chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 26th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema, injection site pain and injection site swelling. The patient was treated with Anti Inflammatory Drug (Nos). On 31st May 2018, the outcome of the injection site rash, injection site erythema, injection site pain and injection site swelling were recovered/resolved. The reporter considered the injection site rash, injection site erythema, injection site pain and injection site swelling to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The healthcare professional (HCP) stated that the patient had an injection site reaction 12 hours after receiving SHINGRIX vaccine. The HCP reported that the patient had a red rash, swelling, and pain located on her right deltoid, arm area where the vaccine was administered. The HCP stated that the patient had this reaction for 5 days, then the reaction fully resolved. The HCP stated that the patient had a low threshold for pain. The HCP was a retail pharmacist stated patient's husband called to report site reaction in the next morning, patient was recommended to rest, apply ice, and take anti-inflammatories for injection site reaction. The HCP was unsure if patient did any of those interventions. The HCP stated that she was unsure if the patient had her second dose as recommended due to the injection site reaction.
Patient vaccinated on Wednesday 4/7/21, left bandaid on until Friday or Saturday, does not recall which day.  States at that time he noticed soreness near injection site.  Does not have fever, chills, or any other complaints.  Presented to vaccine clinic for evaluation.  Informed client is not able to diagnose or treat.  Site has quarter sized yellow bruise to injection site and bandaid shaped area of small raised bumps on either side of inection site.  Not hot to touch, no drainage, streaking or swelling noted.  Area described is in exact shape of bandaid.  Advised client to leave area uncovered and seek medical care for new or worsening symptoms.  Denies known allergy to bandaids or adhesives in past.
10/23/21- SORE LT ARM, FEVER, WEAKNESS, FATIGUE, NAUSEA, CRAMPING IN LEGS,LIGHT HEADED, HEART RACING ALL DAY 10/24/21-  SORE LT ARM AND ARM PIT, FATIGUE, WEAKNESS, SLIGHT LIGHTHEADNESS,HEART RACING ALL DAY 10/25/21-   SLIGHTLY SORENESS TO  LT ARM & ARM PIT TILL AT NIGHT NOTICED RASH ON LT ARM ABOUT 3INCHES BELOW                           WHERE INJECTION WAS GIVEN.  WARM TO TOUCH & SWOLLEN. STOMACH CRAMPING THROUGH NIGHT, HEART RACING ALL DAY 10/26/21- LT ARM & ARM PIT SORENESS . RASH STILL PRESENT ,VERY WARM TO TOUCH.   STOMACH REMAINS UPSET AND                          NAUSEA PRESENT.  LIGHT HEADNESS
Started to take capsules on 03/04/2010. 3/19/2010 the client informed me of the problems he had while taking the oral TYPHOID capsules. The day after taking first capsule client reports he noted some soreness in his gums and behind his teeth on the left side. He continued taking the capsules, 03/06/2010, after the second capsule he noted increased pain, swelling, and a bruise on his gums. On 03/08/2010, client had taken the third dose and later he saw his dentist, who noted: teeth #10,11, 12 "tissue swollen and bruised, very sore, swelling mostly between #11 and 12 lingual". On 03/10/2010 client took the fourth and last dose. The pain, swelling, tenderness was more generalized through the upper and lower jaw, teeth and gums. On 03/11/2010 client saw the dentist again "more areas tender, puffy and itchy" and was given the attached note to make an appointment with dentist if the symptoms continued. On 03/19/2010 client reported to me the problems he had and that the symptoms continued to increase then on 03/13/2010 the symptoms started to subside and by 03/19/2010 the symptoms were almost gone.
Child seen in clinic on 12/12 for large area of redness and swelling, hot to touch and painful. treated with antibiotics.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8732), in left arm and on 26Apr2022 as dose 2, single (Lot number: EW0164) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Lot number: 012H21B), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxycillin and probably other -cillins", notes: Known allergies: Amoxycillin and probably other -cillins. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Positive, notes: Day 0, Sun.19Jun being the first day I tested positive; (2022) Mildly Positive, notes: I tested mildly positive on an at-home antigen test; (30Jun2022) Strongly positive, notes: On Thursday. 30Jun and Monday 04Jul (Days 11 and 15), I tested strongly positive; (04Jul2022) Strongly positive, notes: On Thursday. 30Jun and Monday 04Jul (Days 11 and 15), I tested strongly positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had COVID treatment from 20Jun2022 to 25Jun2022.
Reports red, hard swollen, warm to touch (L) upper arm x 1 week after getting vaccine.
Patient received a Moderna Vaccination @ 1715 approx.  10 minutes later patient presented with rash on her chest and back.  Minor itching.  Patient received 25mg of Benedryl IM@1736.   After receiving medication, patient denied itch, redness or hives.  Patient refused transport to the hospital.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. In late AUG-2021, the patient caught Covid (suspected covid-19 infection, suspected clinical vaccination failure) but was not hospitalized. The patient mentioned he was listed as a moderate case although it didn't felt moderate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210953291. This report was associated with a product quality complaint.; Sender's Comments: 20210952846-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Experienced onset menstruation a day after each injection  for first time in rarely ever. (Nexplanon in left arm causes nonexistent period symptoms.)
mild redness at site,  nausea, vomiting, diarrhea, fever and chills
Approximately 15 minutes post vaccination client exhibited tense muscles, crossed feet, hyper-extended neck, loss of consciousness.  This episode lasted approximately 30 seconds.  Post-episode client yelled out loud, became diaphoretic, nauseated and vomited x 4.  Blood pressure, heart rate and temperature within normal limits. Alert and oriented x 3. Approximately 10 minutes later client attempted to stand with assistance but became light headed and nauseated. Client vomited again, very small amount.  Approximately 15 minutes after that client stated he felt 'ok' and was able to stand.  No longer nauseated or diaphoretic. Applied cold compresses to back of neck and forehead.  Stressed to parent the need for immediate follow up care and importance of using emergency services.  Parent insisted on taking client to emergency room herself.  Client did not appear to be in acute distress at this point.  Was escorted, ambulatory, to parents vehicle.  Telephone call referral made to emergency room physician at hospital.
Starting 12 days after receiving the vaccine booster, I began getting hives and rashes all over my body (top of head to underside of feet). Itchy and burny. The hives and rash all move and continue to move all over my body (never staying in the same place long unless I scratch at the irritated areas). At the same time, a firm touch will make imprints and leave visible welts in my skin that last for hours afterward.  All symptoms are still present. Benadryll and Zyrtec somewhat relieve the itchiness and burning, but the rash still stays present and moves all over - affecting face, back, arms, legs, torso, etc.  5 day prescription for Prednisone given by healthcare provider, but this also has not removed the symptoms or cause.
Patient received 1st dose Moderna ; he was in state for a dermatology appointment which happened to be on the day of his 2nd dose; he came by our drive thru clinic for vaccine administration; he forgot his vaccine record card; administering nurse verified that note had been completed but did not read the contents nor review the Immunization tab prior to administration which showed that Moderna was given in  clinic  Charting on the event happened after he had completed his 15 observation period.  He was observed for 15 minutes as required and did not report any side effects or adverse events
Starting 48 hours post vaccine, suffered from severe fatigue. The fatigue has not improved. I was walking 3 miles per day, playing golf once to twice weekly, mowing yard twice per week,  did various house tasks, and have been unable to barely keep my head up since the COVID vaccine. I have seen my PCP r/g  extreme fatigue after 2 weeks, labs performed, no significant abnormalities noted.
HSV-1 flare on abdomen that developed 2 weeks after vaccine #1 - I have a history of disseminated primary HSV diagnosed following childbirth 4/1/2017 but never had a flare since then, and did not have any primary lesions in same location
Patient received the 2010-11 Flu vaccine at our pharmacy. That evening she became fatigued, had chills, a headache, nausea, and dizziness to the point where she could not stand. She could not eat simple soup. Her boyfriend nearly took her to the hospital because she couldn't stand up. The site of the injection was very swollen, warm to the touch and red. She was sick all weekend into Monday. She came in today, and her arm was still sore, red and somewhat swollen.
nausea; aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and MYALGIA (aches and pains) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced NAUSEA (nausea) and MYALGIA (aches and pains). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Mar-2021, NAUSEA (nausea) had resolved. On 12-Mar-2021, MYALGIA (aches and pains) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Heart rate: increased (High) heart racing/chest felt like it was going to explode..         No concomitant medications were reported.   This case was linked to MOD-2021-058094 (Patient Link).
9/10/21 PATIENT SEEN IN THE ER REPORTS FEELING SICK X 2 DAYS.SHORTNESS OF BREATH, COUGH, BODY ACHES, REPORTS TESTED POSTIVIE FOR COVID ON HOME TEST 9/9/21.  ALSO REPORTS FEVER, CHILLS, ANOREXIA. NOTED TO BE TACHYCARDIC WITH HR 120s. HYPOTENSION 80/60. MILD LEFT CALF TENDERNESS PRESENT WITHOUT SWELLING OR REDNESS. HYPOKALEMIA NOTED. O2 SAT. 99-100%. 9/12/21 DISCHARGED FROM HOSPITAL TO HOME.
Headache; Achy hips; Achy lower back shoulders; Achy neck; sore arm; fatigue; insomnia from pain; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: El9267) via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 10:30 as dose 1, single for COVID-19 immunisation. Medical history included covid-19. Concomitant medication included citalopram (CITALOPRAM) taken for an unspecified indication. Patient known allergies reported as none. On 11Mar2021 at 14:00 the patient experienced headache, achy hips and lower back shoulders and neck, sore arm, fatigue, insomnia from pain. Patient was not received treatment for the events. Outcome of the events was not recovered.  No follow up attempts are Possible. No further information is expected
Headache; Vision problems; Fever; Night sweats; Bodyaches; Confusion is turning yellow again; This is a spontaneous report from a contactable consumer, the patient. A 58-years old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) as a single dose on left arm via unspecified route on 22Mar2021 at 03:00 PM (at the age of 58-years old) for COVID-19 immunisation. The patient medical history included major cirrhosis of the liver needs a liver transplant. The patient was allergic to morphine cipro and motto patch.Concomitant medications was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, at 20:00 the patient experienced major headache vision problems as well both on left side of head, fever night sweats body aches confusion was turning yellow again. The patient did not receive treatment for the reported events. The clinical outcome of major headache vision problems as well both on left side of head, fever night sweats body aches confusion was turning yellow again was not recovered.                  No follow-up attempts needed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Verbatim of Relevant Med History updated as same as source document, note added, "Concomitant medications were not reported" updated as "Concomitant medications was reported as none", "on left arm", "The patient did not receive treatment for the reported events " added in narrative and Reference No. added.
This case was reported by a nurse and described the occurrence of fever in a patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. On 30 June 2003 the patient received an injection of Infanrix (lot DTPA578A9). This vaccine had inadvertently been left unrefrigerated for an unspecified period of time. On the same date, the patient also received injections of Haemophilus influenzae type b conjugate vaccine (manufacturer unknown), inactivated poliomyelitis virus vaccine (IPOL), and 7-valent pneumococcal conjugate vaccine. On 01 July 2003, 24
Initial report was received on 19 September 2014 from a health care professional. A male patient reported over the age of 65 years (date of birth not reported) had received on an unspecified date FLUZONE HIGH DOSE, (lot number, route and site of administration not reported) and within 24 hours of receiving the vaccine suffered cardiac death. Outcome was fatal. Documents held by sender: none.
Cough first, followed by body ache, then chills, then headache and fever, and heart palpitations.
I started having a runny nose mild sore throat, mild 24 hour fever. I called my doctor when I tested positive and he prescribed Paxlovid that I started that night and I am almost finished. I felt like a had a mild cold for about two or three days. I am almost finished with the Paxlovid and aside from the taste I feel better.
I started experiencing muscle pain again and pruritus in my vaccinated arm (left) and an area of epidermis (approximately 4"x6") around the vaccination site is also showing moderate erythema and slight edema on 1/20/21 (12 days after dose 1). I staring applying 1% hydrocortisone cream on the affected area and taking Benadryl 25mg tablets. The pruiritus started to lessen however the erythema and edema did not decrease so I contacted my primary care provider. She referred me to an allergist who I saw via telehealth on 1/25/21. By that time the pruiritus, erythema, and edema was almost gone however I did show her a picture when the reaction was at its most severe state. As of today, it is still present but continues to resolve. My allergist discussed the reported incidence of this reaction, informed me that it did not contraindicate me from receiving the 2nd dose, and that this reaction may or may not occur again.
An hour and a half following vaccination patient developed itchy hives on her bilateral cheeks. She was brought back to the office immediately and treated with 10mg of Zyrtec.
Pt called on 3/29/13 at 0930 reporting on the evening of 3/27/13, she developed fever, chills, nausea, vomiting, headache, dizziness, weakness, palpitations that persisted through 3/28/13. Pt had to take 3/28/13 off but s/s have resolved and pt is back to work today feeling well.
had high pitched cry for 3hr;also had temp 102.1-103.5 during the 3rd hr time period;fever went away w/motrin;
Employee states a raised itching rash on forehead with slight brown coloration along hairline and eyebrows .  Employee unsure of when itching started pre or post vaccine immunization
his left arm started to hurt severely; the back of his neck is also hurting.; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and neck pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and neck pain to be related to Shingrix.  Additional details were received as follows: The patient received the first dose of the Shingrix vaccine and left arm started to hurt severely in the middle of the night. The patient stated that the left arm was very sore and took Tylenol for the pain. The patient stated that the back of his neck was also hurting. The patient consented to follow up.
Pt felt very ill 3 full days post vaccination. Malaise, fever, aches, coughing enough to use her inhaler, nausea, flu like symptoms strong enough to interfere with daily activity and work. Not feeling like herself until Fri when vaccine given Mon. When viewed in pharmacy on Friday 7/27, the red raised rash around injection site about 6 inches wide and 4 inches tall. This reaction may interfere with her choosing to receive the second dose. She was looking for guidance on whether she should see a healthcare professional such as urgent care for her remaining symptoms.
Coughing and bronchitis type effect.  My wife got it about 2 weeks prior.  Both had Flu shots.  Daughters hair salon with 30 employees get it if they had the flu shot.  Those not getting the shot were OK.
Local Health Authority,  volunteer RN mixed vials and withdrew 0.2 ml from a diluted vial, and 0.1 ml from an undiluted vial, resulting in a 60 mcg dose.  Consulted with Pfizer. Consulted with proper authority.  Contacted client who was in stable condition, no acute distress.  Advised client to monitor for symptoms and to go to ER for chest pain and/or shortness of breath.
This spontaneous report as received from a patient's mother refers to a 19 month old male patient. Pertinent medical history, drug reaction or allergies were not reported. On 11-SEP-2014 the 19 month old patient was scheduled to receive DTaP but was inadvertently vaccinated with GARDASIL, "1 single shot", (dose, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. The patient sought medical attention (unspecified). The outcome of the events was unknown. Additional information is not expected because the reporter details were not provided.
Stiffness in arm a few hours later. Next day: headache, chills, fever of 100 all day, warm urine, loss of appetite, muscle aches and join pain
Coughing when not exercising, and that coughing prompting a gag reflex. Essentially, I feel like I'm going to vomit when I cough, and unlike in the past the coughing is not tied to exertion. This started sometime in June (I regrettably didn't record when I first noticed it).   I have been tested by Dr., who is a respiratory specialist, as I originally believed this to be an odd development in my asthma. He currently theorizes that I have in fact outgrown my asthma (which first presented in 2005, at age 9), and this is some new, unknown issue.  Our first move was to stop my asthma medications, positing that if this was asthma, my symptoms would worsen. They have not. Additionally, his first guess was that this may be related to acid reflux (which I have experienced mildly in the past), and he prescribed me Omeprazole 40mg/daily. However, around the sane time that I started the omeprazole (roughly a week ago), I began experiencing debilitating nausea, a worsening of the gagging sensation when coughing, and horrible stomach pain.   As of today, at Dr.'s recommendation, I have reduced the omeprazole to 20mg to try to determine if it is the cause of my worsening symptoms, but it is too early to tell.  I have also contacted the physician I see for Hormone Replacement Therapy, which I began about a month prior to my vaccination. Nausea is a noted side effect of estrodial, so I was advised to take that medicine at night instead of the morning. This advice also came mere days ago, so it is too early to tell if it will affect anything.
Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: COVID-19 Treatment; Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: En6202), on 22Mar2021 as dose 2, single (Lot number: En6206) and on 21Oct2021 as dose 3 (booster), single (Lot number: Ff2587) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: COVID-19 Treatment". Therapeutic measures were taken as a result of suspected covid-19.