chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a covid Pfizer vaccine on 1/24/22 that was originally mixed/diluted on 01/22/22. This vaccine was outside of the recommended "use within 12 hours post dilution).
Information has been received from a medical assistant concerning a 13 year old female with a history of attention deficit non-hyperactivity disorder and no drug allergies, who on 09-SEP-2009 was vaccinated with the first dose of GARDASIL (lot # 659054/0315Y, IM, 0.5ml), on 11-NOV-2009 with the second dose (lot # 663453/0249Y, IM, 0.5ml) and the third dose on 06-APR-2010 (lot # 659054/0315Y, IM, 0.5ml). Concomitant therapy included METADATE CD. On 06-APR-2010 the patient experienced a seizure less than 5 minutes after her third dose. The patient immediately regained consciousness with smelling salts. She was confused for less than 30 seconds. There were no labs or diagnostic tests performed. The patient received unspecified medical attention. On 06-APR-2010, the patient recovered. Follow up information has been received from the medical assistant indicating that the patient had no previous history of seizures and no problems after the first and second doses of GARDASIL. No other vaccine was given on 06-APR-2010. No treatment was required and no referrals were made. Upon internal review, the events were considered to be other important medical events. No further information is available.
no adverse event; We administered 1 dose of Moderna Monovalent that expired on 12Mar2023 . Administered on 20Mar2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Monovalent that expired on 12Mar2023 . Administered on 20Mar2023) and NO ADVERSE EVENT (no adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Monovalent that expired on 12Mar2023 . Administered on 20Mar2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Monovalent that expired on 12Mar2023 . Administered on 20Mar2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Monovalent that expired on 12Mar2023 . Administered on 20Mar2023).    The concomitant medication was not reported.  The patient was administered 1 dose of Moderna Monovalent that expired on 12-Mar-2023. The treatment medication was not reported.
Left arm sore immediately.  Right arm sore as well next day. 3/25/21.  Clammy, dizziness, loss of appetite, back pain, low grade fever (99);  loss of strength, loss of balance  continuing thru Friday 3/26/21.  Feel like flu coming on.
Fever and rash covering back and abdomen. Fever began 5-9-14 (vaccines administered 5-6-14) rash appeared 5-14-14. Encouraged to notify PCP and ask about antihistamine dosage/use. TYLENOL and MOTRIN discussed.
Stomach upset; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset) in a 60-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 Psoriatic arthritis.  No Medical History information was reported.  On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 06-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset) outcome was unknown.  On 06-Jan-2021, the patient experienced stomach upset. On 03-Feb-2021, the patient experienced took covid-19 booster and wanted to sleep all day. On 25-aug-2021, the patient experienced took covid-19 booster and felt under the weather and took covid-19 booster and felt achy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was reported. No treatment medication information was reported.  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.   This case was linked to MOD-2021-624135, MOD-2021-624136 (Patient Link).
Upper arm is red, swollen, hot to touch, and hurts to touch.  Ice helps some.
I woke up with a very sore arm and a headache that has been increasing in intensity. I am tired, but pregnancy has also made me tired. Kind of achy. I?ve been taking Tylenol every 4-6 hours. I am in the beginning on my second trimester. Due December 6. I tested positive for covid at the very beginning of this pregnancy.
Patient called via telephone at 4:53 p.m. on 2/26/2021. Patient reports that she was in for a 3:40 Covid-19 (Moderna) 1st dose shot appt.   She waited her allotted 15 minutes post vaccine before leaving. Patient denied ever having any reaction  to anything or vaccine in the past. Patient reports that once she was on her way home she started to experience nausea while driving home.  She also started to experience a weird kind of numb feeling that in time moved down in to her left arm, up her to the left side of her neck, jaw and eye. She felt like her eyelid might be drooping but she looked in the mirror and it wasn't.  She explained it as a "novacaine feeling" before it is fully numb.  "It starts in a spot then spread."  "Weird sensation, like going to the dentist.  Patient reported that she also has "weird skin" on her arm so can't really tell if there is a local rash.  Patient questioned if she can take Bendedryl and this PHN confirms that she can do that. PHN confirms that patient is not home alone and encouraged patient to follow up if she felt the need if her symptoms did not resolve or continue to spread or worsen.  Patient reports understanding of this.       1/26/2021: 6:30 p.m.  call update from patient.  This PHN called patient back and patient reports that she is lying low.  She took some Bendryl and it helped some. Patient continues to have a little bit of numbness and it did go in to her left teeth a little bit but the numb feeling isn't as bad as it    was.  PHN recommended that patient try to verify with her doctor before dose 2  of what happened and verify that it is okay to get her 2nd dose. PHN also informs patient that the is diphenhydramine ("Benedryl") on site that we can give her if needed when she is here for her 2nd dose.  PHN also recommends that if she comes in for her 2nd dose she would wait for 30 minutes post vaccination vs. the typical 15 minutes. 3/9/2021 telephone update from patient.   Patient contacted this PHN  to inform that she has had continued issues post Covid-19 vaccination.  Patient reports that she continues to have some numbness in the left side of her face and her BP continues to fluctuate up and down ranging from 182-90 to 142/?.  She has been in to doctor 2 times and has 1 more appointment scheduled.  She also is considering doing a neuro consult.  She did have testing done that ruled out a stroke.  Patient is unsure if she wants to follow through with  her 2nd.  PHN did not recommend patient getting her 2nd dose but encouraged her to have this discussion with her primary care provider
Day 1 of first vaccine - injection site pain, lethargy.  Tachycardia, PVC's, shortness of breath, chest pressure, headache, dizziness, high blood pressure, night sweats, body aches, diarrhea, lethargy began about 4 days post injection.  Felt it was just the initial side effects of vaccine, but it continued.  Feb. 26th - Called MD office for an appt.   Could not get an appt. until March 18th.  March 1st - contacted MD's office via internet and explained symptoms, requested labs and cardiac workup since I could not get an appt.  He ordered labs, stated, "?I don't think checking your cardiac enzymes at this time would be helpful.?  Contacted Health Plan customer service, requested new MD, was told to file a grievance against Dr.  New physician Dr - next appt available was April 13th.   March 4th - With no history of high blood pressure in the past but it continued, began taking my husband's Atenolol daily, 25-50 mg.   Tachycardia, PVC's subside, HTN continues uncontrolled. Contact new physician's office, was told to go to Urgent Care for an EKG.  Did so the next morning with Atenolol on board.  EKG normal, heart rate 60, BP normal.  Told to continue to self medicate with Atenolol.  April 13 - Go to appt with Dr.  He says to continue to take Atenolol, "we are all guinea pigs with the vaccine".  I began to hear about some younger people getting myocarditis and realize that THIS is probably what is going on.
I have pretty large amount of pain kind of in that area.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. No investigation assessment. The patient stated he had the first dose of the Pfizer vaccine and had pretty large amount of pain kind of in that area. He asked that how much pain is typical after the injection. He stated he just tried to call regular doctor office. He wanted to make sure if he had to do something that night normal and wanted to talk to somebody to double check. He stated he was sure everything will be fine, it was not, it just lot of specific pain in that area and it was more like just wanted to talk to somebody was that normal. He do not wanted to make a big thing out of this. He stated probably two tylenol and kind of slept it off. He did not thought it was not a big deal, but he would probably take it. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
Was under impression that a single dose was 1.0mL not 0.5mL until after another patient was given the vaccine - did not verify with provider. Following day saw the client and she reported feeling a little fatigue and achey but otherwise no adverse reacctions noted.
Vaccine received at 8:45am. Same day around 9pm, started feeling feverish, entire body ache, and fatigue. 10pm, went to sleep, woke up sweaty and 101F fever. Next day, still feeling body ache and fatigue with addition of headache. 2 days after vaccine, still body ache, woke up with itchy back and noticed red bumps which looked like roseola all over middle of back. Bumps are only itchy for a few minutes once of twice a day, randomly. 3 days post vaccine, only feeling slight headache and still have red bumps on back, above waist only.
I experienced a severe headache that lasted for 2 days, severe fatigue until 4/15/21, soreness in the arm lasted for 2 weeks, had congestion, runny nose, cough until 4/14/21, body and joint aches that lasted for 2 days. I recovered from my adverse reaction after 3 full days.
The baby received an overdose (double dose) of the vaccines.  The nurse administered a dose of each of the 4 vaccines in each thigh.  Baby developed a rash in all four extremities, has diarrhea and vomits.  The baby was given normal saline IV, zofran 2.5 MG IV and pepcid 7.5MG
Chest pain at rest starting about a week after vaccination -> presyncope on an airplane 11-12 days after vaccination
Tachycardia, 114 beats per minute; Joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Tachycardia, 114 beats per minute) and ARTHRALGIA (Joint pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced TACHYCARDIA (Tachycardia, 114 beats per minute) and ARTHRALGIA (Joint pain). On 09-Mar-2021, TACHYCARDIA (Tachycardia, 114 beats per minute) had resolved. At the time of the report, ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 114 (High) 114.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medicine is reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Updated event outcome from unknown to recovered/resolved
Initial case received on 30 August 2010 from a consumer who is also the mother of the patient. A 6 year old male patient received a first dose of IMOGAM (lot not reported) and a first dose injection of IMOVAX (lot not reported) on 21 August 2010 as part of post exposure rabies series. He also received a second dose injection of IMOVAX (lot not reported) on 24 August 2010. He experienced soreness at the injection sites post vaccinations, on 21 August 2010 and 24 August 2010. On 28 August 2010 the patient received a second dose right thigh injection of RABAVERT (lot not reported, manufacturer Novartis). On 29 August 2010, he experienced a fever (101.0-102.0), soreness of both legs and limping on right side. The patient had no illness at the time of the vaccinations. He had no pre-existing medical history and no known allergies. Concomitant medications included vitamin supplements. At the time of this report it was unknown if he had recovered from the soreness at the injection sites, fever, soreness of both legs and limping in right side. The outcome of the adverse events was not reported. This case is linked to 2010-04616 and 2010-04618. Documents held by sender: None.
pt had varivax 20SEP96 & had a high case chickenpox 3wk ago;no problems;
I stated having Contact Dermatitis about 10 days after I received my booster shot.
VENOUS CLAMP ON LOWER LEFT CALF; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to cats, alcoholic, and non-smoker, and other pre-existing medical conditions included patient has no previous medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, the subject experienced venous clamp on lower left calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from venous clamp on lower left calf. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
I?ve had both covid vaccinations, one on 2/10/21 the second 3/10/21. After the first shot I had an arm rash beginning about 5 days after the shot. My arm was extremely sore, and the rash area felt hard under the skin.  The rash disappeared about 3-4 days later. After the second shot the rash appeared on day 2 after vaccination, again the rash area felt (feels) hard, this time it also itches and is very warm  to the touch. As I write this it is the morning of day 5 after vaccination and the rash is large, maybe 3x6? running down my arm (no longer covering the injection site) and is still warm to the touch and very sore.
Fever 100.8 with tylenol on board  Chills And itching at site 3 to 5 days later with  Redness heat inferior to injection site
Site swollen, red, warm to touch, swollen area approx 5cm. No fever c/o pain with motion.
Patient tested positive for COVID on 9/1/2021. Received 1st dose of Moderna vaccine approximately 8/25/2021. Received monoclonal antibody infusion on 9/4/2021. Pre infusion vitals stable. Post infusion vitals showed O2 sat of 92%, all other vitals stable. On 9/8/2021, patient presented to PCP for SOB, weakness, fatigue. O2 sat in the office 78%. Patient placed on nonrebreather at 9LPM and O2 sat improved to 93%. Patient transferred to hospital with lung sounds concerning for pneumonia. Patient admitted to hospital for bilateral COVID pneumonia with acute hypoxic respiratory failure. Patient started on remdesivir, dexamethasone, and zosyn. PCT and WBC on 9/12/21 0.47 and 31, respectfully. On 9/11/21 patient intubated due to worsening hypoxia on 100% FiO2 via optiflow and nonrebreather. Patient respiratory acidosis. Tube feeds started 9/13/2021. Patient hospitalized at time of report. Event due to worsening of COVID-19. Event not related to casirivimab/imdevimab and report completed as requirement as per EUA.
Gave pt. MENHIBRIX instead of missing PREVNAR dose. Looked at chart wrong. No adverse reaction.
pt recv first dose; w/in 7 days exp headache, vomiting, fever spikes; sx resolved w/in 7 days. recv second dose; w/in 24 hr exp  low grade fever; resolved w/in 48 hr; tx antibiotic therapy
I have tinnitus and a clogged whooshing sound in my left ear; my hearing is gone.  It's been almost2 weeks.
Sore arm (a few hours after the shot and still have it) Exhaustion (a few hours after the shot and still have it) Chills (1 am) Fever (1 am-10 am) Muscle aches (1 am-current) Headache (1 am-2 pm)
In addition to common side effects listed (fever, headache, inflammation, muscle soreness, painful skin), also had a drop in blood pressure and my heart rate was elevated from normal resting (normally 60-70s bpm, stayed above 80 and was around 110-120 at one point) starting around midnight after the vaccine through to the late evening. Noted more joint subluxations starting not long after vaccination but attributed that to inflammation + HSD. Lower level Inflammation seemed to remain for a few days
Initial report received from a health care professional on 25 August 2011. A 4-year-old patient experienced itchy ears after receiving an intramuscular injection of IPOL (lot unknown). Outcome was not reported. Follow-up information received from a healthcare professional on 24 October 2011. Per the reporter, the mother does not have the exact date of vaccination, however she stated the patient was vaccinated at 4 years of age, which is approximately in 2006. The mother also does not know the lot number for IPOL. No treatment was necessary, and the patient recovered on an unspecified date. No further information is expected. Documents held by sender: None.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The nurse initially reported a temperature excursion for (Oka/Merck) VARIVAX (lot#, dose/frequency, route not reported) on 09 JUL-2014, but at which time npo doses of improperly stored (Oka/Merck) VARIVAX had been administered. The nurse called back on 14-JUL-2014 and reported that doses of (Oka/Merck) VARIVAX (lot #, dose/frequency and route were not reported) that were improperly stored on 11-JUN-2013 and 18-JUL-2013 had been administered to unspecified patients on unspecified date since the initial temperature excursion. No adverse events were reported. Additional information is not expected.
Covid + on 10/11/2021 Per ED Note: 77-year-old female with a past medical history of COPD and hypertension presents to the emergency department for shortness of breath.  Patient was brought in by EMS from home.  Per EMS, they found patient sitting in a chair and slouched over.  She was 66% on 4 L nasal cannula.  Patient does wear 2 L at home at baseline.  Patient was started on CPAP in route and was given a DuoNeb treatment.  On arrival, patient is awake and alert and states that she has felt short of breath for the past 2 or 3 days and worsened today.  She denies fever, chills, cough, nausea, vomiting, chest pain, abdominal pain and urinary symptoms.  Patient states she has never been intubated or required BiPAP for her COPD.
Left arm swelling causing venous obstruction left brachial vein noted on ultrasound.
Body aches Sore arm Fever Chills Diarrhea  Extreme tiredness
Fever 102.3 for 24hrs. Diarrhea for one week. No cooing for one month.
14 cm x 7 cm area on posterior (L) arm of warmth and erythema, and edema. 2 cm circular induration at injection site. Entire area was pruritic and tender to palliation. Dx of cellulitis and allergic reaction to vaccine. Treated with doxycycline and oral steroids. Pt. was improving 48 hours later.
Syncope. Patient presented to ED due to syncope in the shower. Patient received 2nd dose of Covid vaccination this afternoon. Patient also received dialysis today. EKG sinus rhythm with 1st degree AV block. BP WNL, BG 132. Admitted. It is possible that patient had mild hypovolemia following dialysis or vasovagal event, and less likely by Covid vaccine thus got discharged. Patient had a ground level fall on next day at ALF. No acute findings noted
At his 5 year appointment. He had DTAP and MMR booster. They left the clinic, he started crying, his stomach started to hurt. While on the car ride home he developed angioedema. They turned around and he went to the pediatrician's office. He had diffuse hives and pruritus at that time. He was treated with cetirizine and symptoms improves. He did not vomit. No difficulty breathing. They are not sure if his BP was checked. He has not had vaccines since that time. His vaccines were up to date prior to that appointment. The first time he had chicken pox vaccine he had combined chicken pox mmr and he had a high fever.
1.) Occasional sharp pain in the left rear area of my brain 2.) Tissue just below left arm pit, was sore soon after injection. Two days later the area adjacent to my left pectoral muscle looked a felt bigger compared to my right pectoral muscle. The tissue felt as if there was a water balloon underneath the skin. It is now four days since the injection and the muscle tissue underneath my skin appears to be getting bigger and now firm.
Mom states child woke up crying non stop around 10:00 pm on 7-24-10. She took child to ER. No tests or tx done. Sunday child broke out in red spotty raised rash mostly on arms and legs. She acted like mouth was sore. Had a fever up to 100.2 x 2 days.
After almost a week after getting my first shot, I started noticing cold sores in mouth which are still present (Been more than a month now). After my second dose on 4/21/2021, I started seeing weird acne on my nose. Also seeing some acne on my back and some on my stomach. The acne seems to be self healing but causes lot of skin irritation/itching. Also, just one week before 5/17/2021, I started noticing that I have several inflammations/sores under foreskin on my penis and some pus around the back of the penis's head. This is causing excessive itching on my penis and causing discomfort during sleep. I am uncircumcised adult.
Patient had a recurrence of Afib with RVR 1 month after 2nd COVID vaccine.  Patient had had MAZE procedure in Feb 2021 and Afib had been completely resolved for about 5 months prior to July 2021.  2nd COVID vaccine was end of June 2021
Pain, tenderness, redness, raised swelling, itching, left upper arm, surrounding site of injection. Delayed reaction that began about 4 days after injection. Looks like tip of "tennis ball" size area protruding from site.  Site looks very much like the Moderna "COVID arm" described online. Today,  still present, but better.