chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1 (dose, lot # and expiry date unknown). On 26-MAY-2011, the patient was vaccinated with improperly stored VARIVAX dose 2, from lot # 0552Z (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
5 days since he been experiencing extreme fatigue/Extreme fatigue; For the first 2 days, he had low fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (5 days since he been experiencing extreme fatigue/Extreme fatigue), PYREXIA (For the first 2 days, he had low fever) and CHILLS (Chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 031B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced FATIGUE (5 days since he been experiencing extreme fatigue/Extreme fatigue), PYREXIA (For the first 2 days, he had low fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever and Chills, at an unspecified dose and frequency. In November 2021, PYREXIA (For the first 2 days, he had low fever) and CHILLS (Chills) had resolved. At the time of the report, FATIGUE (5 days since he been experiencing extreme fatigue/Extreme fatigue) had not resolved.            No concomitant medications were reported.  The patient stated that it had been 5 days since experienced extreme fatigue and for the first 2 days, he had low fever and chills. He stated that the extreme fatigue was of concern and was kind hoping it would go away.
Complained of heart burning, sore throat, rash, itching, faint, wheezing loud, swollen eyes. Epi .3 cc SQ and 25mg Benadryl given.
Pt recvd vax & had macular type erythematous rash all over body x/face; pt took DPH;
On day 3-4 feverish rash at injection site that continued to get worse up to about 12 days.  On day 4 tingling, numbness on entire right side of body and face. Especially noticeable in arms and legs. Doubled Eliquis dosage.  Resolved after about 2 weeks.
whole day migraine; right arm was in pain; dizzy; weak and overly tired; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (whole day migraine), PAIN IN EXTREMITY (right arm was in pain), DIZZINESS (dizzy) and FATIGUE (weak and overly tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (whole day migraine), PAIN IN EXTREMITY (right arm was in pain), DIZZINESS (dizzy) and FATIGUE (weak and overly tired). At the time of the report, MIGRAINE (whole day migraine), PAIN IN EXTREMITY (right arm was in pain), DIZZINESS (dizzy) and FATIGUE (weak and overly tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter Treatment medication: Pain killers for the pain on her arm  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Information has been received from a physician concerning a patient who was vaccinated with the first dose of Rotateq and did not return on time for the second dose. The physician reported, that the patient developed chickenpox (unknown if medical attention was sought) since the first dose and was in the office awaiting vaccination with the second dose (unknown if 2nd dose was given). At the time of this report, the outcome was unknown. Additional information has been requested.
Patient came to the pharmacy on 9/22 in early afternoon with significant redness and swelling in her right arm. She stated that her arm had felt "really sore" the evening after the vaccines were administered and that after she took a shower it the area turned red and swollen. I observed the area of redness which covered most of her upper, down into the area of her elbow.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2007, the patient was inoculated with ZOSTAVAX at a medical practice for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. In 2014, the patient was treated at the same practice for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
BODY ACHE; FELT DOWN; CHEST PRESSURE; DIZZINESS; FEVER; HEADACHE; NAUSEA; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FLU A AND B; This spontaneous report received from a patient concerned a 44-year-old female. Initial information was processed along with the additional information received on 14-JAN-2022. The patient's height, and weight were not reported. The patient's past medical history included iron deficiency, iron infusion, Covid 19 infection, and circulation problems. Patient had No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: Unknown) dose was not reported, 1 total administered on 13-JUL-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On an unknown date, the patient had side effects from the vaccine which were fever, headache, nausea, body ache, felt down. On 24-DEC-2021, Patient had tested negative with PCR (polymerase chain reaction) and antigen test. On 28-DEC-2021, she tested positive for COVID-19 with rapid test and had suspected clinical vaccination failure. On 28-DEC-2021, She also tested positive for flu A and B. 01-JAN-2022, She tested negative again on with rapid test. She also stated someone touched her phone at the airport. She felt chest pressure, little cough, and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 01-JAN-2022, and flu a and b, body ache, felt down, dizziness, fever, headache, and nausea, and the outcome of suspected clinical vaccination failure and chest pressure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211586.; Sender's Comments: V0:  20220124040 -Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I began having itching and severe swelling 3-4 hrs after the injection. 3-4 hrs later, after taking Zyrtec (a regular med) I took Benadryl 25 mgm. Thirty minutes after that I felt a lump in my throat, and I was driven to the local ER by a friend. I reported immediately after entering the ER that I was having a drug reaction and my symptoms.  The triage nurse was disinterested and after taking my vital signs, sent me to the waiting room. I had my vital signs taken at one hour intervals "just to make sure I was breathing". After three hours I saw a doctor who prescribed 80mgm of prednisone p.o. and gave me a prescription.  At least he looked at my injection site unlike the nurse.  I should have been given adrenalin and prednisone. Yes, I am an RN and have worked for an allergist, so I recognize a potential systemic allergic reaction.  Deliver me from ER's; they are out to kill you.  They saw all the flu patients ahead of me.  I had a previous pneumonia vaccine seven years ago without incident. After 24 hrs. I still have much swelling below the site with redness and induration. I will live in spite of this.
Starting on 07FEB2023 I had sinus drainage and coughing up mucous. In the evening it continued and worsened  wit no headache or fever it felt like a head cold. Thursday evening I went to dinner and that night or Friday morning and the fever I had was breaking or broke I tested on 09FEB2023 COVID-19 Test-Positive and I remained in my room in isolation. On 13FEB2023 I returned home and on 16FEB2023 I had my annual physical and was clear of COVID-19.
Sudden severe non-stop electronic type tinnitus that began 4 hrs after c19 vax on 5/11/21.   Level 8/9 on scale of 1-10.  Saw Dr. at primary care office 5/25/21, was advised to get 2nd vax.  Also consulted pharmacist prior to 2nd dose, she stated tinnitus was not a contraindication.  Received 2nd dose 6/1/21. Within 5 hrs of 2nd dose, tinnitus increased to level 10+ with piercing, painful "feedback" type episodes (such as when a band is testing sound equipment).  These "feedback episodes" lasted a few days before tinnitus went back to a still severe, non-stop level of  8/9 where it remains to this day now nearly 2 months later.
hand numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (hand numbness) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (hand numbness). At the time of the report, HYPOAESTHESIA (hand numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment information was provided.
4 Y.O. Male inadvertently administered Pfizer 5-11 y.o. covid vaccine when he was to young to qualify for it.
I was extremely tired and fatigued after the shot (also experienced pain at the sight of the injection). I did not go to the doctor or ER. The symptoms finally subsided after I took some Tylenol and rested.
Localized reaction to patients Right arm. Patient has slight redness and swelling. Patient stated itchiness to affected area.
The patient was only 17 years of age when the vaccine was administered. The patient did not have an adverse reaction.
This spontaneous report as received from a medical assistant refers to herself a female patient of unknown age. The medical assistant reported that she received. GARDASIL herself in the past (Lot #, dose/frequency, route, date and duration were unspecified) and experienced pain at the injection site but it was "not severe" and she had recovered (date not provided). It was unspecified whether she had sought medical attention or not. No treatment information was reported. This is one of the several reports received from the same source. Additional information is not expected.
On July 25, 2016 the patient was seen in the office for a routine physical for college. His vaccines needed to be updated for his school, specifically for DTaP. The vaccine was drawn and given to the patient. It wasn't until the following day that it was discovered that he was given the pediatric DTaP as opposed to getting the adult booster. An attempt was made to call the patient and a message was left. The patient returned the call on July 28th, three days later. He was informed of the vaccine error and informed that he was in no physical danger. He was further informed not to get any DTaP boosters for the next ten years - to inform anyone wanting to give him a booster of the fact he got a pediatric dose. Patient said he understood and would follow instructions.
In walker last pm came to mom acted like wanted to cry and gasped for air like couldn't breath, turned blue became limp then eyes rolled back and stiffened body-911 called brought into ER.
She called the pharmacy stating she had a mild, bumpy rash that started on her injection arm and extended to her chest. She stated the rash had small, bumps and not hives. She had no pain, swelling or SOB.
Nipple pain, very tender to the touch. Made wearing a bra or fitted shirt very uncomfortable for about 24hrs without tylenol/motrin. The next day, some tenderness remained with the onset of lymph node pain under my arms.
Per patient: "right arm turned black and swelled from shoulder to wrist and was hot to touch. Noticed on day 8 after vaccine, went to hospital on day 11. Had to get antibiotics for infection"
He apparently had a severe local reaction to his Prevnar vaccine at our last appointment and developed a rash on his back that improved with topical steroids. He also was extremely fatigued for 5 days but is now feeling back to his baseline. I think his symptoms were all due to Prevnar and he will continue to monitor and let us know if he starts feeling different to his baseline.
Ear ringing (tinnitus)  has intensified and happens more often. It's been debilitating.
On 04/12/2022 i received the vaccine and on 5/17/2022 i got symptoms of bad cold head aches and fever. I tested positive for Covid on 5/19/2022. The Symptoms lasted a whole day which i had to go to the hospital. i was prescribed Paxlovid which made the symptoms less.
not received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 19th February 2020, batch number 54YKVAK0VP,expiryy date 22th March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported a patient had not received 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up.
Information has been received from a medical assistant, referring to a 14 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-AUG-2016, the patient was vaccinated with the first dose of GARDASIL lot number reported as "M009378" with expiration date on 23-APR-2018 (strength, anatomical location and administration route were not reported) for prophylaxis. Then, on 17-OCT-2016, the patient received the second dose of GARDASIL lot number reported as "M011840" with expiration date on 01-FEB-2018 (strength, anatomical location and administration route were not reported) for prophylaxis. At the reporting time, on 24-MAY-2017, the reporting medical assistant stated that the patient was at the office to receive a dose of GARDASIL 9 (strength, lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis. It was reported that no adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Muscle aches; This is a spontaneous report from a contactable consumer. This consumer (daughter) reported for a female patient (reporters mother) of unspecified age that she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced muscle aches. When providing her own experience with regards to the Pfizer COVID vaccine, reporter stated that her mom told her that she had a few muscle aches for like 12 hours after her second dose of Pfizer. No investigation assessment provided. The clinical outcome for the event was unknown.  No further information was provided or obtained. Additional information has been requested.
Left thigh swelled up, skin looked red and blotchy. Took one day to react.
Worker states that she has had adverse reactions to flu shots containing preservative in 2015, 2016 and 2017 consisting of fever, metallic taste and red streaks on her arm. In 2018 and 2019 a preservative free flu vaccination was administered without any adverse reaction. Worker received the Seqirus Afluria preservative free vaccination ( left deltoid ) at 10:10 AM on 28OCT2020. Within 10 minutes she experienced a metallic taste, tingling lips and a feeling of the back of her tongue swelling. By 0800 PM she was aware of a swollen, tender area lower on her left arm than the injection site. Worker states upon experiencing the adverse effects, she took 50mg Benadryl and took another 25mg Benadryl 2 hours later as the symptoms were still present.  29OCT2020: worker still has a noticeably swollen area mid shaft anterior left arm which she states is only tender to palpation. Temp: 97.1, Pulse 71, Blood pressure 136/77.
Pt exp fever & vomiting w/in 48 hrs p/immun; Seen in office; exam was normal x/for a few blanching macules;
suspect patient death based on timing  Patient was seen on 3/31 for lumbar back pain with leg pain. had follow up visit scheduled with regular PCP within a few days.  had covid shot the next day. Then we noted he missed his appointment follow up with pcp and were told he had passed. noted his covid shot was the next day. sounds like he may have been found at home expired.
vomited; She developed a fever that night through morning of 12Jun2021; She was lethargic; slept for 2 days; This is a spontaneous report received from a contactable consumer. A 14-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection, Lot number: unknown), via an unspecified route of administration on 10Jun2021 at 12:00 (at the age of 14-years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: unknown) via an unspecified route of administration on an unspecified date (at the age of 14-years) as single dose for covid-19 immunisation and had no reaction on previous exposure to vaccine. On 10Jun2021 at 12:00, the patient received second shot and developed a fever that night through morning of 12Jun2021. On an unspecified date in Jun2021, the patient was lethargic and slept for 2 days. On 11Jun2021, the patient vomited. Event took place after use of product. The outcome of the events was unknown.  Information about lot/batch number has been requested.
States initially lump developed and redness. Sore to touch occurred the day after vaccine. Followed up with patient on Oct31 2018, states no longer sore, but lump still present and itchiness has developed.
Patient states the injection site became red and swollen around where the vaccine was given. The swelling began the evening the vaccine was administered. It continued to get larger for two days after the date of vaccination. The area was hard to the touch and red. After two days, it began to reduce in size. Patient reports diarrhea within two days of receiving the vaccine.
no adverse event; Monovalent dose administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 059H21A and 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Jul-2022, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient).    It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Concomitant product use was not provided by the reporter.  It was reported that 77 Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses were as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2022: Live follow-up received: other dose details were updated.
Headache, malaise, myalgias, nausea, vomiting and swelling and redness and pain at the site of the vaccine. Began 3/19/12. All symptoms except swelling and pain at site have resolved except swelling & pain at site.
pt recv vax 3APR98 & approx 160 lesions on all body part;T100-100.5 x 2 days;h/a, conjunctivitis began 3MAR98;
MS symptoms escalated, everything hurt, major trouble walking, fever for about 24 hours, headache, ache all over.
On 3/3/21, experienced severe headache since morning which got even worse by night accompanied by multiple times vomiting and nausea. Elevated blood pressure with the reading fluctuating between 147/85 - 129/87. (Normal blood pressure range for me below 120/75). BP monitored daily since 3/4/21 shows increased BP with ongoing headache affecting activities of daily life. PCP notified.
I started getting small spots on both my forearms then by noon my arms were "popeye arms" huge swollen and red after visiting various medical locations by 8pm I ended up at emergency room and my face started to swell where my ey