chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 12:30 PM my left arm became stiff and painful, 5 on a scale of 1-10.  As the day progressed I could not move my arm above waist height.  As the day progressed I was unable to lift anything or even grab ahold of anything.  It was #6 on the pain scale to raise my hand to type.  Around 5:30 PM on the day of the vaccine my pain was at an 8.  I took ibuprofen 4oomg at 12:00, 1000 mg acetanubiohen at 2:00 PM.  Then at 6:00 PM I took I took 800 mg of Ibuprofen and at 8:00 I took 1500 mg Acetaminophen.  This did nothing for the pain.  It remained at an 8 most of the night.  It was very difficult to sleep or get comfortable.  The pain was in my shoulder, down my arm, and up my neck, ear, and teeth.  The pain went to a 6 on Sept 4around 8 AM with using both Ibuprofen and Acetaminophen.   I did use ice packs and heating pad, but that did not help.  I was also very nauseous, had a head ache, and could not stop crying.  Today is Saturday, August 5.  The pain is down to a 3 or 4.  Heat helps, but everytime I think of the severe pain I start to cry.  It was so horrible.  I will never get that shot again.
Per patient, his arm is extremely sore and painful due to vaccinations given in the same arm. Patient also states that vaccines may have been given too high up in the arm. Patient is having trouble sleeping due to pain and limited range of motion.
HSV 1 eruption and subli; withdrawal bleeding 3 days late and heavier and longer than usual; migraine; Left index finger petechiae; had an insect bite; lymphadenopathy on the left deltopectoral (1x1 cm tender freely mobile) and on the left supraclavicular (2x1 cm tender freely mobile); temperature was 101 F; Acne flare-up; no withdrawal bleeding and she was on oral contraceptive pill (OCP)/withdrawal bleeding 3 days late; woke up at 2:00 AM and 2:35 AM because of the tenderness rolling over and she had to take central analgesia to be able to sleep; puffy face; tenderness at the site of injection; Constipation; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on the left arm, on 06Jan2021 15:45, at single dose, for covid-19 immunization. The patient has no medical history; unknown if there were any allergies. Concomitant medications included oral contraceptive pill (OCP) and multivitamins. The patient had no Covid prior to vaccination. She did not receive any other vaccines within 4 weeks prior to the Covid vaccine. She took pre-vaccination analgesia. The vaccine was given at the hospital. On 06Jan2021 (day 0) she experienced tenderness at the site of injection. She also experienced constipation on 06Jan2021. However, she couldn't "comment" about temperature since she was taking NSAIDs. She woke up at 2:00 AM and 2:35 AM on 07Jan2021 (day 1) because of the tenderness rolling over and she had to take central analgesia to be able to sleep. On 07Jan2021 she experienced tenderness at the site of injection and; puffy face but it wasn't angioedema. Her O2% was "99-98% repositioning" on 07Jan2021. She still had constipation and still couldn't comment about temperature since she was taking NSAIDs. On 08Jan2021 (day 2) she had an acne flare-up; and no withdrawal bleeding and she was on oral contraceptive pill (OCP). For the constipation she started on OTC fiber gum. On 09Jan2021 (day 4) she experienced lymphadenopathy on the left deltopectoral (1x1 cm tender freely mobile) and on the left supraclavicular (2x1 cm tender freely mobile) which hadn't resolved. She still was experiencing constipation. Her temperature was 101 F on 09Jan2021. On 10Jan2021 (day 5) she had withdrawal bleeding 3 days late and heavier and longer than usual, migraine, constipation, and left index finger petechiae because on "23/11" she had an insect bite on 10Jan2021. On 11Jan2021 (day 6) her lymphadenopathy on the left posterior cervical (1x1 cm tender freely mobile) hasn't resolved; she still had migraine and was now back to regular bowel habit. On 15Jan2021 (day 10) she had HSV 1 "eruption and subli". She received treatment (also reported as symptomatic treatment) for all these adverse events. At the time of the report, she recovered from constipation on 11Jan2021 with lasting effects; while she also recovered from all the other remaining adverse events on Jan2021 with lasting effects. She has not been Covid-tested post-vaccination.
This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 06-APR-2017, the patient was vaccinated with an expired dose of PROQUAD injection, lot # L039268 with expiration date of 05-APR-2017, for prophylaxis (dose, frequency, route and anatomical location were not reported). It was reported that the PROQUAD did not have any previous temperature excursions. No adverse symptoms were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
begin with numbness and tingling to thumb ,pointer and middle finger then numbness and tingle to bilateral body sides from cheeks to ankles, became dizzy though I would pass out, begin shaking then had some nausea, heart was racing. It felt like the tingling was surging through my body. made it to couch to lie down took 12.5 mg Benadrly ODT. some relief then after about 5 min begin again 911 called ambulance to  Hospital
diagnosed an allergic reaction; rash presented  on her right wrist and lower arm area / upper extremities, truck area from under the breasts down to the groin, back; This case was reported by a nurse and described the occurrence of allergic reaction in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On 9th October 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. In October 2020, 2 weeks after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic reaction and rash. The patient was treated with triamcinolone (Kenalog). On an unknown date, the outcome of the allergic reaction and rash were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction and rash to be related to Shingrix. The reporter considered the allergic reaction and rash to be unrelated to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: This case was reported by patient herself. The reporter stated that two weeks later a rash presented on her right wrist and lower arm area.  It slowly progressed to both upper extremities, truck area from under the breasts down to the groin, back and a little on the lower extremities as well but not as severe as upper extremities.  A biopsy diagnosed an allergic reaction.  She had two shots of kenalog that had not helped.  She also had a flu shot at the time but was not contributing that to her symptoms.  The reporter consented to follow up.
she had no voice; She had a sore throat and a raspy voice; cold; raspy voice; This spontaneous report was received from a consumer who refers to her daughter, a 14-year-old female patient. The patient's concurrent condition included Asperger's disorder. Concomitant therapies included amitriptyline, dantrolene and birth control patch. The patient did not have any known drug reactions or allergies.  On 27-NOV-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) a single dose, route reported as "shot in her shoulder" (exact dose and route of administration, lot # and expiration date were no reported) for prevention of cancer. On the same day (27-NOV-2019), she was vaccinated with influenza virus vaccine inactivated (unspecified) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  On 27-NOV-2019 (also reported as "within that week"), the patient developed a cold, she had a sore throat and raspy voice. On 05-DEC-2019, the patient visited a doctor. On 09-DEC-2019, she had no voice and due to the event, on the same day, the patient went to the doctor again. On 11-DEC-2019, the patient visited an otolaryngologists (ENT), she still had no voice and she was in a speech therapy to learn to speak again. It was reported that the patient also visited a neurologist, however no one was sure what was wrong with the patient. The patient did not received any treatment for the events. She had unspecified laboratory tests performed, however no results were provided.  The outcome of the events was reported as not recovered/not resolved.  The relatedness between the events and the suspect vaccines was not reported.
On 16 November 2004, approximately 1 month after receiving the second dose of the Anthrax Vaccine I was diagnosed with a severe case of shingles (herpes zoster) on the left side of my face and scalp.  I was in very good health at the time the second anthrax dose was administered and had no known immune system abnormalities.  The pain in my facial nerves began on 11 November 2004, and the severe rash began on 14 November 2004.  I was treated with two rounds of anti-viral medication, and pain medication.  The total course of treatment lasted from 15 November 2004 to 23 December 2004.  I was able to stop taking pain medication for the nerve damage and return to duty on 6 January 2005.  I still have permanent scarring on the left side of my face.
Dehydration; Thyroid disorder; Hair loss; Weakness; Swollen joints; Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydration), THYROID DISORDER (Thyroid disorder), ALOPECIA (Hair loss), ASTHENIA (Weakness) and JOINT SWELLING (Swollen joints) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included COVID-19 in December 2020.   In March 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced DEHYDRATION (Dehydration), THYROID DISORDER (Thyroid disorder), ALOPECIA (Hair loss), ASTHENIA (Weakness), JOINT SWELLING (Swollen joints) and VISION BLURRED (Blurred vision). At the time of the report, DEHYDRATION (Dehydration) outcome was unknown, THYROID DISORDER (Thyroid disorder) and ALOPECIA (Hair loss) was resolving and ASTHENIA (Weakness), JOINT SWELLING (Swollen joints) and VISION BLURRED (Blurred vision) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 25 25 pounds.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication were reported.  The formulation of co-suspect was reported as Solution for injection in pre-filled pen.  The reporter's causality for the event(s) of thyroid problems, lost 25 lbs, weak, swollen joints, blurred vision, covid-19 and lost hair with Humira(adalimumab) was no reasonable possibility.  No treatment medication were reported.
Day 4  Overall muscle weakness, extreme fatigue, headache, chills, slight dry cough, shallow respirations, mental fatigue, nausea, No fever
It started in March my left arm pain was unbearable radiated from upper arm to hand. I went to the orthopedic was referred to physical therapy for 3 sessions. I went back due to symptoms getting worse recommended FL injection which takes 90% of pain away. The cortisone injection supposed to last 4-6 months.
Chills; light headedness; shortness of breath; headache; This is a spontaneous report from a non-contactable consumer reporting for a patient.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination.  Medical history and concomitant medications were not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unspecified date, the patient experienced chills, light headedness, shortness of breath, and headache. The clinical outcome of chills, light headedness, shortness of breath, and headache was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
CEREBROVASCULAR STROKE 05/04/2021     COVID-19 (JANSSEN), VECTOR-NR, RS-AD26, PF,        1
they gave a 1st dose to a 16 years & 9 months old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (they gave a 1st dose to a 16 years & 9 months old patient) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (they gave a 1st dose to a 16 years & 9 months old patient). On 20-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (they gave a 1st dose to a 16 years & 9 months old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
COVID VACCINE BOOSTER GAVE FLU SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (COVID VACCINE BOOSTER GAVE FLU SYMPTOMS) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products COVID-19 VACCINE for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease.).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form., fourth dose of COVID-19 VACCINE (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, CF. On an unknown date, the patient experienced INFLUENZA (COVID VACCINE BOOSTER GAVE FLU SYMPTOMS). At the time of the report, INFLUENZA (COVID VACCINE BOOSTER GAVE FLU SYMPTOMS) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient received Modena COVID-19 vaccine booster dose and COVID-19 vaccine 2nd booster dose. It was reported that the reporters causality for the event of COVID vaccine booster gave flu symptoms with Humira was not provided and with COVID-19 Vaccine was possible. No treatment information was reported.
Minor little symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minor little symptoms) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Minor little symptoms) and PYREXIA (Fever). At the time of the report, VACCINATION COMPLICATION (Minor little symptoms) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.
Patient was 32 weeks pregnant at the time of vaccination. Prescription was sent by patient's MD and pharmacist administered the vaccine. At the time of vaccination, according to state law the patient was not eligible to receive vaccine at the pharmacy even though it is approved for her patient population. Patient has not reported any adverse effects.
Administered with 2 doses of the vaccine 5 minutes apart; A spontaneous report was received from a physician concerning a (patient age and gender: unknown)patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  was administered with 2 doses of the vaccine 5 minutes apart/Inappropriate schedule of vaccine administered  The patient's medical history was not reported. Concomitant medications taken by the patient were not provided.  On an unknown date, prior to the onset of the event, the patient received their planned doses of mRNA-1273 (Lot number: unknown) through unknown route at unspecified site for prophylaxis of COVID-19 infection.  On an unknown date, the reporter reported that patient was administered with 2 doses of the Moderna Covid-19 vaccine 5 minutes apart on the same arm.  Treatment activities for event was unknown.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event administered with 2 doses of the Moderna Covid-19 vaccine 5 minutes apart  was resolved on an unknown date.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown  with no associated AEs.
Left arm.  A little tender for the 1st 18 hrs; then for the next 24 hrs, "large and inflamed".  Describes a 4-in purulent lesion, hot, red, painful, minor itching associated with a bad headache.  Lasted 48 hrs.  Treated with ibuprofen and Benadryl.  The purulence ("pus-y") and swelling have completely subsided (pain and swelling lasted about 10 days).  Never drained but she could see a "white circle" at the periphery of the lesion.  No associated fever/chills.  No prior vaccine reaction and no other drug reactions.  She had allergy testing on her blood recently due to chronic sinus congestion and headaches and was told she had a strong reaction to wheat and a reaction to dairy which she is not restricting from her diet.  She said the vaccine was given at a  for first responders.  The injection was given midway between her shoulder and elbow because she couldn't get her sleeve high enough (in her "biceps"?).
This person is a patient of ours and she came in stating that she was here to get her second COVID vaccine.  She stated she could not find her card but she received her first dose at the homeless shelter.  I entered her information in the system and administered her Moderna Vaccine.  She then found her card and gave it to me to complete with the second dose information.  This is when I realized that she was given Janssen vaccine on 3/25/2021 per her card.  I verified that she did receive the Janssen vaccine.
Related to a condition called Bell''s Palsy, and I also understand it could be slight paralysis on the side of the face; I started feeling little weird; Something started happening with my eye, my right eye, it wasn''t, it felt like it wasn''t closing; My left eye I was having problems with that; This is a spontaneous report from a non-contactable consumer, the patient.  A patient of unspecified age and gender received an unknown dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient suddenly  started feeling little weird on an unknown date and left eye, the patient was having problems with that on an unknown date and the patient understood this was related to a condition called Bell's Palsy, and also understood it could be slight paralysis on the side of the face related to a condition called bell''s palsy on an unknown date. The outcome of all th events was unknown.  No follow up attempts are possible. information about lot/batch number cannot be obtained. No further information is expected
Possible Tinnitus; ear feels clogged; heavy vibrating when any noise/music; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 15:30 (Lot number: FF2590) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 23Apr2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 29Oct2021 13:00, outcome "not recovered", described as "Possible Tinnitus"; EAR DISCOMFORT (non-serious) with onset 29Oct2021 13:00, outcome "not recovered", described as "ear feels clogged"; VIBRATORY SENSE INCREASED (non-serious) with onset 29Oct2021 13:00, outcome "not recovered", described as "heavy vibrating when any noise/music". The events "possible tinnitus", "ear feels clogged" and "heavy vibrating when any noise/music" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus, ear discomfort, vibratory sense increased.  No follow-up attempts are possible. No further information is expected.
Patient and Mom both presented at pharmacy stating rheumatologist (Dr) reccommended pneumonia and flu vaccines for patient based on immuno-compromised state. In the evening following vaccination, patient developed high fever 103 degree +, and right arm pain/redness. Mom could not get fever to break with Tylenol and Motrin, so took patient into hospital.  Hospital testing revealed possible cellulitis and sepsis, pt started on Vancomycin therapy to treat, but then symptoms did not resolve.  Patient ended up needing dose of Solumedrol in hospital as well to have relief from symptoms and mom stated patient in patient at hospital for 7 nights and was discharged on steroid and antibiotic therapy (precautionary) and believe patient may have underlying immune disorder that created intensified allergic reaction to vaccine.
No additional AE or PQC reported; Caller explained the PROQUAD was administered after a temperature excursion; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The pertinent medical history, concomitant therapies and drug allergy or reactions were not provided.   On 05-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, (lot #U024508, expiration date: 02-FEB-2023, therapy type: rHA) for prophylaxis (strength, route of administration were not provided) for prophylaxis after a temperature excursion: 12.95 F for 21 hours 15 minutes 0 seconds (product storage error). There was no previous temperature excursion. There was no additional adverse event (AE) or product quality compliant (PQC) reported (no adverse event).