chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; Moderate to severe myalgia; Arthralgia; Uncontrollable rigors began 12 h post vaccination lasting for 2.5 h; Mild odynophagia; xerostomia; This is a spontaneous report from a non-contactable physician (patient).  A 72-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL0142), via an unspecified route of administration on 19Jan2021 at 09:30 on the right arm at a single dose for COVID-19 immunization.  Medical history included allergies to mussles from an unknown date and unknown if ongoing. The patient did not have COVID-19 prior to vaccination. Concomitant medication included atenolol (manufacturer unknown), amlodipine (manufacturer unknown), asa (acetylsalicylic acid, manufacturer unknown), tamsulosin hydrochloride (TAMSULO) and hctz (hydrochlorothiazide, manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EH9899) on 29Dec2020 at 10:30 AM on the left arm for COVID-19 immunization. The patient reported that the events began 8 hours post vaccination and peaked 12 hours post vaccination. The patient experienced moderate to severe myalgia, arthralgia, injection site pain, uncontrollable rigors began 12 hours post vaccination lasting for 2.5 hours which was finally relieved by 500mg Tylenol/25mg Benadryl (Tylenol PM ES). The patient also experienced mild odynophagia and xerostomia. All the events were reported to have occurred on 19Jan2021 at 15:00. All symptoms has basically resolved by 60 hours post vaccinations. The events were reported to have recovered on an unspecified date in Jan2021. The patient has not been tested for COVID-19 post vaccination.  No follow up attempts are possible. No further information is expected.
The day after my second dose, I started having chest pain, shortness of breath, fluttering and rapid heartbeat, and numbness in my face and neck. These symptoms were severe for about an hour. Over the next few days, I was still feeling irregularities in my heartbeat and could identify that beats were skipping when I felt for my pulse.
Heart palpitations (22nd; midnight as well and 23rd). Felt quite dizzy (like fainting). Unsure if it's because of the vaccine.
Patient received 1st dose covid vaccine and at the 13 minute mark slumped over in chair.  We promptly went out to keep him from falling and within 10 seconds he regained consciousness and was able to tell us his name, where he was and was alert.  He said he was feeling very weak all over but no other symptoms.  We called 911 and while paramedics were on the way he lost consciousness another 2 times each time for about 10 seconds.  He was alert when paramedics arrived and they took blood sugar, blood pressure, oxygen levels and applied leads to his chest.  From what I could tell all those tests came back normal.  While they were evaluating him, he lost consciousness again and they were able to revive him with sternal rub.  They transported the patient to the ER for further evaluation.
9/16/11 0940 Pt RTC, stated 15 min. after vaccine, felt like she drank 3 shots of vodka, felt drunk, noticed hives & itchy rash on front abd, bilat forearms yest evening at 1900. Pt took one OTC BENADRYL at 2230 & feels fine today.
Fever; Chills; Body ache/sore after days; Fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 23-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248; Expiration Date: 30Apr2021), via an unspecified route of administration (at the age of 23-years), administered in deltoid left on an unspecified date at 11:00 as dose 2, single for COVID-19 immunization. Medical history included , thyroid cancer, hashimotos sip, complete thyroidectomy onset(diagnosed) 10Jul20219 to stop date 05Sep2019 and COVID-19 from an unknown date and unknown if ongoing. The historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK5730; Expiration Date: 31Mar2021), via an unspecified route of administration (at the age of 23-years), administered on 21Dec2201 at 13:30 as dose 1, single for COVID-19 immunization and experienced positive for Covid-19. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication from 05Sep2019 and ongoing. On 21Jan2021, the patient experienced fever, chills, body ache/sore after days and fatigue. The adverse events did not resulted in emergency room and physician office visit. The facility type was reported as hospital. The clinical outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Patient received Moderna  vaccine #2 Left Deltoid at 1 PM. Notified First medical team at 1:05 PM reported left middle finger, left ring finger and left pinky numbness with digits flexed and numbness to left hand at 1:45. Grips = and strong. Has history of a 4 inch screw in the left arm that typically gets numb when the weather is cold. Had  Hx Covid-19 positive in December. Had Moderna vaccine number #1 at 1 PM reports he had [pain, fever, numbness in left middle finger, left ring and left pinky when he awoke 4AM and lasted 12 hrs and resolved at 4 PM.  Denies neck or shoulder medical problems.  DTRs 2+ and = upper extremities.  Pain 5/10.  FROM neck/shoulders, wrist. Tenderness to olecranon. Arm easily irritated at ulnar groove and radial nerve. BP elevated 148/104 pulse 102. Pulse ox 97.  Sensation decreased to light touch left hand and fingers, intact sensation right hand. Motor strength 5/5 b/l UE.  He was instructed  to take NSAID prn and report if symptoms do not resolve. Discussed Ulnar nerve irritation w/o possibly due to surgery post since he has had some symptoms of nerve irritation s/p 16 yr elbow surgery.  Denies Headache, nausea, vomiting, throat swelling or other symptoms. Seen by Dr. and examined patient  also with same findings.
Aches all over the body after booster; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches all over the body after booster) in a 70-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Aches all over the body after booster). At the time of the report, MYALGIA (Aches all over the body after booster) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
swollen, sore lymph nodes under arms; swollen, sore lymph nodes under arms; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 41-year-old non-pregnant female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9269, Expiration date: Unknown), via an unspecified route of administration in arm left on 05Feb2021 19:15 as single dose for COVID-19 immunisation in Health Clinic. Medical history included GERD from an unknown date and unknown if ongoing. The patient was diagnosed with COVID-19 prior to vaccination. Patient received unspecified concomitant medication. The patient did not receive any other vaccine in four weeks. The patient had not been tested for COVID-19 since having the vaccine. The patient experienced swollen, sore lymph nodes under arms on 08Feb2021 18:00. The patient did not receive any treatment for events. The outcome of events was not resolved.  Follow-up attempts are completed. No further information is expected.
sore arm; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization and experienced few chills on 2nd day. On an unspecified date in 2021, the patient experienced sore arm the day after the second shot. The clinical outcome of the event was unknown.  Follow-up needed. Information about batch/lot number has been requested.
Urticaria of the extremities and trunk.  Nausea and vomiting.
Pain/arthritis one joint at a time. Now thru out all my joints including elbow, wrists, shoulders hips and knees. now for 6 months.
Postural orthostatic tachycardia syndrome (POTS); Autonomic Dysfunction; Orthostatic Intolerence; Presyncope; Fatigue; Dizziness; Headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 24-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination postural orthostatic tachycardia syndrome (POTS), headache, dizziness, presyncope, fatigue, orthostatic intolerance and autonomic nervus system imbalance.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007498:
constant crying since inj @ 1030AM, lt leg thigh area 3x4cm red & swollen & warm to touch;$PM seen by MD recommended ice pack, APAP cont w/eye drops prescribed by MD & prescribed alupent breathing tx;
swelling at the site of injection; redness which is 6 inches long and 3 inches wide; A spontaneous report was received from a consumer concerning a 65 year old female patients who received  Moderna's  Covid 19 vaccine(mRNA1273) experienced swelling and redness at injection site.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    On 12-FEB-2021,approximately 1 week prior to the onset of symptoms the patient received first of two planned dose of mRNA-1273 (Batch Number 024M20A)  for prophylaxis of Covid 19 infection.  Patients felt swelling at the site of injection after 1 week of vaccine administration. Patient had redness at the site of injection which is 6 inches long and 3 inches wide .The treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events, swelling and redness at the site of injection were unknown.
One day after vaccine pt c/o hoarse voice, followed by chest tightness and dry cough on day 3. Sxs lasted x 2 wks.
This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain and product supply issue. On an unknown date, the outcome of the pain and product supply issue were unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a lot of pain and really need to start the treatment with HUMIRA, but there was a shortage of vaccines in her area. The reporter stated that, she need to get the second dose of the vaccine to be able to start her treatment with HUMIRA. As per representative there had been an extraordinary amount of demand from patients and healthcare professionals, as the SHINGRIX got the approval. As per representative, the healthcare provider or local pharmacy was temporarily out of stock, to address the current high demand, GSK had significantly increased deliveries and accelerated shipments of doses of vaccine for this year, and SHINGRIX was expected to be available throughout 2018 and shipped on a regular basis. The reporter's practitioner did not know when he would arrange it. Reporter also check with pharmacy and they would arrange it in March.
received dose in his left triceps; is red; hot to the touch; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number K7T79, expiry date 14th April 2023) for prophylaxis.   On 10th November 2021, the patient received the 1st dose of Shingrix (intramuscular). On 10th November 2021, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. In November 2021, the patient experienced erythema and skin warm. On an unknown date, the outcome of the erythema was recovered/resolved and the outcome of the skin warm and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the erythema and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of Shingrix in his left triceps, and it is now hot to the touch and red in appearance, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
I felt like there was fluid in my lungs like when you have a cold so I went to the doctor and they listened to my lungs and took a chest x-ray and it sounded clear and they said that it might have been a muscle spasm.  They were not sure, they sent me home and I did not take anything for it.
Dose reconstituted with another diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.  Additional Information: GSK Receipt Date: 24-AUG-2022.  Reporter's Comments: A nurse reported that the patient received a Shingrix dose reconstituted with another diluent than the recommended AS01B. The consent to follow up was granted. Additional Supportive Information: As patient reconstituted Shingrix dose with another diluent, which led to wrong solution used in drug reconstitution.
mouth was dry; sense of taste was not the same; This is a spontaneous report from a contactable other health professional. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Jan2021, the patient experienced that her mouth was dry and her sense of taste was not the same. The outcome of events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Rash occured all over torso particularly chest, abdominal area and neck about 48hrs after vaccination. The rash is of dense flat small red spots, no bumps, no hives, no flaking, no burning. Did not respond to Zirtec.
headache,  arm lot of pain swollen and hot,  very dizzy ,  VERY exhausted  VERY weak  VERY hard to even just stand walking only few steps knees going VERY weak.    Wheezing  & hard to breath  hard to speak chest heavy
Pt completed series of 3 Hep B vax 1 yr ago, 3rd dose given & it was determined that pt now has Hep B; Pt is asymptomatic, but reporting nurse indicated that liver enzymes are elevated, darkened urine;
Not sure if related to vaccine or not  but on 4/14 at 3pm patient experienced extreme shaking in legs that subsided after sitting down for 5 to 10 minutes. That same evening she encountered sweating and an upset stomach. All was fine the next am.
Last week was just normal injection site pain.  One week after (Monday), I had a hot hive show up on my left arm again.  I felt terrible, very nauseated, and went to bed early.  Yesterday (Tuesday), it grew to cover most of my arm.   Again, I was nauseated from afternoon through bedtime. The pain in my arm and hand made it difficult to go to sleep.  As of today (Wednesday), my upper arm is one big, very swollen hive covering all side, down past my elbow.  The swelling is down to my wrist.  I have terrible joint pain in my shoulder, elbow, wrist and hand, like yesterday.  I woke up with a hive around my left eye and swelling on the left side of my face.  I went to Urgent Care as soon as they opened at 8AM.  The PA said that I was definitely having an allergic reaction
Began to complain of pain on right side of chest below  clavicle area, then shortly after initial complaint, the patient stated it was "moving down" .  Within approx 5 min patient described the pain as moving down to "bottom rib".  No respiratory distress noted.  Patient was on her own portable O2.  No distress, no palor, no diaphoresis noted.  Patient requested ambulance to be called, they arrived within approx 5-8 min.
Patient received Hep B- Peds instead of Hep B- Adult for her 2 of 3 series vaccine. No associated adverse health event. Error would be preventable w/ education.  Patient contacted and informed of error and invalid dose and will receive correct vaccine, Hep B-Adult on 2/19/2021.
Psychiatric adverse reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENTAL DISORDER (non-serious), outcome "unknown", described as "Psychiatric adverse reaction".  Additional information: Patient Age Not Provided. Patient Gender: Non-phone report; not provided in correspondence/communication. Psychiatric adverse reaction to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left side numb for over a week. My butt hole keeps twitching. Loss of self respect
Initial report received from a healthcare professional on 09 October 2014. It pertains to one of two patients from the same facility who experienced adverse events after administration of ADACEL; details for the other patient are captured in case number 2014SA140248. A patient (age, gender, and past medical history not reported) received a dose of ADACEL (lot number C4695AA) on 30 September 2014. At an unspecified amount of time later, on the same day as vaccination, the patient experienced a choking sensation and right arm numbness. The patient received an unspecified treatment, and subsequently recovered. No additional information was provided. Documents held by sender: None.
I had a tingling sensation in my arm and I felt like my arm was on fire. I started shaking my hand and felt like it was burning and it continued for the next couple of nights. The burning sensation kept happening every morning when I woke up. My doctor suggested me to get a brace designated for carpal tunnel. The brace helped reduce the pain and the burning sensation when I awoke; the pain would be light and subsided after stretching my arm in the morning. After a couple of weeks, the burning sensation and waking in the middle of the night from the pain was no longer a thing.
The day after she recieved her immunizations she had a fever she slept all day,she has been very sleepy,weak, personality has changed, dehydrated still to this date which is a week later she will not respond to her name doesn't want to stay awake for very long and doesn't have much of an appetite.
A patient received Quadracel instead of Pentacel, No AE; A 7 month old patient received Quadracel, no AE; The patient received quadracel on right vastus lateralis, no AE; Initial information was received on 10-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 7 month old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] on right vastus lateralis instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered, product administered to patient of inappropriate age and product administered at inappropriate site).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On 10-Aug-2020, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5688AA, expiry date: 26-Nov-2021) once via unknown route in the right vastus lateralis for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered, product administered to patient of inappropriate age and product administered at inappropriate site.  At the time of report, no adverse event was 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Left deltoid inflammation with some redness. Pain with abduction. ADVIL PRN for pain.
Patient dev. hives, swelling of eyelids, and itchiness approximately 30-60 min after vaccine administration. Returned to office (nl pulse ox, RR, BP) given BENADRYL and Prednisone, Sx improved. D/C'd with Rx of BENADRYL, Prednisone.