chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to a 2 years old male patient with asthma and with no drug reactions or allergies. The patient was vaccinated subcutaneously with a dose of VARIVAX (lot number 1474Z, expired on 29-OCT-2012) on 22-APR-2011. There was no other concomitant medication. On 06-JUL-2012 the patient developed hand and mouth disease. The patient developed itchy rash allover the body except his back and scalp. The patient had no fever. On 23-JUL-2012 the patient had a varicella titer test but the titer was negative. The patient sought for unspecified medical attention. No treatment was given. On 26-JUL-2012 the patient recovered. Additional information has been requested.
Headache, scratchy throat, extremely red eyes, congestion, generalized muscle aching, fatigue, low grade fever.
SkinRash, UrticariaPruritus, itchy,red,inflamed 1 1/2 around injection site
Patient presented @ 1356 hrs in observation area. Patient was sitting in chair. Observed patients' head tilt backwards. Care initiated with head/neck support. Patient began seizure like activity lasting approx. 1 minute. Patient transferred to floor for protection. Upon exam Patient was AAO x 2, skin: cool/clamy. Patient began c/o headache and denied any past medical history. Transferred patient to cot for evaluation. VS: HR:92,RR:20,BP:106/64. Patient began vomiting during evaluation. Post vomiting patient said he felt fine. EMS on scene and care transferred to ED.
Grand mal seizure activity. By the time parent reported the situation to the health dept on 2/11/2010, the parent reported that the child had 88 seizures.
Child developed patches of redness on face and in all body creases. Increased dry skin as well. Child with itching all over body.  Child received 2nd dose of imms on 11/21/2005.  Increased itching then led to scratching & infection-ct txed with Keflex & responded well. Two weeks later:impetigo dxed and subsequent Strept A infection on 1/18/06. Lesions healed on forehead but redness in face & creases persists as well as intense itching.
right hand/arm shaking; right hand/arm shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), on 27Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (first dose, lot FD8448), administration date: 30Aug2021, for Covid-19 immunisation, reaction(s): "no adverse effect". The following information was reported: TREMOR (non-serious), TREMOR (non-serious) all with onset 2021, outcome "unknown" and all described as "right hand/arm shaking". Additional information: Shaking started 2/3 months (Nov-Dec) 20212 later. Physical checkup determined "Not  Parkinson's."   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Arthralgia, Fever, Diarrhea, NauseaVomiting, chills Narrative:
pt recvd vax 10AM 9JAN95 t102 started @ approx 130PM; temp went to 105 during noc; APAP q 3-4 hrs, tepid baths q 20 mins;
Pain, tenderness that migrated to bicep from deltoid. Rash started 2 days later.
Client came to our site received 1st dose of Pfizer.   Later found out that client had received Janssen Vaccine on April 7, 2021
STILL FEELING PAIN as soon as she got off the Prednisone; FEELING LETHARGIC; Hand hurt; Feeling really/very tired as soon as she got off the Prednisone; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (STILL FEELING PAIN as soon as she got off the Prednisone), LETHARGY (FEELING LETHARGIC), PAIN IN EXTREMITY (Hand hurt) and FATIGUE (Feeling really/very tired as soon as she got off the Prednisone) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included PREDNISONE for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 11-Oct-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Feeling really/very tired as soon as she got off the Prednisone). On an unknown date, the patient experienced PAIN (STILL FEELING PAIN as soon as she got off the Prednisone), LETHARGY (FEELING LETHARGIC) and PAIN IN EXTREMITY (Hand hurt). At the time of the report, PAIN (STILL FEELING PAIN as soon as she got off the Prednisone) and FATIGUE (Feeling really/very tired as soon as she got off the Prednisone) had not resolved, LETHARGY (FEELING LETHARGIC) had resolved and PAIN IN EXTREMITY (Hand hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: numbers are just at where they need to be.   On unknown date, the patient experienced tired/a lot of fatigue. In 2022, tired recovered/resolved. Treatment detail was not reported. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.   This case was linked to MOD-2022-569498, MOD-2021-620959 (Patient Link).
fever; chills; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Her second dose is scheduled for 07Apr2021. Medical history included knee operation from an unknown date and unknown if ongoing she has gotten amniotic fluid injected in her knee and now scheduled to get hyaluronic acid, a cushioning gel, shot in her knee. The patient's concomitant medications were not reported. The patient experienced fever and chills on an unspecified date with outcome of unknown.    No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN5318) and on 23Feb2021 as dose 2, single (Lot number: EN5318) at the age of 34 years for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient had no Covid prior vaccination. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "COVID-19 breakthrough infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, Covid-19. Patient was not feeling great at the end of last week through the weekend so was focused on resting. Her case was mild so in her head she was thinking the vaccine was doing what it is supposed to!
Right arm at the shot site was mild tender, warmth + indurated, and swollen.  local reaction to vaccination advised to take ibuprofen every 8 hours after food for next 2-3 days as needed for pain. ICE the affected area if any worsening or fever return for follow up in the office
I have that feeling that I have the shingles; Shingles; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). An 87-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ES7229), dose 2 via an unspecified route of administration on 02May2021 (Sunday) (at the age of 87-year-old), as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EP7533), via an unspecified route of administration on 11Apr2021, as single for covid-19 immunisation. On an unspecified date in 2021, the patient experienced shingles like the nerve reactions that I have it on my face. The clinical details of the events as follows: Consumer stated, What I am calling about was I am having the same, I had that feeling that I have the shingles, is that a reaction or am I really getting the shingles. I did not know, I have had the shingles before about 4-5 years ago, but the shingles, this is like the nerve reactions that I have it on my face as I had it before and was this you take a tip thing or should I get a shingles shot. Consumer stated, do I need to get to the pharmacy for shingles shot. Consumer stated, I have not had any problems with either shots, so I did not know just the shingles coming back after 4-5 years or what. Consumer stated, I had shingles, I had no effect from either shot (Unspecified Shot). I have had shingles before long time ago and so I was wondering about. They were not very good because (incomplete sentence). The patient outcome of the events was Unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Significant face and neck swelling; Significant face and neck swelling; redness 20 minutes after injection; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: 59267-1000-01), via an unspecified route administration in the left arm on 12Mar2021 at 17:15 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included mild hypertension. Concomitant medications were not reported. The patient was allergic to bee stings. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced face swelling, neck swelling and redness on 12Mar2021 at 17:35. It was reported that events were not anaphylactic and the condition peaked within 1 hour, returned to normal within 4 hours. The reported events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken for the reported events. The clinical outcome of the face swelling, neck swelling and redness was recovered on 12Mar2021.   No follow-up attempts are needed. No further information is expected.
RED, SWOLLEN, AND WARM TO TOUCH ON UNDERSIDE OF ARM (NOT AT INJECTION SITE). PATIENT HAS TAKEN BENADRYL AND REACTION IS SLOWING DOWN (ON M.D. INSTRUCTIONS)
I received my second dose of the Shingrix shingles vaccine (Shingrix 50 mcg/0.5 ml inj Glax, NDC: 58160-0823-11) and had immediate, persistent injection site pain. The next day I had "flu-like" symtoms: generalized muscle/joint aches, headache, and general malaise. I had a similar reaction when I received the first dose, on 8/9/2019; and still have occasional injection site pain from that today. I would not classify this as a severe reaction, but felt it should be reported so that you would know how common it may be.
Pt vaccinated w/1st dose of vax developed severe rash w/broken skin, scaling & raised welts on the inside of both calves of legs; Rash persisted a couple of months until seen by allergist; tx Pred & unspecified topical ointments;
Mother filled out informed consent form and put the childs dob as 5/28/09. Has pt dob listed as 05/28/10. We did due diligence by having parent sign form.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 12-SEP-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 11-JUN-2016, the patient was treated by a physician's assistant for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed acyclovir for management of his painful symptoms and chronic pain. On or about 15-JUN-2016 the patient sought subsequent treatment from a physician assistant for a vesicular outbreak that was diagnosed as herpes zoster. He was prescribed gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient reports up to date on vaccinations (booster 11/05/21), although initial 2 vaccines not in immunization registry so this writer was unable to confirm.  Patient admitted with acute or chronic respiratory failure with hypoxia and COVID detected test on 02/24/22.  Multiple recent admissions for respiratory problems.  Patient died respiratory failure.  Provider discharge note below: "63 YO man with complex pulmonary history including sarcoidosis, chronic MAC infection, multiple recent hospitalizations most recently with COVID-19 at outside hospital within past two weeks presented to the hospital with acute worsening of chronic hypoxic respiratory failure. In extremis on presentation, on BiPAP with minute ventilation ~40-50 liters/min, full accessory muscle use. His work of breathing would not have been sustainable without the use of invasive mechanical ventilation however the patient and his wife expressed clear care limitations to forego intubation and mechanical ventilation. Ultimately they wished to pursue comfort focused care and symptom management. Spiritual care services were offered and accepted. Morphine was provided for air hunger. The patient died with his wife at the bedside. "
Information has been received from a 43 year old female with allergic reaction to tetracycline who in the fall of 2003 was vaccinated with the first dose of PNEUMOVAX 23 vaccine, IM. On 13-OCT-2008, the patient was revaccinated with PNEUMOVAX 23 vaccine (Lot# 658449/0989U) in her right arm. Concomitant therapy included influenza virus vaccine, in the left arm (name and manufacturer unspecified). On 13-OCT-2008 the patient experienced high fever, pain in lymph nodes, her left side hurt, high injection site heat, extreme pain and heaviness in her arm, malaise, not feeling good and achiness after getting revaccinated in right arm. The patient had symptoms by the afternoon. At the time of the report, the patient was recovering. The patient did not seek medical attention. This is one of several reports received from the same source. No further information is available.
Body aches; Fatigue; Chills; Fever; This is a spontaneous report from a non-contactable pharmacist, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 31Mar2021 at 12:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Allergies to medications, food, or other products was not provided. The patient did not take any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the 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. On 01Apr2021 at 00:30, approximately 12 hours post vaccination, the patient experienced fatigue, chills, fever, and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events fatigue, chills, fever, and body aches were resolved on 01Apr2021 at an unspecified time.  No follow-up attempts are needed. No further information is expected.
Complained of tingling in fingers of left hand, shoulder and side mouth approximately 1 hour after shot. Neuromus v to hand/arm/mouth wnl; Resolved spontaneously within 5 hours.
Received vaccines on 6/14/01 and 5 days later, the right side of her face started to droop; right eye not closing. No other illness. Right-sided Bell's Palsy on 6/21/01.
This case was reported by a healthcare professional and described the occurrence of staphylococcal infection in a subject of unspecified age and gender who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Fluarix in the left deltoid.  An unspecified amount of time after vaccination with Fluarix, the subject experienced staphylococcal infection at the injection site.  At the time of reporting the outcome of the events was unspecified.  Reporter questioned if the lot of vaccine used could have been contaminated.
Body aches, headache, fever 102 started ~16 hours after vaccine and lasted 24 hrs+ then new onset vertigo and dizziness that started couple days after vaccine and lasted ~36-48hrs.
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: vivid dreams-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: general feeling of increased inflammation of joint pain
Subsequent to receiving first and second doses of varicella virus vaccine live the pts laboratory tests revealed a negative varicella antibody titer.
Ears are very sensitive to sound. Voices sound very loud and hurt ears. High pitched ear ringing.
incorrect dose given. Given 0.25 instead of 0.5 mL. No adverse symptoms or signs
Received phone call from Clinic stating the patient was seen today for a rash (hives) from waist down, worse on back and legs that started yesterday on 1/13/2021.  No other symptoms.  Denied any shortness of breath, fever, cough, etc..
Headache nausea chills fever and body aches started about 2 hours after vaccination  3/14/2021 arm was in pain and swollen started feeling better Wednesday 3/17/2021 aftwr vaccination
Sinus infection; Elevated liver enzymes/high liver enzymes; Leg cramps after COVID vaccine; Fatigue/really tired; Bladder infection; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Bladder infection), SINUSITIS (Sinus infection), HEPATIC ENZYME INCREASED (Elevated liver enzymes/high liver enzymes), MUSCLE SPASMS (Leg cramps after COVID vaccine) and FATIGUE (Fatigue/really tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. In March 2021, the patient experienced CYSTITIS (Bladder infection). On an unknown date, the patient experienced SINUSITIS (Sinus infection), HEPATIC ENZYME INCREASED (Elevated liver enzymes/high liver enzymes), MUSCLE SPASMS (Leg cramps after COVID vaccine) and FATIGUE (Fatigue/really tired). At the time of the report, CYSTITIS (Bladder infection) had not resolved and SINUSITIS (Sinus infection), HEPATIC ENZYME INCREASED (Elevated liver enzymes/high liver enzymes), MUSCLE SPASMS (Leg cramps after COVID vaccine) and FATIGUE (Fatigue/really tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: High.         Concomitant product information was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of fatigue/really tired, bladder infection, high liver enzymes, leg cramps after COVID vaccine and sinus infection with Humira(adalimumab) was no reasonable possibility. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
2 days after getting the shot, I lost my smell. 3 days after getting the shot, I lost my taste. My taste was gone for 5 days, and my smell was gone for 7 days.
Stomach pains started 3/13/2021 in the morning and continued the following day. Diagnosed in the hospital on the evening of 3/14/2021 with appendicitis. Appendix was removed via laparoscopic appendectomy.
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. The healthcare worker reported that doses of PEDVAXHIB (lot # L009649, expiry date 29-NOV-2017) (dosage, strength and route were not reported), which were exposed to temperatures outside of the recommended range, had been administered to unspecified patients on unspecified dates since 15-SEP-2015. At the time of the report, no adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.