chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Developed shingles) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Developed shingles). At the time of the report, HERPES ZOSTER (Developed shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided
Oval shaped rash on left arm where the shot was given; it was hard on touch, red, swollen, and a little bit itchy.  The rash went away after 2 days.
RASH ON EXTREMITIES LASTING 2 WEEKS, NO FEVER WITH RASH.
PT CALLED TODAY AND STATES SHE IS VERY SICK. C/O SEVERE NAUSEA, FATIGUE, AND CHILLS. DENIES VOMITING/DIARRHEA AND LOCALIZED S/S AT THE INJECTION SITE. HAS BEEN TREATING S/S WITH PHENERGAN. STATES S/S BEGAN ON SATURDAY 9-24-2022. PT HAS AN APPT 9-28 WITH HER PCP UNRELATED FOLLOW UP, BUT PLANS TO ADDRESS THIS WITH THE PROVIDER AS WELL.   NO KNOWN CONTACT WITH ANYONE SICK.   PT HAS HAD NO VACCINES IN THE MONTHE PRECEEDING THIUS DOSE, BUT DOSE HAVE 3 DOSES OF MODERNA MONOVALENT ON 1-13-21, 2-10-21, 10-27-21.
pt recv vax 20SEP94; w/in 24 hr, devel a gen macular-papular rash; MD visit 11SEP; no tx initiated; rash resolved by 22SEP94;
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB.
Patient stated she awakened during early morning of April 11 with intense itching in hands and feet. A rash appeared on arms and hands appeared red. She administered some benadryl and symptoms improved. Patient is contacting PCP to discuss if she should receive second vaccine.
flushed; noticed some hives on forehead and forearm; This is a spontaneous report from a non-contactable nurse. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK5730), intramuscular on the left arm on 18Dec2020 09:30 at single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications were not reported. The patient previously took NSAIDS and experienced allergies. The patient flushed and noticed some hives on forehead and forearm on 18Dec2020 10:15. Therapeutic measure was taken as a result of the events that included Benadryl. Clinical outcome of flushing was not recovered while for hives recovered on Dec2020.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient presented for routine visit with provider, provider noted the patient received a monkey pox vaccine #1 in August but it was not marked at administered . provider also noticed when viewing the chart that the patient had several bicillin and cefriaxone medication administration that were given but not marked as done so no documentation was noted.
Inj (Pneumovax) given (L) deltoid, was told that injection was given posterior to exact site.
10/14/2013 Mother called the health dept. States R arm red, swollen, warm to touch with hard knot. States had low grade fever, school nurse gave student Advil and Benadryl. Arm better at this time. Also used ice pack.
About a minute after the administration of a Flu shot, pt. lost consciousness for about 3-5 min. We put her feet up and cold pack on her face. Mom made her drink fluid and she recovered quickly and walk out to go home.
devel blanching irregular reticular (lacy)-patterned hyperemic lesions on both deltoid areas which were not raised but was sl warm to the touch;
Shot received on Wednesday. Friday morning right neck and arm painful (side of shot). Lymph node above clavicle became very swollen and tender Friday morning on right side of body.
Pt received flu vaccine. I recommended she stay for 20 minutes after. While in waiting area her daughter approached me said she was having chest pains and feeling short of breath. I took her BP which was 185/77 then called Drs office who advised me to refer her the ER
Vaccine expired on 13 Oct 2021 and Placed in refrigerator on 25 Nov 2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and Placed in refrigerator on 25 Nov 2021) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and Placed in refrigerator on 25 Nov 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and Placed in refrigerator on 25 Nov 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Date vaccine was placed in refrigerator was 25 Nov 2021. No adverse event and no temperature excursions was reported.  No treatment information was provided.
Case PHEH2016USA023709, is an initial spontaneous report received from a pharmacist on 15 Sep 2016. This report refers to a 49 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (batch number: 185285) at a dose of 0.5 ml, intramuscularly on 15 Sep 2016. On 15 Sep 2016, after vaccination, she complained of tingling in the left arm and tingling of the lips and also heartburn, not first time patient has received flu shot. It was stated that, effects were experienced 02 hours after getting the vaccination. Pharmacist advised to patient to go to emergency room due to chest pains. The outcome of the events was reported as unknown. The seriousness of the event heartburn was not reported and event chest pain was reported as serious. The seriousness of the events tingling in the left arm and tingling of the lips was reported as non-serious. The causality of the events was not reported.
Starting a few hours after receiving the vaccine, my right arm swelled up very badly and it was really sore. I put some alcohol on it and took some Tylenol. It went away on its own. I did see my PCP for it, but he said there was nothing he could do about it due to it being a government shot.
Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the above reference who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 17-year-old male patient had received an injection of Tdap vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and within 20 minutes after vaccination, he developed anaphylaxis with symptoms of wheezing, respiratory distress, and flushing of the face and neck. Corrective treatments consisted of epinephrine. The patient had a history of asthma, and milk allergy demonstrated by hives, lip and tongue swelling, diarrhea and abdominal pain at four years of age. Laboratory testing showed the patient had increased IgE levels (>100) within two years of vaccination. Outcome was not reported. Follow-up information received 24 August 2011 from a physician who stated that they did not administer the vaccine to the patient. The patient was vaccinated by their primary physician; therefore, the reporter was unable to provide information pertaining to the name of the vaccine manufacturer, lot number, site and exact date of administration, symptom duration and stop dates/times, and specific medication dates and dosages received as treatment. No additional information was provided at the time of the report. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, 2011-03275, 2011-03276, 2011-03277, 2011-03278, 2011-03279 and 2011-03280. Follow up report received from a physician on 06 March 2017. This case was found duplicate of case number 2016SA073853. Hence, case 2016SA073853 was deleted. No further information was received. List of documents held by sender: none.; Sender's Comments: Follow-up information received on 06-Mar-2017, amends the medical assessment as follows: This case concerns a 17-years-old male patient who was vaccinated with a booster dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and experienced anaphylaxis with symptoms of wheezing, respiratory distress and flushing of face and neck within 20 minutes. Time to onset is compatible with the role of vaccine. The patient had an underlying allergic condition which may increase the chance to trigger the reported events by many other allergens. Further information on immune status at the time of vaccination, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
This case was reported by a pharmacist via call center representative and described the occurrence of difficulty sleeping in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced difficulty sleeping, fever, influenza-like symptoms and headache. On an unknown date, the outcome of the difficulty sleeping, fever, influenza-like symptoms and headache were recovered/resolved. It was unknown if the reporter considered the difficulty sleeping, fever, influenza-like symptoms and headache to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The health care professional reported that difficulty sleeping at night (05 unit not specified) following receipt of SHINGRIX. Upon waking the following morning, the patient noted headache, low-grade fever, and flu-like symptoms. The health care professional did not have time to discuss in detail. It was unable to obtain all necessary information regarding incident (lot or expiry, date of birth, relatedness to vaccine, etc).
after about 11 hours after second dose of vaccine started to have low grade fever and chills. Fever advanced to 103. Headache and body aches developed. Fever lasted for 36 hours. Ongoing fatigue for next 5 days.
pt recv vax 23JAN97 & 12FEB97 pt to ER & was d/c;next morning pt returned to ER lethargic;pt adm to hosp w/encephalopathy & ataxia;14FEB97 lab results from a LP were nl w/glucose 70, WBC 1,protein 22,RBC 10;pt dx astrocytoma;
only 31 out of 52 hosp employees vax w/Engerix-B; had AB levels >10;
No fever. Scabby papules & on around scaling, red lesion along right back to chest-began about 3 wks ago- diagnosis Varicella Zoster- without history of disease. Is resolving now.
pt recv vax 15OCT97 & 2 days later pt c/o redness, swelling, tenderness, pain, hardness & hot to touch @ inj site;
Pt came in 3-4 days after vaccine administration complaining of soreness and range of motion loss in her shoulder (especially in AM). Administration area looked bruised. It appeared to me vaccine was given into shoulder not deltoid.
Patient complains of feeling pain on site of injection and on shoulder since being vaccinated on 10/23/2017. States she has difficulty raising her hand up and trouble dressing her self due to pain. NO rash or itchiness or weakness in the arms just painful. Has been referred to Orthopedic for further evaluation as patient not willing to come in to the clinic for evaluation.
First vaccine given for this 11 year old patient on 4/19/19. No previous Hx of any vaccinations. On 4/28/19 he developed a fever Tmax 103 degrees F. On 4/29/19 he was evaluated at an urgent care facility, negative for strep, flu, mono. Negative chest xray. Had low WBC count. He was seen at PCP office on 4/30/19 after developing a diffuse rash over chest/back/trunk/face/neck/hairline, with fever of 102 degrees F. He also had candidiasis of mouth. He was treated for thrush, physician consulted with peds infectious disease physician and suspected vaccine reaction to MMRV.
Vomiting and diarrhea developed immediately, post vax. Vomiting stopped after 3 days; diarrhea continued for 2 weeks. Pt had this same reaction with Prevnar #2 & #3 though not with #1.
Delayed hypersensitivity reaction after 1st Covid immunization. Swelling of eyes, numbness around mouth 40 minutes after vaccine; Swelling of eyes / swelling around eyes; Numbness around mouth; This is a spontaneous report from contactable consumer (patient, self-reported).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single and dose 2, single for COVID-19 immunization. Medical history included that the patient had appt with allergist and peg allergy was confirmed. Concomitant medications were not reported. The patient experienced delayed hypersensitivity reaction after 1st Covid immunization, swelling of eyes, numbness around mouth 40 minutes after vaccine on an unspecified date. Took Benadryl prior to second shot and symptoms limited to swelling around eyes. The patient received treatment for the events with Benadryl. Outcome of the events were unknown.  Information about lot/batch number has been requested. No follow-up attempts are completed, information about lot/batch number cannot be obtained.
The patient got flu vaccine (quadrivalent) and after 2hours, she experienced redness and pruritis around neck and bilateral shoulders. She was given Benadryl 25mg 1 tab.
Information was received from a nurse concerning a first grade student who on 11 JAN 1999 was vaccinated with a dose of Varicella.  20 DEC 2004 the student developed chickenpox.  According to the school nurse there were 58 other elementary school students and 34 of them had previously been vaccinated with a dose of Varicella.  Unspecified medical attention was sought.  There was no information regarding the present status of the first grade student.  No product quality complaint was involved.  Additional information was requested.
Generalized hives, swollen feet and hands-serum sickness: appeared 09/05/2003.  Prescribed Prednisolone for 3 days, diphenhydramine.
Employee complained of "itchy, red, swollen and hot to site of injection. Reports redness around arm about 4 inches long." Symptoms started approximately one and a half days after administration of vaccine.
Mother reports day after vaccination child was very tired, "acting drunk", "staggering", and "eyes are puffy".
The first dose I had swelling and a hard lump and warm to touch and I contacted my doctor and at that time it became cellulite. I had swelling for a long time.
3 days p/vax began to have fever up to 102.9 ax;no focus until 2FEB99;
Narrative:  Patient had his second shingles vaccine on Friday and that he then developed a rash all over his body, some pain, and blisters are forming. She reports that he also had a testosterone shot morning of the same day prior to coming to the clinic. She says that he has been doing the otc medication (benadryl) that was recommended by nurse that they spoke with on Friday.
Red induration 3in x 2in, some discomfort and hot to touch. Pt to treat with BENADRYL and return to clinic if it gets worse or no improvement. Located Right upper arm, subq area.
Patient will be receiving 2nd shot 60 days after 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient will be receiving 2nd shot 60 days after 1st dose) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient will be receiving 2nd shot 60 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient will be receiving 2nd shot 60 days after 1st dose) outcome was unknown. Not Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
C/o redness, soreness in arm where injection was given at site of injection. Today presents with erythematous area around site of injection measuring 12.5cm x 11.5cm.  Area slightly warm to touch.  Pt also complaining of nausea since 3/28/14.
This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current condition was reported. No pertinent medical history was reported. On 02-SEP-2014, the patient was vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous. No concomitant medication was reported. The outcome of patient received improperly stored VARIVAX was unknown. No further information was provided. No PQC was involved. This is one of the several reports. Additional information has been requested.
red patch/red itchy spots/redness of the skin; itches/itchy/itchiness; rash as red; warm to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "allergic to aspirin and latex" (unspecified if ongoing), notes: he is allergic to aspirin and latex; "Blood pressure" (unspecified if ongoing), notes: Indication for use in the case: Blood pressure. Concomitant medication(s) included: BETAXOLOL taken for blood pressure abnormal. Past drug history included: Aspirin, reaction(s): "allergic to aspirin", notes: he is allergic to aspirin and latex. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Feb2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "red patch/red itchy spots/redness of the skin", "Warm to the touch", "itches/itchy/itchiness", "Rash as red". The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "red patch/red itchy spots/redness of the skin"; PRURITUS (non-serious), outcome "unknown", described as "itches/itchy/itchiness"; RASH ERYTHEMATOUS (non-serious), outcome "unknown", described as "rash as red"; FEELING HOT (non-serious), outcome "unknown", described as "warm to the touch". Therapeutic measures were taken as a result of erythema, pruritus, rash erythematous, feeling hot.  Additional information: He was wondering if it's a side effect of the vaccine if you get a red patch that itches and then goes away. He fired his first two shots in Feb2021, and his third shot was in Apr2021. He also mentioned that he was allergic to aspirin and latex. Caller stated that he received Pfizer Covid 19 vaccines primary 2 shots in Feb2021 and third in Apr2021. Sometime after these vaccines he began noticing red itchy spots that come and go from time to time on his body, they can be anywhere. He doesn't have any issues with them while he sleeps, he stated that they are aggravating during the day. He stated that started on hands and around his fingers and then moved other places. He relays that the only thing that helps was lotion, washing hands more, and sometimes they just go away by themselves. States right now he was itch free. Also states that he can no longer wear jewelry. He will put on a watch and within 30 minutes he starting getting red and itchy. He described the rash as red, itchy and warm to the touch. He has seen his primary care provider and a dermatologist and stated that they did not provide much help.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201336694 same patient/event, different vaccine dose;US-PFIZER INC-202201337846 same patient/event, different vaccine dose;
dizziness; weakness; nausea; rapid heart rate; This case was reported by a nurse via call center representative and described the occurrence of dizziness in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included heart disorder.   In January 2021, the patient received the 1st dose of Shingrix. In January 2021, less than a day after receiving Shingrix, the patient experienced dizziness, weakness, nausea and heart rate increased. On an unknown date, the outcome of the dizziness, weakness, nausea and heart rate increased were recovered/resolved.   It was unknown if the reporter considered the dizziness, weakness, nausea and heart rate increased to be related to Shingrix.  Additional details were reported as follows: The patient received the vaccine approximately 2 months prior to the report at the pharmacy. The patient had experience dizziness, weakness, nausea and rapid heart rate and presented on the same day as the vaccine administration and symptoms lasted for 24 hours. The reporter consented to follow up.
Fever up to 103.7, extreme chills, headache, sore arm, fatigue. Fever reducing medications were taken and reduced the fever to around 100F. Bedrest and cool baths were used. The fever was gone after two days and by three days the fatigue went away.
This is a spontaneous report from a contactable Healthcare Professional (other) communicated to a Pfizer sales representative. An infant (age and gender unknown) received PREVNAR13 on an unspecified date. Relevant medical history,  concomitant medications and past product history were not reported. On an unknown date, following administration of PREVNAR13 it was reported that the infant turned red from crying as it was painful. At the time of this report, the patient  outcome was unknown. The office does not wish to be contacted for further follow-up information. Follow-up (24MAY2011): New information reported from a contactable office staff member includes statement from staff member. Follow-up attempts completed. No further information expected. Follow-up (03JUN2011): Follow-up attempts completed. No further information expected.