chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a patient who was received vaccine ADACEL, lot number not reported via unknown route in unknown administration site after the excursion and this case also involves vaccines temp excursion of FLUZONE QUADRIVALENT (batch number, expiry date, route and site of administration were unknown). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Incorrect product storage as temp excursion with ADACEL and FLUZONE Quad, at 29.0F for 21 hours, unopened product. She also stated that the ADACEL had been given after the excursion It was unknown if any adverse event was occurred. 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. Documents held by sender: none.
Patient with dizziness, feeling off balance persistently for many months ongoing since vaccination. Negative cardiac work-up, resp.
flu; kidney failure; Initial information was received on 24-Oct-2020 regarding an unsolicited valid serious social media case from the consumer (patient).   This case involves a patient of an unknown demographics (current age reported as 67-year-old patient) who developed flu (influenza) and kidney failure (renal failure), while the patient received INFLUENZA VACCINE.  The patient got vaccinated with flu vaccine every year for prophylactic vaccination.  The patient's medical history, medical treatment(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date (reported as several years ago), the patient developed serious flu (influenza) and kidney failure (renal failure), (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for flu on an unknown date for a week and had kidney failure. The event of kidney failure was also assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was not reported.  Information on batch number requested.; Sender's Comments: This case concerns a patient of an unknown demographics who had influenza and renal failure, after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Also, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.  This case was linked to case 2020SA302174 (same reporter).
the evening of vax pt arm ached & got red;pain increased through the noc;following day arm swelled & pained-quite red;the swelling traveled through the elbow area;it was so hot pt went to ER;
Menstruation started 5 days early.  Very abnormal for my cycle, especially with the taking of birth control pill.
Fever Chills Nausea  Swollen lymph nodes on clavicle and under arms
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In June 2011, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (strength, route, dosage schedule, and lot number were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2012, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed ibuprofen and VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, pain, suffering and other damages on unspecified dates. The outcome of the events was unknown. Vaccination failure, emotional distress, painful injury, damages and herpes zoster were considered to be related to ZOSTAVAX.
A massive flare up. i went to the primary doctor and she submitted  me to the urgent care
Single migraine starting 5/6/21 that did not go away for weeks, varying in severity from 3 to 8 (out of 10). Ibuprofen helped dull the pain, but it never fully dissipated. On 5/27/21, I had an urgent tele-health appointment and was prescribed Prednisone 50mg for 7 days and Hydrocodone. Neither helped. On 6/4/21, I went to  urgent care. A CT Scan was done and came back normal. I was prescribed 50mg Sumatriptan. It didn't help. On 6/11/21, I had an appointment with my primary care doctor and she prescribed 25mg Metoprolol twice a day. My migraine was gone 3 days later. On 6/23/21, my Metoprolol was lowered to 25mg once a day. On 6/30/21, I stopped taking Metoprolol. My headache has not returned. When I initially met with my PCP, she knew exactly what had caused my migraine and how to treat it. Unfortunately, it's very difficult to get appointments with  doctors without a long wait.
After booster, on/around 04.23.22, started as tenderness at injection site (left upper arm, all injections at this site). As the week has gone by, tenderness has gotten worst. It's progressed to pain to where it's hard for me to sleep.  I had this 47 day diarrhea problem that I cant figure out. They have tested me for covid, and it's negative. I have to have a colonoscopy, because of the diarrhea. Now seeing gastrologist (listed info on report).
I developed thyroid modules, brain fog, and went into menopause same month as vaccine.  Never had another period after the vaccine.
The client received 0.5 ml/ 50 mcg of the Moderna 6 month -11 years lot number AU5555B.  No adverse symptoms or issues noted by patient
Arm soreness for 48 hour; Fatigue; muscle aches; chills; This is a spontaneous report from a contactable physician (patient). A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number:20201216-830), via an unspecified route of administration on 16Dec2020 15:00 at arm left at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. No other vaccine in four weeks. Medical history included hypothyroidism and hyperlipidaemia. The patient had no known allergies. Concomitant medication included levothyroxine, atorvastatin, ergocalciferol (Vitamin D) for an unspecified indication. The patient experienced arm soreness for 48 hour then fatigue, muscle aches and chills on 3rd and 4th days after vaccination on 19Dec2020 at 08:00 AM. No treatment was received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of the event was recovered.
developed macular papular rash over his left leg that is non-blanching extensive, mildly itchy
Per internal reported event: COVID vaccine given 12/29/20 1500. Pt reports dizziness and feeling hot at 1515, diaphoretic. Vaso-vagal response. Assisted pt to wheelchair, given water and cool compress. Pt was monitored for an additional 15 minutes, and ambulated home with steady gait at 1534.
Employee c/o rash right and left lower arms c/o rash, very itchy. He started taking Benadryl, with relief, no active, wheal or flare was examined by Dr pass reaction to JE immunization. Continued taking Benadryl advised not to travel at this time, hyperemia lesions on the arms and trunk. Got better. Seen 6/28/04 at 10:53AM improved.
lymph node swelling in axillary area on the injection side; lymph node swelling in axillary area on the injection side and it's painful; This is a spontaneous report from a contactable nurse and other hcp (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number: EL1283, expiry date: unknown), via an unspecified route of administration on 11Jan2021 09:00 at single dose (left deltoid) for COVID-19 immunization. There were no medical history and concomitant medications. On 12Jan2021, patient had lymph node swelling on the same arm as the injection site. It got worse on the 13th. She described her experience as uncomfortable. She was asking how long it is expected to last. It was further reported that the patient received first Covid-19 vaccine on 11Jan2021 and is doing well, but had lymph node swelling in axillary area on the injection side and it's painful on 12Jan2021. She wanted to know how long it will be like that and if it doesn't go away when should she seek medical attention. Received the vaccine on the 11th and a couple days later had the lymph node swelling. She then clarified lymph node swelling started the 12th. Mentioned it got worse yesterday and it's staying about the same today with the swelling and is very uncomfortable (Jan2021) and is persisting. Causality not provided. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in the past. Vaccination Facility Type was Clinic. The outcome of the events was not recovered. Events reported as medically significant.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events swollen lymph nodes and lymph node pain.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
S/p pneumatic retinopexy right eye C3F8 (2/14/23) OD CSR
Within 2 minutes of receiving the injection, my feet became tingly/numb.  I felt the need to sit down.  Within 5 minutes of that, my hands were tingly.  These effects lasted between 2-3 hours..  I was able to walk, but I could definitely feel it in my feet.
Patient was given the pediatric dose of Pfizer vaccine. He was 12 at the time so should have received the adult dose.
4h after vaccine administered child developed generalized urticaria. Also joint pain and swelling over subsequent 3-4d. 1 week later, still with erythema multiforme.
aching, swelling, redness at injection site, pain level "7" at injection site per patient - Tylenol given
Chills 2 nights, some nausea without vomiting. Very sore arm with swelling, redness in area of vaccination by day 5. Area "stings" or "burns", is sore to touch & has not improved w/TYLENOL, ALEVE, or ice packs. 3" x 2" area is hard, swollen.
Suspected vacination failure; Potential episode of Shingles; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number K2ZY4, expiry date 13th April 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provide as follows: The age at vaccination was not reported. The patient received both doses of Shingrix within the time frame. It was necessary to report a possible scenario of Shingles on a patient. The reporter wanted to know, If an episode of Shingles was confirmed for this patient, it was told to the health care provider to report it and provide further information if it was necessary. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
Mom took child to ER on 9/10/04 due to the swelling and redness of the injection site, left leg. Child was put on Keflex due to localized reaction. VS early cellulitis (9/10/04) On 9/13/04 child seen for flu and the cellulitis was improving only slight induration, slight red growth. No tenderness. Left leg.
Per Medical Examiner, fourteen hours after receiving vaccine presenting symptoms were fatigue and muscle aches, went to Hospital Emergency Room and was released.  Six hours later family stated symptoms had worsened, fever, shortness of breath and fatigue, admitted to Medical Center, diagnosed with sepsis and died within 48 hours of vaccination, deceased 4/7/2021, cause of death neutropenic sepsis with multi-lobar pneumonia, autopsy scheduled 4/13/2021.
Reaction from the flu shot; Initial information received on 14-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 76-year-old female patient who experienced reaction from the influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.    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 vaccination (Influenza immunisation).  On an unknown date the patient developed a non-serious reaction from the flu shot (allergy to vaccine) (unknown latency) following the administration of influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event reaction from the flu shot.
Info has been received from a physician concerning a 75 year old female who on 10/30/2002 was vaccinated intramuscularly in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (Lot #643504/0735M). On 10/30/2002 concomitant therapy included an intramuscular dose of influenza virus vaccine (FLUZONE) (lot number U0920AA) in the right deltoid. On 10/30/2002 in the PM, the pt developed a local reaction at site of the pneumococcal vaccine 23 polyvalent with redness and itching, that was reported on 11/01/2002. Subsequently, the pt recovered. The physician also reported on 4 other pts (WAES #0302USA02179, 0303USA01861, 0303USA01728 and 0303USA01730). No further info is expected.
After 2nd moderna vaccine, patient missed her period the same month.  Negative pregnancy test. Patient's periods have always been regular and lasting 5-7 days, never missing a period except when pregnant. After moderna booster on 11/22/2021, patient's period started 11/29/2021 and has continued heavy for at least 10 days when she was evaluated by me on 12/10/021.
Information has been received from a physician concerning a 11 year old male with no pertinent medical history or drug allergies who in approximately 1997 was vaccinated with a dose of Recombivax HB. There was no concomitant medication. In approximately 2007 the patient developed jaundice and abdominal pain about two weeks after vaccination. Unspecified medical attention was sought. At the time the patient was hospitalized to perform liver function studies which revealed elevated liver enzymes and the source of symptoms. Subsequently, the patient recovered and had only two office visits for sickness. There was no product quality complaint. Additional information has been requested.
Approximately 15 minutes post GARDASIL vaccine, patient started to feel very tired and feeling "warm" on her cheeks. Mom stated her cheeks appear "puffy" and patient felt slightly dizzy for a few seconds when going from lying down (which we had her do when the complaints started) to a sitted position. EHT's called and transported to local ER due to "puffiness" of cheeks.
The AM I received my shot it swelled up so large it made my bicep shirt sleeve tight from my shoulder to my wrist.  Recieved meds from clinic.
Moderna COVID-19 Vaccine EUA.  Aching Joints and Muscles, runny nose and eyes, Chills, Headache, Sweating
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old female patient who received vaccine MENACTRA. The patient's past medical history and family history were not provided. Concomitant medications included FLUARIX QUADRIVALENT 0.5ml in left deltoid on 09-Oct-2018. On 09-Oct-2018, the patient received a second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6015AA, expiry date 06-Oct-2019 via intramuscular route in unknown administration site. The patient also first dose on unknown date two and half weeks ago for same suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. It was an actual medication error due to extra dose administered. It was reported that MA gave MENACTRA on 10/9/2018 to an 11 yr old had the first dose in the series of MENACTRA 2 1/2 weeks previously and the MA read the record incorrectly and gave it again. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
nausea; nasal drip; acid reflux to the point that she cant eat or look at pictures of food; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-May-2021 and was forwarded to Moderna on 10-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), RHINORRHEA (nasal drip) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux to the point that she cant eat or look at pictures of food) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced NAUSEA (nausea), RHINORRHEA (nasal drip) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux to the point that she cant eat or look at pictures of food). At the time of the report, NAUSEA (nausea), RHINORRHEA (nasal drip) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux to the point that she cant eat or look at pictures of food) outcome was unknown. Not Provided          No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-053003 (Patient Link).
Body aches and low fever (99-100) for 48 hours. Felt like beginning of flu, but resolved in two days (recommend this shot on a Friday). Symptoms manageable with TYLENOL. 2nd dose today about two hours ago. So far no symptoms.
Vaccine is administered COVID 19 , Pfizer BioNTech past its useful life. Shelf life date 11/17/2021 7:00  am
Couple minutes after receiving the vaccine patient was: diaphoretic heart rate mid 30's did drop to high 20's, weak, diazzy.  Blood pressure 149/80. Incident lasted approximately 15-20 minutes and symptoms resolved. Action took was monitor patient.
Night of getting the vaccine she was freezing cold and her joints started to hurt.  The next morning she had a terrible headache and felt achy all over.
9/9/09- Injection 1100 am. 2-Tylenol at 100 pm -  arm tender 300pm- tightness in chest - unease 310pm - Diarrhea /ABN Cramp/ Nausea -vomit dizziness/ sweating/Chills / elevated ABD pain 2 hr -course.
Both shots were given in the wrong place (subcutaneously). They were given on the back of the arm, into fat/tissue. The shot on the left arm has caused sustained redness and pain.
Pt recd 1 dose of Engerix-B 11JUL91 & was uneventful; 2nd dose recd 27AUG91 & 2 hrs post vax, exp facial swelling exp upper lip & eyes, photosensitivity, T104 & joint pain in hips & knees; 6 days post dose exp flu-like sx & herpetic lesion;
Case number PHEH2014US020234 is an initial spontaneous report from the health care professional (patient) received on 01 Oct 2014. This report refers to an adult female patient. She was vaccinated with FLUVIRIN (batch number: not reported) in the previous year and her arm was swollen, red and hot (see case: PHEH2014US020232). She was again vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date, after vaccination her arm was swollen, red and hot. The outcome of the event was not reported. The patient received FLUVIRIN for the next 6 years and experienced similar events (see cases: PHEH2014US020235, PHEH2014US020236, PHEH2014US020237, PHEH2014US020238, PHEH2014US020239 and PHEH2014US020240).
I took my daughter to have her shots done for school on arrival they gave me the paper work for dtp, polio,and mmr. That is what she was supposed to receive.They gave me my paperwork to take to school and I looked it over when i got hon and noticed that they had the days date located on pneumonia conj and not mmr so i called them immediately to see what had happened this had all occured on 3/17/05. well they put me through to the nurse and she put me on hold a minute then came back got my phone number and said it would take a minute to figure out what she had done,then she would call me back. About 45 mins. later she returned the call and said that she had actually received the mmr and not the pneumonia shot and that she had entered in the wrong code and that she had to wait till this morning to change when the supervisor was in. Then someone called this morning and said that she got the pneumonia shot and not the mmr.So after they have gave me two or three different stories I am not sure and really think they are not sure what they actually gave her. I need something done but cannot keep torchering myself nor my daughter. After reading this you can understand why i cannot answer number thirteen fully.