chrisvoncsefalvay/vaers-outcomes huggingface dataset:
autonomic, neurological, heterogenous autoimmune disease; autonomic dysfunction; POTS; radiating pain, body aches; Post-HPV Vaccination Syndrome; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 11-years-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 17-SEP-2018, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) both for preventing cervical cancer.  On 04-SEP-2019, she was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). Shortly after received the second dose, she experienced generalized radiating pain throughout her body and body weakness, specifically her legs. She could not walk further that a city block without needing assistance. She began constantly complaining of many abnormalities including drops in blood pressure, shortness of breath, radiating pain, body aches, heart palpitations and an ongoing fatigue. The patient was seen by physician who stated that she had the symptom complex of headache, fleeting pains, fatigue, dizziness and paresthesias occurring after HPV vaccination. This new Post-HPV Vaccination Syndrome had been described by different clinicians from different parts of the world. Post-HPV Vaccination Syndrome resembles chronic fatigue syndrome/fibromyalgia.  Additionally, based upon her chronic and severe post-Gardasil symptoms, Plaintiff had been diagnosed with various medical conditions, including, but not limited to, autonomic dysfunction. Plaintiffs contends that patient human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating injuries, including but not limited to autonomic, neurological, heterogenous autoimmune disease, POTS, and dysautonomia, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her Gardasil-induced autoimmune disorder. Autoimmune Disease and Other Related Injuries and had resulted in her suffering from severe, debilitating, disabling and painful chronic injuries.  The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review the event of Autoimmune Disease was considered as medically significant
Light headedness & slight headache followed by rash on hands and feet and thighs, then hands and feet turned beet red and swelled, uncontrolled shaking and chills. Went to emergency clinic and was given a steroid injection. Within an hour symptoms began dissipating.
Roughly three hours after the vaccination, my arm started hurting. There was minor swelling.  The swelling has gone away, but the pain persists.  The evening of the vaccination, I experienced severe fatigue and tiredness.  I slept 14 hours that night and after waking up, I'm tired and lethargic and my arm still hurts.  I missed work today (Wednesday 3/24/21) due to the pain and fatigue.
Frequent nose bleeding (even after blowing nose, sneezing, bowl movement, significantly more frequent than before the vaccine), even after treatment by the ENT doctor.
Sharp pain in shoulder with overhead reaching, reaching behind back, lifting, quick movements, dressing, showering. Bruising at injection site, swelling as well. Pain began approx. 2 hours post injection. Currently with 10# lifting/pulling/pushing, no overhead work restrictions.
Started to suffer with cramp in my right calf muscle. Then noticed a swelling behind my right knee. Attended the A&E department at the local Hospital.  Blood pressure taken, 182 over 106, Blood samples taken and tested, came back positive for clotting. Received 2 blood thinning injections into my stomach, and told I would need to repeat that for the next 2 days, then attend hospital for a scan on the 01/06/2021
syncope p/1st & 2nd dose of Engerix-Hep B vax;
The daughter explained her mother is now having trouble moving her arm since the shot and it has only gotten worse not better. At the time of contact (12/10) she explained her mother could barely move her arm.
Immediate unusual scent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. Past drug history included: Neggram, reaction(s): "Known allergies: NegGram". Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EN6203, lot unknown=False,, administration date=12Mar2021,, administration time=06:15 PM, vaccine location=Left arm, dose number=1), administration date: 12Mar2021, when the patient was 62 years old, for COVID-19 immunisation, reaction(s): "Chest (below throat) began feeling raw/inflamed", "Hot flashes", "My eyes became thicker/puffy", "My nose was completely congested". The following information was reported: PRODUCT ODOUR ABNORMAL (non-serious), outcome "unknown", described as "Immediate unusual scent". Therapeutic measures were not taken as a result of product odour abnormal. Additional information:Covid prior vaccination was no.Covid tested post vaccination was no.other vaccine in four weeks was no.treatment to adverse event was no.Best could correlate the experience to was being in a science class during dissection of a frog and whatever the liquid the frog was pickled in. you smell it and it lasts a while once you leave the classroom.  No follow-up attempts are possible. No further information is expected.
Arm redness, cellulitis at site of injection developed within 24 hours, high fever, nausea, vomiting, abdominal pain.
Pt reports feeling "throat tight" like when she "reacts to ibprofen.  25 mg of benadryl given.  Pt with "coughing" clearing throat sound.  Some improvement.  Pt returned for 2nd dose on 4/23 no reaction
Redness, fever, pain in left arm. Started day you got shot. Got better. And got worse.
Headache, NauseaVomiting, Tired, Sore left arm, stomach cramps Narrative:
Swollen lymph nodes under left arm pit and left breast; Currently having tenderness of the breast; Headaches lasting 3-4 days; Slight face swelling 3-4 days; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 14:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 06:00, the patient experienced swollen lymph nodes under left arm pit and left breast. The patient was currently having tenderness of the breast. The patient also experienced headaches lasting three-four days and slight face swelling three-four days. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event headaches lasting three-four days and slight face swelling three-four days was resolved on an unknown date in Apr2021. The clinical outcome of the event swollen lymph nodes under left arm pit and left breast; currently having tenderness of the breast was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A few hours after the infection, I started having small muscle spasms all over, like little pulsations throughout my whole body, especially in legs and arms. They weren't intense or painful, but still unsettling. It's been happening daily, and has subsided a little but it's still happening 5 days later. Also have very sore and tight leg muscles. I don't know if this is considered "adverse enough", but it's still concerning, as muscle spasms are not mentioned in the common side effects, and because it has not stopped completely.
Enlarged swelled at injection site, 3-4 inches. No warmth or redness, not tender to touch.
Caller states patient reported no additional AE; patient was inadvertently administered a dose of PNEUMOV AX23 with a labeled expiry of 8/30/2021 on 9/21/2021; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 21-SEP-2021, the patient was inadvertently administered a dose of expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot #T010293, verified as valid with expiration date 30-AUG-2021) 0.5 milliliter for prophylaxis  (dose number, route of administration and anatomical location were not reported). Reporter stated that patient reported no additional adverse events. The outcome of expired product administered was unknown.
On 11.23.2020 around 3:20 pm, 10-15  minutes after administration the patient started complaining of sharp pain in the arm of vaccination, with pain in the chest and back area as well.
Rash described as hives; Aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Rash described as hives), MYALGIA (Aches), PYREXIA (Fever) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Previously administered products included for Pneumonia: Pneumonia vaccine on 21-Oct-2018, Pneumonia vaccine on 21-Oct-2018, Pneumonia vaccine (Not able to get into any clothes.) on 21-Oct-2018, Pneumonia vaccine on 21-Oct-2018 and Pneumonia vaccine on 21-Oct-2018. Past adverse reactions to the above products included Ache with Pneumonia vaccine; Chills with Pneumonia vaccine; Fever with Pneumonia vaccine; Swelling with Pneumonia vaccine; and Weakness with Pneumonia vaccine. Concurrent medical conditions included Lymphoma, Latex allergy (Blisters, hives and loss of voice), Fragrance sensitivity (loss of voice and tingling tongue) and Chemical sensitivity (Loss of voice ,heart rate increase, tingling tongue and pain in jaws). Concomitant products included AMLODIPINE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced URTICARIA (Rash described as hives), MYALGIA (Aches), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, URTICARIA (Rash described as hives), MYALGIA (Aches), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 100.3 (High) 100.3 F.         Patient reported that she may have had kidney stones.     This case was linked to MOD-2021-036308 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: This follow-up was received on 25-MAY-2021 which updated patient demographics, historical vaccine  allergic conditions and facility details.
Arm hurts when he moves it around but not at rest.  Patient is also on statin therapy.
Double vision; Headache turned migraine, whole head; Shaking like Parkinsons Disease; when I get up, I feel like I've been drinking, but I don't drink; Fell; Can't talk right, sentences don't come out right; Can't eat; Can't hear the phone ring; All my muscles hurt; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision), MIGRAINE (Headache turned migraine, whole head), TREMOR (Shaking like Parkinsons Disease), FEELING ABNORMAL (when I get up, I feel like I've been drinking, but I don't drink) and FALL (Fell) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included GABAPENTIN, BUPROPION HYDROCHLORIDE (WELLBUTRIN), DIAZEPAM, CEFIXIME (FLEXERIL [CEFIXIME]), OXYCODONE and HYDROCODONE for an unknown indication.   On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced DIPLOPIA (Double vision), MIGRAINE (Headache turned migraine, whole head), TREMOR (Shaking like Parkinsons Disease), FEELING ABNORMAL (when I get up, I feel like I've been drinking, but I don't drink), FALL (Fell), SPEECH DISORDER (Can't talk right, sentences don't come out right), EATING DISORDER SYMPTOM (Can't eat), HYPOACUSIS (Can't hear the phone ring) and MYALGIA (All my muscles hurt). At the time of the report, DIPLOPIA (Double vision), MIGRAINE (Headache turned migraine, whole head), TREMOR (Shaking like Parkinsons Disease), FEELING ABNORMAL (when I get up, I feel like I've been drinking, but I don't drink), FALL (Fell), SPEECH DISORDER (Can't talk right, sentences don't come out right), EATING DISORDER SYMPTOM (Can't eat), HYPOACUSIS (Can't hear the phone ring) and MYALGIA (All my muscles hurt) outcome was unknown.            No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-089539 (Patient Link).
Within two weeks of final dose, began experiencing shortness of breath, increased heart rate and heart palpitations. Wore a 24hr Holter monitor in July 2021, began treatment with Metoprolol. Still experiencing symptoms so I was referred to a specialist who ran a 48hr Holter monitor test and a stress echo. Echo came back normal. Began treatment with anti-inflammatory drug colchicine.  Medication is instructed to take for 3 months beginning today. Outcome is unknown at this time.
1/9/06 office visit.  Patient presented to clinic with over 200 vesicles scattered over entire body.  No symptom of fever.  Today is day #2 of rash.
Localized reaction. Redness and mild swelling at injection site. Patient has not had a fever or any other symptoms.
9/29/2022 I was noticing I was having a hard time focusing and concentrating. I also had a lot of worries. It was keeping me from doing my daily activities of living.  I was just not able to do my work appropriately or help work out around the house. I was not feeling myself.  I had an appointment with my nurse practitioner on 9/29/2022 and she set me up with a provider that deals with psychotropic medications who I saw on 10/12/2022. She started me on Venlafaxine and recommended that I see a therapist.  I started seeing a therapist at least four to six weeks later.  I continued to have issues and have since started on an additional medication, Atomoxetine.  I have been feeling better since about the last month
Patient received a booster dose of Moderna. When we went to enter that dose in the state database, we realized the person had already received a booster dose at the dialysis center, but the dialysis center failed to notify the nursing home who were then unable to notify us (the pharmacy administering the vaccine). We checked all residents in the database a week prior, but the dose at dialysis occurred during the interim period. No adverse effects from the 4th dose were noted or reported.
Pt describes sewlling of tongue, lips, and face. Saw physician treatment and received a steroid dosepack.
February mensuration cycle was 18 days late No cycle since February cycle, no period in march or april. Not pregnant
We received the following literature report on 15 JUN 2009:  15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007.  The children received a total of two doses (fully vaccinated).  Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness.  Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group.  This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 and MA2009-1714 to MA2009-1722).  Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.
The pt developed a 2 1/2 X 1 1/2 area of redness that feels hard at the DTAP site on his left deltoid.
Red bullseye type rash around injection site. Appeared about 8 days after shot.
J96.00 ACUTE RESPIRATORY FAILURE 4/25/2023 LETHARGY R09.02 HYPOXIA 4/25/2023 LETHARGY J96.00 ACUTE RESPIRATORY FAILURE 4/25/2023 MRSA CARRIER R09.02 HYPOXIA 4/25/2023 MRSA CARRIER J96.00 ACUTE RESPIRATORY FAILURE 4/25/2023 HEMATURIA R09.02 HYPOXIA 4/25/2023 HEMATURIA J96.00 ACUTE RESPIRATORY FAILURE 4/25/2023 PNEUMONIA R09.02 HYPOXIA 4/25/2023 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 4/25/2023 UTI (URINARY TRACT INFECTION) R09.02 HYPOXIA 4/25/2023 UTI (URINARY TRACT INFECTION) J96.00 ACUTE RESPIRATORY FAILURE 4/25/2023 HYPOXIA R09.02 HYPOXIA 4/25/2023 HYPOXIA
Soreness at injection site (1 week); red spot where needle entered (continuing); pain to fingertips in right arm (one day); ear ringing, slight clamminess, burning on top of feet, slight nausea, hot spell (one day); body aches (one week, ongoing); heavy feeling in lower abdominal area (on and off until present time)
BP 136/58  | Pulse 75  | Temp 97.7 °F (36.5 °C) (Non Contact)  | Resp 22  | Ht 5' 3" (1.6 m)  | Wt 86 lb (39 kg)  | SpO2 92% Comment: o2 at 2 lpm via nc | BMI 15.23 kg/m²  GENERAL APPEARANCE: The patient appears chronically ill, on 3LNC, in no apparent distress.  Alert, pleasant and cooperative. Vital signs are as noted by the nurse.  NECK: No stridor.  HEENT: Normocephalic and atraumatic. No scleral icterus. no conjunctival injection is noted.  LUNGS: Diminished air entry bilaterally without wheezes. Breath sounds are equal and clear bilaterally. No rhonchi, or rales. HEART: Regular rate and rhythm with normal S1 and S2. No murmurs, gallops, or rubs. EXTREMITIES: R arm with 23 x 14.5cm area of erythema and increased warmth with 2-3 lightly excoriated areas from scratching, no evidence of infection or drainage.  NEUROLOGIC: No focal sensory or motor deficits are noted.  PSYCHIATRIC: The patient is awake, alert. Appropriate mood and affect.     ASSESSMENT/PLAN: 1. Allergic reaction to drug, initial encounter Adverse reaction to Prevnar 20 vaccine given on 6/6/23 with superficial rash R arm. No evidence of airway compromise or systemic reaction. Follow up in 1 week for repeat measurement of rash.  - predniSONE 20 MG Oral tablet; Take TWO tablets (40 mg total) by mouth daily for 5 days for 5 days  Dispense: 10 tablet; Refill: 0 - Cetirizine HCl 10 MG Oral Tab; Take ONE tablet (10 mg total) by mouth daily  Dispense: 30 tablet; Refill: 0 - HYDROCORTISONE, TOPICAL, 2.5 % Apply externally Cream; Apply quarter sized amount to R upper arm twice daily.  Dispense: 20 g; Refill: 0
Developed erythematous papular urticarial lesions on trunk and extremities, atypical target lesions on leg. No petechiae. Rash resolved on 8/27/02.
Lymph nodes on left side swollen, Neck, upper shoulder/clavicle, & arm pit, Also right neck lymph node
Red, swollen, used cool compresses swelling went down after couple of days, small knot.
Pain and weakness in the arm that the vaccine was given in. Shortness of breath and chest discomfort.
About 12 hours after vaccination, violently vomited for 15 hours. In hospital by 12/3/21, then had surgery on 12/4 (searching for gallstones) and 12/5 (removed gallbladder). Pt described as pancreas attack. On breathing treatments and low O2 sats.  Since then, pt has been struggling to thrive and put on weight. Occasionally vomiting, and pt now down to 99 pounds, lost about 20 pounds.
This spontaneous report as received from a Licensed Practical Nurse refers to a 40 year old female patient with gastrooesophageal reflux disease and hyperlipidaemia. The patient was not pregnant. The patient did not have any drug reactions and allergies. On 01-JUL-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K021030, expiry date 22-JUN-2016, dose 0.5 ml, intramuscular in the right arm. Concomitant therapies included estradiol (manufacturer unknown). On 01-JUL-2015, shortly after receiving the vaccine, the patient experienced fever rating between 101 F to 102.8F, nausea, vomiting, swelling and tenderness at the site of injection in right upper deltoid. On 02-JUL-2015, while the patient was examined by the physician assistant, the patient had reactive lymph nodes under the left arm. The patient was treated with an unspecified dose of ZOFRAN. White blood cell count test was performed but no result was provided. The patient did not recover from adverse events at the time of this report. Causality assessment was not provided. On 02-JUL-2015, the patient was not able to work as a result of adverse events. Upon internal review the events of fever rating between 101F to 102.8F, nausea, vomiting, swelling and tenderness at the site of injection and reactive lymph nodes under the left arm were considered as disabling. Additional information has been requested.
Severe myalgia, temp 101.8, chills and sweating, headache, nausea and vomiting
Sore arm; A little bit of headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and HEADACHE (A little bit of headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm) and HEADACHE (A little bit of headache). At the time of the report, VACCINATION SITE PAIN (Sore arm) and HEADACHE (A little bit of headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient stated that after receiving the 1st dose of the Moderna COVID 19 vaccine they had sore arm and a little bit of headache.   This case was linked to MOD-2021-395798 (Patient Link).