chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme pain, weakness and tightness in themuscles of legs; Weakness and tightness in themuscles of legs; Weakness and tightness in themuscles of legs; For 48 hours, could barely walk,; Makes it difficult to get up from a seated position; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6203) via an unspecified route of administration in the left arm on 24Feb2021 at 09:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included herniated discs in neck and penicillin allergy. Concomitant medications included cannabis sativa (MARIJUANA) for an 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 vaccination. On 24Feb2021 at 23:00, the patient experienced extreme pain, weakness and tightness in the muscles of her legs. For 48 hours, the patient could barely walk. The patient thought of going to Emergency Room (ER), but did not want COVID exposure. The pain was gone, but leg muscles remained very tight and made it difficult to get up from a seated position and the patient hoped legs would recover. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme pain, weakness and tightness in the muscles of legs was resolved on an unknown date in 2021; while that of the events weakness and tightness in the muscles of legs, for 48 hours could barely walk and makes it difficult to get up from a seated position was resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
received dose 1 /10 months ago / received dose 2 /November 20, 2020; arm soreness; fever; chills; body aches; currently experiencing a sinus infection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose of Shingrix received about 10 months ago, refer case US2020236598).   On 20th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm, fever, chills, general body pain and sinus infection. On 20th November 2020, the patient experienced drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, fever, chills and general body pain were recovered/resolved and the outcome of the sinus infection was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, fever, chills, general body pain and sinus infection to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The patient experienced arm soreness, chills, fever, and body aches. The patient also reported that she was currently experiencing a sinus infection.  Events had resolved, except for the sinus infection which was still present at time of report.  The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020236598:same reporter
Severe abdominal pain, prolonged crying, seen in ED 5 days after vaccine w/ fussiness and decreased appetite. (Concern was intussusception - determined not to be).
My heart started beating extremely fast, it felt as though my heart was going to jump right out of my chest. I had to anxiety attacks back-to-back at work. It left me feeling very shaky after the episode. I went to the closet urgent care. They took my blood pressure, ran an EKG, took my pulse-oxy, they also listened to my heart. All tests came back normal, but they could hear with the stethoscope extra heart beats. They diagnosed me anxiety. I was advised to follow up with my primary care physician who prescribed an anxiety medication and referred me to a psychiatrist. My psychiatrist and I discussed if the anxiety could possibly be long haul COVID-19 side effect as I had tested positive for COVID-19 in December 2022.
FELT SOME SORENESS; This spontaneous report received from a patient concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced felt some soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt some soreness was not reported. This report was non-serious.
Day 9 after first dose injection- woke up with pain, rash, itching, swelling and fevered injection site.(Right Arm).  Pain going to elbow, pain still persists as of today (12 days after first injection).  My arm and shoulder aches like a toothache and I have some weakness in the arm.    I find this very concerning since I only had mild fatigue and a sore arm the 2nd day after injection, then all was normal until day 9 after injection.   I am beginning to be very wary of having the 2nd injection.
Redness, excessive swelling pain at injection site. Muscles in my left arm, shoulder, and at times to the base of left neck experience sharp pain and limited movement. About 2 weeks later, redness began to fade and swelling began to decrease. Now, about 4-1/2 weeks later I still have the sharp muscle pains if I move my left arm a certain way or pick things up.
problems with vision; trouble finding a focal point and could not drive, read or write; could not drive; impaired the daily life life activities; This case was reported by a pharmacist via call center representative and described the occurrence of abnormal vision in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number NT7YR, expiry date 25th March 2022) for prophylaxis.   On 21st August 2020, the patient received the 1st dose of Shingrix. In August 2020, 24 hrs after receiving Shingrix, the patient experienced abnormal vision (serious criteria other: serious by reporter), difficulty focusing eyes, driving ability disturbed and activities of daily living impaired. On an unknown date, the outcome of the abnormal vision, difficulty focusing eyes, driving ability disturbed and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the abnormal vision, difficulty focusing eyes, driving ability disturbed and activities of daily living impaired to be related to Shingrix.  Additional information was provided as follows: The patient experienced problems with vision 24 hours after receiving the first dose of shingrix.  The reporter mentioned that the patient was having trouble finding a focal point and could not drive, read or write. As per the pharmacist, this significantly impaired the daily life activities of the patient. The event was currently ongoing. The patient consulted two ophtalmologists but as of time of reporting, no medical diagnosis for this visual problem was available. The reporter consented to follow up.
Patient was given incorrect booster dose. Dose administered was 0.5 mL, correct dose should have been 0.25mL. Patient states she is doing well, no s/s of adverse reactions.
pt recv vax 4PM 19MAR97 noticed 3" diameter red, blotchy raised warm area @ inj site 7AM 21MAR97;area sore, axilla sore;
Pt. received Flu in L deltoid & PNU 23 in R deltoid 12-27-07 at 3:30pm.  By 9pm pt. c/o swelling R deltoid (size of 1/2 grapefruit).  Pt. had chills & fatigue (severe enough to stay in bed for 3 days).
Pt started to feel flushed and dizzy 15-20 minutes after receiving the vaccine at 11:30am. She then started to feel like her tongue was getting numb and her throat was feeling fuzzy. Benadryl 50mg liquid was administered but 5-10 minutes later she was still feeling like her throat felt better but that the dizziness and flushing were the same or getting worse and her lips still felt numb. 911 was called but pt checked out ok medically and no extra treatment was received. Pt left with her sister by 12:35pm and was coherent and was feeling better just tired from the benadryl dose.
This spontaneous report was received from a pharmacist and refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received series of GARDASIL, intramuscularly (dose, frequency, lot#, expiration date and indication were not reported), that didn't confirm to the normal 0, 2 months and 6 months scheduling. No known adverse effects were reported. Additional information has been requested.
bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 1.75 mg three times a day. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (bad reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all over body, no visible hives, flushed-Medium; symptoms lasted for 1 day
Mild fatigue; Mild chills; Mild nausea; Muscle aches; Severe pain in the back; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Mild fatigue), CHILLS (Mild chills), NAUSEA (Mild nausea), MYALGIA (Muscle aches) and BACK PAIN (Severe pain in the back) 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (Mild fatigue), CHILLS (Mild chills), NAUSEA (Mild nausea), MYALGIA (Muscle aches) and BACK PAIN (Severe pain in the back). At the time of the report, FATIGUE (Mild fatigue), CHILLS (Mild chills), NAUSEA (Mild nausea), MYALGIA (Muscle aches) and BACK PAIN (Severe pain in the back) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not reported.  No concomitant medication reported. No treatment was provided.    Reporter did not allow further contact
Jynneos vaccine was pre-drawn into syringe for administration. The CDC does not recommend pre-drawing immunizations due to lack of stability data for this vaccine.  There are no documented adverse effects.
Tiredness, fever of 99 while taking acetaminophen, head and ear congestion, constant ringing in left ear and increased sensitivity to all sounds.
Catastrophic heart condition; Catastrophic heart condition; This spontaneous case was reported by a consumer and describes the occurrence of CATASTROPHIC REACTION (Catastrophic heart condition) and CARDIAC DISORDER (Catastrophic heart condition) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced CATASTROPHIC REACTION (Catastrophic heart condition) and CARDIAC DISORDER (Catastrophic heart condition). At the time of the report, CATASTROPHIC REACTION (Catastrophic heart condition) and CARDIAC DISORDER (Catastrophic heart condition) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Modern covid-19 vaccine EUA Achy-ness; fatigue; slight headache. Tylenol for the first 24 hours (beginning 12 hours after injection). Lasted approximately 24 hours
pt  inadvertently recv vax intradermally & devel an inj site rxn;sx appeared to be resolving as of the date of this report;this is 1 of 3 pt from this site to recv vax & devel local rxn;
Large local swelling, redness from shoulder to elbow. Seen in ER that evening. Given antibiotics and steroids.
The patient reports swelling from her elbow to her shoulder. Also hives, rash and itching. She also reports the arm is warm to the touch. The patient has felt ill since she received the injection.
Very sore arm, major headaches, fever and body aches the next day after shot.  The second day 4/8/21 after shot still had headache but felt dizzy and very nauseous couldn?t get out of bed without feeling the need to throw up or being dizzy to the point I couldn?t stand up.
First there was some swelling at the injection site. That went away after a few days. It became very painful within 24 hrs and I lost most range of motion for at least a month. I also still have some tingling and numbness in my left hand. To this day I cannot sleep on my left side unless I take MOTRIN for the pain and I do not have full range of motion in my left arm anymore.
Itching and rash around site on left arm starting Tuesday, 3/16 sometime in the morning. It has been fairly consistent since that time.
Chills; Sweat; she could not move without hurting; She could not get out of bed her body felt like it was weighted like it had 100 pounds weight on it; She had fever ; fever of 102 and it last for three day; This is a spontaneous report from a contactable other hcp (patient). A 55-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection) via an unspecified route of administration, administered in right arm on 11Jun2021 (at the age of 55-year-old) (Lot Number: EW0180) as 2nd dose, single dose for covid-19 immunization. Medical history included liver cirrhosis, psychiatric issues and gastroparesis. The patient's concomitant medications were not reported. The patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), administered in left arm dose 1, single dose via an unspecified route of administration on 21May2021 (Batch/Lot Number: EW0179) for covid-19 immunisation and she felt sleepy for three days. On an unspecified date, the patient experienced chills and sweat. On 12Jun2021, she could not move without hurting, could not get out of bed her body felt like it was weighted like it had 100 pounds weight on it and fever of 102 and it last for three day. Patient stated, events did not worsen, no it get slightly better. Patient stated, as far as Pfizer concern or whomever are there any blood works that she should get or have taken to see if I have reaction?. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit, last for three day on an unspecified date. Therapeutic measures were taken as a result of she could not move without hurting with Tylenol. The outcome of events was unknown. Causality reported as pee reporter was reported as definitely.  Information on Lot/Batch number was available. Additional information has been requested
(L) under arm swollen, not able to close arm down. Pain and fatigue for seven days.
Per foster mother about 1 1/2 hours after his vaccinations he had a lacy rash over most of his body and a few hives including one on his face and puffy, red feet.
pt recvd vax; exp soreness & discomfort of lt leg & could not bear weight on it;
Reporting taking 2nd dose of vaccine/Moderna on this morning at 8, sharp injection at injection pain (resolved) now pain is dull; migraine (still present), couldn't swallow/talk (now resolved), became hoarse, dizzy/woozy (still present).   Had  anaphylaxis with these sxs as precursor reactions in past to shellfish and iron infusion. Advised to take benadryl, motrin if available a& seek ER/in-person emergent evaluation
Pt received vaccine 7 days prior to minimum valid date. No adverse reaction noted to receiving vaccine.
This case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a male patient who received FLULVAL QUADRIVALENT (2018-2019 season) for prophylaxis. Previously administered products included FLULVAL QUADRIVALENT 2017-2018 season with an associated reaction of erythema (all other events experienced after dose 1, refer case US2018196965). On an unknown date, the patient received FLULVAL QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLULVAL QUADRIVALENT 2018-2019 season, the patient experienced erythema of extremities, extremities hot feeling of, swelling arm, local reaction and allergy to vaccine. Rechallenge with FLULVAL QUADRIVALENT 2018-2019 season was positive. On an unknown date, the outcome of the erythema of extremities, extremities hot feeling of, swelling arm, local reaction and allergy to vaccine were unknown. It was unknown if the reporter considered the erythema of extremities, extremities hot feeling of, swelling arm, local reaction and allergy to vaccine to be related to FLULVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by an allergist. The age at vaccination was not reported. The patient did not not have an egg allergy. The patient received FLULAVAL vaccination two years in a row and has had large local reactions with each vaccination. In 2018 the patient received FLULVAL QUADRIVALENT 2018-2019 season and experienced large local reaction which was hot, red swelling and involved whole arm. The patient underwent skin testing and intradermal testing. Intradermal testing was very positive. The reporter reported that that this does not predict future reactions to the vaccine, but it has progressively worsened. The reporter was concerned that the patient may be reacting to a component of the vaccine (glycerin, gelatin, etc). The reporter did not know what components were in the vaccine. The reporter recommended receiving an intranasal version of the vaccine.
Dizzy, placed in w/c. Evaluated by paramedics. 12:45 BP 160/104, P88,SaO2 99%, FSBS 93. 1:03PM 154/100. 1:15145/96. No further symptoms and went home.
Red in the area of injection; Arm was heated up; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included flu shot.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced injection site erythema and extremities hot feeling of. On an unknown date, the outcome of the injection site erythema and extremities hot feeling of were unknown.   The reporter considered the injection site erythema and extremities hot feeling of to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient mentioned that a few days after her first dose of Shingrix her arm was heated up and red in the area of injection. The patient is currently dealing with burn on her thorax because she dropped her curling iron, The reporter did not indicated that this was before or after vaccination.
I began to have muscle aches on the night of 9/15/2022 while I was in bed. I immediately knew that I was sick. I got up and took a home antigen test and got a negative result. On 9/16/2022, the muscle aches worsened. On 9/17/2022, I tested positive on a home antigen test. On 9/18/2022, I called the doctor's office and notified them of my situation. I was advised to stay home and rest and take vitamin C and Flonase. They also told me to use my albuterol inhaler if I ever had any trouble breathing; in the first week of my illness, I was wheezing during my illness, so I did end up using the inhaler. After about seven days, I felt like I could do more, so I attempted to do some light gardening. When I bent over three times in succession, though, I became very lightheaded. This scared me, because I had never fainted before. I thought that I might faint, though, so I immediately sat down. My heartrate was very fast at this point, and my vision went dim. I just sat quietly and waited until the feeling passed. That was when I realized that I had not yet recovered from the COVID-19 and that I should stay indoors and recuperate. At about two and a half weeks after the symptom onset, I finally had energy again. It was then that I resumed normal activities.