chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received my Second Pfizer vaccine. A month or so later developed an ache in the upper right arm in the general area of the injection. As of today (10/13/2021) I still have the ache. Not severe but definitely hurts when I lift a tea kettle or try to stretch the arm. Not sure if the ache is due to the vaccine, but I think it's worth while to report.
Pt stated the injection site remained red, unlike the flu and SHINGRIX site on the other arm. He saw his doctor who thought it may have gotten infected.
high pitched cry about 4 1/2 hrs p/inject; high pitched cry cont 45 mins; mom instructed to cont APAP & compress to rt thigh;
Tingling sensation on her fingertips, on the lower part of her face, and chin; Tingling in her tongue and lip; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 26Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient previously took the first dose of BNT162B2 for COVID-19 immunization. The patient received the second dose of the COVID-19 vaccine in the morning of 26Jan2021. From that afternoon on (26Jan2021), the patient had tingling in her tongue and lip. The patient did not have this side effect before. The patient was also feeling it on the lower part of her face today (28Jan2021) and is also feeling a tingling sensation on her fingertips. The patient was now (28Jan2021) experiencing a tingling sensation on her tongue, lips, and chin and it doesn't go. The patient wanted to speak with someone to ask if this is a normal side effect or if she should be concerned. The patient was asking what she can do about this. The patient had not recovered from the events.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
The needle displaced from syringe and some of the vaccine spilled out.; No adverse event; The needle displaced from syringe and some of the vaccine spilled out. The patient feels like she didn't get the full dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (The needle displaced from syringe and some of the vaccine spilled out. The patient feels like she didn't get the full dose.), DEVICE CONNECTION ISSUE (The needle displaced from syringe and some of the vaccine spilled out.) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced UNDERDOSE (The needle displaced from syringe and some of the vaccine spilled out. The patient feels like she didn't get the full dose.). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (The needle displaced from syringe and some of the vaccine spilled out.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (The needle displaced from syringe and some of the vaccine spilled out. The patient feels like she didn't get the full dose.), DEVICE CONNECTION ISSUE (The needle displaced from syringe and some of the vaccine spilled out.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for UNDERDOSE (The needle displaced from syringe and some of the vaccine spilled out. The patient feels like she didn't get the full dose.) and DEVICE CONNECTION ISSUE (The needle displaced from syringe and some of the vaccine spilled out.).    The concomitant medication was not reported by reporter. Caller was not sure whether the patient got full dose or not. The treatment medication was not reported by reporter.
FEVER, BODY ACHES, FATIGUE,HA, Narrative:  Other Relevant History:
Pt recvd 1st dose of Hep B vax in MAR92 & following vax devel a fever of 106 & redness & warmth @ inject site; no further details were provided;
shingles; This case was reported by a other health professional and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash (on the scalp within the same time frame of receiving the vaccine).   On 27th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient fad rash prior to receiving the vaccine. The patient received her 1st dose of Shingrix within the same time frame of receiving the vaccine. It was not confirmed until after receiving the vaccine that it was shingles. On 31st July 2019, the patient was prescribed Valtrex.  The reporter stated that the vaccine after the symptoms of the rash had abated.
I have a large red rash just below the injection site, not really painful but it does itch often.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an 18 months old patient who received vaccine QUADRACEL more than once. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none reported as no other vaccine was received. On an unknown date, the patient received a booster dose of suspect QUADRACEL lot number not reported via unknown route. It was case of actual medication error due to extra dose administered and Inappropriate age at vaccine administration. It was not reported that if any adverse event was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
LOW GRADE FEVER, HEADACHE, NO APPETITE, BODY ACHE(S) STAYED HYDRATED & SLEEP / REST SYMPTOMS LASTED APPROXIMATELY 48HRS
Initially developed normal immune response sx about 12 hours after injection, however has had 2 weeks of persistent fatigue, vaginal bleeding/spotting, body aches.
Coughing; Hives; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) and URTICARIA (Hives) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing) and URTICARIA (Hives). At the time of the report, COUGH (Coughing) and URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
I am not feeling good at all; I am very dizzy; My hands are numb and my teeth are numb too; My hands are numb and my teeth are numb too; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 25Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunisation. The following information was reported: MALAISE (non-serious) with onset 25Aug2021, outcome "unknown", described as "I am not feeling good at all"; DIZZINESS (non-serious) with onset 25Aug2021, outcome "unknown", described as "I am very dizzy"; HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA (non-serious) all with onset 25Aug2021, outcome "unknown" and all described as "My hands are numb and my teeth are numb too".  Additional information: It was reported that the patient took the second dose of the vaccine yesterday and  was not feeling good at all, like very dizzy and hands are numb and teeth are numb too and asked if it was normal  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic hives within 20-30 minutes after vaccines.  No respiratory distress.  No true anaphylaxis.  Steroids given.  Subcutaneous epi given 70 minutes after vaccine.
Roughly 12 hours after I had the vaccine, I woke up with body aches, fatigue, and joint pain. I also experienced a slight headache as well as feeling feverish. 2 days after the vaccine I noticed pain in my left armpit (where I noticed lymph node swelling) as well as pain at the back of my hairline. Since then, I have had intermittent headaches throughout the day - starting from the back of my hairline that extends upward into my scalp and forehead and into my shoulders. I feel fatigued when I have the headaches, but also feel lightheaded as well at times.
Hospitalised with heart condition; This spontaneous report was received from a nurse concerning, a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized with a heart condition/heart disorder.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 07 Feb 2021, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient was hospitalized for a heart condition. No treatment information was provided.  Action taken with suspect drug mRNA-1273 was unknown.  The outcome of the event, hospitalized with a heart condition, was unknown.; Reporter's Comments: The events were consistent with increased risk of cardiovascular complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
I woke up at approximately 2:30 AM feeling very sore, achy, clammy, and feverish. I felt like I needed to get out of bed because laying there felt very uncomfortable. I got up to go to the bathroom. On my way to the bathroom, I fainted in the hallway and landed flat on my face. My front left tooth was knocked completely out of my mouth, and and the two adjacent teeth were knocked loose. I found my tooth on the floor, placed it on a shelf in my bathroom, and then took a shower as I was in shock and felt very sweaty and out of sorts. At 2:41, after the shower, I called 911, but declined an ambulance ride and hung up. I then googled what to do when your tooth is knocked out, and learned that I should put the tooth back in its socket immediately. I put the tooth back in and then at 2:57, I called an emergency dentist dispatch line. The dispatcher told me about a dentist who could make an urgent appointment for me when their office opened at 7 AM. I felt like I needed to be under medical supervision right away, so at 3:37 AM, I took a Lyft to the ER at , where I was observed and given an IV. I was discharged  at 6:45 AM, and caught a Lyft home at 6:51 AM. My husband returned from work at 8:15 AM. He took me to my emergency dental appointment at 10 AM, where the dentist gave me multiple novocaine shots, straightened my two loose teeth and wired all my front teeth together to stabilize the front tooth that had been knocked out. It is unclear at this time whether my natural tooth will be able to be saved.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium
Resident developed fever of 101.2, did not eat 2 meals, had decreased alertness, and loss of bladder control.. NP in to evaluate resident , ordered lab test and Rocephin 1 gram IM x 5 days.
Patient developed bilateral facial weakness starting on 4/3/2021, progressed over the course of five days until she presented to the emergency department on 4/8/2021. Exam with bilateral CN VII palsy and lower extremity areflexia. MRI brain shows enhancement of bilateral CN VII and VIII. Suspect GBS, treating with IVIG.
Information has been received from a physician concerning a 6 year old male who on 04-OCT-2010 was vaccinated with one shot of PNEUMOVAX 23 (LOT# 663998/0623Y expiration unspecified). Secondary suspected vaccination included of dose of seasonal influenza virus vaccine (unspecified) (manufacturer unknown). In October 2010, the patient experienced fever, rash and cellulitis. It started later than the female patient (had captured in WAES # 1010USA00854). Unspecified medical attention sought. The patient's fever, rash and cellulitis persisted. The physician mentioned other patients, including the brother, are beginning to experienced flu-like symptoms with the same vaccine. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Follow-up information has been received via telephone call from the physician's nurse who reported that it was just two patients. The female first (had captured in 1010USA00854) and then the brother started with the same symptoms, although not as severe. Nurse requested a call back regarding whether they sent the remainder of the doses back, or if they were required to do anything else. A PIR will be completed. This is one of the reports received from same source. Additional information is not expected.
A day after 4th dose of the DTaP, developed swelling, warmth, blotchy erythema of the entire left thigh. Incidental cut/scratch (3 cm long) near poplytial area sustained same day swelling was noted.
PATIENT CALLED STATING HER THROAT WAS NUMB AND SHE COULD NOT FEEL HER FOOD GOING DOWN. I ADVISED THE PATIENT TO GO THE ER.  THE STATED "I THINK I WILL BE OK"  I ADVISED AGAIN, IF THIS FEELING DOES NOT SUBSIDE WITHIN AN HOUR YOU NEED TO GO TO THE ER NO LONGER.  PATIENT UNDERSTOOD. BUT STILL SAID "I THINK I WILL BE OK".
sore arm; nausea; feel tired; horrific headache; felt very lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt very lethargic), PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), FATIGUE (feel tired) and HEADACHE (horrific headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer and COVID-19.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LETHARGY (felt very lethargic), NAUSEA (nausea), FATIGUE (feel tired) and HEADACHE (horrific headache). On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, LETHARGY (felt very lethargic), PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), FATIGUE (feel tired) and HEADACHE (horrific headache) outcome was unknown.        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.   The patient takes CBD capsules daily.
Tested positive to COVID-19; Headache; This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive to COVID-19) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive to COVID-19) and HEADACHE (Headache). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive to COVID-19) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Coronavirus test: positive (Positive) Positive.     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.   Concomitant product use was not provided by the reporter.
Fatigue Itching at injection site Swelling at injection site  Elevated temperature (not actual fever as of 8 hours post injection; developed high fever after dose 2 and 1st booster)
Menstrual cycle is late; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 17Apr2021 at 12:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. 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-19 vaccine. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 27Mar2021 at 13:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient experienced menstrual cycle was late. Had taken 4 pregnancy tests, all negative. 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. On an unknown date in 2021, the patient underwent Pregnancy Test and the result was negative. Patient stated to have undergone four pregnancy tests, all of them were negative. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle was late. Had taken 4 pregnancy tests, all negative was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
allergic reaction from the PNEUMOV AX 23 vaccine; entire upper left arm is swollen 3 times the size; pain.; This spontaneous report was received from a 67-year-old female patient who was reporting on herself. The patient's medical history and concomitant therapies were reported as "no". She was allergic to latex and many unspecified antibiotics. She was vaccinated with pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVENAR) last year and never had any issues with it.   On 28-DEC-2020, the patient was vaccinated with dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection into left arm (dose, lot number, expiration date, route of administration and strength were not provided) as prevention for pneumonia.  On 28-DEC-2020, few hours after vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the allergic reaction occurred. Her upper left arm was swollen 3 times the size, she also was experiencing pain. The patient reported that the pain was 10 on 1 to 10 scale. She sought medical attention and contacted her doctor. Her physician informed her to use ice and acetaminophen (TYLENOL) for pain and swelling. The patient still did not recover from the mentioned events. She wants to know how long it would take to recover from the reaction.  The reporter considered all events to be related to with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
pt recvd vax & devel pneumonia which led to resp failure; pt was intubated & mechanically ventialated for  about 10 days; pt is now in a rehabilitation center;
Chills, body ache, headache, possible fever.  All except headache  were from 12a - 4a.   Headache and "run over by a Mac truck" feeling continued throughout March 9.  Feeling 95% normal on morning of March 10.
Egg-sized lump at injection site - very hard. Also aches/headaches for week following injection.
Pt recvd a series of 3 engerix-B vax 22JUL90, 28AUG90 & on 28FEB91 & was a poss non-responder;
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On an unknown date the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23 (dose, route, lot number and expiry date were not provided). No adverse effect was reported. Additional information has been requested.
Admitted with generalized weakness, lethargy, and muscle aches for a couple weeks (since receiving vaccine). Planned to rule out atypical PNA. Blood cultures positive for bacteroides, likely abdominal source. Abdominal CT scan showed portal vein thrombosis, confirmed on MRI.
Fever up to 102 degrees. Pt lost wt 4oz for two days.
Injection instantly felt hot. Within 5 minutes patient was flushed and not feeling well to the point she had to drink water and ingest  candy. I offered her to lay on the ground but she just had to silence herself from the commotion in the pharmacy closed her eyes and slowly inhaled and exhaled to calm her thoughts and reaction to the vaccine. Offered her to call 911 but she declined. Her daughter was with her and waited in the vaccine room for about thirty minutes.
Pt DX with Bell's Palsy possibly rxn to vaccine ? Out of work X 3 months.  2 wks /p 2nd dose fo Hep B developed generalized arthritis for 6 wks.
Red, swollen, hot, painful and firm spot on leg, approximately 2 inches in diameter, at site of injection. Child received four injections, two in each leg, not sure which injection caused reaction. Received DTap booster, MMR booster, IPV, and Varicella.
Pfizer-BioNTech COVID-19 Vaccine EUA. Facial numbness and tingling beginning aproximately 40-45 minutes after injection. Resolved approximately 2-3 hours later.
no adverse reactions or symptoms from injection.    Immunization of Kinrix given to patient 8years of age.  We were instructed by the Health Department to report this as the vaccine is only for ages 4-6yrs of age and patient was out of the age range.
Patient was sleeping, rolled over siezed up body postured with arms drawn. Called 911.Patient was unconscious and appeared to take his last breath as medics arrived. Medics and sheriffs arrived. I verified patient did not hit his head, fall or have any injury. They worked on the patient and transferred him to the hospital. Patient  was pronounced Dead at the hospital.