chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme fatigue 5 days later I am still having extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot and expiry were not available), via an unspecified route of administration in the right arm on 16Jan2021 at 10:30 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included asthma and high cholesterol. No allergies to medications, food, or other products. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT), atorvastatin calcium (ARVASTATIN) and azelastine which were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme fatigue 5 days later (on 21Jan2021 at 12:00). The patient stated, "I am still having extreme fatigue." The event was considered non-serious as it did not result in death, non-life threatening, did not cause/prolong hospitalization, non- disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the event was recovering. No treatment was received for the adverse event.  Information on the lot/batch number has been requested.
Expired Product Used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 7-year-old female patient who received DTPa (Infanrix) (batch number LS444, expiry date 22-SEP-2023) for prophylaxis.   On 05-OCT-2023, the patient received Infanrix. On 05-OCT-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Product Used).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 6th Oct 2023 The practice manager called to inquire how to proceed, as the patient was inadvertently administered an expired Infanrix yesterday on 5th Oct 2023. The reporter did not consent to follow-up. The patient received expired dose of infanrix which led to expired vaccine used.
PUI's symptoms developed on 9/4/21 including an inconsistent fever and brain fog. PUI was hospitalized due to severe fatigue and confusion. His oxygen level remains normal. PUI is retired and hasn't had any additional contacts. Prior history of afib and diabetes.
One day post vax the pt developed an injection site reaction characterized by redness, swelling and warmth. Pt was treated with Benadryl and cold packs.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, race and ethnic origin. 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, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient got Covid (suspected covid-19) and reported that none of the vaccines worked (suspected clinical vaccination failure). Patient stated that, "None of the vaccines are working. It is simply a moneymaker for those in power who want to stay in power. I got JnJ then got Covid. My mum died and I could not go to her funeral. I also missed my uncle's funeral. People will not easily forgot how much pain has been inflicted by these lies and corruption. It will all come out one day." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000217704.; Sender's Comments: V0: 20220236761-COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Information has been received from a physician concerning a patient who was vaccinated PO with a 2.0 mL dose of Rotateq. The patient possibly developed rotavirus. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Abnormal uterine bleeding times 2 weeks. I have an IUD and have not had a period in 9 months. Before that I had very regular periods.
2 weeks after getting the second vaccine, I had a very weird sort of tingling like pins and needles in the crown of my head. It was very non-descript and it was all over my head. Sometimes it would be on the left side and sometimes in the right. After I experienced it for a week I did not like that, so I went to the doctor and asked if they had an idea of what was going on. Then I started having the pins and needles in my left foot and left ankle and it's the weirdest thing. I had that for over a month. I still feel some of the effects of it and some muscle weakness.  When I went to the doctor they did blood work and everything came back normal and they give me a prescription version of Benadryl to help with the pins and needles but I do not think it did.
This spontaneous report was received from a physician, via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 20-OCT-2014,  the patient was vaccinated with an improperly stored dose of (23-valent) PNEUMOVAX 0.5 ml (VIs 10 SDV) (Lot number K007822, expiration date 15-AUG-2015), single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the (23-valent) PNEUMOVAX had temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported and "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
5/1/03 area on left thigh dime size red and painful to touch, looked like head of zit, knot size of $0.50, no fever. Saw doctor on 5/02/2003, 10:40 am "normal reaction" apply ice already, giving motrin.  Other vaccine listed: Synagis-(Palivizumab) Medimmune Lot# 206842
Itching rash; Bilateral rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching rash) and RASH (Bilateral rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitivity reaction. Concomitant products included ESTRADIOL (MINIVELLE) for Hysterectomy, TOPIRAMATE for Nerve injury, LEVOTHYROXINE for Thyroid nodule removal, VITAMIN D NOS for Vitamin D deficiency, AMLODIPINE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PRURITUS (Itching rash) and RASH (Bilateral rash). On 17-Feb-2021, PRURITUS (Itching rash) and RASH (Bilateral rash) had resolved.            Concomitant medications includes levofiranta, steroid treatment medication includes Antihistamines   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow-up information received contain significant information added updated address, Batch number of second dose and concomitant medications added, updated action taken.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication was reported. 190 patients (9 different lot numbers) received a vaccine past the beyond used by date. It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. No treatment medication was reported. This case pertains to the 47th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:  case
Patient became light headed and dizzy approximately 10 minutes after receiving immunization. We gave patient a bottle of orange juice. Patient said she was feeling better in about 15 minutes. Patient left with boyfriend on her own.
lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever, body aches; swollen arm and hand on injection arm,; lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever, body aches; lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever, body aches; Lymph nodes under arm painfully swollen; swollen arm and hand on injection arm; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0158) via an unspecified route of administration in the right arm on 13Apr2021 at 14:30(at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to bandage adhesive. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN) both are started on unknown dates and for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in right arm on 23March2021 at 09:30(at the age of 49-year-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 14Apr2021 at 16:00, the patient experienced lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever and body aches. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 14Apr2021, the patient underwent body temperature and resulted with a temperature of 101(unspecified unit). The clinical outcome of the events lymph nodes under arm painfully swollen, swollen arm and hand on injection arm, 101 fever, body aches were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
right arm hurts to lift up; unable to lift his right arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient was unable to lift his right arm because it hurts.  The event was ongoing. The reporter consented to follow up.
States after vaccine tingling to (R) little finger and then burning to (R) upper arm.
3 weeks to the day after my second shot of the Pfizer Covid vaccine I developed shingles
Information has been received from an office manager concerning multiple patients of unknown age and gender. Information about concurrent condition, medical history, drug reactions/allergies and concomitant therapies were unknown. On multiple unspecified dates, the patients were each vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route were unknown, lot # M020926 with expiration date 11-AUG-2018) for prophylaxis. No adverse effect was reported. The vaccines had been exposed under temperature 29.6 Fahrenheit and were out of range for 55 minutes. Temperatures were not recorded with a data logger and there was no previous excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003274: US-009507513-1612USA003276: US-009507513-1612USA000738.
Swelling of lower lip; itching; severe, red, swollen  welts all over body; tongue itching, then some swelling; swelling of lips and chin area; eye lids swelling almost completely closed. Began 01//05 early am; progressivegly worsening thru 01/08.  Given steroid injection at doctors office and told to take Benedryl or Zytrec and Pepcid
dizzy, feeling funny, and shallow breathing.  vital signs stable,  x 3 02 sat 98% .  Physician discharged to home
This spontaneous report as received from a nurse manager refers to a patient of unknown age. On 29-APR-2013 the patient was vaccinated with VARIVAX (Merck). Other suspect therapies included PROQUAD (Merck). Dosing information was not provided. The patient received a dose of VARIVAX (Merck) and a dose of PROQUAD (Merck) administered during the same visit (Overdose). No symptoms reported. Additional information has been requested.
Patient called the pharmacy Saturday morning and spoke to pharmacist states her lips began to swell ~30 minutes after receiving the Pfizer Covid 19 vaccine.  She was already at home and it wasn't too severe, she took some Benadryl.  The swelling subsided and on Saturday she experienced swelling around her eyes.  Pharmacist recommended to continue Benadryl and seek medical attention if it persisted or became worse.  Called patient on 8-2 she reports doing much better swelling is down and has appointment with physician on Tuesday.
MMR recvd 20JUL93 in afternoon; same day pt felt feverish no thermometer used; by am of 21JUL93 pt had red rash (no raised) covering back & chest; no tiching; referred to pvt MD;
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients had been administered ROTATEQ, intramuscular, (dose, frequency, lot#, and expired date were not reported) that fell to refrigerator temperature outside the prescribing information, despite being supported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a "nurse" concerning a 34 year old white female pt with "chronic sinusitis" who on 05/21/03 at 9:45 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645246/0029N). Concomitant therapy on 05/21/03 included an IM first dose in the left arm of Haemophilus B conjugate vaccine (Lot # 645971/0253N). On 05/21/03 at 1800 the pt developed increased fever and erythema and soreness at the injection site of the pneumococcal vaccine 23 polyvalent. Soreness at the site was a "2.5x3x0.1cm" area at the site of erythema. There was no relevant diagnostic lab data. It was noted that an infectious disease specialist ordered the vaccinations because the pt had been having recurrent infections and "they wanted to see what kind of antibodies she would build".  The pt recovered from the fever, erythema and soreness at the injection site. No further information is expected.
Pain in injection site...still hurts after 24 hours. Slightly dizzy within an hour  Headache within 10 hours Fatigue within 10 hours Symptoms improved after 24 hours, but still have mild headache.
Pt recvd 3 doses of Engerix-B on 26MAR90, 27APR90, & 25SEP90 & was found to be a non-responder;
Pt developed large welt around injection site on left deltoid. Raised, red, warm and painful. Continued to increase in size to 6 inches in diameter. Pt treated with ice, Benadryl and Tylenol/Aleve without relief. Gradually decreased in size, redness, and warmth over the next week or more.
sinus congestion, nasal congestion, post nasal drainage, nonproductive cough. starting 12/22/21
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 19-AUG-2015, the patient was vaccinated with GARDASIL 9 dose number 1, lot #, expiry date, dose, route unknown. The second dose was received on 19-OCT-2015, and then the third dose was received on 21-DEC-2015. The reporter stated that the third dose of GARDASIL 9 was administered earlier than recommended. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Left side of her face began to tingle; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th October 2020, less than a day after receiving Shingrix, the patient experienced tingling. On an unknown date, the outcome of the tingling was not recovered/not resolved.   The reporter considered the tingling to be related to Shingrix.   Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced tingling on left side of face. The reporter mentioned that tingling comes and goes but had not resolved.
Received the smallpox vaccine on 30Jul08. On 15Aug08, hands, wrist and knees developed a rash/papules. Patient went to clinic and referred to Derm. Dx Viral Exantham R/T smallpox vaccination.
Healthy 16yr old boy with no PMHx. Received dose #1 vaccine on 6/9/21 and dose #2 6/30/21. Developed chest pain on 7/1 relieved temporarily with Tylenol but returns when Tylenol wore off. Progressive worsening over next 2 days. Mom took pt to Urgent Care 7/3 who referred pt to ER. EKG with diffuse ST elevation, no fever, Troponin elevated at 11. Afebrile. He was transferred to our hospital and admitted to PICU 7/3. Chest pain initially improved with ibuprofen but worsened on hospital day #2 with higher troponin. Started on IVIG and solumedrol, ibuprofen changed to Toradol with good response. No pressors, otherwise hemodynamically stable.
03-25-21 First Dose. Within 15 minutes I had a headache, lasted 24 hours. Sore arm for 1 week. 04/15/21 Second Dose. Within 15 minutes I had a headache, lasted until05/07/21. Nausea, chills, low grade fever, diarrhea, pain in lower back, overall body pain and swelling, rapid heartbeat, malaise, exhaustion and easily out of breath. These symptoms would come and go over the next 4 weeks. 04/28/21, I left work early I was so sick. 04/29/21 tested negative for Covid. 05/01/21 my right eye swelled, outward pressure, painful, jelly like whites of eye and red. ER trip eye is healthy, CT scan clear (concern because I had this continual headache), prescribed allergy drops that didn't work and prednisone. Prednisone helped with my eye and overall body pain and swelling decreased, headache remained, and eye still had issues but not as bad. Eye, body inflammation and pain increased once prednisone wore off. 05/04/21 Ophthalmology exam. Eye is healthy, swelling believed to be from Covid vaccine causing system wide inflammation. Eye drops prescribed Neomycin, Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, 4 X's a day. 05/06/21 Ophthalmology exam. Eye is still healthy, headache has lessened, but other symptoms still remain. Drops increased to Every 2 hours. 05/10/21 finally able to return to work. It was hard to get through the day. I had been able to take two-to-four-hour naps when needed in addition to sleeping at night, so not being able to rest when needed is difficult. 05/11/21, much better day. Still using medication and taking Naproxen to help with inflammation and headache.
2-4-21 woke up with a red arm where injection was given but a much larger area. It itched and later that day got puffy. Today redness has gone down a lot but still have some redness and very little itching. Can I still get the second dose?
sore arm; body aches; headache; swollen lymph node; nausea; fatigue; mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (body aches), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph node) and NAUSEA (nausea) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tachycardia and Hypothyroidism.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (body aches), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph node), NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (mild fever). At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (body aches), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph node), NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (mild fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. Treatment include Tylenol