chrisvoncsefalvay/vaers-outcomes huggingface dataset:
J and J vaccine: 40 min. after shot, my lower lip began to tingle, then went numb, next my upper lip, next nose felt funny. chest felt tight, no wheezing. Was still at Clinic so I went to Urgent care. I used my albuterol inhaler, chest tightness resolved. Treated in UC with solumedrol, famoditine, 1 liter NaCl. My allergist had me on 2 Zytec, and 2 famoditine the day of shot. Went to urgent care 7/5 for neuropathy. Saw neurologist on 7/8/21. Today is 12 days after the vaccination. My peripheral neuropathy is so bad I can't work. I have constant pain in my shoulder girdle, lower back thighs, calves, feet, hands, and visceral. My PCP won't give my any pain meds, my pain is 8/10.
she had covid vaccine and about a wk later developed RLE DVT, this was at outside heme office and i don't have records and was given anticoagulation for 3 mos w/ improvement, but LE DVT was related to covid shot
Pt. administered influenza high dose at 10:42 12/23/15 and at 4 pm c/o cough, sore throat x 3 hrs, joint pains at neck, knot in stomach (left) x 10 hrs and felt like vomiting, decreased appetite, chills, slight headache. pt says her headaches and neck pain are better now. (Pt denies fever, no diarrhea, no chest pain, no swelling of hips, tongue or throat, no shortness of breath). Offered appointment and pt declined. Discussed urgent care of ER if symptoms or worsen or fail to improve.
I started having itching near the injection site the evening of the shot. The itching has never stopped and it has been 3 weeks. It feels like I have a mosquito bite at the site of the injection but there is no raised bump or redness.
Client denied having had a previous dose of COVID19 Vaccine and was given a dose of J&J. Upon documenting in ALERT, the agency discovered the client did receive a previous dose on 4/2/2021. Previous dose confirmed with vaccinator.   There was no indication of adverse reaction. This is an error report only.
welts on their legs and back and not near the site of injection; This is a spontaneous report from a contactable pharmacist.  A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular route, administered in Deltoid Left on 18Jun2021 (Batch/Lot Number: EW0180; Expiration Date: 31Aug2021) as DOSE 1, SINGLE for covid-19 immunisation; diphenhydramine hydrochloride (BENADRYL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. Pharmacist stated, we are administering the Pfizer COVID Vaccine. One of the patients reported an adverse reaction to the vaccine that we haven't typically seen or have seen as few of the ones we reported. So, reporter just was trying to get more information and see what the correct method of, you know administering the next dose could be. Upon follow-up (29Jun2021) was reported that, the patient received their first dose 11 days ago on 18Jun2021, 3 days after receiving the vaccination (on 21Jun2021), they started forming a 'welt' on both their legs and back, not near the administration site. They have taken over the counter Benadryl in order to try to subdue that just in case there is anything and it looked it helped some, but new welts are still forming even today, 11 days afterwards. And she was concerned about getting her second dose. Therapeutic measures were taken as a result of welts on their legs and back and not near the site of injection. Clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Urticaria cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Rash developed just before midnight - it grew quickly prompting a trip to the ER...after she was released she was very uncomfortable at home (itchiness) some neck pain, fear...took her back to ER the next day, they did nothing other than give her another dose of Benadryl...I took her to an urgent care facility on the 16th also.
Headache, Myalgia, Fever, CHILLS, LOW GRADE FEVER, BURNING DRY EYES, SORE THROAT, BODY ACHES Narrative:
Pregnancy; headache; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of HEADACHE (headache) and EXPOSURE DURING PREGNANCY (Pregnancy) in a 42-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination.     There was no medical history reported by the reporter.  Concurrent medical conditions included Type 1 diabetes mellitus and Hashimoto's disease. Concomitant products included INSULIN ASPART (NOVOLOG) for Diabetes, LEVOTHYROXINE for Hashimoto's disease, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Jul-2020 and the estimated date of delivery was 07-Apr-2021. On 07-Mar-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy. The delivery occurred  on 15-Mar-2021.  The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 11-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.            The reporter reported that there had not been any complications or acute illnesses during this pregnancy to date  The patient did not had a family history of congenital anomalies/genetic disease.  The reporter reported that the patient did not use alcohol, nicotine, marijuana or any other illicit substance in past or present.
Pain, itching, and redness of left upper arm; numbness of entire arm.  Improved with Benadryl 25 mg and Triamcinolone 0.01% cream.  2 days later (6/13/21) developed redness with itching and burning of the entire left breast, upper mid chest and throat.  Resolved 6/17/21 after adding Prednisone to Benadryl 25 mg and Triamcinolone cream.
Local, redness, erythema, whelps. Systemic: fever, myalgia.
Gynecomastia unilateral within a week after Gardasil vaccination. Resolved over two months
This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced swelling which lasted for 14 days. The patient asked if this was a normal reaction and mentioned that she was afraid to get the second shot.
I am experiencing changes in my menstrual cycle. I am having break through bleeding. I am not on birth control and my cycles are always regular. This is extremely unusual and the only connection I can see is with the vaccine.
My menstrual cycle has become longer, extremely heavy and gave me symptoms of anemia during my heaviest flow days. My cycle has always lasted 5 days with a medium flow since 12 years old. My first cycle after getting the first dose of the vaccine is currently at 9 days and has not stopped yet.
red line at nail bed of 4th finger (left). macular rash/erythema to left arm and left leg (only lasted 45 min, warm to touch, occurred 2 days in a row. not appreciated at time of visit), left shoulder/arm/neck/trap pain (also has a torn left labrum). HA 2 days post vaccine (resolved)
pt recv vax 30JUL96 & 22AUG96 pt devel lesions, rash & fever;
Arm a bit sore; Armpit starting to get very hard; pain getting worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm a bit sore), INDURATION (Armpit starting to get very hard) and PAIN (pain getting worse) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm a bit sore), INDURATION (Armpit starting to get very hard) and PAIN (pain getting worse). At the time of the report, PAIN IN EXTREMITY (Arm a bit sore), INDURATION (Armpit starting to get very hard) and PAIN (pain getting worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
On 8/24/21, patient called reporting side effects to Pfizer covid shot received on Saturday 8/21/21. On Sunday 8/22/21, she said she had pain behind her ears, earache, pain behind her eyes, and pain at base of skull. She was informed to call and speak to her primary care provider.
Shingles R eye x 3 months.  Blurred vision, R side facial neuralgias, head ache, fatigue.  Treatment: Valcyclovir 3 x day for 1 month,  Valcyclovir 2x day for adding month, Valcyclovir daily indefinitely.  Erythromycin eye ointment, Eye drops, Amiltryptiline  50 mg qhs
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 17-DEC-2013, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 23-JAN-2015, the patient was treated in a clinic 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.
Vaccinated on 4/14/21 & tested positive for COVID-19 on 8/30/21
vomiting; sweating; clammy; looked like she was having difficulty breathing/grab her throat; This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number XC972, expiry date 29th August 2021) for prophylaxis.   The patient's past medical history included headache (patient complained of a headache prior to the vaccination and it was hot outside to).   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2019, 4 min after receiving Shingrix, the patient experienced vomiting, sweating, clamminess and difficulty breathing. On an unknown date, the outcome of the vomiting, sweating, clamminess and difficulty breathing were recovered/resolved.   It was unknown if the reporter considered the vomiting, sweating, clamminess and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The pharmacist vaccinated a patient and 4-5 minutes later, the patient started to vomit. She was sweating, clammy and started to grab her throat which looked like she was having difficulty breathing. The pharmacist at the time of reporting believes that her response was due to the acid from the vomit.  The Pharmacist followed up with the patient the following day and the patient felt fine and her symptoms were resolved. The patient complained of a headache prior to the vaccination and it was hot outside too.  The reporter consented to follow up and can follow-up with the Pharmacist directly.
Swollen neck area now about 5 cm diameter. Has increased over time. Back of neck - starts at base of skull just under hairline. Tender to touch.  Limits mobility range (hard to turn head,  tilt forward and back). Started with small  1m area Sunday night on 2/28 and has continued to grow. No fever. No pain anywhere else on body
Inadvertently received a third dose of Shingrix; Wrong vaccine administered; Skin hurting; Low grade fever; Headache; All over body aches; This case was reported by a consumer via call center representative and described the occurrence of pain of skin in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose on 1st July 2019, refer case US2019189772). Concomitant products included Herpes zoster (Shingrix).   On 17th October 2019, the patient received the 3rd dose of Shingrix and PNEUMONIA VACCINE. In October 2019, less than a week after receiving Shingrix and less than a month after receiving Shingrix, the patient experienced pain of skin, fever, headache and general body pain. On 17th October 2019, the patient experienced extra dose administered and wrong vaccine administered. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain of skin, fever, headache, general body pain, extra dose administered and wrong vaccine administered were unknown.   It was unknown if the reporter considered the pain of skin, fever, headache and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix intramuscular and she also inadvertently received 3rd dose of Shingrix but was supposed to just be getting a pnuemonia vaccine. She did get the pneumonia vaccine in addition to the third Shingrix, which led to extra dose administered. She noted she was experiencing her skin hurting, low grade fever, headache and all over body aches. She noted she was taking Ibuprofen. She has not notified her physician.  The reporter did not consent to follow up. This case linked with US2019190597, reported by same reporter.
Approximately 1 inch red, raised, itching area developed on left arm after immunization injection. No fever noted. No medical treatment administered.
pt inadvertently splashed flu vax in eye & exp a burning sensation;pt eye was flushed w/cool water & sx subsided;
Immediate sore arm, shortly there after some swelling and redness. 20 hours later chills, fatigue and fever of 102 degrees. Took pain reliever and fever reducer, and within 6 hours fever and chills were gone.  Fatigues subsided shortly there after. Soreness of arm and swelling gravited 6? below injection site and lasted  5 days.
redness reappeared; redness below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness reappeared) and VACCINATION SITE ERYTHEMA (redness below the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) 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) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness below the injection site). On 23-Mar-2021, the patient experienced ERYTHEMA (redness reappeared). On 16-Mar-2021, VACCINATION SITE ERYTHEMA (redness below the injection site) had resolved. At the time of the report, ERYTHEMA (redness reappeared) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and Concomitant medicines were not reported   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up received on 17-MAY-2021: Reporter details updated
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT, RASH, VACCINATION SITE PAIN, VACCINATION SITE PAIN and VACCINATION SITE RASH in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE PAIN. On 23-May-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT, RASH, VACCINATION SITE PAIN, and VACCINATION SITE RASH. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT, RASH, VACCINATION SITE PAIN, VACCINATION SITE PAIN and VACCINATION SITE RASH outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-370196 (Patient Link).
Horrible flu like symptoms, chills, vomiting, diarrhea, dehydration.
first night very high fever, headache, chill, body ache, sweating, no appetite. however specifically the pain was very intense in the lower back and sides almost like back labor and some lower abdominal and with nausea . then next morning the back pain was the same and still nauseous from pain and noticed a full on rash all over chest neck, back and stomach. called my doctor and they asked to go in and check with blood test and Urine sample.  most items were normal on the test except blood in urine and low white blood cell counts which I have to follow up with a second test a week later bec my doctor want to make sure it is not due to vaccine. not sure if these are related. rash is still on , went down a little but not complete with Claritin however it looks like it has come back at the night time. and that is up to now so will see the rest later.  ( very healthy normally , no issue before getting the vaccine ) also want to here mention first dose gave me horrible anxiety and depression and paranoia for few days starting few days after which I was told was due to hormone imbalance.
Patient was given the 0.4% sodium chloride 0.5 ml diluent only. It had not been reconstituted with the Hib vaccine. There are no apparent problems at the injection site at patient will receive Hib vaccine at a future visit. The box was full of 5 vials of diluent and 5 vials of vaccine, but the vaccine literature was laying on top of the vials so that only the diluent was showing. Literature has been moved and staff has reviewed the incident together.
It began with a back arching, high pitch scream, severe vomiting, inablility to breastfeed, high fever and unresponsiveness. After a visit to the ER after severe vomiting, we were told "virus" and "coincidence" and sent home with Tylenol.
Redness at the injection site and distally. There is also a knot at the injection site. (L) deltoid.
Extreme fatigue, muscle soreness, joint pain that persists as of today 6/11/2021
I started having diarrhea on June 6. I had diarrhea since getting the vaccine but at the same time my husband became ill so I tested myself. I had no energy, diarrhea, loss of appetite and nausea. I started feeling like I was freezing and I had a headache. My temperature was fluctuating between 95 and 100 degrees. My oxygen level dropped to the 85% range. My pulse rate would drop causing my heart rate to go into the 40's. My blood pressure stayed low for at least 2 weeks. During the 1st weak my pulse dropped so low that I became lethargic. I made sure I stayed sitting upright due to congestion and pain in my forehead, I also used my inhalers and Mucinex to ward off the congestion. I took cough drops for my sore throat. I had someone around the entire time just in case my pulse went down to low. I used the medication in Primatene mist to raise my blood pressure and pulse levels. I took additional Benadryl for the hives and breakouts that started. I treated the fever with bags of ice while under a heating blanket. I had to use an EpiPen at one point due to a severe asthma attack I suffered during the first week of this process. I experienced a loss of smell and taste also. During this time, all the test came  back negative but after advising my doctor what I experienced, they indicated that it was breakthrough case of COVID. I still have the cough and the tiredness along with brain fog currently. Its been a very slow recovery.
URI symptoms subsequent to each vaccination (Anthrax) worsening (#1-#3). No fever, no chills. Increased localized swelling.
administration of 1-adult dose of Havrix followed by 1-pediatric dose of Havrix; Adult use of child product; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 56-year-old patient who received HAV (Havrix 720) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 adult (1st dose received on 4th November 2020).   On 11th May 2021, the patient received the 2nd dose of Havrix 720 and Havrix Pre-Filled Syringe Device. On 11th May 2021, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated, the administration of 1 adult dose of Havrix followed by 1 pediatric dose of Havrix with patient, which led to underdose and adult use of a child product. The reporter did not consent to follow up. This case was linked with case US2021152082, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152082:Same reporter