chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EL1284), on 16Jan2021 as dose 2, single (Lot number: EL4239) and on 25Apr2022 as dose 3 (booster), single (Lot number: FJ4989) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergy: Yes pain meds" (unspecified if ongoing); "Known allergy: lots of depression meds" (unspecified if ongoing); "Known allergy:all fibromyalgia meds" (unspecified if ongoing); "Known allergy: Yes pain meds, lots of depression meds and all fibromyalgia meds" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "IBS" (unspecified if ongoing); "gastritis" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; METOPROLOL; PANTOPRAZOLE; FAMOTIDINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
This spontaneous report was received from a registered nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with a dose of the improperly stored GARDASIL 9 (lot # N021475) (expiry date: 31-JAN-2020), intramuscularly for prophylaxis (dosage details were not reported) (incorrect product storage). This vaccine underwent a temperature excursion of 29 degree Fahrenheit (F) for a time frame of 168 hours. There was a previous temperature excursion of 47 degree F to 77 degree F for a time frame of 21.5 hours. No known adverse effects were reported. A data logger was involved. No product quality complaint (PQC) was involved.
Pt called stating that her site bled when she received the vaccine. Reports bruising and redness on same day of vaccine. Site is still bruised and red after 1 week. No swelling drainage or heat at the vaccination site reported.
These were the symptoms I was feeling: - Arm pain - Chills - Fever - Headache - Muscle Spasms - Rigidity - Facial Numbness - Chest Pain  Treatment: - Went to emergency room after facial numbness and chest pain. Muscles in both arms were extremely tight and no control of my fingers as it was painful to extend them beyond a fist. Could barely walk and stand for more than 20 seconds as well.  - Took tylenol and benadryl before going to hospital but had little to no effect.  - Arrived at the hospital at 9:30 with severe pain throughout my body and the effects subsided by 12:30am.
On 7/20 I developed a scratchy throat with slight congestion and a runny nose and tested positive the same day.  I reach out to my doctor on 7/20 and was prescribed Paxlovid.  I never felt really bad.  I completed the Paxlovid.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 20 March 2007 from a healthcare professional. An 11 year old male patient received on 19 March 2007 a dose of Menactra (lot number U1860AA), intra-muscular into the left deltoid and a dose of BoosTrix (lot# AC52B009BA), intra-muscular into the right deltoid. After vaccination, he experienced syncope for 30 seconds, unresponsive, pallor and weakness for 15 minutes. He was treated with 02 and recovered. The patient did not have illness at time of vaccination. Medical history and concomitant medications were not reported.
Shaking chills, joint pain, fever, and headache started later in the evening the day of the vaccine. That persisted for about 3 days. Developed a rash along around injection site.
Intense migranes. Became aphafic, unable to speak. Numbness in the arms. Seisures. Numbness in arm for a 2nd time. 3 trip to the emergency room. 2 trips to the hospital. Trips to the emergency room and one of hospitalization happened with a month (August 1 2021- August 27th 2021). After the first hospitalization, started losing sight in left eye. Has not regained sight. Went to a neurooptomologist. Second hospitalization happen after this trip to the neurooptomologist. Received steriods. Diagnosed with inflamation of the optiic nerve and autoimmune disease of MOG. 5 days of IV steriods and 5 rounds of Plasmapheorsis. Now under the care of a rhuematologist and has other clinic visit scheduled.
Had Varivax vaccine in year 2000 now broke out with chickenpox rash on back and chest 9-11-07.
Within a week (3 days) after the SHINGRIX vaccine and the flu shot (pharmacist said he could have them both together) my husband developed extreme pain running down both legs to feet with tingling and weakness, lower back pain. And stabbing pain in groin area. Could not sleep in any position. Had to walk around to feel better. Took a long walk outside in the middle of the night to try to feel better. Pain got so bad I brought my husband to ER at 4:30am because his legs felt so weak. He does not normally have any leg pain and is very active (plays hockey regularly, plays tennis and sails, walks aggressively weekly) His legs still feel painful but slowly dissipating. He does not have any neurological issues, no herniated disc or any other related problems.
Narrative:  71 ya M pt. presented to the ED on 12/17/21 with tongue swelling that had been ongoing for 2 days. Pt. received his second Shingrix vaccine on 12/15/21 (first dose administered 7/26/21 with no adverse effects). In addition to tongue swelling, pt. been having increased discomfort to tongue with eating/speaking; no difficulty swallowing or breathing. Pt. was seen in ED and treated with IV methylprednisolone, IV diphenhydramine, and IV famotidine and pt. was released home the same day.
Got both the Seasonal Flu vaccine and COVID-19 booster shot on the same day (10/31/2021) in the right and left arms respectively. Right arm was sore for a couple of hours and then got better. Left arm (COVID injection site) started feeling sore a few hours after, there was slight redness and swelling about 1/2 inch in diameter around the site the day after (11/1/2021). On 11/2/2021 swelling had increased to the size of an egg and stayed like that until 11/3/2021 until about 9:40 AM. At around 10:15AM that same day, the swelling and redness spread to the entire arm from the top of the shoulder to the elbow and has remained as such until now at 5:03PM on 11/3/2021.
I am reporting about a huge mistake they made on this vaccination site. Pt was suppose to receive his second dose of the moderna vaccine on 04/01/2021. He received the first dose of the moderna vaccine on 03/04/2021. However, they gave him the pfizer vaccine on 04/01/2021. There was a report that was supposedly made by supervisor EOA . The nurse who administered the vaccine is unknown and the admin who also failed to "catch" (according to supervisor) the mistake is another nurse. I want to know what can be done, his physician has been notified.  What is going to happen if the mix of vaccines has unreversable effects? Who's is going to be held accountable for the mistake? Thank you.
The pt developed a fever of 102F on Sunday after receiving the Flu-Shield on Saturday, 12/8/01. It is persisting despite Tylenol alternating with Motrin q 6 hours.
Local reaction 5cm x 5cm erythema/warmth/swelling/tenderness. Symptomatic treatment given.
No immediate reaction to Moderna COVID-19 Vacination 01/15/2021. Swelling, tenderness, at vaccination site started on 01/21/2021.  Increasing discomfort over few days included swelling, tenderness,and  increasing bruising / hematoma on upper arm extending past elbow.  Ultrasound of neck to wrist ordered by on Monday, 01/25/2021, revealed no venous blood clots.  Swelling, tenderness, discomfort, range of motion limitation, though somewhat less intense,  continuing through today (01/31/2021).
Low back pain in the coxxic area. Pain when walking, sit to stand, stand to sit, for 3 weeks. No Hx of any back pain or injury.
started out as extreme chills with lower back soreness and headache, then went to a fever of 102 degrees with a severe headache severe fatigue for twenty four hours
stroke on 3/8/2021. 2nd dose was 1/4/2021
It started with an itch rash under my armpit. I then spread to under my breast. It was extremely itchy. I went to a doctor who had no idea what it was. I was prescribed prednisone and topical cream. They did food sensitivity test. The cream and steroid didn?t work. I went to another doctor where I was given a double dose of steroids and another cream. I went to an allergist who eliminated allergies. He then said it might be eczema which I have never had in my life. I am now using store bought lotion and taking oatmeal baths. I am still itching, and it has spread all over my body.
After taking the 2nd dose, I had a sore arm and was very tired. The day of the adverse event, I was shaky. My heart rate and blood pressure was high. I went to the ER. I took multiple tests and was given medication. I spent the night at the hospital. By the morning, my heart rate & pulse was back to a normal rhythm. I am still taking medication.
Hives on knees, upper thighs, ankles, lower calves, elbows and arms. Noticed on ankles around 3 PM and slowly spread to other areas. Applied cortisone and took a BENADRYL.
Information has been received from a physician's assistant concerning a 29 year old female who in May2003 was vaccinated with the first dose of varicella virus vaccine live. It was noted that the pt did not receive the second dose of varicella virus vaccine live. The PA reported that in 2003 the pt had a negative varicella titer. Unspecified medical attention was sought. Additional information has been requested.
This case was reported by a consumer and described the occurrence of local swelling in a female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced local swelling, localized erythema, skin warm and skin induration. On an unknown date, the outcome of the local swelling, localized erythema, skin warm and skin induration were unknown. It was unknown if the reporter considered the local swelling, localized erythema, skin warm and skin induration to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. On Tuesday afternoon the patient received SHINGRIX and experienced a lot of redness, warmth, and swelling below the injection. It was kind of hard also. About the size of a pancake. The patient has been putting ice on it but it has not gone down. The patient asked that how long can she expect the swelling and warmth to last. It has been almost 3 days.
supposed to administer Pentacel- gave the DTAP and IPV but didn't reconstitute with the HIB powder/ was given only the diluent portion of the Pentacel vaccine with no reported adverse event; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from an other health professional via a consumer via phone call (under Medical Information (MI) Inquiry Number: 00864370).  This case involves a 2 years old male patient who was supposed to administer DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] he was given the dtap and ipv but didn't reconstitute it with the hib powder and was given only the diluent portion of the pentacel vaccine with no reported adverse event (product preparation issue).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On 02-Nov-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: UJ474888 and expiry date: 18-Jul-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "What are the next steps for handling?"  It was case of an actual medication error due to inappropriate reconstitution technique (latency was on same day).   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received vaccine on 5/9/19. She arrived at office on 5/14/19, reporting allergy to vaccine. (L) arm red rash, warm, lump hard to touch. Patient reports fever on 5/10/19. Applied cool compress and APAP w/no relief. PCP (Dr.) evaluated patient. Advised to take Benadryl and call office back in 3days.
This spontaneous report was received from healthcare worker refers to an unspecified number of patients of unkonwn age and gender. On an unknown date the patients were vaccinated with VAQTA (dose, lot # and route were not reported), after being stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to the reporter did not want to be contacted again.
16 year old was given 2 doses of Moderna Vaccine. First on 4/20/21 and the second on 5/18/21. No reaction reported or noted.
Moderna COVID-19 Vaccine EUA Fatigue, Muscle Pain, Chills, Joint Pain, Nausea x 24hrs. Headache x 3 days Pain at injection site x 4 days
Four separate bouts of hiccuping, all lasting about an hour, unprompted and inconsolable. Nothing serious, but very odd.
drew from the vile, it was an bivalent vile instead of a primary series vile same color
Bone aches, both legs, mid-thigh to mid-shin. Felt like growing pains when I was a teen. Was not joint or muscular.  Abated with ibuprofen.
01/29/2022 two days after my vaccine I began to experience a large swollen lymph node swelling in my right armpit. Came with redness from armpit to breast, 9 out of 10 on pain scale. I also had a fever until the 2nd of February of 102 degrees. lasting about four days long. Ibuprofen did not take away the pain. Extreme muscle and joint pain, chills, headache.  It took about four days for it to go down, and as of today one week post symptoms swelling and redness have gone away including pain and tenderness.
Had 2 series of the Covid vaccine. I was fine, no symptoms, no whole body pain. Received the 3 shot which is known as the booster January 3, 2022. Found out after being tested at work same day, positive with Covid. Next month, February 2022, I noticed my menstrual cycle has moved from being 28 days to now 23 days. I also experienced heavy bleeding and large blood clots. I also experienced bleeding around the clock, as prior, would not bleed throughout the night, usually stop around 12 midnight and picks back up close to 6 AM.
This spontaneous report as received from a medical assistant refers to a 70 year old male patient with allergic to oxycodone. On 01-AUG-2013 the patient was vaccinated with PNEUMOVAX23 (lot number, route and injection site were not reported) (0.5 ml). Concomitant therapies included EXFORGE, ZYRTEC. The patient experienced ad adverse reaction after receiving PNEUMOVAX23 on 01-AUG-2013. This patient reported that on 01-AUG-2013 a short unspecified amount of time after receiving PNEUMOVAX23 he began to feel fatigue, experienced a headache and noticed that the unspecified injection site was tender to touch, red and warm, had some swelling and was painful. The patient called his unspecified physician on an unspecified date for medical attention to report these symptoms and his physician recommended the use of ice to the injection site and to administer an unspecified amount of TYLENOL to manage the symptoms. There was no treatment given for adverse events and no lab diagnostics studies performed at the time of report. The outcome was reported as not recovered/resolved. Additional information has been requested.
72 yo F with cardiac history presented with nausea after vaccine administered. No vomiting. Endorsed skipping dose of Lasix today because she did not want to have to urinate so frequently at vaccination site today. Denies any chest pain, states she had chronic SOB, which is her baseline, no changes. NO additional symptoms. HR 70, BP 115/65, 96% on RA. Symptoms resolved spontaneously. DIscharged home after 30 minute obs, but advised to go ER should symptoms recur and/or worsen.
Pt complained of diarrhea, fever to 101, soreness, quarter size lump, redness 5x5inch, nausea 1 day after all other symptoms 4 days after shot.
Developed severe fatigue for 3.5 weeks after second vaccine dose. Around the same time, I was diagnosed with right elbow tendinitis and placed on meloxicam for approximately 1 month. Beginning in June, I began to experience progressive dyspnea on exertion, to the point that I could not perform my usual workout. Also experienced substernal chest tightness and eventually went to the the ER for further evaluation. CT angiogram of the chest obtained on 7/3/2021 showed segmental and subsegmental bilateral acute pulmonary emboli. No lung or pathologically enlarged lymph nodes were seen.
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 9/18/2021 ABNL ALPHA FETOPROTEIN G47.33 OBSTRUCTIVE SLEEP APNEA 9/18/2021 ABNL ALPHA FETOPROTEIN I95.9 HYPOTENSION 8/18/2021 ABNL ALPHA FETOPROTEIN J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/18/2021 ABNL ALPHA FETOPROTEIN D68.9 COAGULOPATHY, UNSPECIFIED TYPE 9/18/2021 DM 2 W RENAL MANIFESTATION G47.33 OBSTRUCTIVE SLEEP APNEA 9/18/2021 DM 2 W RENAL MANIFESTATION I95.9 HYPOTENSION 8/18/2021 DM 2 W RENAL MANIFESTATION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/18/2021 DM 2 W RENAL MANIFESTATION D68.9 COAGULOPATHY, UNSPECIFIED TYPE 9/18/2021 SEPTIC SHOCK G47.33 OBSTRUCTIVE SLEEP APNEA 9/18/2021 SEPTIC SHOCK I95.9 HYPOTENSION 8/18/2021 SEPTIC SHOCK J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/18/2021 SEPTIC SHOCK D68.9 COAGULOPATHY, UNSPECIFIED TYPE 9/18/2021 DM 2 W RENAL MANIFESTATION G47.33 OBSTRUCTIVE SLEEP APNEA 9/18/2021 DM 2 W RENAL MANIFESTATION I95.9 HYPOTENSION 8/18/2021 DM 2 W RENAL MANIFESTATION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/18/2021 DM 2 W RENAL MANIFESTATION
Off-label use; Booster; after the 3rd dose I experienced chills; joint pain; very sore soles of my feet - felt like burning - I couldn't walk; very sore soles of my feet - felt like burning - I couldn't walk; This is a spontaneous report from a contactable consumer (Patient).  A 69-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 301558A ), dose 3 via an unspecified route of administration, administered in Arm Left on 06Oct2021 at 09:15 (Age at vaccination: 69 years old) as DOSE 3 (BOOSTER), SINGLE for covid-19 im-munisation at pharmacy or drug store . Medical history included blood cholesterol increased, atrial fibrillation. Concomitant medications included Lovastatin 20 mg; Metoprolol 50 mg; aspirin [acetylsalicylic acid] 81 mg . Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 on 22Feb2021, Batch/Lot No: EN6200, Location of injection: Arm Left Vaccine, Administration Time: 10:00 AM for covid-19 immunisation. Historical vaccine included bnt162b2 (COMIRNATY) as dose 2 on 16Mar2021, lot number: EN6208, Location of injection: Arm Left Vaccine Administration Time: 01:00 PM for covid-19 immunisation. It was stated that "After the 2nd dose I experienced waves of discomfort just below my rib cage and above my belly button for 4 days along with chills and joint pain on 16Mar2021 at 22:00". after the 1st dose she just felt a headache and joint pain. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported "after the 3rd dose i experienced chills, joint pain, very sore soles of my feet - felt like burning - i couldn't walk in Oct2021, off-label use and booster on 06Oct2021 at 09:15. Adverse events resulted in doctor's office visit. Since the vaccination the patient was not tested for COVID-19.No treatment was recived for the events. The outcome of the events was recovered in Oct2021.  Follow-up attempts are completed. No further information is expected.
COVID BREAKTHROUGH CASE. I felt unwell on Thursday May 19th and I tested and I was negative. My husband was diagnosed on May 16 so I kept testing to ensure I was still negative. Fever the night before, Congestion, Sore throat, Very tired/rundown, Some nausea. These symptoms weren't 100% constant they would come and go from time to time. My first positive test was May 21st. I went to urgent care and tested positive.
This spontaneous report as received from a Licensed vocational nurse refers to a patient of unknown age and gender. On 20-APR-2016, the patient was vaccinated with an improperly stored dose of VAQTA (lot # M003011 exp date 15-NOV-2017) (dose and route not reported). The vaccine's temperature excursion was 47.5 degrees F for 30 minutes. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
soreness in lt upper arm p/vax, swelling in area didn't go down; 1 wk later still sore w/a knot; Today has 1 1/2 cm nodule lt deltoid (hematoma);
1 of 9 pts immunized from same lot# 366949; not the same vial; who exp induration & poss erythematous nodule approx 2 inches in diameter @ the inj site; nodule persisted 6-8 wks;
was given her dose of the Moderna Covid-19 Vaccine subcutaneously; has an extravasation bubble at the injection site; her right arm is still aching; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE EXTRAVASATION (has an extravasation bubble at the injection site), VACCINATION SITE PAIN (her right arm is still aching) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was given her dose of the Moderna Covid-19 Vaccine subcutaneously) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (1st two primary doses (Second dose)), Pfizer COVID-19 vaccine (1st two primary doses (First dose)) and Pfizer COVID-19 vaccine (1st booster dose). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. In April 2022, the patient experienced VACCINATION SITE EXTRAVASATION (has an extravasation bubble at the injection site) and VACCINATION SITE PAIN (her right arm is still aching). On 22-Apr-2022, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was given her dose of the Moderna Covid-19 Vaccine subcutaneously). At the time of the report, VACCINATION SITE EXTRAVASATION (has an extravasation bubble at the injection site) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was given her dose of the Moderna Covid-19 Vaccine subcutaneously) outcome was unknown and VACCINATION SITE PAIN (her right arm is still aching) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-549000 (Patient Link).