chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. In 2012, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On unknown date, the patient experienced shingles (herpes zoster) and in approximately October 2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Reported after receiving 2nd GARDASIL vaccine feeling like she had a stiff neck, arm where vaccine was given felt stiff and back felt stiff. Advised OTC NSAIDS, rest and call if symptoms failed to resolve. Pt did not call back.
ImmediaTe pain aT site of injection. Pain increased over severaL hours. Very painful To LifT arm. LosT work for week. Pain conTinued for 2 months. Pain aT injecTion site for another month. numbness in right Thumb, pain!
Chills, very cold, lethargy.   I just feel bad. (but not critical)
Flu; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who had flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
shortness of breath; raising of heartbeat; This is a spontaneous report from a contactable consumer (mother). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on 27May2021 as 2nd dose, single dose for covid-19 immunization (he got it yesterday at around 5PM, time zone unspecified). The patient medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162B2 for COVID-19 immunization. States that about an hour ago, her son started experiencing shortness of breath and raising of heartbeat on 28May2021 (started an hour to 17 hours (and running)) and they were not sure if this was normal; and it was after getting the 2nd dose of the Pfizer Covid-19 vaccine shot (he got the it yesterday at around 5PM). She was seeking answers to help decide if her son needs to go the ER. Outcome of the events was unknown.   Information about lot/batch number requested.
This case was reported by a consumer and described the occurrence of influenza in a 55-year-old female patient who received Influenza vaccine (batch number unknown, expiry date unknown). The patient's past medical history included breast cancer, surgery (breast tumor removed) and pulmonary embolism. Previously administered products included radiation therapy and ADVAIR DISKUS with an associated reaction of drug ineffective. Concurrent medical conditions included depression, post-traumatic stress disorder, difficulty breathing, chronic bronchitis and allergic asthma. Concomitant products included ADVAIR DISKUS, BREO ELLIPTA, LAMICTAL, AMBIEN, CELEXA, KLONOPIN, SEROQUEL, ABILIFY, Albuterol, COUMADIN, hydrocodone, metformin and Nebulized Albuterol. In November 2014, the patient received Influenza vaccine. On an unknown date, the dose was an unknown dose. On 6th February 2015, 61 days after receiving Influenza vaccine, the patient experienced influenza. The patient was treated with TAMIFLU and Steroids. On an unknown date, the outcome of the influenza was recovering/resolving. It was unknown if the reporter considered the influenza to be related to Influenza vaccine. Additional details were reported as follows: On 6 February 2015, 2 or 3 months after receiving Influenza vaccine, the patient caught the flu. She went to the emergency room and was given steroids and TAMIFLU. She did not have to be hospitalized. Lack of effect of influenza vaccine was reported but the GSK criteria of vaccination failure were not met. Please refer to case US2015GSK029684 for tolerance to ADVAIR DISKUS, BREO ELLIPTA and LAMICTAL.
I got a rash within the 4 hours mark; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "I got a rash within the 4 hours mark".  Additional information: After first vaccine patient got a rash within the 4 hours mark, but it was not a severe rash so patient just can't find that information on what to do, if it wasn't severe but it still was within 4 hours. Patient did not get second shot because patient was advised back at that point, patient think they didn't have as many common adverse reactions and so patient was advised not to get it, but now patient was trying to get the second one, patient just don't know about that whole 4-hour period.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021218401 similar report from same reporter
Information has been received from a physician concerning a 6 month old male, with no medical history and no allergies, who on 27-DEC-2007 was vaccinated with a third dose of Rotateq. Concomitant vaccines included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of PREVNAR. On 27-DEC-2007 the patient experienced vomiting. On 31-DEC-2007 the patient recovered. No product quality complaint was involved. No other information was provided. This is one of two reports from the same source. Additional information has been requested.
Fever; Muscle aches; Pain at site of injection; Second dose may have been only the adjuvant; Second dose may have been only the adjuvant; This case was reported by a pharmacist and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2021, the patient received the 2nd dose of Shingrix. On 4th March 2021, less than a day after receiving Shingrix, the patient experienced fever, muscle pain, injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the fever, muscle pain, injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the fever, muscle pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: 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 only received the adjuvant part of vaccine, but reporter was not sure and wanted to inquire about the adverse events in a patient that only received the adjuvant versus a valid dose adverse events, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient experienced fever, muscle pain and injection site pain. Due to the limited information, health care professional declared that the patient would probably get a third dose since they were not sure if the second dose was valid or not. The reporter had no patient or case information at hand.  No mailing address requested by agent due to involuntary omission. The reporter consented to follow-up.
Chest tightness; Feeling light headed; Off balance; She developed a rash that burns and hurt all over her body; She developed a rash that burns and hurt all over her body; She developed a rash that burns and hurt all over her body; Booster; Off label use; This is a spontaneous report received from a non-contactable consumer (Patient). A 51-year-old female patient received third dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 18Aug2021 as dose 3 (booster), single for covid-19 immunisation and patient also received co-suspect as ibuprofen (MOTRIN [IBUPROFEN]), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) for an unspecified indication. Medical history included she is allergic to antihistamine from an unknown date. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1 single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 2 single for covid-19 immunisation. The patient experienced she developed a rash that burns and hurt all over her body on 19Aug2021, feeling lightheaded, off balance, chest tightness on an unspecified date. booster and off label use on 18Aug2021. Therapeutic measures were taken as a result of she developed a rash that burns and hurt all over her body. The patient reported she has been consulted to 10 different doctors, no one knows how to treat the rash and seeing Dermatologist twice as well. She was asked what to do to treat the rash. How long are the side effects going to last. The patient had a reaction to motrin, everything she takes reacts with the vaccine now and she has always taken motrin for 45 years but when she took one she thought she would end up in the ER. The patient reported she was feeling lightheaded, off balance and chest tightness. The patient reports according to the CDC your not supposed to use steroids, but the Doctor prescribed steroids to be applied 3 times a day and when she applied the steroid to the rash her skin burned and cracked and she is allergic to antihistamine so she cannot use that and trying Neosporin Plus pain relief and it was the only thing that has worked. She had an appointment with a new family doctor on 29Sep2021. She reported the rash comes and goes, the rash was on her arms and breast which is gone but now the rash is in her private area. The outcome of the events was reported as unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
The morning after getting the shot in my right arm, my Rt temple was where my headache was focused. The skin at the temple and Rt eye area felt "weird" to the touch and my Rt eye ached. In my mouth on the upper right gum were little bumps and on the corner of my mouth (Rt side) were 3 cold sores. Headache gone by Monday. Rest gone in 6-7 days.
This case was reported by a consumer and described the occurrence of swelling injection site in a male subject of unspecified age who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included anaphylactic reaction to food. Previous and/or concurrent vaccination included PEDIARIX; GlaxoSmithKline; unknown; unknown given on an unspecified date. Concurrent medications included EPIPEN. On an unspecified date the subject received 2nd dose of INFANRIX (unknown, unknown leg). At an unspecified time after vaccination with INFANRIX, the subject experienced swelling injection site. The mother of the subject was concerned about her son receiving a 3rd dose of INFANRIX vaccine after receiving a DECADRON injection on 03 May 2011 and contracting an illness as well as having reduced immune response because of receiving the steroid. The mother reported with the previous dose of INFANRIX the subject experienced swelling. She clarified the swelling was at the injection site on the leg. She stated this would be the third dose of INFANRIX and the injection site swelling was with the previous dose of INFANRIX. At the time of the report, the outcome of the injection site swelling was unknown and the reporter refused to be contacted for follow-up.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. consulted with the  Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Between 20-60 minutes of receiving the vaccine in my left arm, my lips and face started tingling and going numb, a sensation very similar to receiving  novocaine when visiting the dentist. The sensation was primarily felt on the left side of my face, and had also affected my left arm, chest and leg by the time I was seen at the urgent care clinic. A MRI was conducted to rule out any kind of stroke event.
Pneumococcal 23-valent vaccine 0.5 ml and influenza virus vaccine 0.5 ml documented given 10/8/13, both in the (R) upper arm 10/8/13 1400 area of redness and swelling ID'd as area of the vaccine administration 10/8 1228 BENADRYL 50mg IV, 10/8 1630 BENADRYL 50mg IV, 10/8 1754 BENADRYL 40mg IV.
red area on rt arm about size of fifty cents piece;warm/hot to touch;immed rxn
Symptoms started at 3:00 AM on 01/05/2021, complains of headache, body aches, temp 100.4, congeston, fatigue. Took Tylenol for fever.
Patient woke from a nap. Took usual feeding, then vomited. Mom laid patient on his back and he ?, shaking, eyes rolled back; lasted for 10-20 seconds. Vomited some juice about 1 hour later, but had no recurrence. Hospitalized for observation; no recurrence. The discharge summary states low grade fever. Also, the diagnosis is stated as "Possible seizure post vaccination with vaccination reaction."
BLOOD SUGAR WAS OVER 200; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, allergy to penicillin, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included insulin for type 2 diabetic. On 25-MAY-2021, the subject experienced blood sugar was over 200. Laboratory data included: Blood glucose (NR: not provided) over 200 (unit unspecified). On 26-MAY-2021, Laboratory data included: Blood glucose (NR: not provided) before breakfast blood sugar was 150 (unit unspecified), after eating blood sugar was 200 (unit unspecified). Laboratory data (dates unspecified) included: Blood glucose (NR: not provided) normally was 100-150 (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood sugar was over 200. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
1. Excrucitating pain going down her hip-she was crawling on the floor unable to walk 2. High fever 103 3. Vomitting 4. Lost sight completely momentarily
54 y/o M with PMH of HTN, HLD, Alcoholic Cirrhosis, Aortic Valve Stenosis, and angina BIBA as a Medical Alert for cardiac arrest noted PTA. Per EMS, the patient called because he was having constant, diffuse abdominal pain x 1 day that radiated to his chest. On scene, the patient had a witnessed arrest with EMS starting CPR. He was given 3 rounds of epi without ROSC. Pt had no associated shockable rhythm. Of note, pt's wife, had noted pt had received covid vaccine the prior day.
Information has been received from a physician concerning a 9 year old female who was vaccinated with VARIVAX vaccine (Oka/Merck) (route, lot number and site not reported). Subsequently the mother of the patient told the physician that the patient experienced a 4 inch by 5 inch softball size swelling at the injection site of the arm within 24 hours. There is no information of which arm. The patient was treated with oral diphenhydramine hydrochloride and has recovered. This was a recent occurrence, but unknown date. There is no other information. The patient sough medial attention. Further information has been requested.
patient developed unprovoked deep venous thrombosis in left leg one day after receiving 2nd Moderna vaccine
25 year old pregnant female received covid vaccination approximately 2-3 weeks prior to her expected delivery date. Her and her husband lost their baby due to placenta separation caused by a blood clot to the fetus. The root cause of the blood clot was determined to be the vaccination.
Woke up entire body was still.  Extreme dry mouth.  Nausea.  Every joint aching (wrists, ankles, neck, elbows, knees, and shoulders.  Fever over 100.  Runny nose and cough.  Extreme fatigue, especially when standing.  Burning sensation in eyes (possibly related to the fever).  Got tired when walking short distances, taking deep breaths because of chest tightness.  Pins and needles sensation in no particular location (felt like I was being poked).  Need to mention that this injection was painful and the other two were not, I wonder if it had something to do with the technician not injecting in the right sport or hitting nerve).
Patient called and reported leg pain and numbness starting today. I advised patient to go to the emergency room as similar side effects were reported by other patients who had clots after receiving the Janssen vaccine.
1 of 5 pts ranging in age from 4-10 yrs who had inject site rxn (redness & swelling) & fever of 102-104 w/in 24 hrs post immun, despite premedication w/APAP; pt had previous rxn to DTP & therefore was immunized w/DT;
severe headache.  both inner ears ached.  trembling - could not get warm.  entire body ached - even my fingers
I started to feel very sick, I felt very hot, my teeth started to chatter, I started tremble all over my body.  I needed to lie down.   I fell asleep for a few hours.  When I woke I was feeling better.  By nighttime, I was back to normal.
Flu like symptoms; General body aches; Low graded fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (General body aches) and PYREXIA (Low graded fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (General body aches) and PYREXIA (Low graded fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (General body aches) and PYREXIA (Low graded fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
backache; lymph node inflammation; arthralgia; headache; pain at the vaccination site; Vaccination site inflammation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Vaccination site inflammation), BACK PAIN (backache), VACCINATION SITE PAIN (pain at the vaccination site), LYMPHADENOPATHY (lymph node inflammation) and ARTHRALGIA (arthralgia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Apr-2021, the patient experienced VACCINATION SITE INFLAMMATION (Vaccination site inflammation) and VACCINATION SITE PAIN (pain at the vaccination site). On 17-Apr-2021, the patient experienced BACK PAIN (backache), LYMPHADENOPATHY (lymph node inflammation), ARTHRALGIA (arthralgia) and HEADACHE (headache). At the time of the report, VACCINATION SITE INFLAMMATION (Vaccination site inflammation), BACK PAIN (backache), VACCINATION SITE PAIN (pain at the vaccination site), LYMPHADENOPATHY (lymph node inflammation), ARTHRALGIA (arthralgia) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information not provided.