chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight discomfort in ears; ringing in the ears; Booster; he also received the Flu vaccine on the same date as this one; Chills; Headache; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Dec2021 11:30 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), intramuscular, administered in arm right, administration date 09Dec2021 (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 02), administration date: 19Apr2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "Tired"; Bnt162b2 (Dose: 01), administration date: 28Mar2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "Tired". The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 11:30, outcome "unknown", described as "Booster"; PRODUCT USE ISSUE (non-serious) with onset 09Dec2021, outcome "unknown", described as "he also received the Flu vaccine on the same date as this one"; TINNITUS (non-serious) with onset 09Dec2021 21:00, outcome "not recovered", described as "ringing in the ears"; CHILLS (non-serious) with onset 09Dec2021, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 09Dec2021, outcome "recovering", described as "Headache"; NAUSEA (non-serious) with onset 09Dec2021, outcome "recovering", described as "Nausea"; EAR DISCOMFORT (non-serious) with onset 09Dec2021 22:00, outcome "unknown", described as "slight discomfort in ears".  Additional information: Expiry Date of Pfizer COVID vaccine booster: Unknown. He did not have a manufacturer, lot or expiration. Family Medical History Relevant to AE(s): none Relevant Tests: None. Ringing in ears was reported as worsened. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
have a bad flu; Initial information received on 25-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who have a bad flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.     On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for flu (Influenza immunisation).  On an unknown date the patient had a bad flu (influenza) (unknown latency) following the administration of influenza vaccine. It was reported I got the flu shot and I still have a bad flu.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
bruise on her arm; head cold; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (head cold) and VACCINATION SITE BRUISING (bruise on her arm) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced NASOPHARYNGITIS (head cold). On an unknown date, the patient experienced VACCINATION SITE BRUISING (bruise on her arm). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (head cold) was resolving and VACCINATION SITE BRUISING (bruise on her arm) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment for the event included allergy medicine which did not help. The patient took guaifenesin (Mucinex) and was helping.   Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD21-072083, MOD21-072096 (E2B Linked Report).; Sender's Comments:  MOD21-072083: MOD21-072096:
Swelling in arm and hand....next day, sever stiffness and pain in elbow and shoulder. Hand remained swollen and stiff. That evening, pain also felt in opposite shoulder and elbow. Rather than getting better, it has progressed - now my hips and knees also hurt, and I'm stiff everywhere, like an old man (I've never experienced any joint paint/arthritis before).
Extreme tiredness Foggy brain Headache Muscle pain at injection site - painful to move arm
I did not have an adverse reaction to the vaccine. In 09/2022, I was diagnosed with vitreomacular traction (VMT). I had surgery to correct VMT on 01/14/2023.   After that surgery, I had a detached retina and had surgery on 03/01/2023.  I had second retina detachment surgery 04/2023.  I will have another surgery in about one month.
instantly started bleeding after getting the shot; bump on the arm; Bruise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (instantly started bleeding after getting the shot), VACCINATION SITE MASS (bump on the arm) and VACCINATION SITE BRUISING (Bruise) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (instantly started bleeding after getting the shot), VACCINATION SITE MASS (bump on the arm) and VACCINATION SITE BRUISING (Bruise). At the time of the report, VACCINATION SITE HAEMORRHAGE (instantly started bleeding after getting the shot), VACCINATION SITE MASS (bump on the arm) and VACCINATION SITE BRUISING (Bruise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up document is received on 08-JUN-2021 and it doesn't have any new information
swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 13:15 (Lot number: ER8T34) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acute asthma" (unspecified if ongoing), notes: Verbatim: Acute asthma; "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: LEXAPRO; FLONASE ALLERGY RELIEF; ALBUTEROL SULFATE. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Apr2021 13:15, outcome "unknown", described as "swollen lymph nodes".  Additional information: patient had covid prior vaccination. No covid tested post vaccination. No Known allergies. Patient had reactions 48 hours after first dose with need for inhaler and swollen lymph nodes. No other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 38-year-old female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine and Hepatitis B vaccine. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder and drug dose administration interval too long. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too long were unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. In 2005, the patient received 2 doses of Hepatitis B vaccine. In 2009, the patient received the 3rd dose of Hepatitis B vaccine, which led to lengthening of vaccination schedule. On an unknown date, the patient had titers drawn after inadvertent occupational needle stick which were below 10, leading the patient to be a therapy non-responder.
After getting the Moderna Covid-19 injection today, I felt slightly weak and light-headed about 3 hours later.  I took 200 mg of ibuprophen and a 2 hour nap and felt fine when I woke up.
I woke started having chest pain I went by ambulance to the hospital, I was having heart attack. I had a 100% blockage and they put a stent in. The doctors could not find any reason, my BP has been normal and cholesterol always been amazing and no precursors, my A1C always been good.
Swollen Lymph node, called Teladoc, said to monitor. Lymph node no longer swollen after few weeks
mild asthma attack 10-15 minutes after shot while waiting in store. Light headed and richness in my chest. Used my levalbuterol inhaler, which resolved all my symptoms within 15 minutes.
17 year old patient was injected with Flublok with no AE; received a 0.5mL dose of Flublok Vaccine in error instead of the appropriate Fluzone Quadrivalent 0.5ml with no AE; Initial information was received on 04-Nov-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involved a 17 year old male patient who was vaccinated with 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] via intramuscular route at right arm for prophylactic vaccination (lot number UJ509AA and expiry date 10-May-2021) on 01-Nov-2020 in error instead of the appropriate INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no adverse event (AE) (product administered to patient of inappropriate age and wrong product administered).   The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  It was a potential medication error due to product administered to patient of inappropriate age and wrong product administered (latency same day). The reporter reported that she went to grab the vaccine the INFLUENZA QUADRIVAL A-B VACCINE but as both INFLUENZA QUADRIVAL A-B VACCINE and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE  were side by side and the 180 and over was not circled and also the trade names of the vaccines namely Flublok and Fluzone were too similar and the boxes were very similar and she was in a hurry and accidentally grabbed the wrong box.   The patient has not exhibited any AE as a result.  There was no treatment received by the patient. The patient also received no other series of vaccines.   The event outcome was not applicable for both the events.  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.
Left upper arm warm, swollen, warm to touch. Treated with Clairtin Benadryl
Patient became aware that arm was tender, itchy and reddened about 2 1/2 inches diameter.  Patient applied hydrocortisone cream and warm washcloth.  She also took Ibuprofen 200 mg every 4-6 hours starting 4/24/10 at 1:00 pm till 4/26/10 morning.  Patient also stated slight weakness in left arm started 4/25 AM and continued till 4/26 at around 12N. Patient states tenderness, itching gone and less redness by 4/26 AM.
Fever, chills, sore abdomen, tired, aches, headache, earache
I felt fine after until a few hours later. I started having a intense pain in my neck, under my jaw around where my lymph nodes are located. For about 9 hours, any time I swallowed, talked or had movement in my neck,  I had sharp pain on the right side. I took a few doses of benadryl and Tylenol to try and ease the swelling (slightly visable). After this I started sipping on hot chicken broth, since I hadn't eaten, which seemed to help ease the pain and eventually go away. During this time, I tired a heating pad then ice which neither helped. No fever during this time.
I had a fever, cough, clear phlegm, runny nose, sinus pressure, and headache. I had low oxygen level. I'm tired all the time, exhausted. My doctor prescribed PAXLOVID for COVID-19. I started taking it on June 23rd. At first I got better, but then I got worse. The doctor called it a rebound.
Patient was incorrectly administered a monovalent Pfizer vaccine as a booster dose. He should have received a bivalent booster as he had previously completed the Pfizer two dose series.
I have felt injection site pain since about 10:30pm on March 1st, 2021. At about 12:00pm on  March 2nd, 2021 I started to feel tired and developed a mild headache. I felt chills at about 3:00pm on March 2nd, 2021.
My son grabbed my wrist just after the vaccine. His eyes rolled to the back. His pupils were fully dilated. He was lying down with his eyes open, fully dilated and he stopped breathing. The doctor was in the room with his back to us. I alerted the doctor. I had 2 younger children with me. I removed them from the room and got a nurse. As she opened the door we saw my son having a seizure. He was yelling and moaning. It ended. When getting ready to leave the office about 1/2 hr later he vomited. After another 1/2 hour he had a violent vomit attack and then he was all better.
Starting at 8 pm on 12/28/2021: fatigue, arm soreness at injection site and slight headache. I went to bed at 9:30 pm with chills. I woke up every 2 hours. Upon waking at 6 am on 12/29/2021, I had tingling in my hands, very dehydrated and aches in my legs making it painful to walk.  Fell back asleep in a recliner. I was unable to get comfortable in bed and slept until 9 am. I did not seek medical attention and figured it would run its course. Body aches ended at 11 am, felt like I was "in a fog" the rest of the day on 12/29/2021 with a very sore arm. 12/30/2021 brought more tiredness throughout the day. I had to take breaks when walking around a store, but arm soreness was better. 12/31/2021 again felt almost lethargic with back pain. I had to take many breaks throughout the day while cooking dinner. Felt better after dinner and resting for the rest of the night. Arm soreness waning. Saturday, 1/1/2022 was the first day I felt better. The arm soreness went away. The booster was worse for me with the longevity of symptoms than the 2nd dose of Moderna.
Information has been received from a registered nurse concerning a 30 year old Asian male patient who on 10/24/2003 at 14:00 and on 01/08/2004 was vaccinated on the left side subcutaneously with a first and second dose of varicella virus vaccine live and failed to seroconvert, respectively.  There was no concomitant medication.  It was noted that in approximately December 2003, the patient was ill in between injections.  On 02/17/2004, a titer was drawn and the patient was found to be below acceptable titer with no other symptoms.  Unspecified medical attention was sought.  There was no product quality compliant involved.  Additional information is expected.
Vaccine had a low temp excursion.  Declined revaccination per GSK recommendation.
After vaccination during the initial monitoring phase for adverse reactions, the patient reported numbness in her face around her eyebrows. This occurred about 10 minutes after administration. After another 10 minutes she said the numbness had moved to the left side of her face. She said it did not seem to affect her breathing or anything else, but the numbness was apparent. I recommended patient go to either a doctor or emergency room.
pt recv vax 16DEC98 & next day large red area @ site rt arm;redness dec but lump persists;5 days later 2x2cm sc mass "sterile" abscess
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 30-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) was 120, 31 and R, respectively. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Severe fever lasting greater than 72hrs.  Severe tonsil swelling lasting great than 72hrs.
Rash on left arm. Left breast. Right and left forearms. Chest amd back.
patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The date of vial initially stored in the refrigerator was unknown. Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.   The vial did not undergo any temperature excursions.  No treatment information was reported.
Fever of 99-100 degrees for 24 hours, consistently.  Took aspirin every 5 hours.
Pt seen at urgent care 10/23/15 c/o (L) arm pain/redness/swelling from deltoid down to elbow. Lateral and posterior reaction. Given KENALOG 40mg IM in office, prednisone 20mg BID x 5 days, ZANTAC 150mg BID x 7 days, loratadine 10mg qd x 7 days.
This spontaneous report as received from a physician via a field representative refers to an unspecified number of patients of unknown ages and gender. On unknown dates the patients received 4th dose of GARDASIL (dosage, lot# and route unknown). No adverse effects were reported. Additional information has been requested.
extremely tired; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist) from a sales representative.  An 80-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) at the age of 80 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extremely tired". It was unknown if therapeutic measures were taken as a result of fatigue. Additional information: It was unknown if the patient received any other vaccines on the same date as the suspect vaccine. It was unknown if the patient received any other vaccines within four weeks prior to the suspect vaccine. It was unknown if the patient was taking any other medications within two weeks of the event starting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300372581 same reporter/vaccine/event, different patients;
I wanted to report an incident regarding a two-part mixed component vaccine that was not given correctly. After going through inventory, a vial on vaccine Pentacel was missing, I searched for all patients that were given the vaccine with lot# UJ799AA, three patients were a result. One out of the three patients were given only the DTap-IPV component and is missing the HIB.
Rash to elbows hands knees and feet, 5 days of zyrtec and benadryl
Student alert, active parent present. No report of any symptoms or illness. H1N1 vaccine injection given at 12:15 P with 20 min observation. No reaction.
Hives all over body  3 hours after shot, lasted for 5 days Felt Hot, Low grade temp for 2 days Headache, Could not think, lasted for 3 1/2 weeks Short of breath for 5 or 6 days, had to use asthma inhalers Cough Extreme fatigue 3 1/2 to 4 weeks, in bed 12-14 hrs per day Unsteady - not vertigo, it was different Large golf ball lump at vaccine site - still sore
During consult patient disclosed she received shingles vaccine while on Gilenya therapy.  Combination is recommended to be avoided due to immunocompromised.   Pt has not noticed any signs or symptoms at this time and is 1 week post 2nd dose of vaccine.
Initial unsolicited report received from a nurse on 16 Jun 2016. This case is linked to 2016SA114800 (same reporter). This case involves an 11-year-old male patient (one of the two boys) who was vaccinated with first dose of Yellow Fever Vaccine (lot number: UI291AA, expiration date: 20 Apr 2018, dose, route of administration not reported) in deltoid on 13 Jun 2016. The medical history incuding any allergies, illness at time of vaccination and concomitant medications were reported as none. It was unknown if any other vaccine administered to the patient within four weeks of suspect vaccine. On 14 Jun 2016, one day after vaccination, patient experienced pain in the axilla. The patient also had lymph node swelling that was obvious to the mother. The reporter planned to advise the mother to take the patient to see their pediatrician and have them evaluated for their symptoms. It was reported that patient required doctor visit. The lab data was reported as none. Corrective treatment was not reported. The outcome for the events was reported as unknown. List of documents held by sender: none.