chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a tingling feeling through out my body, like it was affecting my nerve endings.  muscle aches, joint pain , feeling cold inside my body, and the worse headache in the very back of my head..... after about a week the tingling had gone , but the muscle aches, joint pain, headache and feeling cold lasted  2 weeks.
This spontaneous report has been received from an office manager referring to a 12 months old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not reported. Concomitant therapies included sterile diluent. 22-FEB-2018, the patient was vaccinated with VARIVAX lot # N024567, expiration date of 07-SEP-2019, for prophylaxis (strength, dose, route and anatomical location were not provided). No adverse events reported. The vaccine was exposed to a temperature range of 39.5°F, during a time frame of 15 hours, which was called by a data logger. No previous temperature excursions were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1802USA012116: US-009507513-1802USA012115.
On 9/1/2021 I started with just a scratchy throat, along with sense of taste loss. I decided to take a PCR for CoVid. Found to be positive the next day and contacted my PCP. Was advised to quarantine for 10days. After about week it seemed I was over it but kept quarantine and got a new test. On 9/14 I took a test and it turned up negative.
pt recvd vax & w/in 5hrs post vax exp h/a,nausea,vomiting,muscle aches,& fever;these sx were not treated;they persist;
Pt stated arm inflamed up into neck for up to 5 days after vaccination. Extreme pain in shoulder, armpit, & neck area.
Chronic hives full body rash comes while asleep between 3-6am can last all day
Mindlessness, dullness, lack of ability to recall facts. This isn?t me. I?m sharp as a tack and should have been a lawyer for pharmacists. Since my second dose, I have been having very obvious trouble with my mind and memory. Recall is also ruined. I?m an aviation/avionics technician and don?t feel like I can work the same right now. I hope this clears up, otherwise it?s going to seriously affect my life.. I will see my primary physician ASAP. I don?t know what to do.
Patient received Hep B #1 then as he was leaving, I realized he needed varicella vaccine as well (approximately 10 minutes between vaccines) 20 minutes after varicella given patient had capious rhinouchea, nasal congestion, eyelid swelling and tearing-received Benadryl 25mg and Epinephrine 0.4mL SQ 1:1000.
nauseated on and off/ was a little nauseated; chills; not feeling any better; a little dizzy; she was not eating much today because she was nauseated; Booster; did not sleep well for the rest of the night; This is a spontaneous report from a contactable consumer (patient herself). A 83 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via unspecified route of administration on 31Oct2021 16:00 (Lot number: 32030BD) at the age of 83 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Afib" (ongoing) (diagnosed 6 years ago. Medication is working); "CKD" (ongoing); "Osteoporosis" (ongoing); "Hypertension" (ongoing) and "Increase Cholesterol". Concomitant medications included: LOVASTATIN, XARELTO, DILTIAZEM, FLECAINIDE and TIMOLOL. Vaccination history included: Bnt162b2 (Dose: 1, Lot/Batch number: EL9263), administration date: 23Jan2021, when the patient was 83 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot/Batch number: EN6201), administration date: 15Feb2021, when the patient was 83 years old, for COVID-19 immunization, reaction(s): "headache". On 31Oct2021 16:00, the patient had booster and on the same day, did not sleep well for the rest of the night. On 01Nov2021 11:30, the patient experienced nauseated on and off/ was a little nauseated, chills, not feeling any better, a little dizzy and she was not eating much today because she was nauseated. The clinical outcome of the events nauseated on and off/ was a little nauseated, chills, not feeling any better, a little dizzy and she was not eating much today because she was nauseated was recovering and for remaining was unknown.  Follow-up attempts are completed. No further information is expected.
Pain, swelling, redness, itching. Itching continues on day 6 despite hydrocortisone cream.
she couldn't walk  (1st booster); so much pain in her hips (1st booster); This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (she couldn't walk  (1st booster)) and ARTHRALGIA (so much pain in her hips (1st booster)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013P2M, 004C21A and 039B2?D) for COVID-19 vaccination.     The patient's past medical history included Cancer (NOS) (Cancer Survivor. No change reported) and Polyp removal (Precancerous polyps removed. No change reported). Concurrent medical conditions included Seasonal allergy, Fruit allergy (Multiple allergies including grapes) and Drug allergy (Allergic to the colonoscopy "Prep" medication). Concomitant products included VITAMINS NOS, VITAMIN D [VITAMIN D NOS] and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 01-Dec-2021, the patient experienced GAIT DISTURBANCE (she couldn't walk  (1st booster)) and ARTHRALGIA (so much pain in her hips (1st booster)). At the time of the report, GAIT DISTURBANCE (she couldn't walk  (1st booster)) and ARTHRALGIA (so much pain in her hips (1st booster)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: negative (Negative) Negative.         It was reported that lot number for dose 1 and 1st booster dose was illegible. No treatment medications were provided.   This case was linked to MOD-2022-559967, MOD-2022-559967 (Patient Link).
Patient was given .5ml of Moderna vaccine instead on .25ml for 2nd covid booster. No adverse reaction reported.
Pt to Emp. Health 3/30/11 with c/o left upper arm pain in general deltoid region with initial redness soreness, sl swelling resolved after a couple of days. Sore to sleep on L arm x 2 wks now with continued soreness "ache" of (L) deltoid, no lump, no redness or swelling, no burning, no w/n/t, no joint pain, increased pain with movement of (L) arm - pain moves around deltoid region only no specific point tenderness. Pain is 6/10 at worst decreased with NSAID.
One week after injection, I developed swelling, hives, itching and redness at the site
Headachem dizziness, increased heart rate, light-headness, shortness of breath. Symptoms began approximately 40 minutes after vaccination.
1) Dull ache at injection site, continuing (04/15/2021-present, 27 days after vax 1st dose) 2) Sharp pain in upper arm, from injection site to elbow (04/16/2021 - present, sporadic) 3) Stiffness and pain from injection site to neck, up to ear (04/20?/2021 - present, sporadic) 4) Stiffness and pain in both knees (04/17 - 04/22?/2021) 5) Sharp pain to the left of breast bone when lying down (04/20/2021 - present, very sporadic) 6) Tiredness (even after 8-9 hours sleep) (04/16?2021 - present)  Symptoms 1) and 4) respond to Tylenol, but pain from 1) returns Symptoms 2) and 3) do not respond to Tylenol Item 18, continued: Teleconference with PCP on 05/11/2021: She advised take 2d dose and come in for office visit next week if symptoms continue  Never had fever; or rash or bruise at injection site
Injection site soreness; Body aches; Fever; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration in the right arm on 13Apr2021 at 15:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included birth control. Concomitant medications included cetirizine hydrochloride (ZYRTEC), birth control pill (MANUFACTURER UNKNOWN), naproxen sodium (ALEVE) for an unknown indication and from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the right arm on 22Mar2021 at 10:30 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. 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 14Apr2021 at 06:00 after the second shot the patient had injection site soreness, body aches and fever that started about 15 hours of the shot. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of injection site soreness, body aches and fever were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Swelling, lump in Left armpit area, size is larger than golf ball smaller than a baseball. No other symptoms.
c/o of weakness, lightheaded.  Placed on stretcher. V/S BP 98/60, HR 60 SAO2 99 color good, skin warm and dry.   Patient had fasted for lab work prior to receiving vaccine.  Serial v/s done, drank ginger ale and felt better.   Discharge BP103/67, HR 72 SAO2 96%
Cough; Chest congestion; Body aches; Chills; Headache; Felt exhausted; Voice was in and out, voice is gone, can barely talk, voice was horse; Achy and sore voice; Temperature would go up, fever; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT CONGESTION (Chest congestion), DYSPHONIA (Voice was in and out, voice is gone, can barely talk, voice was horse), PAIN (Achy and sore voice), COUGH (Cough) and PYREXIA (Temperature would go up, fever) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0451321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nasal congestion from 15-Apr-2021 to 20-Apr-2021, Fatigue from 15-Apr-2021 to 20-Apr-2021, Ache from 15-Apr-2021 to 20-Apr-2021 and Sore throat (One week before second dose, allergies were acting up... developed a sore throat) in April 2021. Concurrent medical conditions included Thyroid disorder and Allergy (Unspecified allergies). Concomitant products included LEVOTHYROXINE SODIUM (UNITHROID) for Thyroid disorder.    On 24-Apr-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced DYSPHONIA (Voice was in and out, voice is gone, can barely talk, voice was horse). 25-Apr-2021, the patient experienced PAIN (Achy and sore voice), PYREXIA (Temperature would go up, fever) and FATIGUE (Felt exhausted). On 25-Apr-2021 at 6:00 AM, the patient experienced MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache). On 26-Apr-2021, the patient experienced LOWER RESPIRATORY TRACT CONGESTION (Chest congestion). On 26-Apr-2021 at 7:00 AM, the patient experienced COUGH (Cough). The patient was treated with PARACETAMOL (TYLENOL) on 25-Apr-2021 for Myalgia and Headache, at a dose of 1 dosage form. On 28-Apr-2021, PYREXIA (Temperature would go up, fever), CHILLS (Chills) and HEADACHE (Headache) had resolved. On 29-Apr-2021, MYALGIA (Body aches) had resolved. At the time of the report, LOWER RESPIRATORY TRACT CONGESTION (Chest congestion), PAIN (Achy and sore voice), COUGH (Cough) and FATIGUE (Felt exhausted) had resolved and DYSPHONIA (Voice was in and out, voice is gone, can barely talk, voice was horse) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: negative (Negative) Negative. On 19-Apr-2021, Influenza virus test: negative (Negative) Negative. On 19-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 19-Apr-2021, Streptococcus test: negative (Negative) Negative.         Patient reported that concomitant products also included an unspecified sinus medication.  The action taken with mRNA with the events was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: The follow-up was received on 6-JULY-2021 and has updates regarding additional adverse events, concomitant products, patient history and events outcome.
developed nasal congestion and headaches that persisted over 1 month, initially treated as sinusitis but eventually diagnosed with granulomatosis with polyangitis
Lost muscle control, could not raise up out of bed, could not walk, lost bladder control, slept 24 hours, no appetite, weakness, headache, fatigue
I experienced pneumatic bronchitis with shortness of breath, severe cough and low grade fever.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 24-month-old male. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 22-Jan-2012. On 27-Jan-2012, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age.
patient got a 1st dose in Oct 2019 in another pharmacy and then by mistake got another Fluzone HD in their pharmacy on 06Jan2020/no AE; Initial information was received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 76 years old male patient got a 0.5 mL dose of first dose in OCT-2019 in another pharmacy and then by mistake got another INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (prefilled syringe) in their pharmacy on 06-JAN-2020.  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.   In October 2019, the patient received a first dose 0.5 ml of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ288AA) via an intramuscular route at the arm (not otherwise specified). On 06-Jan-2020 he also received  second dose 0.5 ml of the same vaccine (lot UJ288AA) via an intramuscular route at the arm(not otherwise specified).  It was a case of actual medication error due to extra dose administered.   At the time of reporting, no adverse event reported.  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.
Fever 101, body aches,  severe full body convulsions lasting 10 minutes. Cardiac PACs starting on day 3 post vaccine and lasting 3-4 days. Nausea.
Pt received vaccination and approximately 30 minutes later started to feel itchiness on her arm. Her coworker had experienced an anaphylactic reaction approximately 7 hours prior and she was concerned about her symptoms. Patient started feeling her heart racing, noted to have a heart rate in the 122s. Patient had a coworker take her blood pressure and was noted to be hypotensive. Patient stated she had difficulty breathing and was given a breathing treatment with Duonebs as well as a dose of Benadryl and Dexamethasone. I am especially concerned as this is the second patient to receive an adverse reaction to this same vaccine within the ER alone at our hospital. Both patients have received the flu vaccine yearly, as required per hospital protocol, without prior problems.
Interchange of vaccine products; a mild increase in the tachycardia; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 2023NVX-US-000001185 (Novavax).  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 2, SINGLE, in the 150's then ended up in the hospital), for COVID-19 immunisation, reaction(s): "tachycardia"; Moderna covid-19 vaccine (DOSE 2, SINGLE, had to be treated with beta blockers), for COVID-19 immunisation, reaction(s): "postural orthostatic tachycardia"; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, in the 150's then ended up in the hospital), for COVID-19 immunisation, reaction(s): "tachycardia"; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, had to be treated with beta blockers), for COVID-19 immunisation, reaction(s): "postural orthostatic tachycardia". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovering"; TACHYCARDIA (medically significant), outcome "recovering", described as "a mild increase in the tachycardia". Therapeutic measures were taken as a result of tachycardia. Clinical Course: BioNTech Covid-19 vaccine, and had a mild increase in the tachycardia, but it was not as severe. It lasted for months, and then it kind of went down to baseline, but still requires beta blockers. Two years later, the patient is still on beta blockers. No further follow-up is anticipated.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect vaccine product to the reported event Tachycardia cannot be excluded. It was noted that "BioNTech Covid-19 vaccine, and had a mild increase in the tachycardia". Case will be reassessed upon receipt of additional information. 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.
Bilateral lower extremities red, painful and endured. Swelling as well with pitting edema, most prominently at the end of the day. Wearing compression socks daily, treated with azythromycin with mild relief.  Meloxicam and Bethasone cream for 10 days with no changes. Switched to Celebrex , OTC Butcher's Broom and Horse chestnut, Troxevasin gel locally. Mild improvement when resting, worsening at the end of the work day ( I am mostly on my feet at my job). Awaiting to see a Vein Specialist on February 17th.
This case was reported by a pharmacist and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). On an unspecified date, a few hours vaccination with FLUARIX, the subject experienced injection site redness, swelling injection site and injection site soreness. The events occurred within "possibly a few hours after vaccination." At the time of reporting the outcome of the events were unspecified. The pharmacist reported another subject with same events. See case A1002688A for details on the other subject.
Subsequently the pt experienced injection site pruritus, redness and swelling for 3 days following the vaccination. No further information is available.
Went to hospital ER on 4-7-03 with complaints of lightheadedness and palpitations.  States palpitations began 4-5-03.  Was very anxious.  Heart rate was 95, regular, fast.  Did have some chest pain.  MD dx=viremia.
A few days after my 2nd Pfizer shot, I woke up to a ringing in my left ear.  At first it was mild and hardly noticeable.  After a week or two, the ringing increased, but at times would go away.  I put up with this symptom for several weeks, perhaps even a month or more.  Eventually, I went to my primary care doctor who looked into the ear, and felt I could be at the start of an ear infection.  I was prescribed a routine anti biotic for 10 days.  It seemed to improve slightly but returned after a few weeks.  I have been putting up with a mild ringing ever since.  In the past 2 weeks, the loudness of the ringing has increased.  This has prompted me to fill out this form, just in case you have any suggestions.
This spontaneous report as received a 59 year old female patient with asthma, and high blood pressure. The patient's medical history included allergic to MOBIC, allergic to penicillin and allergic to BACTRIM. On 17-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX in the left arm (strength, dose, dose number and route unspecified), lot # reported as K009771, expiry date reported: October 2015. Other suspect therapies included influenza virus vaccine (manufacturer unknown), which was vaccinated on 17-OCT-2014, in her right arm, (strength, dose, dose number, route and lot # unspecified). Concomitant therapies included lisinopril (manufacturer unknown) and SINGULAIR. On 25-OCT-2014, the patient had one blister on her left chest, a whole big cluster under her left armpit and two small spots on her left forearm. She sought medical attention and was seen by a physician's assistant to address her symptoms and was diagnosed as having shingles. Patient was prescribed with "valcyclovir" and started taking it on 26-OCT-2014 to treat the symptoms. The outcome of events was reported as not recovered/not resolved. The causal relationship was not reported. Additional information has been requested.
Immediately after the second vaccine, I had typical flu like symptoms.  Body aches, fever, headache, nausea, pain in muscles and back.  I also had a pain in both of my shoulder blades that continued to ache, when the other symptoms subsided.  Six days after the second vaccine, I started sweating profusely, my heart went into afib, The pain from my shoulder blades, moved to in between my shoulder blades and I began having chest pressure.  I became nauseas, fatigued and weak.
After second shot on 4/9/2021, that night I had chills, headache and muscle pain. This lasted for 2 days. Within a week, my left wrist began hurting and left fingers became numb. Within 3 weeks, right fingers became numb, knee joints, elbow joints and ankles began to hurt. Shoulders, back and hips began to hurt. These symptoms lasted up to the current date (11/10/2021).
11/8- swollen arm, tingling, numbness 11/17- blood clot; DVT 11/28- Pulmonary embolism