chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest pain, chest tightness, difficulty breathing, all of which were worse when lying down. Soon developed fever, chills, and night sweats, and eventually tachycardia (resting 160 bpm) with atrial flutter and then atrial fibrillation   Original pain was within the week of the vaccine, but the fever came on about a month later and lasted for 2 weeks.
red, raised tender area at the injection site 3in by 3 in  Narrative: recommended ice and Benadryl
administered Kinrix as the third dose in the DTaP series; This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 5-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments:  The nurse reported that the patient was administered Kinrix as the third dose in the DTaP series. At the time of call, the nurse did not have the patient details, date of administration, lot number, expiration date, or the information of what vaccines were given for the first two DTaP series. The vaccine administration facility was the same as primary reporter The reporter give consent to follow up. Additional Supportive Information:  The patient received Kinrix as the third dose in the DTaP series which leads to Inappropriate age at vaccine administration, Inappropriate schedule at vaccine administration and wrong vaccine administration. This is 1 of 5 link cases reported by same reporter.; Sender's Comments:  US-GSK-US2022136456:Same reporter US-GSK-US2022136455:Same reporter US-GSK-US2022136459:same reporter US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136466:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136465:Same reporter
Patient sais arm still sore and kinda difficult to lift arm. Spoke w/ patient on phone 11/8/16.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: LOC and vasovagal after vaccine administration. Tonic clonic movement to all extremities with head deviation to R. History of seizure after vaccine x1 in the past. EMS activated. Strongly advised patient to follow up in ER.
Myalgia in arm of vaccination on day 0 of vaccine. Then with severe headache, myalgias, joint pain, upset stomach for 2 days after vaccine.
PATIENT DEVELOPED A PAINFUL BUMP ON RIGHT SIDE OF MANDIBLE S/P 1 DAY AFTER TWINRIX VACCINATION.  CONTINUE TO OBSERVE AREA FOR PROGRESSION IN SIZE AND ADDITIONAL SX.  PATIENT WILL F/U WITH PCM AS NEEDED.
Subsequently post vax, the pt developed an injection site reaction characterized by erythema and swelling.
Patient received a rash on arm just below site of injection within 24 hours of injection.  It was warm to the touch and slightly itchy. No medications or treatments were pursued, just observation.  The rash resolved spontaneously within 4 days.
Nodule on extremity; This spontaneous case was reported by a physician and describes the occurrence of   in a 52-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 aggravated.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
I got shaking chills at about 10 in the morning five days after my second vaccine. My fever spiked to 102.3. I normally run a temp slightly above 97.  I called my doctor, who prescribed Tamiflu. I had taken two tablets of extra strength acetaminophen and electrolytes via Gatorade, which knocked the fever down. By late afternoon it had crept back up to 101. Still, I didn?t feel as badly as one would expect with a fever that high, even at 102.3, and was able to work from home until 5 PM. At 7 PM, with the 101 fever still persisting, I took my first dose of Tamiflu (and continued to take it as prescribed).  During the night, I could feel myself sweating. By morning the fever was gone. I have had no other adverse effects.
10am vaccine given. No side effects noticed. 630pm developed chills, headaches, ringing in ears, dizzy, eyes fluttering and 102.0 fever.  645pm - Took 3 Tylenol  and BP 144/85 HR 83. Bed rest with Gatorade and water. 1100pm - Took 2 Tylenol. Fever reduced to 99.8. Headache and extremely tired. No energy. Bed rest with fluids. 24 hours after vaccination : Fever almost gone, 11am 2 more Tylenol,  extremely tired and weak. Low energy. Ringing in ears. Minor headaches.  48 hours after vaccination; No fever, extremely tired and weak. Low energy. Ringing in ears.
Immunocompromised patient who received 0.25mL instead of 3rd 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient who received 0.25mL instead of 3rd 0.5mL dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 13-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient who received 0.25mL instead of 3rd 0.5mL dose). On 13-Nov-2021, ACCIDENTAL UNDERDOSE (Immunocompromised patient who received 0.25mL instead of 3rd 0.5mL dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Vaccine dilution error.  The Pfizer vaccine was diluted with 1.5ml of the diluent NaCl 0.9% instead of the recommended 1.8ml.  The 0.3ml dose was given with this slightly higher concentration of vaccine.  On 7/20/21, Leta's father reported that she felt tired and had a mild fever.
Temperature Excursion. Vaccine was stored refrigerated (2-8 degrees Celsius) for greater than 10 weeks. Vaccine stored for a total of 6 days past it's beyond use date in the refrigerator. Patient did not experience any adverse events
Patient reported red and swollen reaction almost immediately. She went to her PCP to assess the reaction the same day as the vaccination administration.  She was given a 10 day regimen of Doxycycline Hyclate 100 mg (1 cap. twice daily x 10 days) on 7.14.2020 after the area had not shown any signs of resolution.  Patient reports that the left side of her body down her arm and down her leg all the way to her left foot developed redness and numbness.
About 4 hours, post vax, fever sharply came on to 103.1F (axillary). He became very lethargic and whimpered. Tylenol did not reduce fever so after 6 hours, gave children's Advil which eventually put him to sleep and fever went to 100F.
Fever on 6/24 and 6/25, then developed a measles like rash on her legs on the 26th. The rash was very faint on the morning of the 27th, and gone by that evening.
Cellulitis, that is moderate, well demarcated, on the (RT) tricep, warm to touch, Measured 9 cm x 5 cm.
This spontaneous report has been received from a 49 years old female patient reporting on herself. The patient's drug reactions included  allergy to x-ray dye. The patient's concurrent conditions included high blood pressure and acid reflux. The patient had no further pertinent medical history. Concomitant therapies reported unspecified medication for her aforementioned high blood pressure and acid reflux. Approximately in November 2016, reported as "about two months ago", the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration, lot# and expiration date were not provided) for shingles prevention. Three days after the vaccination, on an unknown date in 2016,  the patient experienced a "large red splotch" on the back or her left arm (the same arm were the vaccine was administered), (injection site erythema)  the area was itchy and she felt "a big lump, that it was the size of half a baseball, under the skin" (upper extremity mass)(pruritus). One week later, on an also unspecified date in 2016, the patient recovered from her symptoms. On an unspecified date in January 2017 (reported as "two weeks ago"), the patient noticed a rash on the back of her head. So, she sought for medical attention by making an appointment to saw her dermatologist, who stated that the rash on the back of her head was shingles. The patient did not received treatment for the adverse events and also no laboratory diagnostics were performed. At the time of reporting, the patient had not recovered from her shingles. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Administered 1ml instead of 0.5ml; A spontaneous report (United States) was received from a pharmacist concerning a 75-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced administered 1ml instead of 0.5ml of the vaccine.  The patient's medical history was not provided. Concomitant medications were not mentioned.   On 01 Mar 2021, approximately 1 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 014M20A) in the left arm for prophylaxis of COVID-19 infection.  On 02 Mar 2021, the pharmacist reported that one of the pharmacists at the store incorrectly administered 1ml instead of 0.5ml of the vaccine to the patient. The patient has been notified of the incorrect administration as per pharmacist. No treatment information was provided. No lab tests and results were provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event administered 1ml instead of 0.5ml, was considered recovered/resolved on 01 Mar 2021.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-033777:Crosslinked case
1. Day after vaccine administered, Had headache 2. 2nd day after vaccine administered had headache and ears ringing 3. 7 days after vaccine administered in pm,  a red raised patch appeared on arm around injection site.  Felt hard and hot to the touch and became itchy. 4. 8th day after vaccine administered in am had slight fever, runny nose, breathing a bit impaired, a red raised itchy patch around injection site and an itchy rash in small patches on face, neck. and arms.    5.  9th day finally got the OK from doctor hat Benadryl was OK to take.  Started Benadryl late PM 2 ea 25 mg tablets 6. 10th day after vaccine administered, Found itch relief, reduced swelling of red raised area, and small rash patches diminished. continued Benadryl at 1 ea 25 mg tab every 4 hours and will continue until small rashes are gone.
Blood clotting; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in arm left on 21Apr2021 at 09:00 (at the age of 44-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and COVID-19 from an unknown date and unknown if ongoing. Concomitant medication included desvenlafaxine succinate (PRISTIQ) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: FR2613), administered in arm left on 25Mar2021 at 09:30 AM, for COVID-19 immunisation. The patient experienced blood clotting on 16May2021 at 22:00. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on an unspecified date (prior to vaccination). There was no treatment received for the event. The outcome of the event was recovering.    No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.
Pt. c/o after an hour passed that she felt warm and redness noted on her cheeks and c/o itchiness all over her body. Then further c/o of chest pressure with palpitations. BP elevated 212, was seen by Dr., the called 911 and went to ER.
Diagnosed with Shingles; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer. The patient previously received sulfur (MANUFACTURER UNKNOWN), on unknown dates for unspecified indications and experienced drug allergy. Concomitant medications included losartan potassium (LOSARTIN) and amlodipine besilate (AMLODIPINE), both for unknown indication, from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021, 10 days after receiving 1st dose of vaccination the patient was diagnosed with shingles. Therapeutic measures were taken for the reported event of shingles and treatment drugs included valtrex. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
CHILLS; ARM SORENESS; SUPER NAUSEOUS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case No concomitant medications were reported. On an unspecified date, the patient experienced chills, arm soreness, super nauseous, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from super nauseous, and the outcome of fever, chills and arm soreness was not reported. This report was non-serious.
Pt developed Henoch Schonlein Purpura on 10/3/14. Dx'd via classic rash. No other sequelae developed.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Shingrix (batch number 524S7, expiry date 12th February 2021) for prophylaxis. On 16th August 2018, the patient received the 1st dose of Shingrix. On 23rd August 2018, 7 days after receiving Shingrix, the patient experienced shingles, nerve pain and painful rash. The patient was treated with Valtrex. On an unknown date, the outcome of the shingles, nerve pain and painful rash were unknown. It was unknown if the reporter considered the shingles, nerve pain and painful rash to be related to Shingrix. Additional information was received as follows: The shingles rash and associated nerve pain ran along the left side of the abdomen and around into the back. The physician said that the patient came down with Shingles on 26th August 2018. The rash developed in the left groin area and extended to lower knee area. The patient reported the rash being very painful. The physician did not say if the patient's outbreak of shingles was resolved. The reporter agree to follow up from GlaxoSmithKline.
Trouble lifting left arm due to pain in my armpit on the arm that I had the injection. This is the third shoot that I have had really bad swelling for in my arms and arm pit.  There has been no treatment or outcome to this situation as of yet.
Patient had sore shoulder and arm . She went to urgent care and her primary care doctor. Her Primary care doctor said it would take a few months to get better. She is still having trouble raising it.
Headache CHILS, FATIGUE, ONE NOSTRIL STUFFED, SWOLLEN ARM, TENDERNESS IN ARM, LUMP NEAR VACCINE SITE, BUT IMPROVING Narrative:  if arm continues with edema and tenderness, told to contact PCP
This case was reported by a consumer via call center representative and described the occurrence of pain in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 30th June 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 1st July 2018, 1 days after receiving SHINGRIX, the patient experienced pain, weakness, pruritus, skin warm, swelling and erythema. On an unknown date, the outcome of the pain, weakness, pruritus, swelling and erythema were recovering/resolving and the outcome of the skin warm was recovered/resolved. It was unknown if the reporter considered the pain, weakness, pruritus, skin warm, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient planned to follow-up with her physician on an unknown date.
Shortness of breath, fatigue, fever, muscle soreness / aching.  Shortness of breath was immediate; paramedics called.  Transportation to hospital refused due to lack of health insurance.  Other symptoms began the next evening.  Six days later, as I complete this form, the symptoms have improved.  The fever is gone.  The muscle soreness is gone except in the arm that received the injection.  The shortness of breath has improved.  It was really quite concerning.  It is still present but to a lesser degree.  The fatigue is somewhat better but still very much an issue.  There is no appropriate field below regarding the outcome because after only approximately one week, I am expecting that the remaining issues will resolve.  Since I was not hospitalized and did not die, I will mark 'Disability or Permanent Damage' since I definitely can not currently do many of the things I normally do, however, I expect to recover those abilities.
1st vaccine  1-29-2021 - had Red, swollen at site. Urgent Care gave antibiotics - did not take - got better- 2nd Vaccine- Feb 19, 2021 - 11:00 am - had higher Heart Rate for 3-4 days - felt tired 23 Feb 21- URGEnt Care Felt numbness lower leg, foot, shakey, tight neck, arm sore, cold feet. Said had Urinary tract infection. 16 April 2021- Went to Urgent Care AM - High BP. 16 April 2021- went to Hosp ER PM 18 April 2021- Went to Regular Physician, felt weak, High Blood Pressure 20 April 2021 8:00 AM felt burning in arms, Neck, Head, heart Racing, felt Skip Heart. 24 April 2021 - went to ER by ambulance - High BP - not treated. 26 April 2021 - Saw Dr. High Blood Pressure Changed medication dosages several times, finally leveled off. June 2021 - Regular dose of Medications - Blood Pressure leveled out Sept 7, 2021  Blood pressure high again - sill ongoing as of today Sept 11, 2021
This is a spontaneous report received from contactable consumer. An adult non pregnant female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP6955), via an unspecified route of administration on 07Apr2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were unknown. The patient's vaccination history included BNT162B2 (Lot number: EP655) on 17Mar2021. The patient was not allergic to medications, food, or other products. On 08Apr2021, the patient experienced headache, fatigue and flu like symptoms. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient was not been diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
Patient received the second dose of Moderna COVID vaccine, within a few minutes of receiving, patient passed out for approximately 90 seconds.  Patient then stated that he has had this happen in the past as a vasovagal response, which he did not explain prior to receiving the vaccine.  He states he has a history of syncopal episodes associated with needles since he was a teenager.
rash broke out on both legs the one shot was taken in & also had a knot on legs 2 days later the rash has been there & knot for 2wk;
pt called office at 820am on 8/27/21 and stated around 12am she had fainted falling off her front porch and hitting her head
Had severe headache immediately after booster, then a series of severe headaches lasting for over a week a few weeks later.  Suddenly developed ongoing pain in knees, beginning about a month after the booster.
Rash at injection site; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Mar2021 at 00:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included High Blood Pressure (HBP) and high cholesterol. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 13Mar2021 at 00:00, the patient experienced rash at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash at injection site was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I'm unsure of the maker/type of flu vaccine I was given. However, when the vaccine was placed I could immediately tell something was wrong. Working in a hospital, I have to get these every year. This time the injection was excruciatingly painful and I could tell it was not placed properly. Subsequent to the vaccination, I have experienced pain in my shoulder with decreased range of motion. It is almost 2 months post injection and I am still experiencing these symptoms.
Pt c/o left arm pain and small lump to injection site since 4/20/05.
The pt received three different vaccines on the same day. Six hours post vax, the pt developed pruritic erythematous swelling of a 20 x 20 mm diameter painful area at injection site. Pt also complained of fatigue, fever, muscle cramps and headache. Treatment was cold compresses, Benadryl, Prednisone.