chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pnt called Saturday 6/6 stating he developed tightness in chest within hours and laryngitis, a stutter, hard to articulate thoughts and generally didn't feel well by that evening. I advised to go to ER for evaluation. I followed up on Tues 6/8/21 and he stated the ER said he has inflammation of the heart and lungs but sent him home. Also none of the previous symptoms had resolved and he also has pain in left upper chest, decreased energy and loss of appetite. The patient said he doesn't have a PCP so I advised to go to ER again.
not feeling well after getting the shingrix vaccine; This case was reported by a other health professional via other manufacturer and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) unknown for prophylaxis.   Concurrent medical conditions included psoriatic arthritis.   On an unknown date, the patient received Shingrix at an unknown dose. On 23rd January 2019, the patient started Xeljanz (oral) 11 mg at an unknown frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. The action taken with Xeljanz was unknown. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient was not felt well after receiving Shingrix vaccine. No other information was reported.
Of a total 65 pts, 4 were determined to be nonresponders p/3 doses;
Head Hurt when Coughing; Inner Ear Hurt; Fatigue; Muscle Aches; Mild Chills (After Second Vaccine); Mild sore injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Mild Chills (After Second Vaccine)), HEADACHE (Headache), EAR PAIN (Inner Ear Hurt), FATIGUE (Fatigue) and MYALGIA (Muscle Aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced HEADACHE (Headache). On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Mild sore injection site). On 14-Apr-2021, the patient experienced CHILLS (Mild Chills (After Second Vaccine)). On 15-Apr-2021, the patient experienced EAR PAIN (Inner Ear Hurt), FATIGUE (Fatigue) and MYALGIA (Muscle Aches). On 16-Apr-2021, the patient experienced COUGH (Head Hurt when Coughing). On 18-Mar-2021, VACCINATION SITE PAIN (Mild sore injection site) had resolved. On 16-Apr-2021, HEADACHE (Headache), EAR PAIN (Inner Ear Hurt), FATIGUE (Fatigue) and MYALGIA (Muscle Aches) had resolved. On 17-Apr-2021, CHILLS (Mild Chills (After Second Vaccine)) and COUGH (Head Hurt when Coughing) had resolved. Not Provided          Treatment included Tylenol   This case was linked to MOD-2021-080321 (E2B Linked Report).; Sender's Comments:  MOD-2021-080321:Second dose of vaccine case
Patient c/o brief episodes of myalgia on left deltoid that occurs daily and lasts about 15 min. Started about 1 week after HPV #3 administered and is still ongoing. (This was her second HPV vaccine received on left deltoid). Describes her left deltoid as intermittently "achy" and "feels like I need to move it." Occurs when she's at rest and is not using the arm/shoulder. Relates it to "when you write a lot and your hand starts to ache."
Immunizations given and hives developed within 2-3 minutes. BENADRYL given and pt. went to ER. Patient was discharged from ER.
p/1st set of vax pt was irritable & unable to be consoled; t101; had localized swelling @ site of DTP;
Arm was immediately sore and still feels different.  The bandaid was bloody and spasms are constant.  Definitely much different from first injection.
Low grade fever Body Aches Headache Eyelid swelling - Lasted almost 2 weeks intermittently Increased heart rate Breathlessness on exertion Fatigue lasting 3 days
Injection site itchy; Headache; Hot around the injection; Hurt around the injection; Red spot around injection/injection site is 2.5 inches round red; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Hot around the injection), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Hurt around the injection), VACCINATION SITE ERYTHEMA (Red spot around injection/injection site is 2.5 inches round red) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).  On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot around the injection), VACCINATION SITE PAIN (Hurt around the injection) and VACCINATION SITE ERYTHEMA (Red spot around injection/injection site is 2.5 inches round red). On 04-Jan-2021, the patient experienced HEADACHE (Headache). On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy). On 04-Jan-2021, VACCINATION SITE PAIN (Hurt around the injection) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot around the injection), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (Red spot around injection/injection site is 2.5 inches round red) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported. Treatment information was not provided.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient reports mild facial swelling.  No airway impairment, no breathing difficulty.  Patient took their own Zyrtec 15ml.  No facial swelling noted, no airway impairment. Patient was observed for 30 minutes.  Symptoms resolved
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: tingling sensation on the arm that got the vaccine-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: as soon after giving vaccine, pt fainted. Woke up after 1-2 mins, pt was positioned flat on her back with legs elevated. Pt took apple juice and 25mg benadryl @7:30pm, watched pt for another 15 mins and took blood pressure before leaving. BP was low but mom states she always has low blood pressure. Followed up next day around 1pm, mom states pt has pain at the injection site, headache, no fever, and sleeping
patient was vaccinated with expired Fluzone Quadrivalent syringe from the 2019-2020 season, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 11 years old female patient who was vaccinated with once 0.5 ml dose of expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ304AB and expiration date: 30-Jun-2020) via intramuscular route in the right deltoid for prophylactic vaccination on 28-Sep-2020. The vaccine syringe used was from the 2019-2020 season (PT: expired product administered).  Medical history was not reported.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (same day latency).  No adverse event reported at the time of reporting.  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.
Cold; Coughing; Sore throat; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, NDC number, UPC number and expiry date were reported as unknown) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced cold, coughing, and sore throat, no fever on an unknown date in 2021 over the weekend. The patient wanted to get the second dose on 18Mar2021. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had mild headache and fever which has lasted longer than typical for a vaccine (going on 4 days now).
pt recvd vax & w/in minutes p/vax pt passed out & had a sz;this event was labelled a pseudoseizure by MD;pt is currently fine
Has large red area (approx. 3 by 1.5 inch rectangular area), tender and sore, firm knot-like spot at injection site - said there was some redness after her first dose but not like this. She has been taking an anti-inflammatory but said it is not helping much. Patient says it is very painful. Patient reports NO fever.
Information has been received from a nurse concerning a 17 week old male who on 3/9/2006 was vaccinated in the left thigh with the second dose of Hib conj vaccine (OMPC) (lot 651072/0185R). Concomitant suspect vaccinations received on 3/9/2006 included the second dose of Diphtheria toxoid (+) hep B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3 component (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX) (lot # AC21B034AA) in the left thigh and the second dose of Pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (Crm197) (Prevnar) (Lot A56117D) in the right thigh. On 3/9/2006, within minutes of vaccination, the patient developed facial redness and a raised, oval patch on his trunk. The patient was seen at physicians office and diagnosed with having an anaphylactic reaction. The patient was treated with diphenhydramine hydrochloride Benadryl. The patient subsequently recovered from the anaphylactic reaction the same day. The anaphylactic reaction was felt to be an other important medical event (OMIC) and was felt to be related to the Hib conj vaccine,  Diphtheria toxoid (+) hep B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3 component (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX), and Pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (Crm197) (Prevnar) vaccines. Additional information has been requested.
Pain and stiffness in my neck and shoulders and back.  After suffering for months, thinking it was just a stiff neck, I then was diagnosed and began physical therapy.
reports feeling nausea, malaise & ?hallucinaitons approx 3hr p/vax;the malaise has been cont for 1wk;thinks may have had fever-none now;arms are still sore enought ot awaken pt @ noc;
The day after the 1st vaccine, I started to have a flare up of my ulcerative colitis. This flare up lasted 11 months before I was able to get it under control. I lost so much blood that in September of 2021 I had to have 2 blood transfusions and an iron infusion. I then had to have 2 more iron infusions in December of 2021. I had severe stomach pain, nausea, vomiting, diarrhea, rectal bleeding, severe fatigue, hair loss, lost 60 pounds due to not being able to eat/keep anything down, terrible back pain, and hot flashes.
Adacel given afternoon 4/11/07. Patient states itch started that evening. Presents on 4/19 with red raised warm rash on left upper arm. There is 3 separate area 1 at injection site 2nd 2 below. Skin expected to return to normal
The day following my vaccine, my arm was sore and red. I also had a bit of a fever. On 04/08/2023, I had coughing, shortness of breath, and a slight fever. I continued having shortness of breath and coughing for the next 2 days. That Monday, I went to the doctor's office and got a shot of Rocephin. I was using an albuterol, steroid combined inhaler as well as Flovent inhaler. Tuesday, I still felt the same way with a fever of around 101 and still had a productive cough. Wednesday, I felt bad most of that morning. I thought I was feeling better that afternoon. However, Thursday morning, when I woke up, I felt really bad. I went to the doctor's office and received a shot of steroids. They also started me of Levaquin and oral steroids. They suggested admitting me into the hospital, but I declined. Friday, I felt a tiny bit better. Saturday and Sunday, things got better each day. I was able to return to work on Monday.
Injection site is red; injection site is swollen and increasing in size; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine. The patient stated that after receiving Shingles vaccine he/she experienced injection site red and swollen and it was increasing in size. The patient thought the symptoms would decrease as time passed. The patient wanted to know was this symptoms concerning. Additional supportive information: Follow-up would not possible as no contact details were available.
ON 24 OCT 06, RECIEVED LIVE INTRANASAL FLU VACCINE. ON 25 OCT @ 0600 PT STATES HAD A NOSE BLEED CONTINIOUS BLOOD FLOW FROM THE RIGHT NOSTRIL. BEGIN TO FEEL DIZZY, LIGHT HEAD, HEART PALPITATIONS, BEGAN TO FEEL FUNNY AND WEAK. PT WAS SEEN FOR TREATMENT. IV THERAPY, PT RECEIVED 24 HR QUARTERS.
Within 5 minutes of receiving MMRV, the patient began vomiting and was pale. In another 2-3 minutes developed hives and diffuse pruritis. No respiratory distress, drooling, or facial swelling. Patient was given 7.5 ML of Benadryl and observed for 25 minutes. The vomiting resolved about 15 minutes prior to discharge. Itching and hives were improving but still present.
Patient noted swelling in left arm twenty four hours after receiving vaccine. During 1/6/01 exam, right deltoid showed a non-tender, red, warm circle 8cm x 6.5cm. She was treated with Benadryl and cool compresses.
About 45 minutes started seeing clear shapes, the eventually get bigger, that lasted about 30 min or so, then I had trouble getting my words out, I couldn't think straight, I was calling a little boy a she or her main thing I couldn't get my brain to work with my mouth. This lasted for about an hour.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune" (unspecified if ongoing), notes: Autoimmune. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 14Dec2022 to 19Dec2022. Clincal course: After paxlovid, patient started initial symptoms again of scratchy sore throat, aches. Then after 2 days of that, Patient had sinus with head ache for 2 additional days it was all light symptoms but kept myself in quarantine for additional week with positive read.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 12-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (which had a lot # of L042264 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt recvd vax 18FEB92 & devel hives AM 19FEB92 & no other apparent cause found;
90-year-old male with past medical history of anemia of chronic disease, dementia, TIA, hypothyroidism, hyperlipidemia, who was admitted to the hospital because of fatigue. The patient was having generalized fatigue and generalized body aches with cough and shortness of breath for about 10 days.  The patient's symtpoms were progressively getting worse.  Pt tested + for COVID on 10/25/2021.  Pt is having body myalgias and joint pain.  Elevated troponin.  Treatment inclued Plavix, IV decafton, oxygen, IV remdesivir.
lip numb; tongue got swollen; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that an unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date patient stated that she experienced with lip numb and tongue got swollen after the first shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
The day after my vaccination I noticed severe palpitations upon standing to get out of the bath tub. Over the next two weeks I started getting dizzy, and the palpitations became more frequent and consistent. I also developed debilitating fatigue and brain fog. My mid-February, I was mostly bed-bound and not able to return to work even virtually. It was around this time we identified the symptoms as being consistent with POTS, and the official diagnosis came later that summer when I visited the dysautonomia clinic. Nearly one year later, although no longer bed-bound, I am still suffering from daily tachycardia, dizziness, fatigue, brain fog. In order to maintain some degree of function, I follow a daily exercise protocol specifically for POTS patients, must be sure to take in large amounts of electrolytes and fluids every day, I also have tried numerous supplements and nutritional regimens.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unspecified. On an unknown date in April 2016 (reported as on or after 06-APR-2016), the patient was vaccinated with an improperly stored doses of (Oka/Merck) VARIVAX (lot # L040422, expiry date: 15-OCT-2017). Nurse reported that the vaccine underwent temperature excursion at -10.2 degree Celsius for a duration for 15 hours, 37 minutes and 30 seconds. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Nausea and headache within a minute of vaccination, then after going home began to feel fatigued and achy. By 7-8 hours after receiving the shot, I started noticing a fever. Had a fever of 102 all night along with chills, extreme body aches, and headache. Temperature stayed between 100.5 and 101.5 all day today (the day after the vaccine), and the body aches and general feeling of being unwell are still being experienced. I am guessing my immune system is reacting to the vaccine and hopefully the symptoms will subside soon. I have not reached out to my doctor at this time.
Confusion lasting < 24 hours 5 days after vaccination, no fever but felt warm. Now back to normal. No other s/s illness.
At around 10pm.i began to feel warm, began to experience a nasty headache, chills , myalgias,  and this continued for about 30 hours
Day after 2d Pfizer shot on 2/18/2021,, I had moderate dizziness, like throbbing sensation in brain causing light headedness.  Not like the room spinning as in vertigo.  Would last for hours and occur when driving or trying to sleep or just sitting down.  Seemed to lessen when active like walking, golfing, or gardening.  Maybe because my mind was distracted by the physical activity.  This went on until around the first week in June when I noticed it was gone, except for very occasional dizziness every few days.  I went to Dr. who referred me for a Brain MRI, blood tests and a CT scan w follow ups with a neurologist and vascular surgeon.  The March 4. 2021 Brain MRI showed 3 small and one medium ?strokes? appearing to be bleeding strokes, possibly caused by episodic high blood pressure.  I had a Brain MRI in 2007, as part of an evaluation for memory loss and brain fog.  There were no signs of stroke or bleeding in the brain in the 2007 Brain  MRI.  There may be a connection between the Pfizer vaccine and the small bleeding brain strokes shown by the Brain MRI taken a few weeks after my 2d Pfizer vaccine shot.
High fever (103) and inflammation in neck and limbs, to the point of being unable to sleep comfortably
Multiple vesicles that developed on my son?s  arms, hands and legs but spared his torso. Was told this is a Gianotti Crosti Syndrome. Lasted 2-3 weeks.
A physician reported that an 86 year old female received an injection of Pnu-Imune 23 vaccine on 11/3/99 and on 11/4/99, she developed an injection site reaction characterized by a 2.5" X 4" raised area of redness and itching. She was treated with applications of warm compresses. This is 1 of 4 pts form this facility who developed an injection site reaction following receipt of Pnu-Imune 23.