chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately a week and a half after my second Covid vaccine, I began to have pins-and-needles sensation in my toes. It was subtle at first, making it hard for me to pin down exact day. I did note for sure, while driving to an appointment, on the morning of 2/17/21 that I did have this pins-and-needles and numb sensation in all my toes, bilaterally. It continued over the next weeks. The sensation was persistent with pins and needles to toes and somewhat to balls of feet, numbness to the tips of my toes. After about 2 weeks of this, I began to have slight numbness to the tips of my fingers with intermittent tingling surges through my hands. After 3 weeks of this not getting better, I started to become concerned.  I do have an undifferentiated connective tissue disorder and was on Arava (leflunomide) at that time (started October 2020). I called my rheumatologist as I thought it might be related to my disease process or medication and had a visit with her 3/19/21. They were not sure of the connection with leflunomide, but stopped the medication due to other issues (persistently low blood counts). I was started on Plaquenil at that time. I started a B vitamin supplement as well, as low vitamin B can be related to small fiber neuropathy. Since that time, my neuropathy has continued in my toes with worsening numbness. I am not diabetic. The plan now is for me to have biopsies of my ankle, calf and thigh, to be performed at my next rheumatology visit in July.  Also, I had Covid end of October, and was quite ill. I am still dealing with quite a few long covid symptoms that both my primary care physician and my rheumatologist are trying to sort out: intermittent chest pain, fatigue, ongoing diarrhea, lung nodules and granularity. This has made the diagnosis of the neuropathy more complicated.
Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Swollen lymph nodes; This is a spontaneous report received from a contactable consumer, the patient.  A 61-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration on left arm on 18Mar2021 at 09:45 (at the age of 61 year) as a single dose for COVID-19 immunisation.  Medical history included high blood pressure, asthma and food allergy (some food sensitivities). The patient received unspecified medication within 2 weeks of vaccination.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration on left arm on 25Feb2021 at 09:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation.  Past drug history also included DEMEROL for which patient developed allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine.  On 18Mar2021 at 15:30, the patient experienced vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell and swollen lymph node.  No therapeutic measures were taken in response to the events.  The clinical outcome of the events vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell and swollen lymph node were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
24 hours after vaccine administration patient developed subjective fever, headache, nasal congestion and cough.
SHARP ACUTE PAIN IN LEFT SIDE OF ABDOMEN IN FRONT AND BACK AS WELL; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: environmental allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced sharp acute pain in left side of abdomen in front and back as well. On JUL-2021, Laboratory data included: Blood test (NR: not provided) Negative, and Diagnostic ultrasound (NR: not provided) No abnormalities found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp acute pain in left side of abdomen in front and back as well. This report was non-serious.
Vomited, achy felt feverish never took temp, around 9:00pm had strange feeling in throat felt like she couldn't breathe, waited and this feeling subsided in 30min and then went to bed.
This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored post temperature excursion doses of GARDASIL lot # K006960 and expiration date on 19-FEB-2017 (doses and route were not provided) on the following dates: 03-APR-2015, 25-APR-2015, 07-MAY-2015, 28-MAY-2015, 04-JUN-2015 and 16-JUN-2015. No adverse effects reported. Additional information has been requested.
7/24/2014 at 5pm at EOH c/o "itchy" all over (no rash) - feels like her throat is tight with normal speech. BENADRYL taken by employee TX: (1)CLARITIN and PEPCID (2) prednisone 60 mg x 5 days (1 dose given). 7/25/2014 SOB (shortness of breath) chest tightness at ED. Temp 97.8.
Injection side is swollen,  Warm to the touch. Reddish, Pain level of site is a 3 out of 10
Child was sleepy on 12-9-09 - EMT called due to child walking "funny" - was examined. Mother took child to pediatrican - was told not due to vaccine.
Patient was seated in observation area and RN noted she was crying.  Caregiver accompanied patient stated she was upset because she was separated from her son. Caregiver also reported the patient was experiencing nausea.  11:33 patient taken via personal wheelchair to observation area with son, caregiver, RN & EMT patient encouraged to take off her mask, face shield and take some deep breaths; door opened for fresh air & waste basket provided;  caregiver & son reported that patient frequently has nausea, and also got car sick on the drive to vaccine clinic 11:35 VS 169\94 | HR 94 | PO2 97% water provided to patient and son gave her an aspirin (brought from home) 11:37 son gave patient alcohol based hand sanitizer and stated she often smells this to help with her nausea 11:40 patient reported she felt better, nausea passed, and had calmed down 11:43  VS 140\78  11:45 patient discharged via personal wheelchair to home with caregiver & son
5-10 minutes after receiving influenza (Fluzone) vaccine, pt c/o throat swelling. Epi and Benadry administered. O2 administered. Transferred to ED.
Had Flu Shot L Deltoid, 1 half hours later numbness from mid forearm (outer aspect) radiating into l little finger, approx 15 minutes later numbness l side face. 11/11/07- symptoms  persist no improvment - saw physician 11/7 who stated that s/s unlikely to be vaccine related.  11/26 FU with client  sysmtoms decreasing, has put in Workman's Comp Claim  - client's physician ref her to neurologist -  first appointment  12/21 2007
L upper arm swelling, redness, pain extending from injection site. Entire arm swelled from site to finger tips. Numbness in hands and fingers. Currently recovering.
Received IM flu vaccine, had local pain at time of injection, no swelling or erythema, now with ongoing local pain 2 months later.
first dose of ROTATEQ was given to unspecified patient at "15 weeks old"; Information has been received from a Medical Assistant referring to a 15 weeks old infant. Concomitant medications, concurrent conditions, historical conditions were not reported. On an unspecified date, the patient vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) at 15 weeks old (product administered to patient of inappropriate age).
Patient stated that she start getting a shooting pain in her arm immediately after taking the shot. Her arm was red. She can barely lift it.
Lot of swelling; Large red patch; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 30Mar2021 (Lot Number: EP7534, expiry date: unknown) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Apr2021, the patient experienced lot of swelling and large red patch. Patient Stated had the Pfizer vaccine first dose last week and still having the side effects that was not noted on your, any of your material. It's related to a lot of swelling and large red patch after three days of vaccine which apparently is sometimes seen with the Moderna vaccine. But was just trying to find if there is anything need to do and if it's okay for me to still have my second shot in which due date is 20Apr2020. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient received flu vaccine on 9/26/17 has swelling, redness, pain on the left thigh after the shot. Was seen in our office yesterday 9/27/17 and had benadryl po for allergic reaction at the shot site.  Seen again on 9/28/17 lesion getting worse with increase redness, warmth, and tenderness , no fever. Dr. has placed patient on Cephalexin and ibuprofen. Patient has a recheck appointment scheduled for 9/29/17. Will continue to observe and treat accordingly.
From 2019 until the vaccine I had only had 3 periods. I have always had a hx of PCOS however would have 1 cyst rupture approximately every 4-6 months. Since receiving the vaccine I have had monthly periods, much heavier than the few I had before. I have also had multiple ovarian cysts rupture monthly. Usually 1-2 per day for 4-5 days. So my menstrual cycle has definitely changed as well as hormones.
Light headed, syncope, emesis x 1. Lasted 3 mins total. Patient A & O x 3 post event.
Mother of the patient indicates patient has not stop menstruating since vaccination and she has not suffered from this before.
18 year old female became dizzy and fainted after administering GARDASIL vaccine was taken to the hospital where she got staples on her head.
Pt had localized erythema and induration. He also had a 3-day course of fever.
Patient presented to clinic for a 1 year well child check along with her 4 year old sister. While getting shots ready for each child we placed the shots on separate trays. However when entering the room the trays were placed side by side and one nurse removed 2 shots from one tray so we were left with 2 trays with 2 shots on them. The second nurse then picked up the incorrect 2 shots for the 1 year old and administered them. The parents, nursing supervisor and provider were notified right away and the CDC was called. They stated patient would be fine may just be sore at the site and to keep an eye on her. Following incident reports and VARES filed.
Chills - fever of 100.8 - extreme headache  - arm pain and rash by injection site - joint pain through the whole body - swollen lymph nodes on left side of neck - pain so bad couldn't roll over in bed - fatigue
Reported that he experienced chest pain, irregular heart beat, difficulty breathing and fatigue staring the night he got the 1st dose of the vaccine 6/5/21. Chest pain lasted approx. 7 days (more at night). Palpitations lasted for about 2 weeks (intermittent). Difficulty breathing was only at night when he tried to lay down (lasted about 10 days).  When last seen in clinic 6/29/21 reports all symptoms resolved.
Information has been received from a RN via a company representative concerning a 25 year old female pt, with no past medical history and who was not pregnant, who was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) . Subsequently the pt developed a case of mumps. The mumps diagnosis was verified through urine testing and throat culture. The pt recovered without any treatment. Follow up information received from a RN indicated that on 28Apr1980 the pt received a first SC dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) . On 14Jun1996 the pt received a second dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  SC into the right arm. Concomitant vaccination on 14Jun96 included a 0.5cc dose of diphtheria toxoid (+) tetanus toxoid. It was unknown if the pt was ill at the time of vaccination. On 21Sep2003, the pt complained of ovary pain, bilateral parotitis for approximately one week. It was reported that the pt had malaise, a sore throat, a fever of 103 F, headache and vomited for two evenings. The rapid strep test was negative and throat culture was showed no beta hemolytic streptococci isolated. Serum WBC was 7.2. On 23Sep2003 IgM mumps was .06 and IgG mumps was 2.77 (+) WBC was 10.9 and absolute neutrophils were 7.2. Mumps virus was isolated in cell culture, urine and throat swab. It was unknown if the pt was treated with antibiotics. It was reported that the pt never went to get a requested convalescent IgM and IgG. It was reported that the pt recovered. It was reported  that the pt had no adverse events following prior vaccinations. Prior vaccinations included the first dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid on 22Jan1979, a second dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid on 18Jun1979, a third dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid on 20Aug1979 and a fourth dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid on 19Jan 1981. She received the first dose of poliovirus vaccine live oral on 18Jun1979 and third dose of poliovirus vaccine live oral on 28Apr1980.  No further information is expected.
did not feel well the rest of the day; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (did not feel well the rest of the day) in an 81-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MALAISE (did not feel well the rest of the day). At the time of the report, MALAISE (did not feel well the rest of the day) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742771 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742771:Wife Case
1 week of fatigue, poor sleep. Serious event (seizure activity lasting 1 min followed by 2 hour postictal state) occurred on 12/11/2020.
Onset of intense hyperthyroid symptoms after each dose of Moderna. First onset after combination of two doses  3.5.21 and 4.5.21; second onset after third dose 10.26.21; third and worst onset after 4th dose 4/4/22 and still ongoing as of 8.15.22. Anxiety, nervousness, weak, rapid pulse, heart palpitations, lightheaded, loss of appetite: all symptoms of hyperthyroidism I believe were caused by an immune reaction set off by Covid vaccines.
Pt vaccinated with Engerix-B & felt terrible all over, petechiae rash like Stevens Johnson.
Hospital course: hx of significant chronic kidney disease, diastolic congestive heart failure, hypertension, hyperlipdemia, hypothyroidism, dermatomyositis with respiratory involvement/restrictive lung disease on home oxygen prn, prior PE/DVT on Eliquis; presented to the ER with dyspnea, hypoxia, COVID infection. Dx'd with COVID on 09/03; associated headache, fever, cough, weakness/fatigue, diarrhea, nausea/vomiting since dx. Received monoclonal antibody infusion; sob became significantlu worse after infusion; found to be hypoxic in the 70s on room air, placed on nrb and transferred to to higher level of care center. CT negative for PE, atypical pneumonia patter consistent with COVID diagnosis. Pt received breathing treatments, dexamethasone, remdesivir. Pt subsequently intubated, sedated, and paralysed, broad spectrum iv abx, aggressive pulmonary toileting and ventilator management and seroquel.pt continued to require aggressive ventilator support but unsuccessfully. Prognosis deemed poor. PEG tube placed for nutrition. ICU care continued, remained on PEEP of 10 FiO2 of 60%. 10/17 pt found to have asystole; pronounced at 7:40 am by intensivist.
expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported. The vials were placed in the refrigerator on 6 Dec 2021.
Severe pain in left arm starting on the 9th and still occurring on the 11th. Extreme fluctuate in being hot or cold (not running a fever) just felt extremely hot then cold the next second. Very exhausted on the 10th all day the day after I got the second vaccine.
-High Fever (101+)=10 days; -Sore Throat=10+ days; -Constant Cough=16+ days; -Headaches=10+ days; -Extreme Lethargy=10+ days; -Difficulty in concentration=10+ days; -Loss of appetite=7 days; -Post Nasal Drip 16+ days.
administered the vaccine subcutaneously instead of intramuscularly; a 66-year-old female was administered Menactra; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 66-year-old female patient who was vaccinated with a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via subcutaneous route in unknown administration site on an unspecified date.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error case due to inappropriate route of vaccination and Inappropriate age at vaccine administration. It was reported that they administered it subcutaneously instead of intramuscularly.  It was not reported whether the patient had any adverse event or not.  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.  Information on the batch number was requested  List of documents held by sender: none.
12/31/20-pm upset stomach;   1/1 /21 woke up with diarrhea and mild headache thru the day.  Around 7 pm  felt like a dizzy spell loosing ability to move  with like fog in my head and uncontrolled strong shaking and vomiting.   1/2/21 woke up with no symptoms and feeling fine.
We have some past expiration administrations that have surfaced; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced). On 22-May-2021, EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Was exposed to COVID-19 and started having a bad cough 2 days later; Took a home COVID-19 test and it was negative; Next day took another COVID-19 test and it was positive; Went to an urgent care and was given cough medicine with codeine and prescribed azithromycin; Started feeling better really soon then 3 days later I became really sick again with a severe cough, headache and fever; Went back to urgent care and was prescribed LAGEVRIO and took for 5 days; Retested for COVID-19 and was negative.
Patient was exhausted at the end of each day, starting Tuesday evening. By Wednesday evening, she had chills (but no fever), a headache and was extremely tired. She also had a sore throat, which may mean she was struggling with a virus. Thursday, she was tired, had a sore throat, and late in the day had a headache. She even napped Thursday, which she hasn't done for years.  But, her tiredness lasted until Friday morning, when she started to feel better. All symptoms, except for a slight sniffle, had resolved by Friday morning.
Fever over 103°, chills, severe headache with light sensitivity, rash halfway down my arm on the arm where injection was given
the site of the vaccination (upper left arm) started to turn very red; itchy in big area of the arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (the site of the vaccination (upper left arm) started to turn very red) and VACCINATION SITE PRURITUS (itchy in big area of the arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (the site of the vaccination (upper left arm) started to turn very red) and VACCINATION SITE PRURITUS (itchy in big area of the arm). The patient was treated with TRIAMCINOLONE for Adverse event, at an unspecified dose and frequency; Manual therapy (Cold compress) for Vaccination site erythema and Manual therapy (Cold compress) for Vaccination site pruritus. At the time of the report, VACCINATION SITE ERYTHEMA (the site of the vaccination (upper left arm) started to turn very red) and VACCINATION SITE PRURITUS (itchy in big area of the arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.    This case was linked to MOD-2021-370411, MOD-2021-370412 (Patient Link).