chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (parent). A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as dose 1, single (lot number and expiry date not reported); then via an unspecified route of administration on an unspecified date (Lot Number: EW0187; Expiration Date: 31Aug2021) as dose 2, single; for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced covid-19 on 01Oct2021.  The outcome of the event was unknown.  Conclusion of Completed Investigation (FCI/SI/OffCI) from Pfizer product quality group was reported as: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EW0187 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0187, fill lot EP8737, and the bulk formulated drug product lot EP8618. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Tinnitus; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Information has been received from a physician concerning a female "in her 70s" who was vaccinated with a dose of PNEUMOVAX 23. The patient underwent a splenectomy 2 days after the vaccination. No AE was reported. Upon internal review, splenectomy was determined to be an other important medical event. Additional information has been requested.
Fatigue  Muscle or body aches  Headache  New loss of taste or smell  Sore throat  Congestion or running nose
Swelling, redness & tender to touch at site of PNEUMOVAX administration. Diffuse body aches & fatigue & fever x 2-3 days. No specific treatment.
I received the second COVID 19 shot on Wednesday, 24Mar2021 and tested positive for COVID-19 on Sunday, 28Mar2021; I received the second COVID 19 shot on Wednesday, March 24, 2021 and tested positive for COVID-19 on Sunday, March 28, 2021.; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Batch/Lot Number: EL3247) dose 1 via an unspecified route of administration, administered in right arm on 03Mar2021 at 10:45 and second dose (Batch/Lot Number: EP6955) dose 2 via an unspecified route of administration, administered in right arm on 24Mar2021 at 10:45 as single dose for covid-19 immunisation. No other vaccine in four weeks. The patient medical history was not reported. No known allergies and Concomitant medications included metformin and losartan. On 28Mar2021 the patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab and Rapid) and tested positive. The patient went to doctor or other healthcare professional office/clinic visit. The events drug ineffective and sars-cov-2 test positive considered as medically significant. The patient did not take any vaccines prior to this vaccine. The outcome of events was recovered.
7/8 - Fever of 102.5 - subsided in evening. 7/10 - Rash developed on stomach, leg and vaginal area, blisters scattered (1-3 in each area). Taken to Urgent Care - diagnosed with chicken pox at that time.
About 5 minutes after injection, began feeling faint and experienced loss of vision. I had ringing in my ears as well. My brother who received the injection with me experienced the same symptoms at the same time. Due to us being disoriented, we are unsure how long initial symptoms such as the vision loss lasted.
Pt in waiting area after vaccine, became diaphretic, pale and lightheaded. Pt was assisted to vaccine room and laid on floor with feet up on chair. 911 called and came to check vitals and blood sugar. BP was elevated. Pt feeling a little better but stated still didn't feel "right." She did not want to go to the hospital. Her boyfriend arrived and stated he could drive her home and stay with her. Pt stated she would call 911 or go to hospital if she started feeling worse again.
Pt called pharmacy and reported having low grade fever since day after her 2nd dose of Moderna or 12 days of fever.   Recommended that pt seek medical attention to rule out other causes.
Patient reports lingering pain, tenderness from Tdap vaccine on 8/11/15. Patient states that she experiences pain when lifting heavy objects or lift arm.
shingles rash appeared the day after vacc. on back of neck, soon later diagnosed by doctor
It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Yes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Yes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Yes). At the time of the report, VACCINATION COMPLICATION (It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Yes) outcome was unknown.            Concomitant medication were not reported Treatment medication were not reported
Pediarix administered L vastus laeralis, 0.5cc IM per protocol. Pt became red and stiff, eyes rolled back in head. Episode lasted approximately one minute. Then patien was pale for approximately 5 mins. Dr. attending. O2 sat 85 % on room air. O2 via pedi mask, 3L applied. EMS activated. O2 sat upon paramedic arrival 99%. Pt to ER via ambulance. Breathing and conscious upon departure. Carried by mother to ambulance. Mother states child subject to similar episodes when changing diapers or not picked up quickly. Mother states this episode "stronger". Evaluation at Hospital.
Pt. called and said within 3 hours of vaccine she started vomiting that resulted in ER trip. Also complaining of sore arm, which I said is normal.
Pt was given the vaccine. Within a couple of days, the patient noticed two bumps on the left arm - the same arm as the injection was given. A large area around the dots became swollen red, and warm. The patient applied ice and the swelling went down. 6 days after the vaccination there was still an area approximately 4-6 in diameter that was red and warm. The area started at the elbow and went midway up the upper arm - entirely below the injection site. Patient did not remember being bitten by anything. Benadryl did not help the rash at all. Patient was referred to doctor for follow up.
Left arm did not have any feeings when I woke up in middle of the night; Chills; Fever 101.0; Body aches in both knees; Sore right arm; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6206), via an unspecified route of administration in the right arm on 10Mar2021 at 09:15 for COVID-19 immunization. The patient was not pregnant. Medical history included Hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EI9267) in right arm on 19Feb2021 for COVID-19 immunization. The patient received other medication in two weeks. On 11Mar2021 at 03:00 AM, the patient experienced chills, fever 101.0, left arm did not have feelings at night, body aches in both knees and sore right arm. The patient did not receive any treatments for the events. The clinical outcome of chills, fever 101.0, left arm did not have feelings at night, body aches in both knees and sore right arm was recovering.  No follow-up attempts are possible. No further information is expected.
The evening of the vaccination I had a knot under the skin, was sore for several days but went away. 7 days after vaccine the injection site started itching really bad and the knot under my skin started getting larger. Day 9 around 8pm I noticed a large pink spot with a lighter center at the injection site 7 cm X 8 cm round/oval, slightly raised, swollen, itchy, and slightly warmer than surrounding skin.  I took diphenhydramine 50 mg.  I first notified my manager and reported the event to employee health nurse. The employee health nurse asked me to report the reaction to this website and contact PCP if symptoms got worse. Day 10 morning  swelling and discolorization improving.
Received vaccines 11/16/2005 mom noticed left leg red, swollen, and patient had tactile fever slightly irritable.
mom reported pt rt thigh became very red & swollen 11APR98 & has gotten progressively worse;12APR & 13APR98 pt had been scratching;area breaking skin especially p/getting hot from playing outside;swollen down to knee;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient received second dose of RECOMBIVAX HB "at least 12 months ago" and attempting to receive the third dose of RECOMBIVAX HB (dose, frequency, indication, route not reported) on 07-JAN-2014 (today). No adverse effect reported. Additional information has been requested.
Increased sensitivity to noise, "meltdown" - crying, inconsolable day after immunization.
With in a few hours skin felt like it had a bad sun burn. General nausea. General not feeling great. Next day didn?t feel great but went to work. Two days since vax and  had significant tachycardia, resting heart rate very high. Set off alarms on dr?s  pulse machine.  Pulse was very erratic.  Sent to ER. High rate remained high for 3 days, slowly coming down.  2 weeks later and heart rate is still higher than normal.  Get light headed/dizzy just walking from room to room.  Extremely fatigued for two weeks. Just now starting to be awake more.  ER didn?t know what to do. Assigned holter monitor and waiting to see cardiologist.
C/o neck pain and stiffness 3 hours after vaccine. Mother gave child aleve and felt that he was improving. Suggested that possible urgent care or ER visit or doctor visit may be warranted if not improving.
fever 103 1st day then low grade, rash, lethargy, vomiting, refused to eat/drink;
Large, red, swollen, tender, itch rash to (L) deltoid area.
initial swelling at left thigh injection site only, 3 days ago developed redness and induration at left thigh site.
horrific pain at the injection site; swelling at the site of the shot/ both arms are swollen; lymphnodes in the underarm; both arms are sore; lymph nodes nodes in my underarms sore; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (as a child).   On 25th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, peripheral swelling, enlargement of lymph nodes, pain in arm and lymph node pain. On an unknown date, the outcome of the injection site pain, peripheral swelling, enlargement of lymph nodes, pain in arm and lymph node pain were unknown.   It was unknown if the reporter considered the injection site pain, peripheral swelling, enlargement of lymph nodes, pain in arm and lymph node pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had strange side effects. There was horrific pain and swelling at the site of the shot. But what was bad was that all the lymph nodes in my underarms, both arms are swollen and sore.
I was very weak and dizzy.  I also had a tingling feeling on my face and numbness at the top of my head.  I felt confused and off balance.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were inadvertently vaccinated with VAQTA (lot#, expiration date, dose and route were not reported), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Initially low grade fever turned quickly into skin rash beginning from the site of injection to all over the face, buttocks, hands and legs.
Called parents of patient to inform of adverse event on 1/20/2022. Mother of patient reported that son has been having heavy bloody nose, light headed, and headaches. Son has also had a sore injection site. MOP had not given pt any medication. MOP would like to talk to clinician to discuss side effects and incident. Contact information will be given to Clinical Official for a call back. MOP was informed that due to this being son's second covid vaccine dosage does not need to be repeated and he can get his booster in 5 months.   CCO called mother of patient. Mother stated patient had one nosebleed at school today. Then had a second one in car on the way home.  Last about 3 min.  Pinched nose. No prior history of nosebleed.  Has Humidifer at home.  Did not go to school on Wednesday 1/19/2022 - had a little swelling in face, but that went down over the course of the day.  Rested, hydrated.   Still felt a bit "down", but he felt okay to go to  school....so went to school today 1/20/2022.  Also, had a serious headache that day after the shot on Tuesday 1/18/2022.  Body aches, chills, busted out in tears. Took Tylenol for headache after school today and is resting now.    Instructed to go to ED for eval if nosebleeds recur.  Rec to check blood count, for example, as one rare SE can be low platelets.  Instructed on how to stop nosebleeds with pressure and prevent wiht hydration and humidification.  (Has forced air heat.)  Offered appointment tomorrow in peds for eval, but mom declined as had some other important stuff to do tomorrow.  Will watch him and see  how he does.    Offered to call and check in tomorrow 1/21/2022. Mother accepted this. CCO followed up on 1/21/22 and got no answer. Called again on 1/25/2022, mother stated that child is fine, had a minor nosebleed but no concerns.
Welts, rash appearing on arms....got worst throughout the day, appearing on chest, back.  Even worst on 11/14/10, on legs, face, severe itching.  Gave my son Benadryl 11/14/10 so he could sleep.
Severe pain in the left side of the chest. Intermittent pain throughout the next day. Confirmed via x-ray, blood test and ct-scan as blood clot in lungs (pulmonary embolism). Facility where tests were conducted: Hospital.  Admitted immediately to Emergency Unit for treatment. Have been  on daily blood thinner since this incident.  There was no adverse reaction to the second dose of the Pfizer vaccine.
L arm swelling and redness on 6/15/05. Was very swollen and red and has been slowly getting better.
after rotateq. developed inspiratory stridor  pulse ox. always 100%; was given saline  nebulizer and resolved. Episode of stridor  intermittent lasted approximately 30!
an infection; This is a spontaneous report from a Pfizer sponsored program Support. A Non-contactable Pharmacist reported that, A 91-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced an infection. Reporter was asking if that would affect the dosing schedule. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client's initial 2 doses in series were Moderna. Pfizer administered in error. No history of anaphylactic type reactions in the past.
chest pain; This is a spontaneous report from a contactable consumer. A 25-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 26Jul2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that for the first 2 days after the first dose, the patient experienced chest pain which felt like someone was sitting on him. The patient needed a confirmation if it was okay for him to get the second dose of the vaccine as he was suggested by his doctor to confirm if he could get the second dose. The outcome of the event was unknown.  Information about lot/batch number has been requested.
pt recv vax 13SEP97 & felt okay & did not have rxn until 19SEP97;went to bed noticed a small bump on arm;it was very itchy;next morning arm was twice its normal size (from elbow to top of shoulder)
patient did not inform us she received the Pfizer vaccine on 5/11/21 and 6/1/21. no reaction. Patient marked to have never received the vaccine before.
A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to 13 separate patients on different days with no adverse event; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional (pharmacy manager) via call center.  This case is linked to cases 2020SA323787, 2020SA323899, 2020SA323872, 2020SA324116, 2020SA323616 and 2020SA323597 (same reporter).  This case involves a 37 year old female patent for whom it was reported that a pharmacist was supposed to give fluarix, however accidentally grabbed and administered influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] to 13 separate patients on different days (wrong product administered) on 13-Nov-2020 (batch number: UJ552AA and expiration date: 30-Jun-2021) at a dose of 0.7 ml once via intramuscular route in the left arm for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong vaccine administered (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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.
fainted in my kitchen; she is very clammy and very hot; she is very clammy and very hot; She is been very tired all day and been very achy; She is been very tired all day and been very achy; This is a spontaneous report from a contactable consumer (patient's mother). A female patient (reporter's daughter) of an unspecified age received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that the patient fainted in my kitchen, she is very clammy and very hot, she is been very tired all day and been very achy. Reporter stated, "My daughter had the Pfizer shot yesterday and she just fainted in my kitchen and I am curious if this is the side effect that is common. She is awaken now. She is very clammy and very hot." Reporter added "She is been very tired all day and been very achy and now she just fainted in my kitchen. She had her second shot yesterday about 24 hours ago. I am just trying to see if this is the medical emergency enough to take her to the hospital or if this is the common side effect she is been dealing." Outcome of the events was unknown. The patient received first dose of BNT162B2 on an unspecified date.  Information on the lot/batch number has been requested
Dizziness, Headache, Myalgia left arm pain, tingling arm, Narrative:
very bad case of hives; horrible idiopathic hives; Painful; cannot function; cannot sleep; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (very bad case of hives), IDIOPATHIC URTICARIA (horrible idiopathic hives), PAIN (Painful), MOBILITY DECREASED (cannot function) and INSOMNIA (cannot sleep) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 037L20A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced URTICARIA (very bad case of hives), IDIOPATHIC URTICARIA (horrible idiopathic hives) and PAIN (Painful). In November 2021, the patient experienced MOBILITY DECREASED (cannot function) and INSOMNIA (cannot sleep). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) for Adverse reaction, at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse reaction, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse reaction, at a dose of 1 dosage form and OMALIZUMAB (XOLAIR) for Adverse reaction, at a dose of 1 dosage form. At the time of the report, URTICARIA (very bad case of hives), IDIOPATHIC URTICARIA (horrible idiopathic hives), PAIN (Painful), MOBILITY DECREASED (cannot function) and INSOMNIA (cannot sleep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.
Pt currently has covid 19 Vaccine #1 06/01/2021 Modrna lot # n/a vaccine #2 06/11/2021 Janssen lot # 203A21A