chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 1/31/21, 8 days post vaccine, I noticed bruising on my torso and left leg.  Over the course of the next three days I noticed more bruising on my arms, elbows, legs, and knees.  At 11 days post vaccine I had a telehealth doctor visit and she ordered a CBC blood work panel to test my platelets.  At 13 days post vaccine I was notified that my blood work panel revealed extremely low platelets and I needed to see an adult medicine doctor immediately.  My primary care doctor referred me to a hematologist for immediate treatment.
I don?t remember everything that happened because it was several months ago. I do remember getting tingly limbs and almost immediately after getting the vaccine having brain fog. Not being able to think as clearly as before, feeling dumber. This lasted for a while, probably weeks. I felt like the vaccine messed with my nerves. I was so worried about these effects that I made an appt with my doctor. I think the appt was made a few days after I was vaccinated. I had been seeing doctor. I received my vaccine elsewhere. I felt as though I had cold or hot water being poured down my legs. Even though that wasn?t happening. If you message Mardi, she could probably look up exactly what I experienced in more detail. She told me that because I had experienced some of these feelings before that I was probably okay. I had experienced prior to my vaccine feeling a wet spot on my leg when there was no water there, but nothing like this. Before the vaccine the wet spot feeling would be infrequent, happening every great once in a while. Maybe once a week or less. This was much more intense , after the vaccine, and it came and went often throughout the day. I would get the feeling of water being poured down my legs several times a day after getting the vaccine. I think this lasted for a couple of weeks. I don?t remember if it felt like it was hot or cold water, but it was one of those. I would be interested to know if anyone else had experienced these problems with the covid vaccine and if they went on to get a second dose of the moderna covid 19 vaccine, safely, or if the CDC recommends I do not pursue getting fully vaccinated because of the adverse side effects I experienced from the first vaccine dose. Please let me know what you think I should do.  I feel like after a few weeks or months, I felt better again. Just those few weeks right after, I had a lot of crazy symptoms of things I had never experienced before.
By 8 pm, I had significant pain in all my joints. By 6 am the next morning, I had a headache and was having chills. I still had significant pain in all my joints. By 5 pm that day, symptoms were gone.
didn't feel very good after the second dose of the COVID Vaccine; COVID; COVID; drainage; a small, little cough; itchy throat; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 09Jan2021 as dose 2, single (at the age of 56-year-old) for COVID-19 immunization. Medical history included allergies (environmental or seasonal allergies. She has had allergies for a long time). Concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 22Dec2020 in left upper arm as dose 2 single (at the age of 56-year-old) for COVID-19 immunization. Patient stated that she had received second dose of COVID vaccine on 09Jan2021 and now has COVID. On 26Jul2021 (yesterday) patient diagnosed with COVID. They did a nasal COVID test and it took about 20 minutes to get results. Her symptoms started Saturday 24Jul2021. She thought it was a head cold. She had stuff running down the back of her throat. She had drainage and a small, little cough on 24Jul2021. She didn't feel bad. Today she felt a little worse. She was really stopped up, super stopped up. She doesn't feel good today.  It sounds like the Delta variant. She had a little bit of an itchy throat on Saturday, 24Jul2021, and Sunday, 25Jul2021, but it was not a sore throat. She thought it was just the stuff draining down the back of her throat like she normally has. On 27Jul2021, patient experienced didn't feel very good after the second dose of the COVID Vaccine, She gets a red arm and all that with the flu shot. Caller doesn't have the lot, and expiry for the flu shot. They would have that information at the hospital or work care. Her primary care doctor was not the one that diagnosed COVID. Quick Care was the facility that diagnosed COVID.  Patient only had phone number to provide for her primary care doctor. Vaccination facility type was hospital. It is the company she works for. The patient underwent lab test and procedures included nasal covid test resulted positive and Flu test resulted negative on 26Jul2021. The outcome of the events was unknown.   Information about lot and batch number was requested.
Information has been received from a registered nurse concerning a female who on Dec 22 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). Subsequently, the patient experienced cellulitis at the injection site which spread to her elbow, The patient was seen at the emergency room, She was treated with antibiotics and was released. The patients outcome was unknown. The nurse requested a lot check into this lot number. No product quality complaint was involved. Additional information had been requested. It was also reported that another patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P) and experienced adverse events (WAES0501USA04327). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory, The lot complies with the standdards of the Center for Biologics Evaluation and Research and was released.
My 1st vaccination, I didn't have many adverse reactions at all.  My 2nd vaccination (02/10/2021), I had chills, headache, muscle ache and 101 degree fever for one day. On August 13th, my genital Herpes appeared after being dormant for 35 years.  My 3rd vaccination, I started to feel "achy" around 11 p.m. and woke up with muscle ache, headache, tiredness and 103.1 degree fever. It subsided after the first 24 hours, but still felt achy and disorientated for the next 2 days after taking 500 mg Tylenol every 6 hours. Ever since the 1st vaccination, I have had occasional blockage in my Eustachian Tube, and a lymph node in my left jaw swollen, varying in size. Don't know if the vax had anything to do with this at all.
On 7/1/03 pt had varicella vaccine and Prevnar. Mother called 7/4/03. Rash/fever ? related to vaccine.
Information has been received from a physician concerning a patient who on 02-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 and a dose of VAQTA in the same arm. On 02-DEC-2009 the patient experienced pain and swelling at injection site. On 03-DEC-2009 subsequently, the patient complained of pain and swelling at injection site, although the swelling had gone down since yesterday. It was unknown if the patient sought medical attention. Additional information has been requested.
Erythema and swelling on 12/6/17 (vaccine administered on 11/27/17).
w/in 25 mins p/vax pt devel periorbital edema bil w/wheals of upper eyelid & hyperemia also clear nasal discharge;
Subsequent to receiving first and second doses of varicella virus vaccine live diagnostic laboratory test confirmed a negative varicella titer. Pt received both doses more than 3 months prior to becoming pregnant.
This spontaneous report as received from a 56 year old female patient with medical history of auto-immune disorders and brain infarction and with drug reactions/allergies to enalapril, MOBIC KEFLEX, tetracycline and penicillin. The caller(patient) stated she had had shingles in the past and had experienced post herpetic nerve pain. The caller stated her immunology doctor(who she did not wish to specify a name) had advised her to ZOSTAVAX. On 21-MAR-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot #, dose number were unspecified). Concomitant therapies included aspirin, CELEXA, acetaminophen, NORCO and XANAX. Patient stated that after she received ZOSTAVAX, the same night she developed severe muscular pain in every joint. She ran a Fever of 100 to 102 degrees which lasted for 3 days. She began feeling nervous and "edgy". She continued to have severe pain in the nerves in her back. It feels like post herpetic nerve pain. Patient had sought unspecified medical attention. TYLENOL and other pain medication were given for the events. The outcome of fever was reported as recovered on 23-MAR-2013, "lasted for 3 days", the outcome of other events were reported as not recovered. Drug relationship was not provided. Additional information is not expected.
After observation, pt experienced some discomfort in her throat as if fingers were pressing against it.  BP WNL per pt.  After pt laid down she felt better after a few mins.  Pt reports that she has many medical conditions but did not specify. Vitals: 139/80, 92, 18, 99% Pt given 25mg PO benadryl @ 12:35. Pt stable and released from the vaccination site.  Recommend pt f/u w/ healthcare provider
This spontaneous report as received from a medical assistant refers to a 12 year old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 29-SEP-2017 the patient was vaccinated with improperly stored dose of GARDASIL 9 from lot N017697 expiry date 21-JAN-2020 by intramuscular route for prophylaxis. No adverse events reported. The call was made due to a digital data logger. The vaccine was exposed to a temperature of 50.5 degrees Fahrenheit for a time frame of 1.5 hours. There was no previous temperature excursion involved. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1711USA004678: US-009507513-1711USA004679: US-009507513-1711USA004680: US-009507513-1711USA004678: US-009507513-1711USA004676: US-009507513-1711USA004677.
Pt. reported feelings of shaking and shivering to whole body, mostly upper body, unsure if related to vaccines.
Headache 3-5/10  for DAYS 1-5 Itchiness of the face, scalp and right hand DAYS 1-5 Itchiness of lips and tongue DAY 1 and DAY 5 Bilateral Hip and Knee pain DAYS 1 and DAYS 3-5 Flank Pain DAYS 3-5
Shingles on head ,bad headaches.... prednisone 20mg...gabapentin 300 mg....valacyclovir hcl 1 gram tablet
Fussiness, dizziness, crying, having chills (goosebumps on her limbs), turning red, vomiting after tried to feed her, curled up because of stomach pain, diarrhea.
Upon administering the vaccine, the patient pulled her arm away as the medication was entering her arm. There was 0.1 mL of the vaccine that did not get injected and was lost. The patient was informed and had no immediate adverse reactions.
Acne type rash spread from chest to neck, face and back. Given Kelfex, Medrol Dosepak and Benadryl.
The evening of the inkection I felt nauseated. The next morning I had fever and chills (100 F) and fatigue. The next morning I had lymphedema on the rt side of my jaw and down my anterior neck. The next day I developed a large ulcerated area at the back of my throat on the right with intense ear pain. I went to the clinic and a covid test was done (I don't have the results yet). Today (7days after the injection) I returned to the clinic because  my throat ulcer had gotten larger and spots were appearing on the roof of my mouth. I again ran a low grade fever. I was again diagnosed with either a viral infection or an unusual immune response to the vaccine.
muscle pain; headache; dizziness; lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), HEADACHE (headache), DIZZINESS (dizziness) and DIZZINESS (lightheaded) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SPIRONOLACTONE and ESTRADIOL for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced MYALGIA (muscle pain), HEADACHE (headache), DIZZINESS (dizziness) and DIZZINESS (lightheaded). At the time of the report, MYALGIA (muscle pain), HEADACHE (headache), DIZZINESS (dizziness) and DIZZINESS (lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment medication were not reported/unknown.
This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received first dose of vaccine on 16Mar2021 and Second dose scheduled for 06Apr2021. The patient reported that she has Rheumatoid Arthritis and takes Humira. The patient reported that she is not currently taking it. She would like to know if there is any information on taking Humeral and getting the vaccine or if there is a time period she should pause her medication. The outcome of the event was unknown.  Information on the lot/batch number has been requested
TIRED THAT LATE AFTERNOON; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes type 1.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On 10-MAR-2021, the subject experienced tired that late afternoon. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired that late afternoon, and headache. This report was non-serious.
headache; tired; general feeling unwell; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (18Oct2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "She also had covid before any of the Pfizer shots", start date: 06Jan2021 (unspecified if ongoing), notes: She also had covid before any of the Pfizer shots; "Osteoporosis" (unspecified if ongoing); "Rheumatic polymyalgia" (unspecified if ongoing); "polymyalgia", start date: Jun2023 (ongoing); "Thyroid (low)" (unspecified if ongoing); "Colesterol (high)" (unspecified if ongoing); "immunization" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 29Sep2023 as dose number unknown, single; ALENDRONATE SODIUM taken for osteoporosis (ongoing); PREDNISONE taken for rheumatic disorder, myalgia (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); PRAVASTATIN taken for blood cholesterol increased (ongoing); OMEPRAZOLE (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot: EW0164), administration date: 15Apr2021, when the patient was 73-year-old, for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE, Lot: EW0172, Anatomical Site of injection: Left arm, Route of administration: Intramuscular), administration date: 06May2021, when the patient was 73-year-old, for COVID-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, lot number: FE3590, Anatomical Site of injection: Left arm, Route of administration: Intramuscular), administration date: 12Nov2021, when the patient was 73-year-old, for COVID-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Lot: FM7553, Anatomical Site of injection: Left arm, Route of administration: Intramuscular), administration date: 13Jun2022, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tired"; MALAISE (non-serious), outcome "unknown", described as "general feeling unwell". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321140 Same patient, different vaccine dose and event;
Within 24 hours of receiving the FLUARIX vaccine patient had a brief generalized seizure. She has a known seizure D/O - last seizure was 1yr-prior. Medication levels were not obtained.
HCP calling in to report that a patient was inadvertently administered an expired dose of PROQUAD.; No additional AEs/no PQCs; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 04-NOV-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter (1 dose) (route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number U009259, with an expiration date of 19-SEP-2022) administered for prophylaxis (expired vaccine used). No additional adverse event (AE) or product quality complaint (PQC) were reported.
No additional adverse event; Improperly stored VARIVAX was administered to the patient; This spontaneous report was received from a registered nurse and refers to a 12 month old patient, gender not reported. The patient's concurrent conditions, drug reactions or allergies and pertinent medical history were not reported.      On 21-DEC-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T000344, expiration date 05-JAN-2022 ( dose and route were not reported) for prophylaxis. The vaccine was stored at -8.5 Celsius degrees (°C) for 8 hours. The vaccine also had previous temperatures excursions at -14.1°C for 1 hour and -11.9°C for 2 hours and 30 minutes. The vaccine was reconstituted with a properly store sterile diluent (MERCK STERILE DILUENT). No additional adverse event. The call was made due to "data logger".
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/9/2021 and 3/9/2021. Presented to ED with complaints of shortness of breath. Admitted for acute heart failure exacerbation and pneumonia due to COVID-19. Received dexamethasone, antibiotics, zinc, vitamin C, vitamin D, anticoagulation, diuretics, and pressors.  On 1/24/2022, patient's respiratory status decompensated and she was transferred to the ICU. Patient was immediately intubated, central line was placed.  Despite maximum interventions continued to decline. Expired  1/24/22.
This report was received from a pharmacist via Pfizer and was assigned manufacturer report number 2015348600 for PREVNAR 13 regarding a female of unknown age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. In approximately 2009 (reported as six years ago), the patient was vaccinated with a dose of PNEUMOVAX 23, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. In approximately 2009, the patient had an allergic reaction to the PNEUMOVAX 23. Her arm swollen and red for two weeks after she received PNEUMOVAX 23. The reporter queried for literature. At the time of the report, the outcome of her arm swollen and red for two weeks was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Cycle disturbances. Bleeding every 2 weeks since 1 month after 2nd shot.
Patient developed severe swelling and cellulitis in his left arm about 5 hours after receiving both vaccinations in his left arm.
itching began 630PM; fine red rash (over) all of body severe itching; 2 episodes of lightheaddness things seemed darker this 630 18DEC92; diarrhea last noc;
A rash appeared covering his face, arms, and legs. The doctor thought it was due to something he ate, but he had eaten no new foods and has not had a reaction since then to any foods.
No adverse event; Took first dose on 20-Apr-2021 and second dose on 18-Jul-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took first dose on 20-Apr-2021 and second dose on 18-Jul-2021) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took first dose on 20-Apr-2021 and second dose on 18-Jul-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took first dose on 20-Apr-2021 and second dose on 18-Jul-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      No concomitant medications were reported.  It was reported that the patient did not have any flu shot last year.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-653965 (Linked Report). This case was linked to MOD-2022-654324, MOD-2022-654236 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2022: Follow up received contains no new information.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-653965:Wife's case.
a 16 years old patient received FLUBLOK vaccine with no adverse event; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 16 years old male who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- UJ448AA, expiration date- 22-Mar-2021) via unknown route in the left deltoid for prophylactic vaccination (product administered to patient of inappropriate age) on 26-Sep-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.   No concomitant vaccines given to the patient.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  The patient experienced no adverse events.  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.