chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt went from walking without aids to requiring cane or walker and having severe  pain that started in his feet and ascended to his knees and sometimes to his thighs and hands.  Unable to walk more than 10 feet without sx.  Once sx start it can take an hour or more for them to resolve while lying down.
Received shots 2/13/13, at dinner time she "slumped over" in high chair, would not respond, when pulled from high chair had jerking movement.
Uncontrollable rapid head jerking! Non stop crying and screaming for 1 1/2 to 2 hours and redness and swelling at injection site. Glassy eyes.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 22May2021 as dose 1, single (Lot number: EW0179), in right arm, on 18Jun2021 as dose 2, single (Lot number: EW0178), in right arm and on 06Jan2022 as dose 3 (booster), single (Lot number: FJ1611) at the age of 32 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Tested negative on COVID 19;(28May2022) Positive, notes: I was tested positive again on COVID 19. Therapeutic measures were taken as a result of covid-19. Clinical course: Anti viral Paxlovid was given from 21May2022 to 25May2022 for Treatment of COVID-19. After finishing taking Paxlovid, patient tested negative on COVID 19 but three days later he was tested positive again on COVID 19.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and allergies were not reported. Concomitant therapies were not provided. On 08-JUL-2016, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB  "10 microgram/1 ml, 10X1 DS/V TF" with lot number L042846 and expiration date of 15-SEP-2017, (dosage schedule, route and anatomical location were not reported), which was stored at 12 Celsius Degrees for 136 hours. The type of excursion and the storage criteria were reported as refrigerator (R) and the vaccine status in excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Redness/pain/swelling at her vaccination site developed shortly after receiving her COVID-19 vaccine on 12/27/2020.   She states the pain improved after a couple days, but the redness and swelling has remained about the same.  She also reports daily low-grade headaches in this timeframe.  She has been taking Tylenol and Aleve, in addition to her regular meloxicam for knee arthritis.  She denies any fever/body aches/chills, no nausea/vomiting/diarrhea, no other associated symptoms
Started day of injection (Thursday) with some soreness and feelung a small lump at injection site, the next day i was very tired and nauseous and the swelling had increased to a golf ball sized lump and my armpit was sore. The next day (saturday) it was swollen a little more. Today (sunday) its still swollen and red, about the same as it was saturday, and my armpit is still sore.
Muscle aches; tiredness; injection site pain (left arm); swollen and painful lymph nodes in left armpit and left side of neck; painful lymph nodes in left armpit and left side of neck; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0172), via unspecified route of administration in left arm on 30Apr2021 16:30 at age of 40-year-old at single dose for COVID-19 immunization. Medical history included allergies, arthritis. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant at time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0158) in Apr2021 05:45 PM in Left arm for COVID-19 immunization. The patient received medications within 2 weeks of vaccination included ibuprofen. The reported event included muscle aches, tiredness, injection site pain (left arm), swollen and painful lymph nodes in left armpit and left side of neck. Adverse Event start on 30Apr2021 07:00 PM. Seriousness criteria was reported as non-serious. No Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. It was unknown if patient recovered from events.    No follow-up attempts are needed. No further information is expected.
Severe headache, body ache , extreme fatigue, rapid heart rate 112 fever chills
Hospitalized 9/30/2021; COVID-19 positive 09/30/2021; fully vaccinated  CHIEF COMPLAINT: Pneumonia due to COVID-19 virus  Weakness, found down at home  Assessment/Plan  ASSESSMENT/PLAN: Principal Problem:  Pneumonia due to COVID-19 virus  Sepsis due to COVID 19 PNA with concern for superimposed bacterial pneumonia  Positive Test: 9/30 Symptoms Onset: 9/23 First Date of Eligible clearing of covid restrictions: pending review Symptoms: weakness, cough, emesis and diarrhea Tachycardic, tachypnic, WBC 27, LA 2.1   Treatment: Started on Decadron 6 mg and Remdesivir  Supplemental O2, wean as able. Worsening tachypnea with RR 30s. STAT VBG pending. There was a question of a possible bacterial component in the ED and vanc cefepime ordered. CXR seems viral. Procal added and elevated - will cover for superimposed bacterial pneumonia with Rocephin/Zithromax  Supportive Care with PRN anti-emetics, anti-tussives, anti-pyretics. Isolation and prone as much as possible and as frequently as possible. Daily CMP, daily complete blood count and D-dimer x3. VTE prophylaxis with Lovenox.   Current oxygen requirement: SpO2: 94 % O2 Flow Rate (l/min): 2 l/min Note from 10/4/2021: Note from 10/4/2021: CHIEF COMPLAINT: Pneumonia due to COVID-19 virus  Assessment/Plan   ASSESSMENT / PLAN:  Acute Hypoxic Respiratory Failure COVID19 Pneumonia Sepsis secondary to above  S/P vaccination earlier this year Symptom onset was on 9/23, tested positive on 9/30 Initial CXR with diffuse abnormal parenchymal opacities, left greater than right  Follow up CXR on 10/4 with increase bilateral airspace disease and less likely vascular congestion  Currently requiring HFNC with 100 % FiO2 at rest- increased in past 24 hours  Immune labs including CRP and D-dimer very elevated but improving Patient also with elevated Procalcitonin  On Decadron 6 mg daily x 10 days Remdesivir started on 9/30 x 5 days Continue with antibiotics for superimposed bacterial pneumonia coverage x 5 total days Give one time dose if Diuril with findings of possible CHF component on follow up CXR  Encourage proning Continue with anti tussive medication PRN Follow immune labs which are improving  Lovenox SQ increased to treatment dose due to high d dimer and superficial thrombus seen on venous US Note from 10/7/2021: CHIEF COMPLAINT: Pneumonia due to COVID-19 virus Assessment/Plan  ASSESSMENT / PLAN: Acute Hypoxic Respiratory Failure COVID19 Pneumonia Sepsis secondary to above S/P vaccination earlier this year. Symptom onset was on 9/23, tested positive on 9/30 Initial CXR with diffuse abnormal parenchymal opacities, left greater than right. Follow up CXR on 10/4 with increase bilateral airspace disease and less likely vascular congestion Currently requiring HFNC with 100 % FiO2 at rest Patient also with elevated Procalcitonin On Decadron 6 mg daily x 10 days Remdesivir 9/30 x 5 days Completed abx course x 5 total days  Encourage proning. Lovenox 1mg/kg BID for DVT. Patient remains critically ill and receiving maximum non-invasive oxygen support. DNR/DNI
Area around injection site became red the next day after the injection. The site was still red and itchy 2 weeks later. Advised Benadryl and hydrocortisone cream to treat, and to see the doctor if symptoms persist.
Approximately 1 min post vaccination pt reported tingly all over for started to swell, chest became tight and throat swelling EMS contacted given Epi 0.3 and 25mg, Benadryl IM and throat swelling on around minimal wheezing Solu/Tosant/Benadryl monitoring x 4 no insult.
Persistent cough with mucus since 9/10 when 2nd dose was administered on 9/7. Tested negative for COVID.
Dizzy; twitching; foggy; fatigue; swollen glands; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizzy), MUSCLE TWITCHING (twitching), FEELING ABNORMAL (foggy), FATIGUE (fatigue) and LYMPHADENOPATHY (swollen glands) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Since childhood), Drug allergy (sulfa), Drug allergy (amoxicillin), Latex allergy, Food allergy (pork) and Allergy (gelatin). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced MUSCLE TWITCHING (twitching), FEELING ABNORMAL (foggy), FATIGUE (fatigue) and LYMPHADENOPATHY (swollen glands). On 13-Mar-2021 at 5:00 AM, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy), MUSCLE TWITCHING (twitching), FEELING ABNORMAL (foggy), FATIGUE (fatigue) and LYMPHADENOPATHY (swollen glands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIZZINESS (Dizzy), MUSCLE TWITCHING (twitching), FEELING ABNORMAL (foggy), FATIGUE (fatigue) and LYMPHADENOPATHY (swollen glands) to be possibly related.    Patient experienced significantly sinus swelling and pressure with pain behind eyes, nose and cheek tows. No treatment medication were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received vaccine. It was unknown if patient had taken other medications in two weeks. Anti-viral details provided as, Paxlovid used for covid 19 treatment, start date 06Aug2022 and treatment stop date given as 11Aug2022. Indication was reported as treatment of COVID 19. Event Rebound start date was 15Aug2021 and start time was 12:00 PM. It was unknown if patient recovered. No treatment for AE.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
It is 22 days post vaccine and still having pain at the injection site.  Pain and achiness when moving arm with certain activities or moving in certain directions such as taking off shirt
Arm a little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm a little bit sore) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm a little bit sore). At the time of the report, PAIN IN EXTREMITY (Arm a little bit sore) outcome was unknown.            No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-368995, MOD-2021-369010 (Patient Link).
received an expired dose; a 65 year old / received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 65-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA14AB, expiry date 31st March 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th May 2021, the patient received the 2nd dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 5th May 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows:  The certified nurse aid (CNA) reported that on 5th May 2021, the patient received Bexsero which was already expired on 31st March 2021.  The patient was 65 year at the time of vaccination which led to inappropriate age at vaccine administration. The reporter consented to follow up.
This is a spontaneous report from a contactable nurse. A 58-year-old female patient received PREVNAR 13 (Lot # G41025; expiration date 31Dec2014) intramuscular at 0.5 ml, single dose in the left arm on 19Dec2014. Patient medical history and concomitant medications were none. On 20Dec2014, the patient experienced swelling of LOA and area of injection LOA 3 cm erythema and induration with outcome of recovering. The events were treated with BENADRYL. The reporter considered the PREVNAR 13 had a causal effect to the adverse events. Follow-up (09Jan2015): New information obtained from a contactable nurse includes: Lot # and expiration date, time and anatomical location, onset date of the events, event description erythema indurated updated to erythema and induration, reporter's assessment. Follow-up attempts completed. No further information expected.
shingles after getting the first dose; she is experiencing lower left quadrant back pain; This is a spontaneous report received from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number unknown) as a single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unknown date in Mar2021 after getting the first dose, the patient experienced shingles and lower left quadrant back pain. The clinical outcome of the shingles and lower left quadrant back pain was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
I received the first dose of the Moderna COVID vaccine; My L arm is still bright red, swollen, and very itchy. It has been 8 days;
During post-vaccination observation period patient reported sensation of throat feeling "thick".  No other complaints.  diphenhydramine 25mg oral suspension administered with resolution of symptoms by time of discharge from facility.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
Patient stated redness, swelling, and itching at the site of injection site on Wed 17 Oct 2012 after she got injected.
When lifting arm, or flexing deltoid, deltoid muscle will quiver and spasm. Long term side effect, has been continuous since 2nd dose in the series
With my second shot my arm got very red painful and swollen, That lasted about 10 days and since then I've had tingling in my left arm along with pain and some swelling. So much so that I mostly sleep on the couch due to being woken up from the pain and burning feeling in my upper arm around the injection site, All that has caused me to have numbness and tingling in several of my fingers as well as what feels like fluid rushing through that area as well. At first I thought maybe it was a pinched nerve but its been happening pretty much since my second shot so I'm leaning more towards a side effect from the vaccine. Before I go to the doctor to spend thousands of dollars on tests I may not need I was hoping there might be a cheaper way to go... Like maybe this is common and I just haven't heard about this side effect. But I also don't want to be having a reaction that cold impact my health or possibly kill me. I would love to know if this is something that will go away or if I need to fly to get treatment since our medical here is less than desirable. And if I do need to be seen... Who's paying for this?
Fainted, urinated, nauseated, chest pain start @ 2010. Evaluated by EMS- Transported to Emergency room/department or urgent care.
Swelling in joints, mainly my knees.  And wheezing/bronchial constriction.
Dizziness, Headache, NauseaVomiting, Patient stated she experienced chills, sever low back pain, tingling and chills , dizziness, nausea,headache and fatigue . Narrative:  Patient stated she experienced chills, sever low back pain, tingling and chills , dizziness, nausea,headache and fatigue . was seen in local ED and treated with Tylenol and ?Toradol  Other Relevant History:
Information has been received from a RN concerning an approximately 32 year old female with no past medical history who on 10/31/97 (Lot # 623131/0801E) and on 12/08/97 (invalid Lot # 623890/0701E for this product) was vaccinated with varicella virus vaccine live. There was no concomitant medication. In 2000, the pt tested negative for antibodies. The pt sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Information has been received regarding a case in litigation concerning a 4 year old male who on 13-OCT-2000 was given a multi-vial (first) dose of RECOMBIVAX HB (lot # not reported). On 20-DEC-2000, at the age of 2 months old, the patient was given a (second) dose of RECOMBIVAX HB (lot # not reported). On 25-APR-2001, at the age of 6 months old, the patient was given a multi-vial dose (3rd dose) of RECOMBIVAX HB (lot # not reported). Between October 2000 and November 2004, the patient was vaccinated with vaccines made with the preservative Thimerosal, which contains toxic substance mercury, causing him to develop and sustain autism. In 2004 the patient's doctor diagnosed him with Autism-"ASBERGER". Upon internal review, the patient's Autism-"ASBERGER"was considered to be an other important medical event. No further information is available.
Shingles vaccine given on same day as, or close to time of, receiving other vaccines such as hep B and other travel vaccines - maybe typhoid.  Several days later, I did not feel well - had some pain around chest - doctor said it sounded like I had shingles, but I had no rash.  On May 11 2006, I did have one rectangular rash, diagnosed by doctor as shingles.  This is exact date, but date of inoculation is approximate - it might have been a day or so earlier.  No treatment was required - but I remember this date because I didn't feel well for son's wedding.  I had  not been told that you could get shingles from shingles vaccine.
High Fever (103) for 4 days, lower lobe pneumonia, headache pain, real fatigue, lack of appetite, dehydration.
Approx 3 min /p vax, became clonic & nonresponsive for 1 min, stated has hx of past seizures while semiconscious. Parent signed permission slip, school records have no hx of seizures as noted by parent
Fully vaccinated with Moderna: 2/17/21, 3/1921.  Hospitalized 12/20/21
About 12 hours after my second Pfizer vaccine, I developed the typical muscle aches and fatigue lots of people experience.  I had no reaction to the first shot but occasional hypoglycemia.  About 8 days after the second shot, I started to itch on my upper back  and over the last 3 days have developed a red, splotchy rash on my upper back.  The inside of my left arm and both lower legs also itch, but have few hives. It took me a few days to figure out this must be a reaction to the vaccine, as I have not been exposed to any other allergens.
got INWARD SHINGLES ended at  for 3 weeks; They were just as painful; Suspected Vaccination failure; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles (serious criteria hospitalization) and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingles vaccine at least two years before the date of reporting and then doctors told the patient that the patient had inward shingles and ended at hospital for 3 weeks and it was just painful. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.