chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 101 to 102 for 36 hours, chills, muscle aches, headache, diarrhea.
Sore Arm, Exhaustion both for 4 days Headache and Nausea the first day
Patient reports redness and discomfort due to vaccines being administered too low on the arm. He states that they were injected midway on the arm between shoulder and elbow. He had to visit a doctor for treatment.
The current episode started in the past 7 days. Localized site reaction, mild nausea, fatigue, no other sx, patient advised she is ok, increase fluids, rest, ice to injection area, recheck prn.
This spontaneous report was received from an administrator, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications were not reported. On 03-FEB-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB intramuscularly, with lot # M039642 and expiration date on 20-JUL-2019 for prophylaxis. It was stated by the reporter that, RECOMBIVAX HB was exposed to a temperature of 34 °F, for a 2 hours and 12 minutes time frame. Additionally, the vaccine was not involved in any previous temperature excursions and data logger was involved. It was also reported, that no adverse effects were suffered and that no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002808.
Bad reaction; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2020) for prophylaxis.   On 27th April 2019, the patient received the 1st dose of Shingrix. On 27th April 2019, less than a day after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional case details were reported as follows: The reporter confirmed the shingles vaccine as Shingrix. The reporter gave permission to follow up. This case had been linked to the case US2019129925, reported for same patient.
I felt my skin was irritating while coming back from work at evening on 10/27. Next day started some urination problem and on 10/28, I was not able to pass urine at all.
body pain; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer Sponsored Program,  A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 04Mar (2021) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she experienced body pain in Mar2021 and she was going to receive her second dose on 24Mar (2021). The clinical outcome of body pain was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
tenderness in thigh and leg also it developed  a lump and he went to urgent care which they prescribed meds and he followed up with internal medicine and told him it was clot. Went to
Late entry 0953 11 year old female received Tdap and MCV-4 while getting in position to administer last shot (HPV-9) she had a syncope episode with Skin pale, clammy, jerking activity, unresponsive and sliding to the floor. Assisted patient to floor safely and elevated her feet. Patient regained consciousness immediately. Alert and oriented to name and place. BP 110/62 HR 88 respirations 22. No rashes noted, denied itching, no SOB Complained of nausea and headache. Lungs clear all 4 lobes. Patient hands shaking. After monitoring for 10 minutes on the floor with feet elevated, skin pink, alert and oriented to name place and year. Patient denies SOB, dizziness and stomach ache. Assisted patient to chair slowly and she tolerated well. HPV was given and patient tolerated well while laying down. Monitored patient for 15 more minutes and she was discharged home to follow-up with PCP. Mother was really nervous about family members with epilepsy and thought her daughter had a seizure. Explained syncope to mother and referred her to PCP for seizure/Epilepsy concerns. 1030 Patient sent home with mother ambulating with only complaints of pain in her arm. Vitals BP 108/62, Pulse 80, respirations 16. Mother verbalize good understanding of her follow-up instructions. On outreach unable to print AVS.
Pt's arm was swollen and swelling was moving toward elbow for 2 days after injection pt went to primary care MD and was told to place ice and take ibuprofen.
This spontaneous case was reported by an other health care professional and describes the occurrence of the first episode of PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer - no DDL temp monitoring) and the second episode of PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer - no DDL temp monitoring) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced the first episode of PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer - no DDL temp monitoring) and the second episode of PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer - no DDL temp monitoring). At the time of the report, last episode of PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer - no DDL temp monitoring) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Reporter stated the pharmacy hasn't been using a data digital logger to monitor the freezer temperatures that the Moderna COVID-19 vaccine is stored in. The HCP reported 6 patients have received vaccination since February 2022 from these potentially affected vials that were originally stored in the freezer with no DDL monitoring. No concomitant medication information were given. No treatment information were given.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279741, 2018SA279748, 2018SA279744, 2018SA279745, 2018SA279746, 2018SA279747, 2018SA279740, 2018SA279743 and 2018SA277209 (same reporter). This case involves a 64 years old male patient was vaccinated with a 0.5 ml dose of FLUBLOK QIV lot QFAA1829; expiry date; 30-Jun-2019 via intramuscular route in the left deltoid on 02 Oct 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received HEPATITIS A as concomitant. It was a case of actual medication error due to incorrect product storage. It was reported that the patient did not experience any adverse event. 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 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. List of documents held by sender: none.
Patient develops an itchy rash on 3/19/19. Rash present on wrist/finger/hands and arms/trunk/neck. Provider considered varicella rash although no blisters and no other symptoms.
Woke up on 11/23 with a runny nose and sore throat.  Decided to stay home from work.  Scheduled Covid test. Woke up 11/24 with additional symptoms - sinus congestion, fever, chills, fatigue, loss of taste.  Visited doctor at 3:45pm.   Heartrate was elevated.  Flu test was conducted.  Came back negative.  Doctor diagnosed it as another virus (Rhinovirus, adenovirus, etc).  Recommended ibuprophen or acetamenophin and plenty of fluids.  If it got worse I would need to go to emergency room.  Over next two days I started feeling better.  Was back to normal activity by 11/27
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On 03-MAR-2016, the patient was vaccinated with an expired dose of oral, ROTATEQ (Lot # K006458; expiration date: 24-FEB-2016), 2 ml, oral. Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Patient complained of dizziness, nausea, weakness, and numbness of face and extremities. 911 was called and patient was recommended to be taken to the hospital. Patient refused. Mother picked up patient to take her home. Patient was transported to vehicle via wheelchair.
Marked swelling of left anterior thigh 19 centimeters by 30 centimeters area of redness with central area (around immunizations sites) with increased redness, warmth, and multiple clear yellow vesicular lesions, onset occurred within 24 hours of immunizations, antibiotics started 72 hours after immunizations. Currently being treated.
hives; 2 red blotches under my right arm; patient received 1st dose of Shingrix vaccine in late june, in my right shoulder; body aches; slight fever; This case was reported by a consumer and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hives.   In June 2022, the patient received the 1st dose of Shingrix. In June 2022, 1 day after receiving Shingrix, the patient experienced general body pain, fever and vaccine administered at inappropriate site. On an unknown date, the patient experienced hives and red blotches. On an unknown date, the outcome of the general body pain, fever, hives, red blotches and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the general body pain, fever, hives and red blotches to be related to Shingrix.     Additional Information: GSK Receipt Date: 1-Aug-2022 Reporter's Comments: On an unknown date, less than 2 months after receiving Shingrix, the patient experienced hives and red blotches. The patient received the 1st dose of the Shingrix vaccine in late June, in right shoulder. The patient had body aches and a slight fever the following day. The patient believed that he/she had hives which appeared as just 2 red blotches under right arm. The patient absolutely not sure they were hives but patient had hives in the past and they appeared to be hives. The patient wanted to know he/she should receive the 2nd dose or not. Additional Supportive Information: As patient received Shingrix vaccine in shoulder, which led to vaccine administered at inappropriate site.
Lightheaded, dizzy, sweating then vomited and felt better. Symptoms occurred approximately 4 hours after vaccines administered-grandmother called approx 2 pm stating patient has a fever of 101.2 and a headache.
On 26Aug2021, I received the first dose of the AstraZeneca COVID-19 vaccine at around 11 am. In the afternoon, I experienced myalgia. In the evening, I felt very cold. At around 10 pm, I had fever & chills. I was literally shaking all night. On 27Aug2021, I still had myalgia & chills. I also had a headache. I took paracetamol & naproxen affording relief of the headache & myalgia. By 28Aug2021, the symptoms resolved. I think the adverse events were probably caused by the vaccine.
soreness at site of vaccine when lifting arm and some movements, tender to touch-mild; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration administered in left arm on 13Mar2021 at 13:45 (at 60 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included allergic rhinitis and known allergies: peanuts and penicillin. The patient previously took vancomycin and experienced allergies. Concomitant medications included fluoxetine, fluticasone propionate (FLONASE), calcium, vitamin B complex (B COMPLEX), and colecalciferol (VIT D3); all from unspecified date for unspecified indication. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced only soreness at site of vaccine when lifting arm and some movements, tender to touch-mild; non-serious on 13Mar2021. No treatment received for the events. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Low grade fever-was gone within 36 hours of vaccine. Pain in back muscles has not gone away as of 5-23-18.
Breakthrough case admission after three vaccines  Pfizer 1/27/21 Lot# EL0142;  Pfizer 2/23/21 Lot# EN6200;  Pfizer 11/22/21 Lot# 3320308D
KINRIX and varicella given in left leg. KINRIX given in a site past the vastus lateralis closer to the buttocks. As a result, the buttocks swelled up, and became very red. Child had difficult walking. Acetaminophen helped. Reaciton solved within a few days. Father took pictures. Father brought this to clinics attention last week.
side effect; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (side effect) in a male patient of an unknown age 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 IMMUNISATION REACTION (side effect). At the time of the report, IMMUNISATION REACTION (side effect) outcome was unknown.            No concomitant medications were reported. Patient had a side effect from the booster. No treatment medications were reported.   Reporter did not allow further contact
Patient reported on 1/03/18 to pharmacist on duty that he experienced pain in the upper left arm and sometimes tingling approximately 2 weeks following the flu shot administration on 9/10/2017. He continues to feel pain. He has been doing 6 weeks of acupuncture and 2 physical therapy treatments. His cardiologist advised him to rest, exercise the area, and take pain relievers. He continues to feel pain.
pt recv vax 12JUN97 & 27JUN97 pt devel one lesion on abd, & one on back;pt recovered from sx on 30JUN97;
First shingles shot didn't work and I got it on my back and my stomach area; It was painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient mentioned that, his/her first shingles shot did not work and he/she got shingles on back and stomach area. The patient mentioned that it was painful and did not take pain pills. The patient mentioned that second shot seems to be working better. The follow-up would not possible, as no contact details were available.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, skin breakout, injection site warmth and fever. On an unknown date, the outcome of the injection site erythema, skin breakout, injection site warmth and fever were recovered/resolved. It was unknown if the reporter considered the injection site erythema, skin breakout, injection site warmth and fever to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient developed broke out and fever, and a 2 to 3 inch circle around the injection site that was hot and red. The events were lasted for about 3 to 4 days.
Left deltoid 7x4 cm red tender swollen area at site still present 22 days after admin/moist warm compresses. HA's, myalgias since vaccine undetermined if related to vaccine or patient's other health problems.
Immediately after administration patient felt extremely dizzy and about to faint. We placed her on the floor with her feet elevated. Placed an icepack behind her neck. Patient never lost consciousness. But, since patient was reporting a "body buzz" we called 911 to be on the safe side since patient has severe allergies. Paramedics came, checked the patient and decided she did not need further treatment.
Mom states that Patient got his COVID vaccine at 10:30 on 06/29/2022.   Mom states that about 2:30pm on 6/29/2022 he started to have swelling to right eye and faint hives on head and neck. Mom states he did not have any symptoms of distress.  Mom states he has a history of anaphylactic reaction and she has EpiPen on hand.  Mom did give Benadryl and took pictures before dosing and is taking new pictures of him now.  Mom states she will post them to the patient portal.  Mom states that his symptoms are improving.   I advised Mom to go to ER/UC if any new/worsening symptoms or s/s of respiratory distress.  Mom verbalized understanding and agreed with POC.
Approx 5 minutes after receiving the vaccine client started c/o severe breathing difficulty. Client carries an epi pen with her at all times. Albuterol given, Husband administered epi pen in her right thigh. she was placed on o2. she was monitored for 30 minutes and felt better and released to home with her husband. she did call her PCP which told her to take 2 doses of Benadryl that evening.
10min after vaccination, Pt began experiencing "body tingling" and mild runny nose, VSS and no other complaints. Symptoms resolved in 15min without intervention . Pt DC'd home NAD after being monitored for 30min.
pt recv vax & noted pain @ site immed;a half hr p/inj noted pain radiating up the arm to scapula & neck;cold pack applied;small amt of swelling noted @ inj site;250PM BP 110/70, P80, R16;4PM redness & induration @ inj site;some tingling
Allergy to tetanus toxoid; tetanus toxoid intolerance; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a healthcare professional by e-mail via other company (Pfizer) (Manufacturer report number: 2019054353).  This case involves a patient of an unknown demographics who reported allergy to tetanus toxoid and tetanus toxoid intolerance, while he/she received vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported).  On an unknown date, the patient developed a non-serious allergy to tetanus toxoid (allergy to vaccine) and tetanus toxoid intolerance (product intolerance), following the administration of TETANUS TOXOID.  No lab data was reported.  Final diagnosis was tetanus toxoid intolerance and allergy to tetanus toxoid.   It was not reported if the patient received a corrective treatment.  The outcome of the events was not reported.  Documents held by the sender: none.
sore arm, beginning several hours after shot and lasting about 30 hours; body aches, beginning in the evening and lasting about 24 hours; pounding headache, beginning the next day and lasting about 12 hours as an intense headache and gradually lessening but not disappearing until several days later; vomiting, beginning the next morning and lasting about 12 hours
Patient stated that approximately 5 minutes after receiving Pfizer COVID-19 vaccine (1st dose), she began to feel nauseous and notified RN gave patient a bottled water. RN assessed patient and notified EMS on scene. During assessment, patient admitted allergies to bee stings (was previously prescribed an Epi-Pen, but has "not had one in a while"). Patient also admitted having recent allergic reaction to seafood 2 months ago that caused lightheadedness and nausea; patient was seen at Hospital for this reaction. Patient also stated an allergy to aspirin that causes "flu-like symptoms."  During this assessment, patient appeared to be alert and oriented x 3 with no signs of respiratory distress. During assessment, patient developed red patches on the posterior and bilateral neck, along with red hives (approximately 1/2 inch in size). Patient complained of feeling lightheaded and nauseous. Hands were trembling. Patients vitals were within normal limits, although blood pressure was slightly elevated.
pt recv vax & devel a high fever;no further info was available @ the date of this report;
Redness, swelling, and pain around injection site (DTaP). Macular rash on chest, abdomen, and thighs. Treated with Benadryl and Keflex for possible infection.
Brief syncopal episode. 33 year old female had syncopal episode while sitting in chair. EMS witnessed and able to reach for patient and prevent from falling. Patient came too and refused transport
Initial report received from a health care provider on 03 October 2007.  A 27-year-old female patient had received a right deltoid intramuscular injection of Adacel, lot number C2825AA on 18 September 2007 and two days later, she developed redness, pain, warmth and hardness 6 cm x 7 cm around the injection site.  On 23 September 2007, the skin at the affected area peeled like a sunburn.  Corrective treatment included Tylenol, ice packs and a topical steroid.  The symptoms subsided however the reporter stated that "a 1 cm and a 2 cm knot" were present under the skin at the affected area.  The patient had not received any other vaccines during the four weeks prior to the receipt of Adacel.  The patient had not experienced any adverse reaction after receipt of a tetanus and diphtheria booster dose in 1998.  The patient had not recovered from the event and no further information was provided.  Follow-up information received on 15 November 2007 from a health care professional.  The redness, warmth, and pain resolved on 03 October 2007.  One of the knots had resolved, and one knot of approximately five mm in size remained.  Treatment included ice packs and topical Desonate.  At the time of this report, all events had resolved except for one small knot at the injection area.
PATIENT PRESENTED WITH A BRUISE AND SLIGHT PAIN 24 HOURS AFTER RECVEIVING VACCINE