chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US009861 is an initial spontaneous report from the nurse received on 09 May 2014 with a follow-up received on 09 May 2014 with a follow-up received on 17 Jun 2014. This report refers to a 14-year-old male patient. On 09 May 2014, the patient was accidentally vaccinated with only 0.5 ml of Men CYW-135 liquid component of MENVEO (batch number: M12131) intramuscularly without reconstitution with the lyophilized Men A component. No adverse event reported following the medication error (inappropriate preparation of medication). Follow-up received from a nurse on 17 Jun 2014: Batch number amended.
Temp 102. Arm soreness Chills Body Aches felt faint when standing
2 MO admitted for acute life threatening event requiring CRP. PT did well in hospital, tolerated Enfamil AR with no episodes of reflux after UGI normal, CXR normal, BC Neg, no A's + B's while in hospital, PE-VSS, APOF mouth pink, skin pink, Lungs CTA, RRR, no murmurs, BS + soft, no NT, ALTE (near SIDS), GERD, vaccine rxn.  Pt d/c home, feeds Enfamil AR. F/U children's clinic in 2 days.
LIP SWELLING, TROUBLE BREATHING AND THROAT SWELLING AFTER 4 HOURS OF VACCINATION.
Extreme fatigue, nausea, chills. Nausea and chills lasted about 2 days, extreme fatigue is ongoing
The person in the pharmacy that gave me my fluy shot had never given one before, she was nervous and hesitated with the injection once the needle was in my arm. She then proceeded to comlete the injection, it immediately hurt more than I was used to with any ype of shot.  My right arm has been unusally sore and I get shooting pain into my the right side of my neck down to my right hand. My right bicep contstantly aches.
itchy, red, warm, painful (similar to discomfort immediately after injection). Warmth and pain dissipated within 3 days, redness and intermittent itchiness remained through this point; but improved.
pt recv vax 12JUN95 & lab eval revealed an IgG level of 0.18 for rubella;it was also noted that the pt was pregnant @ the time of the report;
Vertigo, nothing has caused this no head injury no infection. Have had it for a week now, nothing is helping this.
ANAPHYLASXIS/DIFFICULTY BREATHING - ER EVALUATION AND 23 HR OBSERVATION; MED ADMINISTRATION OF EPI X3; BENADRYL; FAMOTIDINE; STEROIDS.
Patient developed a headache and a squeezing sensation in her chest shortly after receiving her first dose of the Covid vaccine. Otherwise she appeared well and had normal vital signs. No other symptoms. She was observed for 40 minutes and her symptoms persisted so she was transferred to the ER. There were no objective findings at the ER after a workup. She was given toradol for her headache and the plan is for her to be discharged home today.
Day 0 was Monday June 27, 2022. Two mild symptoms were a feeling of thickness in my throat. There was no soreness but a thick coating in my throat and occasional cough. On Tuesday the 28th, I did a rapid test at home and it came back positive in 20 seconds. I began to self-isolate. I contacted my doctor and did a telehealth visit that day. My doctor prescribed PAXLOVID. I held off taking the medication that evening because I took a statin at 9:30 that morning. She said to wait at least 12 hours until I began. I took that medication during the next 5 days. My symptoms remained mild and I had a low grade fever at 100.5. Within 48-72 hours it returned to normal. I felt fatigued but not too horrible. Cough went away right away. I would say mentally, I had some lack of clarity when one has a flu. I would say that gradually got better over 5-6 days. On Saturday, July 2, the rapid test was still positive. Day 8, July 4th, a rapid test came back negative. On that day, it was like flipping a light switch and the fatigue wasn't as present and the mental clarity was much better. I'm doing pretty good now.
neck stiffness; vertigo; neck was hot to touch; felt unwell; joint pain; injection site pain; headache; chills; fatigue; nausea; swollen lymph nodes on left side of neck; neck muscle pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (neck stiffness), VERTIGO (vertigo), FEELING HOT (neck was hot to touch), MALAISE (felt unwell) and ARTHRALGIA (joint pain) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (neck stiffness), VERTIGO (vertigo), FEELING HOT (neck was hot to touch), MALAISE (felt unwell), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea), LYMPHADENOPATHY (swollen lymph nodes on left side of neck) and MYALGIA (neck muscle pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (neck stiffness), VERTIGO (vertigo), FEELING HOT (neck was hot to touch), MALAISE (felt unwell), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea), LYMPHADENOPATHY (swollen lymph nodes on left side of neck) and MYALGIA (neck muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported
Shot admin. 1/11/08. 1/18/08 break out upper Rt eyelid outer corner. Itchy & tender, eye swollen, red open sore. Contained to the eye. 1/30/08 swelling & sore almost healed, still somewhat itchy using OTC NEOSPORIN & hydrocortisone, cold press.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid treatment on unspecified dates.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350934 same patient, different drug/event (Paxlovid case);
High fever of 102.7-103.2 from 9 pm on 11/6 to 10 pm on 11/7. Took Tylenol and ibuprofen and placed ice packs on groin, armpits, back of neck and forehead. Drank lots of water. Fever still 101.9 with that treatment until around midnight on 11/7. On 11/8 fever was only at 99.6
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning an adult patient of unknown age and gender who on 13-MAY-2015 was vaccinated with a dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 103 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
BODY ACHES; NAUSEA; HEADACHE; 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 pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, the subject experienced body aches. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, nausea, and headache. This report was non-serious.
Migraine Headaches Nausea, Body Aches, chills, Joint pain,    These symptoms lasted 2 days.     After the 2nd dose I experienced Headaches after an hour, within hours experienced Migraine Headaches, Body aches, Chills, Fever, Several short duration of sever pain behind right eye, some residuals still after 3 days.
After my second dose Pfizer vaccine, on the day or day after I suffered a miscarriage.
Awoke from sleep with muscle tremors & jerking of arms, legs & neck (seizure-like activity). Arching back during episodes. This happened repeatedly during times of sleepiness (feeding & np/bed times). Continued into next day, only mild twitching noticeable by mom at noon on 10/22/14. Seen in ER & by PCP.
Left arm is very swollen and red. Pt c/o 7/10 left arm pain. C/o limited ROM of left arm.
Client reported that after receiving her vaccination in the morning, she noticed at 4pm that her right ear was red and hot. This was followed by her right cheek becoming itchy. At 5pm when she got home from work, she noticed that the right side of the back of her throat was itchy and a little puffy. She called urgent care who directed her to go the ED. Client decided to stay home under the careful watch of her husband. The symptoms went away on their own. That night and the next day she developed chills and body aches.
This case was reported by a other health professional via sales rep and described the occurrence of tingling in a adolescent patient who received BEXSERO (batch number 15B201, expiry date unknown). On an unknown date, the patient received BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced tingling. On an unknown date, the outcome of the tingling was unknown. It was unknown if the reporter considered the tingling to be related to BEXSERO. Additional details were reported as follows: The patient's age at the reporting time was 17 years. The age at vaccination was not reported. In 2017, the patient received BEXSERO on the left arm. The vaccine was administered approximately 2 weeks before the reporting date (on a Tuesday or a Thursday). In 2017, the patient experienced tingling, but the area on the body was unknown. The field representative had very limited information. All questions were asked and unknown answer was provided by the reporter. The health care professional's title was unknown. The expiry date of the vaccine was unknown. Clarification was raised regarding the qualification of primary reporter but resolution was not received.
Constant fever, body ache and headaches for one week along with extreme high blood pressure which is still ongoing  as of today.  Latest high being 177/111.
Bi-lateral purpura on lower legs.  Treated with antihistamines.  Still ongoing.
This spontaneous report as received from a pharmacist refers to an 11 month old patient. On 25-SEP-2013, the patient was vaccinated with a dose of VARIVAX and a dose of MMR II, lot#, dose, frequency and route for both vaccines were unspecified, before 12 months of age. No symptoms reported. Additional information has been requested.
Cellulitis of L upper arm.  Treated with Bactrim x10 days.
Information has been received from a nurse concerning a 5 year old male who on 18-JUN-2008, today, was inadvertently vaccinated with two doses of VARIVAX (Oka/Merck) (lot no., route and site of administration were not reported), instead of one dose of VARIVAX (Oka/Merck) and one dose of MMR II. It was reported that this was staff error only. The patient sought unspecified medical attention in office. Additional information has been requested.
Pass out in chair in monitoring Did not hit floor. EMS eval P91 SaO2 97% BP 140/78 P55 -80 EMS wanted to take to ER for cardiac. Client refused. Instructions get PCP for eval. Fiance is drove client home. To go to ER or call 911 if passes out again
On 2/11/11 pt had swollen thighs, warm to touch, redden area, rash, & pain.
Client developed a reaction to 1st dose of COVID-19 vaccine.  Client described symptoms of dizziness at 11:20am on 5/27/21.  Client refused vital signs and verbalized feeling better.  Client exited the facility at 11:45am.
It was reported that a 4 year old pt (1 of 3) received a Tripedia vaccination and reportedly, sometime after the vaccination, the pt developed a 3" local reaction at the injection site. Further information is requested. From additional correspondence received on 4/26/01, it was reported that the pt received the Tripedia vaccination as well as an IPOL and a MMR vaccination on 3/27/01. The pt reportedly, recovered from this experience. This case is closed.
Severe depression episode occurring the first and second nights.  First night I felt suicidal which is very unusual for me.  Some accusing the following 3 days.  Still waiting to see what happens moving forward but feeling much better.
Small blisters on fingers and hands appeared about six weeks after second shot.  Blisters have white heads and are filled with clear liquid.  They are still popping out about 2 weeks after first appearance.  Blisters repture and dry up.  No itch, but can be painful.
Pain on right leg; Soreness on lower right back and hip/ soreness above his waist; Left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), BACK PAIN (Soreness on lower right back and hip/ soreness above his waist) and PAIN IN EXTREMITY (Pain on right leg) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness). On 07-Apr-2021, the patient experienced BACK PAIN (Soreness on lower right back and hip/ soreness above his waist). On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain on right leg). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. On 07-Apr-2021, PAIN IN EXTREMITY (Left arm soreness) had resolved. On 08-Apr-2021, BACK PAIN (Soreness on lower right back and hip/ soreness above his waist) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain on right leg) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications  were provided.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received and updated the outcome of the event (pain on right leg) from unknown to recovering.
Pt recvd a series of 3 doses of Engerix-B 8NOV90, 13DEC90 & 21MAY91 & pt did not respond; 19AUG91 titer 0.9; pt was then given Immunoglobulin & a 4th dose of Engerix-B; titer will not be drawn for 8 wks;
Information has been received from a consumer who was vaccinated with a dose of ZOSTAVAX. Subsequently the patient developed injection site warmth, swelling and bruising. It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. No further information is available.
Information has been received from a health professional concerning a 5 yeqr old healthy female, with NKDA and no medical history who on 03/25/1977 was vaccinated with the first dose of varicella virus vaccine live, in the right arm. There was no concomitant medication,  On 05/15/2001, (also reported as 05/16/2001), the pt developed lesions on her body. On 05/16/2001, she was seen by a doctor and diagnosed with varicella, at which times, it was reported that she had more than 150 lesions over her entire body. The lesions were described as "several papular lesions with blistering centers". It was reported that comfort measured were ordered and that there were no other symptoms. It was also reported that the pt recovered on 05/26/2001. No further information is available.
Information has been received from a health professional concerning a female who on an unspecified date was vaccinated with one dose of varicella vaccine. "While on vacation" the pt was exposed to chicken pox and subsequently developed an outbreak of the disease. It was also noted that the pt's brother was also vaccinated and experienced similar events. Additional info has been requested.
1/13-1/15 sore arm, 600 MG OF ADVIL FIRST DAY,   ONE WEEK LATER : 1/21 itching, lump in arm and redness. 1/22 same with larger swollen area, 1/23 more swelling and red  type rash, 1/24 same, 1/25-present, minimal itching, most swelling gone, red rash a bit LARGER  JUST REPORTING REACTION, NO MEDICAL ATTENTION SOUGHT
unsure if she got a full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (unsure if she got a full dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Hypertension. Concomitant products included CANDESARTAN for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, ACETYLSALICYLIC ACID (ASPIRIN (E.C.) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to UNK dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (unsure if she got a full dose). On 08-Apr-2021, ACCIDENTAL UNDERDOSE (unsure if she got a full dose) had resolved.            Treatment information was not provided.
Left arm pain, hard area-lump, decreased range of motion of left upper extremity. Symptoms started within a few hours after vaccination and have worsened over the past 6 weeks. Symptoms still present.
chills, flu symptoms, shivering, fever, headached, bodyaches, weakness/lack of energy
Left arm swelling red and hot, Sunday felt ill, itching, pain in neck and left side of face felt swollen, trouble breathing, hot cold and shaking. Went to ER, oral prednisone and continue Benadryl. Dizziness, worsen very dizzy and chest broke out Monday. Off work for 2 days.
The resident who was known to have seizures, and under control for many yeas with Keppra 1000 mg twice a day, on the second day after vaccination developed recurrent seizures requiring hospitalization to an intensive care unit, with intubation and mechanical ventilation until 1/5/21 (to be extubated today). She is still at the hospital.
On the night of the vaccine I started with fever, articulation pain (spine, knees, fingers), headache and loud ringing in left ear. This continued over the weekend (Saturday and Sunday). On Sunday night I developed pain in my right eye. On Monday morning, the right eyelid was swollen and my inside eye was a deep red color. It was oozing pus (at first I could not open my eyelid). On Tuesday morning, my left eye is also now swollen and red with pus. On Monday the fever and body aches have gone BUT I started with a very bad, continuous cough and sore throat that continues today (Tuesday). I am taking cough suppressant in order to sleep. Both eyes are inflamed, I believe due to the vaccine. My ears are sore (feeling of fullness and are ringing) I believe due to the vaccine. The vaccine made my previous mild cough much worse. On Tuesday I had a medical appointment with my health provider at health care, who advised me to report to this system.
Child began having mild body tremors and nausea about 30 hours after the vaccine, then vomited repeatedly over the next ~20 hours. Experienced malaise and dehydration for about 24 hours after vomiting stopped. No fever at any time.
Product Availability; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. 2 people on patients wait list had ironically gotten Shingles.  Both had suggested that If the patient would have given them the shot this was not have happened. The patient would not give out patient's information.  But, general questions were fine. The reporter consented to follow up. This case has been linked with US2019220446 and US2019GSK238613, reported by same reporter.
Information has been received from a physician concerning an adult female (age not reported) who on 29May03 was vaccinated with a dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). On 26Jun03 the pt presented to the doctor with parotitis and thyroiditis. The pt's temp was 99.9. The reporter stated that the pt began to feel ill in mid June. It was unknown if this was the pt's first vaccination with  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) because the past medical history was reportedly unclear, but since the pt was traveling to a foreign country she was vaccinated. No further information was available at the time of this report. Additional information has been requested.