chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender with an medical history and drug allergies not reported who on 18-DEC-2012, was vaccinated with GARDASIL (Lot #, dose and route not provided). No other co-suspects were reported. No concomitant medications were reported. The medical assistant stated that on 18-DEC-2012, a patient may have been administered an incomplete dose of GARDASIL due to possible syringe leakage during administration. No adverse effect reported. Additional information is not expected.
Swelling and pain at injection site, slight discomfort at former injection site(left arm), malaise, joint aches/pains
By March 6, fever, increased blood pressure and pulse, regular headache, upset stomach --  The fever subsided on March 7 but then came back that night.  I also developed ocular migraines (not a regular headache) on March 7 and 8. These include aura and interrupted vision. I do get this kind of migraine from time to time. My temperature is also running a little low.
Tingling/numbness started in feet and then worked it?s way to the top of my head.  The tingling/numbness lasted about 10 hours and gradually diminished from my feet up to my head.  About 2 hours after the tingling/numbness started I felt my blood pressure or blood sugar start to fluctuate up and down for about 2 hours.  I stayed in bed for this time period.  I felt light-headed and scared.  After about two hours, I felt stable enough to get out of bed and ate some food and drank some liquids.  The numbing/tingling sensation seemed concentrated around my head for hours.  I couldn?t really focus on anything.  It felt like when your foot falls asleep.  I felt as if I was having a neurological reaction because of the weird tingling numbness sensation.  It felt like my nerve endings were firing all over; like having the chills without being cold.  Although the biggest event was on 2/28, I felt the tingling ing/numbness in my arms on and off for at least another week.  I?m scared to get the 2nd dose.
Chills, fever, weakness, headache, blurry vision, loose bowel movement, rash, enlarged lymph nodes (confirmed by mammogram and ultrasound ), dizziness ; welt
Itching, red, and swollen at site of injection. Received shot on 3/25, went to doctor on 3/28 because of pain and other symptoms unresolved. MD said to ice and take TYLENOL. 3/31 same symptoms but swelling and redness worse.
Headache fatigue, injection site pain/arm soreness more severe than the 1st dose Narrative:  Was able to sleep off her side effects. Took 800mg Ibuprofen OTC which helped. Afebrile.
left arm was so sore, hurt; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 29Jan2021 09:52 (Lot number: EL9264) at the age of 65 years, as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Meniere's disease" (not ongoing), notes: in 1993 or 1994; last episode was probably about 15 years ago; "High Cholesterol" (ongoing); "Thyroid pill use" (ongoing); "lost hearing in left ear" (unspecified if ongoing); "allergy to wasps/wasp venom" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder, start date: 1991 (ongoing); ATORVASTATIN taken for blood cholesterol increased, start date: Nov2020 (ongoing). Vaccination history included: Pneumococcal vaccine (around late Oct2020 or Nov2020), administration date: 2020, for immunization; Flu vaccine, for immunization, reaction(s): "no adverse effects". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Jan2021, outcome "recovered" (Feb2021), described as "left arm was so sore, hurt". Additional information: The event onset was at late night of 29Jan2021 and lasted for 3-4 days (as reported).  No follow-up attempts are possible. No further information is expected.
I was diagnosed with post-partum hypothyroidism 4/6/20 (labs below) and put on medication (levothyroxine).  Based on lab trends over the next 9 months, medication was weaned down and after labs on 12/28/20 (below), I was taken off medication as my physician felt that this condition was resolved .  I received my first COVID vaccination on 12/31/20.  Over the next month, I felt progressively more tired.  On 1/25/21 @noon I started having symptoms of hypotension unrelated to dehydration. These symptoms were intermittently persistent for the next  2 weeks.  On 1/27/21 @0400 I started having profuse uterine bleeding (menorrhagia) which resulted in a call to the MD later that day who recommended high dose ibuprofen and rest.  I omitted AM ibuprofen dose on 1/29/21 and received the second COVID vaccine on 1/29/21.  Repeat thyroid labs were drawn on 2/8/21 (below) and were  completely unexpected given previous lab trends.  My physician placed me back on medication and I will get my labs drawn again in a month.  Acknowledge that there isn't data with the COVID vaccine and autoimmune conditions; however, I am wondering if the vaccine induced the TPO antibodies  along with the COVID antibodies.  This may be something to look more into for other autoimmune disorders as well as more patients are vaccinated.
I have been having irregular late periods ever since receiving the vaccine.  My periods have always always been regular & normal my entire life. Now they are heavier & late by  3 weeks then again by 5 wks late.
Woke with body aches, fever (101 degrees F), sore throat, nasal congestion. Took ibuprofen and used OTC nasal spray to clear sinus. Used ice packs on my face to cool off. Was also very dehydrated and drank copious amounts of water. Next day, fever and aches were gone, but congestion remains, accompanied by fatigue. These symptoms continue through today, 10/07/2022.
Swelling in his knee and legs; Soreness; Swelling in his knee and legs; This is a spontaneous report from a contactable consumer. This consumer (wife) reported for a male patient (husband).   A male patient with an unspecified age received BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: unknown) via unspecified route on an unknown date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. It was reported he got the Pfizer shot last weeks. On an unknown date, the patient experienced swelling in his knee and legs and soreness from last couple of days. At the time of this report the outcome of the events were unknown.  No follow-up attempts were possible, information about lot/batch number cannot be obtained.
Information has been received from a consumer concerning her daughter, a 25 year old female with no known drug reactions/allergies and a history of migraine who in 2007 was vaccinated with a total of three 0.5 ml doses of GARDASIL vaccine (yeast) (exact time of each dose not reported). Concomitant therapy included birth control pills. In 2008, a "couple months ago" the patient experienced wart like growths on her fingers. Biopsy was done and no result was provided. The patient's wart like growths persisted. Unspecified medical attention was sought. Additional information has been requested.
severe allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Rabies NVS (Rabies Vaccine) for prophylaxis.   In February 2019, the patient received Rabies Vaccine. On an unknown date, less than a year after receiving Rabies Vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Rabies Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in her 50s or 60s. On 5th February 2019 or 6th February 2019, the patient received an unknown Rabies vaccine. The patient experienced severe allergic reaction. The reporter had no more information and declines to provide any more information or follow up.
flu; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Past vaccination(s) included INFLUENZA VACCIN with every year.  Medical history, medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
3:35pm - Pt waited full 15 minutes without reporting issues. Pt stated that she felt difficulty breathing, but "thought it was because of the mask", went to her car, and used her asthma inhaler. Pt stated she began feeling chest tightness, so came back into the clinic. Reported no change from inhaler, and complained of nausea.  3:32pm - 135/78, 99%, 101/min - chest tightening has gotten worse. 3:44pm - Quick Response Team called over, pt stated sx started to subside. 3:46pm - 142/70, 99%, 100/min - offered pt ER transport, declined at this time 3:53pm - 131/87, 98%, 93/min - tightening in chest 3:56pm - 143/89, 99%, 124/min 5:59pm - 198/93, 98%, 113/min 4:03pm - 184/106, 98%, 107/min 4:07pm - pt called family to bring her home as she did not feel comfortable driving.
Patient fainted approximately 5 minutes after receiving vaccine.  Patient fainted about 3 times after initial incident.  He was evaluated and cleared by paramedics
My COVID-19 symptoms started on 11/24/2022 with scratchy throat and congestion. The next day I started feeling dizzy and I headaches. On 11/25/2022 I tested with the home test and it was positive. On 11/28/2022 I called my doctor who  prescribed me with LAGEVRIO (molnupiravir) for 5 days.
No additional AE; Patient received a dose of the RECOMBIVAX HB vaccine that was improperly stored.; This spontaneous report was received from other health proffesional and refers to a patient of unknown age. No information on patient's medical history, current conditions and concomitant medications was provided.      On 23-MAY-2023 the patient was vaccinated with dose of improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # W012032 and expiration date 19-NOV-2023 for prophylaxis (exact dose, frequency and route of administration were not provided) (product storage error and no adverse event). ; Sender's Comments:  US-009507513-2306USA003084:
COVID 19 (Drug ineffective); COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6198), in right arm, on 18Mar2021 as dose 2, single (Lot number: EP7534), in right arm, on 09Oct2021 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). No known allergy. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2014, stop date: 22Sep2023. The following information was reported: COVID-19 (medically significant) with onset Sep2023, outcome "unknown", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset Sep2023, outcome "unknown", described as "COVID 19 (Drug ineffective)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID), from 22Sep2023 (Lot number: GK5810) to 27Sep2023.   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.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with allergy to B12 and B6. On 09-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J005719, expiration date 13-AUG-2014 0.65 ml one dose, subcutaneous in the arm). There were no oncomitant medication. On 11-OCT-2013, the patient experienced itching, swelling, a hard knot and redness at the injection site area but was also spreading around and back of the patient's arm. The patient also experienced a fever and one blister that popped up near the patient's wrist in the same arm where ZOSTAVAX injection was received. The patient was given cold compress, hydrocortisone ointment and ALLEGRA for treatment. No lab diagnostics studies performed. The patient sought medical attention via contact pharmacist. The outcome of the events was reported as recovering. Additional information has been requested.
Information has been received from a nurse practitioner concerning a child who was vaccinated with a dose of varicella virus vaccine live. Approximately two weeks later the child developed a rash. Unspecified medical attention was sought and it was unknown if a prescription drug was required. A product quality complaint was not involved. Follow up was received from the nurse practitioner which indicated that information regarding the name of the patient or any particulars of the event could not be recalled. No further information is expected.
Body aches day after injection. Soreness, knot and fever at injection site. Knot and fever at injection site sore for 6 days after injection.
She was seen at urgent on 8/28/21 for increasing shortness of breath and chest congestion for the past 2 to 3 days.  Her baseline oxygen is around 93.  She came into the Urgent Care using the nasal cannula 3 L with the saturation over 90.  She states that she has fever and she has sore throat.  She is coughing.  She feels fatigued and tired. Over-the-counter cough medication including Robitussin was used with very minimum help.    Upon arrival to the hospital, the patient was found to be febrile with the temperature over 100.  Her heart rate is around 100, blood pressure stable, and her saturation is 95% on 2 L nasal cannula.
tightening and swelling in her throat; tightening and swelling in her throat; slight swelling of the tongue; panicky, uncomfortable feeling; panicky, uncomfortable feeling; headache; Sore throat; Extreme tiredness; achy joints; sore muscles; generally feeling sick/unwell; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at right arm on 23Jan2021 13:30 at a single dose for  COVID-19 immunization.  Medical history included ongoing hypothyroidism (has had for 15 years or so). The patient's concomitant medications were not reported. The patient previously took glycerin and had allergy (has been allergic to glycerin for at least ten years). The patient received the Covid-19 vaccine on Saturday. About 10-15 seconds after receiving it, she felt like it was moving up her arm. She also had a headache and sore throat on the same day. About 20 minutes later at 13:50, she had a tightening and swelling in her throat. It was a panicky, uncomfortable feeling. She reported a "narrowing of my airway" and slight swelling of the tongue/back-of throat. She was unsure if she should wait or go to the emergency room. She took some deep breaths and waited it out. It went away 40 minutes later. She also reported feeling extreme tiredness, achy joints, sore muscles, a headache, and generally feeling sick/unwell in Jan2021. The events did not require a visit to Emergency Room and Physician Office. No prior vaccinations (within 4 weeks). The outcome of the event headache and sore throat was recovering; event tightening and slight swelling of the tongue/swelling of throat was recovered/resolved with sequel on 23Jan2021; and unknown outcome for the other events.  Information on the lot/ batch number has been requested.
Patient said she experienced "cramping in both legs and feet". It started the night of the shot, "lasted through the night", and occurred again eight days later.
Previously documented redness and pain at injection site, but had additional symptoms of pain upon raising arm above head, and neck pain as same side as injection.  Three days out, symptoms still exist, although I am able to raise arm above head without pain.
Approximately 6-8 hours after vaccination, experienced severe nausea/vomiting/ dizziness, vision changes, had to leave work, lasted 3-4 days. Denies experiencing shortness of breath, changes in breathing, swelling of face, lips and eyes.
Headache for 3 days so far. Swelling of lower extremities, joint pain, difficult to concentrate/decision making.
This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, an unspecified number of unspecified patients received a dose of improperly stored VARIVAX (Lot# N012618, expiration date 21-APR-2019 or Lot # M043582, expiration date 28-OCT-2018) (dose, frequency and route were not reported). The lot numbers and expiration dates of the sterile diluent (manufacturer unknown) used for reconstitution was unknown by reporter (dose, frequency and route were not reported). The sterile diluents did not undergo any temperature excursion. The vaccine was exposed to temperature excursion of 6 F to 14 F for 4 hours and the data logger was involved. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA000600:
Pain, swelling, redness in left arm around injection site. Pt stated whole arm hurt. Pt given Augmentin 875mg 125mg, Prednisone 20mg x 5 days, and Ibuprofen 600 mg.
less than12hr p/vax pt devel dec appetite & increased sleep;10/4/99 had h/a, vomited once;no fever;
Speech regression immediately, lethargy immediately. Joint pain weeks and months following. Long term: food allergies; wheat, dairy, peanuts. Diagnosed Systemic Juvenile idiopathic Arthritis. 11/2015.
LARGE RASH/REDNESS ON ARM, HOT, SWOLLEN, AND PAINFUL.
Minor swelling and hives at injection site. Has not spread more than 3 in from injection site
I had debilitating migraines for 3 days. I spoke with the clinic doctor about it off the record as I am a nurse in the hospital. The subsided after 3 days
patient was given a dose from a vial that was past it's dilution period expired time. patient was brought back and re vaccinated.
client was inadvertently given pediatric pfizer dose instead of adult dose, immunization coordinator consulting with pfizer for further instructions
At 48 hours, ipsilateral axillary pain, fullness. Low grade (unmeasured) fever. Local tenderness, swelling at the injection site.
On the night of 07/12/2022 I had a little scratchy sore throat, drainage and nasal congestion. I took a home test the next morning which was positive. I made an appointment at my doctors office on the same day and had another test which was positive. I was given a prescription for PAXLOVID. I started medication on the same day, I took my last dose on 07/18/2022. I noticed my symptoms improving within a couple of days. I have had a very mild case main symptoms is fatigue. I tested negative on 07/20/2022. Today I woke up with a stuffy nose and retested twice both being positive.
Acute on chronic respiratory failure with hypoxia. Patient hospitalized for 14 days; received first dose of COVID vaccine in the hospital.
Flu-Like Symptoms, Exhaustion, Lethargy, Aches, Leg cramps, Fever of 101.8
Vomiting began @ 12:20 a.m. 5/17 with fever to 105 F and chills. slight diarrhea later on 5/17. Went to ER and given phenergan and antibiotic shot. urinalysis and blood culture drawn. Chest x-ray.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 027L20A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-Jun-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Mild rash with signs of airway compromise. Went to ER prescribe inhaler and prednisone.
A large percentage of pt recvd Engerix-B  Intradermal & it was determined that pt did not develop titers;
brain fog grassy; Feeling off; cold; This is a spontaneous report from a Pfizer-sponsored program, . A contactable nurse reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had cold for 1 week (brain fog grassy feeling off) on unspecified date. He stated he felt the same way after a flu shot. The outcome of the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient felt a little shaky and had increased heart rate about 15=20 minutes post vaccine,
48 hrs p/vax pt runs high grade temp; has been seen by MD w/no significant findings; treated this occurance w/ATB for poss bronchitis;
Client is a 7 year old male who came in to receive his Pfizer pediatrician and became "itchy" within 10 minutes of vaccination. Client received 12.5 mg liquid Benadryl orally @ 10:01 AM.
Information has been received from a medical assistant concerning a male who was vaccinated with a dose of VARIVAX (Merck) and a dose of  MMR II (MSD). Concomitant therapy included a dose of poliovirus vaccine (manufacturer unknown). Subsequently the patient developed severe local site reaction 2 days after vaccination. The site was red and swollen, but the patient had no fever. It was not a cellulitis. The patient received unspecified medical attention. The patient had not recovered at time of reporting. No further information is available.
16.5 cm x 11.75 cm Rx (L) thigh site KINRIX decreased pain today but larger today.