chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX for prophylaxis. In January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, 5 hrs after receiving SHINGRIX and an unknown time after starting Valacyclovir, the patient experienced injection site swelling and injection site pain. On an unknown date, the patient experienced shingles. The patient was treated with Valacyclovir. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site pain and shingles to be related to SHINGRIX. Additional case details were provided as follows: The age at administration was not reported but it could be 71.5 or 71.6 years. The patient received the dose of SHINGRIX in left arm and experienced swelling and soreness at the injection site approximately 5-6 hours later. The patient could not sleep on her arm for 2-3 nights and then the issues was resolved. Since then the patient had a mild outbreak of shingles 3-4 weeks later. On 09th April 2019, the patient called back to report that the suspected shingles outbreak on 5th April 2019 was diagnosed by a physician and was not shingles. The patient gave the consent for follow up.
Devel erythematous papules @ site of Hib inject-12 hrs /p wards /w progression to general urticarial hive-like lesions over trunk, extremities & face.
pt recvd vax 28NOV94 w/Tetramune & OPV;30NOV MD visit-8cm round area around inj site in which all the hair follicles were red & papular;no fever; no rx; pt had prev been immunized w/vax
D10ECQ8 appointment moderna vaccination #1.  Patient presented with mild cough, appeared nervous.  upon immediate assessment, the patient stated she was having difficulty swallowing.  She was alert, respiration were easy and unlabored, skin was pink, warm and dry.  Deep breaths, encouraged; patient responded to support and denied distress or shortness of breath. EMS evaluated patients, BP 128/80, O2 saturation 99% on room air. patient verbalized that she was feeling anxious and nervous about having had received the vaccination, but was feeling better after EMS evaluation.  Patient was advised to share today's event with her PCP, and discuss recommendations for future vaccinations.
He felt faint and complained about not being able to see or loss of vision. Pupils were dilated.  Treatment: One dose of Epipen was administered.  Within minutes adverse symptoms were reversed.
PT REPORTED A THROBBING PAIN IN HER LEFT ARM THAT HAS NOT GOTTEN ANY BETTER.
Vertigo, severe spinning. Few minutes after looking down or bending over. Never experienced before. Steadied myself and closed my eyes until it was over.
Admit for COVID infection. Fully vaccinated. Vit-c, singulair, zinc, steroids. Did not require O2, no pna. Discharged home.
Intractable headache, fever 102.4, arthralgia, myalgia, vertigo. These symptoms awakened me at 2am 3-18-21.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Abdominal Pain-Medium
administered only adjuvant; administered only adjuvant; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 15th November 2022) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 30th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. The reporter stated that, administered only Shingrix adjuvant to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The nurse then got another vial of adjuvant, mixed it with the lyophilized powder and administered a full dose of Shingrix to the patient. The reporter consented to follow up.
Blood surges not controlled, slept ca 24/7,  tired, felt out of place r kilter
pt was admitted to hospital for covid pneumonia. treated with remdesivir and dexamethasone
Pt. states that it is very hard and painful for him to use the arm where the vaccine was administered unable to lift it well.
Pfizer booster vaccination given to a 14 year old patient.  At time of report, have spoken with father and no adverse effects have been reported at this time.
Fever,  headache, chills, body aches and chest pain the day after vaccine, 12/12/21.  Worsening chest pain and shortness of breath the second day 12/13/21.  Severe chest pain, stomach pain, shortness of breath the third day 12/14/21 and hospitalized
pt recv vax & exp dry mouth & h/a;It was reported that these exp are constant & nothing seems to help;
Pt w/known hx of feb sz & Arachnoid cyst rec'd MMR/HIB on 29MAY91; On 2JUN cranky & fever; 3JUN had 2 generalized sz assoc w/fever; pharyngitis noted;
Dramatic decrease in concentration, ability to comprehend information; loss of concentration; severe fatigue; difficulty complete daily routine tasks; forgetfulness; constant feeling of tiredness while.
Immediately after administration of vaccine, patient reported feeling light headed.  Raised head of bed slightly, leaned back and placed ice pack on back of neck.  Noticed pale color.  Took blood pressure (77/44, pulse 44).  Went to get provider for assistance. FNP came to room, noted poor color, raised legs to above level of heart, had head of bed lowered, and requested additional ice pack be placed on chest.  Blood pressure re-checked, 97/68, 82. Color slowly returned.  Over about 15 minutes color continued to improve and more talkative, reported decrease in nausea and lightheaded feeling.  Slowly sat patient up with bed in low position.  Once standing, reported feeling ok.  Was discharged from clinic by PCM with brother to drive home.  Patient left clinic in good condition, talking and joking.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 1:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 1:47 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 31.28.  Concomitant products were not provided.  On 29-Apr-2021, excursion time was 10 AM, temperature was 33, total doses given for the day was 201, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: not provided, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 AM: 45, 1PM: 45, 2 PM: 44, 3 PM: 45, 4 PM: 44 and 5 PM: not provided.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Tinnitus in both ears, sounds like a high-pitched ringing sound. Moderate volume. Interferes with hearing other sounds and speech.
Red, feverish induration at right deltoid site with red 7" streak extending downward from site, slight warmth c/o muscular tenderness to touch, slight chill with fever 24 hrs after injection relieved with Tylenol.
Patient presented with redness and swelling of the left arm distal to the injection site. She said she was itchy upon initial symptom development but it isn't anymore. It is getting better, but she was still concerned so she came in and had me look at it.
next morning after injection, i was extremely cold and lethargic; next morning after injection, i was extremely cold and lethargic. midbrain, low level headache (sameas after dose 1), started about 2h postinjection.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 14:15 (Lot number: EP7534) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Papillary thyroid cancer" (unspecified if ongoing), notes: papillary thyroid cancer survivor. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (lot number: EN6203, vaccine location: Left arm, dose number: 1, administration time: 13:15), administration date: 28Feb2021, when the patient was 66 years old, for COVID-19 immunisation, reaction(s): "unusual headache". The following information was reported: HEADACHE (non-serious) with onset 21Mar2021 16:30, outcome "recovered" (23Mar2021), described as "midbrain, low level headache (sameas after dose 1), started about 2h postinjection."; FEELING COLD (non-serious) with onset 22Mar2021, outcome "recovered" (23Mar2021), described as "next morning after injection, i was extremely cold and lethargic"; LETHARGY (non-serious) with onset 22Mar2021, outcome "recovered" (23Mar2021), described as "next morning after injection, i was extremely cold and lethargic.". Therapeutic measures were not taken as a result of headache, lethargy. Therapeutic measures were taken as a result of feeling cold.  Additional information: The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have fever, chills, just constantly felt really cold to the point of double wool socks with hot feet in them, 3 layers of sweatshirts, insulated pants and ski pants, gloves which lasted about 24 hours and then completely disappeared, along with the headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 12 year old male who on 18-JAN-1999 and on 13-AUG-2001 was vaccinated with the first and second doses (HSA) of MMR II, respectively. On 03-JAN-2010 the patient experienced left mumps. On the same day the patient was diagnosed with mumps. The patient was afebrile, had cough productive for 2 weeks and had coryza green for 1 weeks. The first blood work was done on 03-JAN-2010 and the results indicated IgM0.38, IgG 4.99 and serum amylase 193. It was reported the patient had exposed to mumps and 2 kids in his family also had mumps. At the time of the report, the patient's outcome was unknown, this case was non-serious. Additional information has been requested.
Increased swelling, itching, and redness at injection site 7 days following administration. Entire area to date has grown to the size of a clementine while 2 days following injection it was approximately like a silver dollar.
At 1124 patient close to be released from post-vaccine 30 minute observation area, complained of itchiness to head, back and chest and lightheadedness. No shortness of breath or difficulty breathing,  lung sounds clear to all lobes, no hives or rash, complained of some fatigue that is similar to when she has allergic reactions in the past.  A&O x3 VS 139/110 P60 R18 Temp 99.3Discussion of use of epinephrine. At 1130 patient reports that itchiness is subsiding. No SOB, no Reports did not eat anything so far today. 1135, itchiness continues to subside. No use of epinephrine. Agreed to stay in observation arear until sypmotoms subside. 1130 VS 122/78 P 78 R18 Lung sounds clear.  Decreasing itchiness. 1145 VS BP122 palp P72 R18 Lung sounds clear. Decreasing itchiniess. 1153 Itchiness confined only to low back area. 1215 VS BP120/72 P72, R18, lung sound clear.  By 1315 lowback itch resolved. Released.
hearing loss at high frequencies; developed ringing sensation in both ears/Tinnitus symptom is still persisting; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss at high frequencies) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included ALLOPURINOL from 01-Jan-2015 to an unknown date for Gout.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced TINNITUS (developed ringing sensation in both ears/Tinnitus symptom is still persisting). On an unknown date, the patient experienced DEAFNESS (hearing loss at high frequencies) (seriousness criterion medically significant). At the time of the report, DEAFNESS (hearing loss at high frequencies) and TINNITUS (developed ringing sensation in both ears/Tinnitus symptom is still persisting) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported.  Company comment: 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.       Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up received contains information about developed ringing sensation in both ears/Tinnitus symptom is still persisting, sore arm injection site :Case upgraded to Serious.; 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.
Patient came in a couple of hours after receiving vaccine with swollen lip and no reaction at injection site. No difficulty breathing.
I got the shot around 5:20. About 4 hours later I started to feel nauseous and ran to the bathroom and vomited. About an hour after that I had diarrhea. I went to bed, couldn?t fall asleep until 3. I woke up at 6 am sweating a lot and having body aches that were very persistent and painful in my legs. This persisted to 3/12/2021 until about 6 or 7 pm and I began to feel a lot better. That entire day I was hot and cold and had body aches. But no longer had vomiting. Then on Saturday, 3/13/2021 I woke up with a sore left armpit and neck but the armpit was way worse. I looked it up ?sore left armpit after covid vaccine? and it said swollen lymph nodes - so I?m guessing that?s what both pains were as my roommate who had the second dosage of Pfizer vaccine  the week before had a protruding lymph node on her neck. They both are still in pain until today 3/15/2021.
After receiving HPV #3, child got navel pierced.  The next day she had nausea, vomiting, light-headedness, dizziness.  Stayed home from school.  Today (5/9/08) noticed a few white spots on her feet-turned to red, spread to legs, hands & arms.  Took Benadryl 5/8/08 for "cold or sinus infection".  Reports itching with rash.  Advised to see a doctor - clinic info given.
The patient received her first dose of the Pfizer Covid-19 vaccine in her home. About 15 seconds after administration the patient subjectively stated, "I can't breath", and "my throat and chest feel tight".  I objectively evaluated the patient who appeared unchanged from baseline. The daughter and caretaker were present during the event, and the daughter stated that "she always say's that". However, the patient replied, "she is lying, I don't always say that, I can't breath!". Due to the patient's subjective complaint of shortness of breath EMS was called and arrived within 10 minutes. During that 10 minutes the patient remained stable. No hives, no wheezing, no eye tearing or nasal discharge. No facial, tongue, or throat swelling observed. Patient continued to speak in full sentences and did not have any labored breething. Epinephrine was not adminstered during this time due to the lack of objective signs of anphylaxis. EMS arrived and performed an evaluation; vital signs were stable; however, the patient continued to state that she "couldn't breath". No medications were administered by EMS on-scene at the patient's house. The patient was taken to the hospital for observation and possible treatment. Symptoms most likely due to a panic attack but anaphylaxis could not be ruled out and the patient was trasferrred to a higher level of care.
High fever, dark urine and not able to urinate efficiently even though well hydrated for approximately 3 days. Have been having similar reactions to flu vaccinations.
Nasal congestion started 2 days after vaccine and has not stopped. Patient has trouble breathing out of nose and suffers from disturbed sleep every night. Doctor has prescribed nasal steroid spray to relieve symptoms.
Site: Bruising at Injection Site-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Vaccine drew blood and patient vomited in bathroomo shortly after seeing the blood
Patient received dose #2 of Pfizer vaccine on 6/6/2021 @  Vaccination center. and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Affiliated Physicians re-administered dose on 6/26/2021 as recommended. No adverse reactions identified on site.
hot flashes were significantly relieved for 2-3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hot flashes due to menopause" (unspecified if ongoing); "hot flashes due to menopause" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), described as "hot flashes were significantly relieved for 2-3 days".  Additional information: Customer stated, after I received my first Covid vaccination, my hot flashes were significantly relieved for 2-3 days. Is there a possibility there is something in the vaccine that can be developed to treat hot flashes due to menopause.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After receiving the flu shot, patient experienced pain in the shoulder lasting a few days. Patient then had an X-ray of the shoulder and her physician said she had calcification tendonitis.
Got the Flu most the time; Initial information received on 16-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves a patient (unknown age and gender) who had got the flu most the time (influenza) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.   The patient's past vaccination included Influenza vaccine (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination and had flu.  The patient's past medical treatment(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu most the time (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "Why, when I got the flu shot I got the Flu most the time."   There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. In 2015, between February 2015 and 13-APR-2015, the patients were vaccinated with a improperly stored doses of VARIVAX (Merck) lot # K002915 and expiration date on 26-FEB-2016, (route was not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The dose for the Moderna vaccine is .5 mL. The patient inadvertently received a higher dose of 0.01 to 0.02 mL. The manufacturer instructed us to contact the patient to inform them that the increased dosage could potentially lead to side effects that could be local or systemic. No serious adverse events were reported by the patient.
PATIENT RECEIVED VACCINES IN THE LATE AFTERNOON BY AROUND 11:30PM SHE STARTED HAVING SYMPTOMS OF DIZZINESS, SHAKINESS, AND LETHARGIC. SHE WAS AT WORK SO SHE WENT HOME AND WAS STILL DISORIENTED SO WENT TO THE ER. PER PATIENT THE ER JUST MONITORED HER AND NO TREATMENT GIVEN. HOWEVER AFTER SPEAKING TO THE PATIENT SHE DID GET AN ANTIBIOTIC FROM THE ER TO TREAT WHAT APPEARS TO BE UTI AND COULD BE THE REASON FOR HER SYMPTOMS.
tingling down arm flu sx-flush-feverish feeling x 3 days;extreme dizziness;
Pain upper arm, unable to rotate or move shoulder due to pain. No numbness, no swelling. Pain felt within hour of administration.
Pt received a ZOSTAVAX vaccine at our facility on 1/21/16. Approximately 24 hours later, his arm swelled up and was in considerable pain. Physician confirmed it was allergic in nature and suggested BENADRYL. Sx resolved approximately 10 days.