chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Certified Medical Assistant concerning an approximately 14-year-old female with no known drug allergies who was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL vaccine (655604/0052X) abut three weeks ago (approximately December 2008). The patient experienced pain at the injection site during administration of GARDASIL vaccine. The patient was recovered. This is the second of two patients for reporter. The patient sought medical attention. Addition information has been requested.  Follow up information was received from a Certified Medical Assistant concerning the 14 year old female patient who on 04-JAN-2009 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (lot# 655604/0052X). She reported that "there was no adverse reaction just painful at time of injectiob than normal shot due to prefilled syringe of GARDASIL caused rough exiting of injection". The spring caused painful exit of needle. The patient was fine with no problems after injection.   The patient sought unspecified medical attention.  No further information is available.
Patient received first dose of moderna vaccine on 8/15/21 in her left arm. She came in on 8/24/21 in the evening stating that her arm had no redness or swelling, but then as of yesterday was red, swollen and felt warm to touch. I recommended otc options to help her with the discomfort. But I told her if it continues, gets worse or shows signs of infection she should visit her doctor. She was satisfied with this response
Pt to ED 9/4 for SOB and cough. COVID+ 8/26 at urgent care, symptoms progressively getting worse. 9/5  no anti-COVID rx needed, no signs of acute distress. Pt discharged 9/6.
Narrative:  COVID infection after COVID vaccine completion 03/12 COVID vaccine (dose 1 of 1) 03/15 pt reports dry hacking cough started 05/24 pt calls PCP report "he is feeling tired. He has had a dry hacking cough since 3/15.21. He feel as though it is related to the Covid Vaccine. He also states that he has multiple boils in his back that bleeds." 05/28 PCP visit: "Pt has a open ulcer in that scalpular region which is 2x3cm in size and looks fresh which he says is because of the COVID vaccine, pt has been having oozing pus with blood from it for 6 weeks and denies any picking at this point. It looks dry on my exam though. The surrounding is indurated. Skin looks normal around. Pt has dry cough and malaise since getting the vaccine and has no HF exacerbating symptoms. Pt at the end of the visit shows me the home kits which was positive for COVID." COVID test positive 05/29 Pt reports mild productive cough, diarrhea resolving, low grade fever, runny nose, myalgia 05/30 Pt reports new onset chest pain, did not seek care in ED as advised
COVID-19 INFECTION; CONFIRMED CLINICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 44 year old male. The patient's weight, height, and medical history were not reported. Past  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, injection site left arm) dose not reported received on 08-APR-2021 for COVID-19 prophylaxis. Co-suspect medication included Moderna COVID-19 prophylaxis vaccination (solution for injection, intramuscular, batch number 066F21A, injection site left arm), unspecified dose received on 14-NOV-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 11-MAY-2022 the patient experienced initial COVID symptoms and confirmed clinical vaccine failure .  On 11-MAY-2022 the patient had positive nucleic acid amplification test (NAAT) cue test.  On 11-MAY-2022 the patient started treatment with Paxlovid (nirmatrelvir tablets, ritonavir tablets), from 11-MAY-2022 till 16-MAY-2022 as COVID-19 treatment.  By 14-MAY-2022 the patient was symptom free. On 20-MAY-2022 the patient had a negative COVID-19 antigen test.  On 22-MAY-2022 the patient experienced mild cold like symptoms and had a positive COVID-19 antigen test.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 infection, confirmed clinical vaccine failure was not recovered. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 This report concerns a 44 year old patient experienced covid-19 infection and confirmed clinical vaccine failure, approximately 13 months after receiving Janssen covid-19 vaccine (6 months after receiving Moderna COVID-19 prophylaxis vaccination). The events show an incompatible temporal relationship. Therefore, the events are considered not related to Janssen covid-19 vaccine .
She got her vaccine, had no reaction at all.   She woke up in the morning and had the hand shaking, her body quivering and feeling like shew as having a panic attack and weakness, feeling like she had cerebral palsy.  Everything aches but does not have a headache.  She went to pharmacy as she had to leave work at 12:00 and her hands were shaking, and they told her that some people have that reaction.  She cannot drive in this condition.  Because of the shakiness she has to get up real slow and watch her steps.  Says it feels like she has a mixer in her abdomen and that her whole body is shivering.  She has had panic attacks in the past and feels like she is in one, but has not had them in a while, and nothing like this.   They told her to take something for her body aches, headache, but the trembling is what is concerning her as she is not able to work like this.  She is fearful of loosing her job as she cannot work like that and is afraid she cannot keep calling in.    She is not able to drive in this condition either.
Spongiatic dermatitis. I have an itchy rash that has spread between my groin and moved throughout my stomach, chest, and back. The dermatologist and doctors I have seen cannot determine what is causing it, but they cannot rule out the vaccine being the cause of the breakout.
Patient received a rash red rash on the upper arm . recieved the moderna on 12-27-2021 and the afluria on 12-21-2021. both on on  left arm
Pt received booster dose of Moderna; 2 minutes after, pt reported that she was feeling shaky.  Pt stated that she was also diabetic and had not eaten breakfast.  VS taken at 10:09; SpO2 99%, HR 104, BP 104/60, temp 98.2.  Pt stated that she normally takes her blood sugar every 3 hours but has not taken since 4 am (4 hours prior).  Staff gave pt snacks and orange in which pt ate and was symptoms were resolving.  Pt stayed with staff for around 20 minutes in which pt reported feeling better, looked better, and had husband take her back home to check blood sugar and to eat food.
Patient received injection and within 1 minute reported his "lips were tingling" and had pain in the left side neck. Vitals: 1045 195/139, 96%, HR 106; 1105 153/119, HR 105; 1119 182/115, HR 89.
Has developed new onset headaches which present as brief, throbbing headaches 6.5/10 in intensity and occur several times daily
The adult vaccine was reconstituted per the pediatric vaccine instructions (1.3 ml) and a pediatric volume (0.2 ml) dose was given.  The only reaction reported by the patient was a sore arm.
Redness & pain in (R) arm beginning 1/18/12 & increased 1/19/12 & went to ER. C/o rash & severe pain. No fever, no induration, no fluctuance or discharge. Dx - possible acute cellulitis. Rx - Doxycycline 100mg po bid x 7 days.
Day after 2nd shot, after waking up, had headache and high fever. Took 600 of Advil so suppress fever. Headache disappeared fast. Whole body was in pain, very sensitive to touch. Very painful when touched. Took another 400mg of Advil before going to bed. Constipated, could not move bowel.  Day 2. Still feel sensitivity all over body when being touched. Developed fever again at nighttime. Still constipated with no bowel movement.  Day 3. Severe, stabbing, tingling pain develops around shoulder blades, had bruises (light green) around it.  Pain was a 10 out of 10. Felt like there was a hand under my skin pinching, pressing, trying to take my organs out of my body.  Day 4. Developed red rash from breast bone to the back, only on left side of my body.  Extremely painful, stabbing, crushing pain.  Day 5, 6, 7, 8. Red rash becoming bigger and pain is still 10 out of 10. Took prescription for Shingles night of Day 8. Applied Floucinonide around affected area.  Day 9. Took 2nd pill of Valtrex and applied Floucinonide ointment again around affected area.
Patient was given the chicken pox vaccination during a routine doctor's visit. All was well, but then she developed shingles this spring and she had never had chicken pox before and how could this happen without her having the chicken pox or being exposed to it? Doctor concluded it must be the vaccine. She was very ill and had a lot of pain but she is okay now. Patients are getting a false sense of security about this chicken pox shot...the whole reason I got it for her was to avoid all this.
devel migraine (initial) w/in 1hr;fever 101 mult episodes of vomiting;went to ER 9hr later due severe h/a;CT done negative;platelet count 114,000;
Child received immunizations PM of 4/26. Arm was slightly red on 4/27, when woke up. Child told mother bumped on bed. 4/28, child c/o very sore arm, red, swollen, hard and warm. Came to HD and was referred to PMD. Seen in PM of 4/28. Instructed to apply warm compress and massage area (3x3) to help hardness decrease. Given Benadryl 1 tsp q 6 hrs until 4/30. Better on 4/29 and cleared by 4/30. 5/2/06, Talked in person to RN that saw child at clinic on 4/28. Area on arm that reacted was deltoid where DTAP was given, not posterior where MMR was given. Reaction to DTAP entered.
several pt devel an inj site rxn p/vax;no further info was available @ date of this report;this is 1 of 2 reports from this facility of inj site rxn p/vax lot# 4978199;
Case previously recorded as MA2009-5156. Initial case report received from a physician via MedCom on 19 NOV 2009. A 1-year-old male patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) i.m. on 13 NOV 2009. No adverse effect was reported. MedCom reference no.: NA09-008308.
Immediately (3 mins.) after injection was soreness in arm.  12 hours after injection began running 100.9 fever with chills.  Progressed by 6AM to body aches; headache involving jaw and teeth; one bout of stomach cramps with diarrhea and vomiting.  Continued symptoms other than diarrhea and vomiting with intemittant fever (around Tylenol doses) until 2AM 4/16)  2:00 AM 4/16 fever broke and though very tired was symptom free as morning went on. However, my injection site remains sore thru Sun. 4/17 with a large area of red with heat moving down from from the injection site. Currently  4-5 inches above the elbow. Using cold compress for discomfort and redness.  Still present.
On July 3 2022 in the evening I started to feel sick. I woke up middle of the night I woke up dizzy and fainted. I did an at home COVID-19 on July 4 2022. From then I got sicker. I couldn't eat or drink with nausea. Then I thought I was getting better. I spoke with my doctor and they told me to go to the emergency room. I went to the emergency room on July 11 2022. I was hooked up with fluids. I have never been that sick. I had a CT of my face, chest x-ray, and EKG at the emergency room. I was given Zofran.  I was sent back home from the emergency room the same day with Zofran. I still a cough and congestion today. The fatigue lasted about one week.
Severe case of palpitations; Premature atrial contractions; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Severe case of palpitations) and SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contractions) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Severe case of palpitations) and SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contractions). At the time of the report, PALPITATIONS (Severe case of palpitations) and SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contractions) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. No concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Additional information received on 17-May-2021 has no new information. On 16-Jul-2021: ADR Form attached.
death R56.9 - Unspecified convulsions R56.9 - Focal seizures
6 HOURS AFTER VACCINE ADMINISTRATION INFANY BECAME LETHARGIC ABD PALE. (DURATION X 50 MINUTES). THEN 2 DAYS FOLLOWING DECREASE IN APPETITE. INCREASED FUSSINESS AND FATIGUE.
Started noticing in March my heart rate was very elevated on pulse oximetry at work, started having major sensitivity to heat and becoming tired very easily.  My eyes began to become swollen and red when I first woke up in the mornings.
No adverse reaction.  Patient had already received a dose at an alternate provider.  Doses were too close together.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER2613), on 12Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing), notes: Other medical history: Migraines; "osteoporosis" (unspecified if ongoing), notes: Other medical history: osteoporosis; "hx colonic polyps" (unspecified if ongoing), notes: Other medical history: hx colonic polyps. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: As per the available information the causality of the events vaccination failure, covid-19 with the suspect can not be ruled out completely.
Sudden infant death syndrome occurred on 3-2-05. Immunizations were given on 2-28-05.    2/29/08 Autopsy report states COD & manner of death as Undetermined.  Reviewed autopsy report which states patient had been fed & placed in crib on back.  Found approx 12 hrs later, on stomach at other end of crib, face to the side.  Unable to resuscitate w/CPR at scene & in ER.  Fire department did carbon monoxide testing of residence which was neg.
Narrative: No documentation located in chart regarding vaccine administration information. Only available documentation available regarding side effect of paresthesia to COVID-19 vaccine is pt report in RN note that "Pt states after the first moderna covid vaccine, she could not walk for a couple of days,, and was advised not to take any more of the covid vaccine, will list as an allergy on chart today."
My child's face flushed red within about 15 minutes of receiving the vaccinations. Her cheeks remained red for some time after. She developed a fever within hours of vaccination. My child screamed and cried inconsolably for almost 24 hours. Child was lethargic and unresponsive. Rash developed on chest and upper back which lasted about one week.
After the second booster I got Covid; After the second booster I got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After the second booster I got Covid". Clinical Course: Just to let them know, all of patient's vaccines were Pfizer two Covid and three boosters.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300220100 same reporter/patient, different dose/event;US-PFIZER INC-202300220101 same reporter/patient, different dose/event;
Returned to clinic with complaint of redness to injection site and dx with cellutlitis and vaccine reaction. Was started on cephalexin.
Pt received second dose of varicella virus vaccine live on 02/25/1997. ELISA testing on 051/12/1997 revealed negative seroconversion.
5 days later, very similar to autoimmune disease flare up, had not been diagnosed with autoimmune before this, altho had higher CRP markers possibly due to obesity.  Hands, feet, leg, arm, neck swole up twice it's size, excruciating pain, hot,  NEVER had this happen until after the vaccine.
Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8731) via an unspecified route of administration in the left arm on 13Apr2021 at 10:30 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, since unknown date. The patient had no known allergies to food, medications or other products. 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 receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included metoprolol tartrate (METOPROLOL) 50 mg, losartan 100 mg (MANUFACTURER UNKNOWN), all on unknown date, for unknown indication and unknown if ongoing. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6207) via an unspecified route of administration in the left arm on 18Mar2021 at 09:00 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. On 13Apr2021 at 11:30, the patient experienced vomiting. No therapeutic measures were taken as a result of reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vomiting was recovered on 13Apr2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous case was initially received on 03-DEC-2015. The case report was received from a(n) Health Professional and concerns a(n) 54 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing conditions surrounding the onset of reaction9s)/event(s): The patient received AFLURIA on 03-DEC-2015 - 03 DEC-2015, Batch no: U59308, Route of administration: Intramuscular, Dose; 0.5 ml. AFLURIA was stored correctly. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 03-DEC-2015, immediately after administration of AFLURIA, the patient experienced Swollen arm/Arm swelled up (non serious, outcome: Recovered / Resolved), Red arm at injection site (non serious outcome: Recovered / Resolved), Bleed at injection site / Bleeding from site after injection (non serious, outcome: Recovered / Resolved). Rechallenge/Dechallenge information: N/A. For relevant test results see appropriate report section. Reporter's assessment: non-serious.
4 in x 4 1/2 in induration; warm to touch. Red, itchy and painful site. All localized.
Woke up AM with vaccination. Lg. red swollen area at site of inj. (? Varicella) Developed nausea/vomiting, fever increased to 104.6 (oral) Mom contacted MD. Fever cont'd for 48 hrs up to 102. (Info Rec'vd from pt's mother)
Site: Pain at Injection Site-Severe, Systemic: Bursitis-Severe, Additional Details: Patient called and said she can't lift her arm and now has bursitis
Low grade fever(99-100),chills, stiffness, aching in hands and joints within less than 24 hours of receiving MMR vaccine for negative Mumps IGG titer. Continued to have c/o body and muscle aches, fatique and loss of appetite. Evaluated by ED and Family Practice Physician. Also c/o heart rate speeding and slowing down, insomnia since vaccine. Has missed approx. three weeks of work since vaccine. Has been referred for 24 hr. cardiac monitor and to be referred to Rheumatologist. Follow up 03/03/05: Patient has not recovered.
This spontaneous report was received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that on an unknown date, an unspecified number of patients were administered GARDASIL (lot #, expiry not reported) that were exposed to 31 F (Fahrenheit) for up to 6 months. The Nurse will gather information for processing the need for revaccination and call back. This is 1 of 2 reports from the same reporter. Additional information has been requested.
Patient reported flushing and tingling on scalp.  Waited an additional 20 minutes, blood pressure was 128/99.  Gave a cold bottle of water.  Patient reported she thought mostly likely anxiety induced as she was not comfortable getting shot, but was required to do so for employment.  After waiting additional period of time, patient felt comfortable to leave.
Health Department, not sure which nurse or provider, gave pt a Dtap on left arm. Pt was then seen 2 days later and the area was swollen and black and blue the size of a baseball.
FEVER, SWELLING OF INJECTION SITE, INJECTION SITE PAIN, BODY ACHES, KNOT AT INJECTION SITE
Budding headache , at night about 9pm, starting on April 14th, and again tonight the 15th at 9pm
My daughter got her vaccines and within hours was lethargic, no appetite, clammy to the touch, whimpering and pale.
posterior head pain that would come forward reaching forehead with flash sharp pain happened randomly for 4 days weakness lasted 2 days n/v lasted 2 days diarrhea continues skin felt burning and sensitive all over body as if she had a rash, but no rash present lasted 4 days upper back/shoulder pain "felt like being crushed" Came around to chest & abd. lasted 5 days
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a third dose 0.5 ml  of GARDASIL (Lot#: not reported). The nurse advised that, on an unspecified date the patient completed the series of GARDASIL injections. After the last injection the mother of the patient called into the physician's office and advised that the patient was having a headache and a stomachache. The patient sought unspecified medical attention. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Shortness of breath. Dizziness. Back pain. Patient had to go the ER for treatment. Sx started the evening of 8/15/14.
Moderna COVID-19 Vaccine EUA I had the worst chills I ever had in my life for 2 days I had no energy for 2 days, was lightheaded--just like getting over the flu. Weak as a kitten. Not life-threatening, but thought you should know. and of course the injection site hurt like hell. But it does that for everyone--but I'm the only one I know of who's experienced such severe chills.