chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US025115, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 17-year-old male patient. Historical conditional were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at  a dose of 0.5 ml on 24 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following the maladministration (incorrect storage of drug).
Chills, fever, vomiting, nausea, severe body aches and severe headache
Terrible arm pain/bruising the first couple of days; could not lift arm past chest; could not lift any weighted objects.  Took ibuprofen for pain. Gained back mobility in arm, and swelling/bruising decreased after about 3 days. Over the course of the past year, shoulder pain flares up frequently (daily/every other day).  Seems to be getting worse over time.  Pain (sharp/throbbing) is present even with little activity: laying in bed, sitting at desk/computer. Applying pressure on the injection site yields a bruising pain as well. Frequently taking ibuprofen and Aleve for pain, as well as applying menthol creams/sticks.
Last injection Jan. 28th. On March 15 I started with sore throat and my husband seemed to have head cold. On Tues. his job told him to get a COVID test. He went in Wed. and the rapid test was positive.  I went down hill.  I had headache, chills, sore all over, sore throat, coughing, shortness of breath, sore tongue, diarrhea, didn't have fever.  Was up Thursday night because of shortness of breath. Called Doctors office and was told to go to walk in clinic and someone would come out and get me.  Was seen by PA I think. Not a doctor. They only did a rapid test and it was negative. She didn't do the second test and send it off. I have found two people who had the rapid rest and results were negative that the results s Results sent in from second test came back positive. She prescribed Prednisone  which helped.  I was sick for over two weeks and still struggling with fatigue, aching , sore throat and shortness of breath.
This spontaneous report was received from a medical assistance regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated improperly stored with GARDASIL 9 lot # L020015, expiration date-16-AUG-2017. No adverse event was reported. The outcome of the event was unknown. Temperature was 28 F, time frame 185 hours. Yes it was administered and no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Severe pain, tenderness and swelling in L axillary, Ibuprofen, Tylenol and warm compress to site effected
Patient is approximately 17years old and 10 months. Calculated year for age 18 years for the FlubloK age 18 and older.
pt recv vax & drove 4-5 blocks as passenger, started to c/o stomach pain, nausea, unable to see;mom drove 2 more blocks then pts eyes rolled back into head, slumped over & totally unresponsive, then body stiffened & started shaking like sz
Flush/warm face followed by dry mouth/tongue and then shakes/jitters. Flush went away but dry mouth/tongue and shakes/jitters continued. The monitoring staff kept me under observation for 1.5 hours, and then I left after symptoms mostly subsided. I've never had any adverse reaction to a vaccine or other medication ... although I tend to be medication sensitive so I avoid it if possible. My only allergies are seasonal/pollen (outdoor) and some indoor (mold, etc.) What was my reaction? Can I take the 2nd dose or not?
10 minutes after receiving Flu vaccine and while parents were currently getting their flu vaccines client had a vasovagal syncope episode. Client was held in father's arms when occurred. Laid down on exam table and lower extremities raised. Ammonia Pearl inhalant used. Feet elevated. Cold compress to back of neck. Apical strong. Breathing stable. Non verbal. BP 84/60. Responded  and juice and crackers given. Father refused blood sugar test. Called Dr. to report incident. Walked out independently.
06-02-21 Started with itching and small area of swelling 5 hours after vaccine.  06-03-21 Redness and swelling increase along with pain in right arm with movement. 06-04-21 Seen in clinic with 11.5cm x 11.5cm area of redness, swelling and warm to touch right arm at injection site.  Treated with Benadryl, cool compresses and Augmentin. 06-09-21 Mom states no more redness or swelling.
Sever rash at injection site almost 8 days later; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Sever rash at injection site almost 8 days later) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE RASH (Sever rash at injection site almost 8 days later). At the time of the report, VACCINATION SITE RASH (Sever rash at injection site almost 8 days later) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided. No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Pain at the injection site shortly after the injection. Pain and tenderness in bicep began generally later the first day and lasted 2 weeks; I still have some bicep stiffness and tenderness today on Day 18. I had tenderness under the right armpit for about a week (assumed swollen lymph nodes).I had redness on the bicep below the injection site on Days 5-7. I also was tired on Day 2, 3, and 16 and took short naps. I experienced some muscle twitching in the bicep on Day 1, which still continues. On Day 6, I woke up with muscle twitching all over my body, randomly and intermittently. I was able to go about my day normally, but every few minutes something would twitch for a few seconds (my right arm, my left arm, my left knee, my right hip, my lower back, my left pointer finger, my left eyebrow, my diaphragm, etc). I drank a lot of fluids and took magnesium, zinc, D, B, C, omegas, turmeric, a multivitamin, and ate a banana for potassium on Day 6 and 7. Day 7 and 8, I only had muscle twitching in the right bicep again. Starting on Day 9 and continuing through the present, I continue to have intermittent twitches lasting a few seconds all over my body again. It is less frequent than on Day 6, but continues.
very very sick; uncontrollable shaking; very very weak; cough not bad; low grade fever; vomiting; lymph node under the left arm is the size of a soft ball; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (very very sick), TREMOR (uncontrollable shaking), ASTHENIA (very very weak), COUGH (cough not bad) and PYREXIA (low grade fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 013L20A and 066M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced MALAISE (very very sick), TREMOR (uncontrollable shaking), ASTHENIA (very very weak), COUGH (cough not bad), PYREXIA (low grade fever), VOMITING (vomiting), LYMPHADENOPATHY (lymph node under the left arm is the size of a soft ball) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MALAISE (very very sick), TREMOR (uncontrollable shaking), ASTHENIA (very very weak), COUGH (cough not bad), PYREXIA (low grade fever), VOMITING (vomiting), LYMPHADENOPATHY (lymph node under the left arm is the size of a soft ball) and HEADACHE (headache) had not resolved.            No concomitant medication details was reported. She Started off with tylenol for the first two days and called the pharmacist and told her to put ice packs on it and to took Advil.
w/in 4hrs of vax 24MAY96 pt became real fussy devel temp which lasted x 3 days levels to 103;APAP given q 4hr;
It was reported that a 50 year old female pt, a few hours post vax, complained of thick tongue sensation (left side of tongue), no numbness. The pt was not evaluated by a MD. From additional information received on 10/30/1998, it was reported that the pt improved in 24 hours and fully recovered within 4 days.
Initial misuse report received from a healthcare professional on 29 April 2013. A child received partial dose of DAPTACEL since part of vaccine leaked from around needle and plastic syringe durign administration. No adverse event was reported. List of documents held by sender: none.
Her husband called to report that he could not arouse her on 3-28-21. Advised to call 911.
The patient received dose from vial beyond 30-day use by date.; The patient received dose from vial beyond 30-day use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
immediately after vaccine pt states feeling sweaty, spots in vision, muffled hearing,  brought to OBS via wheelchair by reaction nurse. given water and transferred self to stretcher, placed in tredelenburg, vs monitored as noted. pt feeling better once laying down, pt slowly positioned to sitting up to dangle and then to standing. feeling better with position changes pt states normally has lower BP   no further symtpoms. ok to discharge home  pt ambulated to exit at 0935 vs 0913 bp 97/60 hr 73 rr 18 o2 96, 0919 bp 109/65 hr 77 rr 18 o2 98, 0924 bp 108/76 hr 91, rr 18 o2 97 low fowlers,  0926 bp 98/64 hr 92 rr 18 o2 98 dangle 0932 bp 110/64 hr 86 rr 18 o2 98  0933 bp 111/72 hr 92 rr 20 o2 98 standing
This is a spontaneous report from the non-clinical study program from a contactable consumer (patient). A 80 year old female patient received, in the right upper arm, on an unspecified date, in Aug2015, PREVNAR 13 single dose. Relevant medical history included allergy (she is allergic to all statins, sulfa and clove oil, ongoing) and breast cancer (the patient received tamoxifen for 5 years and also radiation; breast surgery was performed). Colon surgery was performed on an unspecified date, in 2002 (18 inches of lower colon removed because of precancerous polyps), gallbladder surgery (gallstones were removed) on an unspecified date and hysterectomy on an unspecified date, in 1970. She is a cancer survivor. The patient previously took sulfur and experienced drug hypersensitivity. Concomitant medications included THYROLAR 0.115 (units unspecified) every day for thyroid disorder, ongoing, and oral Aspirin ongoing. On an unspecified date, in Aug2015, the patient experienced pain in extremity. On an unspecified date, in Sep2015, the patient experienced sleep difficult, petechiae, memory disturbance and pain aggravated. On an unspecified date, in Oct2015, the patient experienced atrial fibrillation, potassium decreased, light headedness, and nausea. She never had diagnosis of heart problems before. She was not admitted to the hospital. Activities of daily living impaired (it was difficult for her to get up and down off toilet) on an unspecified date in Nov2015. On an unspecified date, she experienced also joint pain, malaise and movement disorder and she was very tired from lack of sleep. Emergency room or doctor visit was required. Treatment was received for the event atrial fibrillation (metoprolol), and pain (ibuprofen). She saw a cardiologist. She will get monitored every 6 months. The patient recovered from the events, atrial fibrillation, and potassium decreased. She did not recover from the events, pain in extremity, sleep difficult, petechiae, memory disturbance, pain aggravated, and activities of daily living impaired; while clinical outcome of the other events was unknown. Follow-up (11Jan2016): New information reported from the same contactable consumer includes: patient details, medical history, suspect drug (changed from "PREVNAR" to "PREVNAR 13") and concomitant medications details, reaction data, case seriousness changed from "non-serious" to "serious".
Information has been received from a physician concerning a 36 month old male with no medical history or allergies who on 03/06/2003 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live.  There was no concomitant medication.  On 02/23/2005 the patient experienced breakthrough varicella with 8 lesions and no fever.  The patient recovered in February 2005.  No laboratory tests were done.  Unspecified medical attention was sought.  No product quality complaint was involved.  No additional information is expected.
Rash at injection site within 12 hours of administration. Non Pruritic. 1-2 mm papular skin cover to numerous to count right deltoid, shoulder, right side face.
had both shingles vaccinations, still gotten very mild cases; shingles, very mild cases; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had both shingles vaccinations and still gotten very mild case of shingles. The patient stated he/she received the anti-viral as soon as had any signs of getting shingles again. The patient stated he/she could not imagine how awful a full-blown case. The follow-up would not possible as no contact details were available. The question was asked had physician not given the antiviral? Valacyclovir was what should be taking and using the cream. It would help a lot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Severe menstrual cramps, bleeding between period, and most recently extremely heavy bleeding during menstruation.
Four days post vaccination, pt. broke out with whole body hives. Pt. was given an antihistamine per parent (M.D.) and some relief resulted, however, within seven days post vaccination, hives returned. Pt. hx includes allergies to cats, dogs, pollens. No historical rx to prior vaccinations.
5 minutes after Hep A And Varivax, Patient developed infra orbital edema, discoloration, and acute wheezing, with O2 sat 88%. Child given nebuliZed albuterol (2.5 mg x 2), SQ epi, nebulized pulmicort (.5mg) and po Zyrtec. Child had gradual improvement with decreased wheezing and rise in O2 sat to 96%. Child transported to local hospital by ground EMS for further care.
5ml syringes that had been provided were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/21/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
8 days later pt exp a peripheral ulnar neuropathy on lt side;also exp distal polyneuritis worse on lt side than on rt side;fasiculations @ rt orbiculans persist;intermittent sensory problem mainly lt ulnar;weakness;atrophy;
I haven't slept in days; I had headache so badly that my right eye which is to the opposite side to where I got the shot/ like whenever I take a step to walk it's feels like my head is going to explode; really bad back ache; My face and my back started getting like hot, like heat, like very hot reaction/like radiating heat in my back it is like surrounding my spine, its right in the middle of my back; It feels like heat and pressure around my spine area; high pressure behind the right eye; My arm started hurting; the arm I got the shot in; This is a spontaneous report received from a non-contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733), intramuscular (reported as in the muscle) in left arm on 01Apr2021 (at the age of 43-year-old) at 0.3 ml, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that initially, right afterward she meant her arm started hurting which was normal the arm she got the shot in, she wasn't worried about that. But then her face and her back started getting like hot, like heat, like very hot reaction. She did not know how to describe it, it was like radiating heat in her back it was like surrounding her spine, it was right in the middle of her back. It felt like heat and pressure around her spine area. And in her head, it had not lit up. She had headache so badly that her right eye which was to the opposite side to where she got the shot. She had very high pressure behind the right eye. It was literally like whenever she took a step to walk it was felt like her head was going to explode. It was for her a headache and really bad back ache. When paraphrased the above concern, patient stated It was for days at the time of this report. First adverse reaction was on the actual day that she received the vaccine that was 01Apr2021. Second shot was reported as 29Apr2021. When probed for if patient still experiencing adverse event patient stated that she was still experiencing. As per outcome of event patient stated for its persisting. As per treatment she took an ibuprofen (ADVIL) for the first-time last night before the present report. Just because she needed to get sleep. She had not slept in days. So, she took ADVIL to get rid of the pain last night that was only the things she had done since Thursday 01Apr2021. But it didn't even work. She woke up and felt the exact same. Dose of Advil was reported as 200 mg, she took one 200 mg tablet. She just took it the day before the present report (04Apr2021). The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Redness, pain and swelling in arm. Headache and temperature 100.2 degrees 24 hours after vaccine. 5 cm swelling and erythema.
This case was received from the health authority on 23-Nov-2012. GB-MHRA-ADR 21922474. This case is not medically confirmed. The primary reporter is a consumer. A 44-year-old female patient received an injection of pneumococcal polysaccharide vaccine (manufacturer unknown; batch no, route, dose and site of administration not reported) on 03-Nov-2012. One day post vaccination, on 04-Nov-2012, she presented with diarrhoea, high temperature, nausea, swelling arm, metallic taste in mouth and weight loss. On an unreported date she also experienced appetite loss and painful arm. The patient's medical history included hypothyroidism and rheumatoid arthritis. Concomitant medications included methotrexate and thyroxine sodium. The patient recovered from diarrhoea, nausea and metallic taste on 06-Nov-2012. The duration was reported as 2 days but the recovery time was reported as 3 days for these reactions. She recovered from high temperature on 07-Nov-2012. The reaction duration was reported as 3 days but the recovery time was reported as 4 days. She recovered from weight loss on 08-Nov-2012. The reaction duration was reported as 4 days but the recovery time was reported as 5 days. On an unreported date, the patient recovered from appetite loss. At the time of reporting she had not recovered from painful arm and swelling arm. The reporter stated that the pneumococcal vaccine was recommended by a rheumatologist. The agency considered this case to be serious as an other medically important condition.
Subsequent to the 1st Hepatitis B injection on 03/15/1999 pt developed a rash with severe itching and swelling that lasted for approximately one week. Pt states that with the 2nd and 3rd injections the same reactions were present.
injection site is tender; injection site is red; injection site is red tender and warm; This case was reported by a consumer and described the occurrence of injection site tenderness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site tenderness, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site tenderness, injection site erythema and injection site warmth to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.