitis B virus vaccine rHBsAg (yeast) vaccinations, the first in July 2002, the second in August 2002, and the third in March 2003.  He reported, "a recent Hep B titer showed a positive core".  The consumer questioned, "why did my core come back positive?"  It was noted the consumer did not provide any other information.  There was no product quality complaint reported.  Unspecified medical attention was sought.  Additional information has been requested.
Arrived in Er with complaints of SOB, chills and cough since the evening of he second injection.  Also reported one episode of nausea with ABD pain about 30 hours after injection; that had passed and not reoccurred.  Noted to be anxious on arrival with elevated blood pressure.  Wheezes present on arrival, negative chest xray.  Oxygen saturations were 94-97% on room air.  Labs WNL.  Treatments: Solumedrol & Xopenex
Developed Shingles; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old female non pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 22Aug2021 13:00 (at the age of: 19-years-old) as dose 2, single for covid-19 immunisation. Patient medical history included covid-19 (Prior to vaccination). The patient's concomitant medications were not reported. Previously she had no allergies. The patient previously 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 an unspecified date as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccine with in 4 weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Sep2021 the patient developed shingles. The patient received treatment with anti virals and steroids as a result of developed shingles. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Dizziness, Headache, Myalgia, Fever, Sweating Narrative:  Other Relevant History:
102 DEGREE FEVER, SEVERE HEADACHE (OCULAR MIGRAINE), JOINT PAIN AND BODY ACHES, DIARRHEA  AND SWOLLEN LYMPH NODES UNDER ARMPITS (SIZE OF SMALL TANGERINE) FOR 4 DAYS - SINCE THEN PERSISTANT HEADACHE (MODERATE), JOINT PAIN, SWOLLEN FEET, TACHYCARDIA, DIZZINESS, LIGHT HEADED, ODD RAISED RASH THAT COMES AND GOES
COVID-19 resulting in inpatient hospitalization of a vaccinated patient.  Pt was also boosted 11/12, unknown lot number with Moderna
Fever, headache, large  red and swollen and sore 3 inch circle around injection site (COVID arm)
Hives, & states difficulty breathing several hours after vaccine administered.  PREDNISONE & BENADRYL prescribed.  12/14/09 MR received for DOS 10/16/09. DX: allergic rxn.  Pt c/o hives, mild difficulty in breathing, diffuse rash in legs and neck. Tx: prednisone.    12/18/09 Office visit notes received for DOS 11/20/09. DX: Urticaria. Pt c/o hives continuing despite Benadryl and steroid treatment. On examination: diffuse red patches suggestive of urticaria plaques resolving. Pt had wheal and flare rxn to scratching of skin. Other tx: Allegra. Dr. considered this event as possibly due to vaccination given the proximity in time.
ear congestion; ear pain and felt like water was in her ear; She felt like her ear was quite swollen in the ear on the same side she got the shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EAR CONGESTION (non-serious), outcome "recovered", described as "ear congestion"; EAR PAIN (non-serious), outcome "recovered", described as "ear pain and felt like water was in her ear"; EAR SWELLING (non-serious), outcome "recovered", described as "She felt like her ear was quite swollen in the ear on the same side she got the shot.".  Additional Information: The reporter stated that her daughter got her first dose of the vaccine and had ear congestion, ear pain and felt like water was in her ear. She felt like her ear was quite swollen in the ear on the same side she got the shot. She stated that had gone away and she was scheduled for the second dose of the vaccine on Thursday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient who received a dose of Fluzone QIV intranasal instead of intramuscular; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient (unknown demographic), who received a dose of fluzone qiv intranasal instead of intramuscular (incorrect route of product administration), while he/she vaccinated with QUADRIVALENT INFLUENZA VACCINE [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b vaccine at a dose of 0.5 ml (lot number not reported) via intranasal in unknown administration site.  On an unknown date (unknown latency), it was reported that patient who received a dose of fluzone qiv intranasal instead of intramuscular (incorrect route of product administration). It was a case of actual medication error.  It was not reported if the patient received a corrective treatment.  Outcome was Not Applicable for the event.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.   No further information was reported.
Patient reports swollen knot in arm that is tender and Fatigue greater that 1 week.
Patient passed out about 1 minute after receiving the vaccine and had a small seizure lasting less than one minute.
0650: Pt in observation after receiving 2nd dose of Covid vaccine. Husband present. Pt states felt a "rush" , urge to swallow over and over, legs shaky, feeling claustrophobic. Hx of feeling similar when having shell fish or receiving contrast. Water given feeling somewhat better.  BP 175/93, HR 75, O2 sat 100% 0655: feeling increase salivation and urge to swallow. 0700 Benedryl 25mg po given with water.  BP 157/76 HR: 68  02 sat 100% 0715: Pt states feeling much better, salivation and urge to swallow gone.  BP 139/63 HR 67, 02 sat 99% 0725 Pt states no further c/o of anything. Ambulated with husband to car.
Pain in right arm; Headache; Chills; Temperature of 100.6 for several hours 11/3/2021; Could not get enough water down; Experiencing dehydration; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (booster) (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the right arm on 02Nov2021 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to vaccination which included influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) on 28Oct2021 for immunization. The patient did not receive any medication within two weeks of vaccination. The patient had no problem until 02Nov2021 at 21:30 and from then onwards she experienced pain in right arm, headache, chills and temperature of 100.6 for several hours 03Nov2021. She could not get enough water down and experienced dehydration. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 02Nov2021, the patient underwent body temperature test and the result was 100.6 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of temperature of 100.6 which lasted for several hours was resolved on 03Nov2021 however the clinical outcome of the events pain in right arm, headache, chills, could not get enough water down and experienced dehydration were resolving at the time of this report.
Beginning 12/16/12, 2 days post flu vaccine, pt complained of dizziness which became progressively more severe. It's more of the eyelids flipping upwards/jumping movement. Per wife, hospital ruled out stroke, aneurysm and are leaning toward viral infection or flu vaccine adverse event as cause. It has not been determined.
Muscle weakness in arms and legs. Rash on left arm  from injection site to wrist, inside of elbow. Red raised itchy painful. Extreme shakeiness in body.
SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included spinal cord degeneration.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included morphine for spinal cord degeneration. On MAR-2021, the subject experienced soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness. This report was non-serious.
The pt developed a red discoloration of skin from shoulder to wrist on his right arm which was warm to touch. He complained of a headache within 1 hours, post vax. His mother is to take pt to the doctor today for evaluation.