chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experienced an auto immune reaction in the form of a flare up regarding my dermatographia.; progressively worse hives; itching; swelling at face; swelling at lips; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151), via an unspecified route of administration in the left arm on 22Apr2021 at 15:15(at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included sports induced asthma, depersonalization/derealization disorder and dermatographia. Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ), topiramate (TOPAMAX), cetirizine hydrochloride (ZYRTEC) and vitamin d (MANUFACTURER UNKNOWN) from an unknown date and for an unknown indication. The patient had a history of allergy to sulfa drugs. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the left arm on 01Apr2021 at 15:15 (at the age of 22-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021, the patient experienced an auto immune reaction in the form of a flare up regarding dermatographia, progressively worse hives, itching, and swelling in the face and lips. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with prednisone, ALLEGRA, BENADRYL and PEPCID. The clinical outcome of the events an auto immune reaction in the form of a flare up regarding dermatographia, progressively worse hives, itching and swelling in the face and lips was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Pfizer 1/11 and 2/1. Positive on 9/15
This case was reported by a consumer and described the occurrence of back muscle spasms in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included back disorder and muscle tension. Concomitant products included Steroid Injection. On 18th November 2018, the patient received the 2nd dose of SHINGRIX. On 19th November 2018, 1 days after receiving SHINGRIX, the patient experienced back muscle spasms. The patient was treated with diclofenac and cyclobenzaprine. On an unknown date, the outcome of the back muscle spasms was not recovered/not resolved. It was unknown if the reporter considered the back muscle spasms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had been seeing a chronic pain specialist for other back issues. The patient received an epidural steroid injection at his T9/T10 location on 1st November 2018, 3 weeks prior to SHINGRIX vaccine. Since then the patient had received 1 more epidural and 8 trigger point injections, all in his upper back. The patient's physician said his muscles were very tense. The next day, after receiving SHINGRIX, the patient woke up with severe pain in his lower back right side just above the waist line. This turned out to be muscle spasms. The patient finally went to urgent care and was prescribed cyclobenzaprine. The spasms calmed down on the following Sunday. Since then the patient had spasms all over his back not as severe and was taking Diclofenac and cyclobenzaprine to manage it.
The vaccine immediately stopped my period menstrual cycle, and I haven't had a period since.  I had stomach, back, and head pain following the vaccine and felt nauseous.  The constant pain eventually subsided, but I have not had a menstrual cycle, and i believe the vaccine is the cause of that.
body ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) in a 69-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.   On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced MYALGIA (body ache). At the time of the report, MYALGIA (body ache) outcome was unknown.            Concomitant medication was not provided by the reporter.  The treatment information was unknown.
Eight hours after the second dose of the Pfizer vaccine was administered to me, my temperature shot up from the usual 96.9-97.3 to 103.9. I was violently shaking and freezing with chills. I took Tylenol to reduce the fever and it didn't reduce it under 100. The next day my fever was at 103 before fever reducer, only down to 100 with the fever reducer. Day three my fever was 102. Day four was 101. From day 5 until this instant that I type this complaint my temperature hasn't went under 100. In fact, it seems that six weeks after the second dose of vaccine, 100 is my new normal. I'm sluggish and extremely exhausted. I'm becoming short-tempered and aggravated because I just feel like I am running at about 65% of my normal capability. It's horrible.
Patient became sick 3 hours after the vaccine and was found deceased 1 day after his vaccination. He passed away in his sleep.
Severe injection site pain. Went to UC. Followed up with PCP. Supportive measures recommended.
Felt dizzy weak passed out. Feel mentally confused and have been breaking out in hives ever since vaccination. Extreme sweating since vaccination.
pt recvd vax & noted jt aches; fever w/ t 101 & pain;
torn MCL; her knee was very painful; often difficult to walk / unable to bear her full weight on her knee; chest congestion; difficult for her to raise; arm was very sore; red at the injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 10th September 2019, less than 5 months after receiving Shingrix, the patient experienced pain and injection site erythema. On an unknown date, the patient experienced ligament tear, knee pain, unable to walk, chest discomfort and mobility decreased. On an unknown date, the outcome of the pain, injection site erythema, ligament tear, knee pain and unable to walk were recovered/resolved and the outcome of the chest discomfort and mobility decreased were unknown.   It was unknown if the reporter considered the pain, injection site erythema, ligament tear, knee pain, unable to walk, chest discomfort and mobility decreased to be related to Shingrix.  Additional information was provided as follows: The patient received the first dose of Shingrix intramuscularly. The patient's injection itself did not hurt at all, but shortly after her arm was very sore, it also became very red at the injection site. The symptoms lasted about 1 week and her arm was sore enough it was difficult for her to raise it. About 1 month after the injection she was running and suffered a knee injury.  The patient was diagnosed, without an magnetic resonance imaging, as a torn MCL. over the next several months her knee was very painful and it was often difficult to walk.  She was unable to bear her full weight on her knee and it felt very unstable. Due to continused knee problems, she had an appointment scheduled with the orthopedist on 16th January 2020. About 1 week prior to getting the second dose of Shingrix she developed some chest congestion, which she still had when she got the second dose. The outcome of the events were reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved in Argus. For tolerance of 2nd dose, refer case US2020AMR017267.
Patient has arm pain since vaccination. (approximately 4 weeks). She uses are less now and finds the pain worse at night.
Raised red rash at ejection site Heated skin in area of rash  Tenderness/pain when touched
Patient received her first covid vaccine and started developing SOB and DOE 2 days later. she then was diagnosed with bilateral PE and left leg DVT on 3/6/21
pt recv vax 6DEC95 & 36hr p/vax pt exp urticaria on thighs, face, arms & back of neck & swelling of hands;MD visit was required;tx antihistamine;pt has mad a full recovery;
Arm swelled and turned blue and purple from above the elbow to mid forearm. Her md told her to apply cold compresses. Lasted 1 week.
Patient received PFizer vaccine at 8:37 am.  She began to complain of dizziness at 9:00 am.  RN obtained vital signs, did assessment and gave patient some water to drink.  Patient reported a history of anaphylaxis to flu vaccine previously.  RN continued to monitor.  At around 9:37 am patient began complaining of tightness in jaw and lip tingling,  At this time 911 called.    Patient was transported to hospital due to continuation of dizziness.  While paramedics here, lip tingling and jaw tightness improving.  Patient also received 25mg of Benadryl just prior to paramedics arriving.
patient reports have blisters and hives, and also reported feeling like she had shingles like in past
When vaccine was administered patient stared off into the distance and started to fall forward. I caught him and sat him up, checking respirations and pulse which were normal. Patient came back to in about 1.5min and felt better. Stated that this "always happens when I get shots or IVs". I double checked the consent and this was not disclosed to the pharmacist prior to injection. Held patient for 45 min, he refused an ambulance or more medical care, and he left. At time he left he stated he felt back to normal completely.
Caller received first dose, then tested positive for covid; Caller received first dose, then tested positive for covid; This is a spontaneous report received from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose, then tested positive for COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
5 hrs after administration redness noted. Swelling noted 12 hrs after at site (L upper arm) 20 hrs after blister noted. KEFLEX 500mg PO at 2015 9/23/10. See office visit note.
Headache, Myalgia & Fever Narrative:  Adverse effects lasted for 2-3 days  Other Relevant History:
Pt entered observation @ 09:42 AM. At 09:52 AM, patient came up and stated that she felt "light-headed", and that her HR was 150.  This nurse explained to patient that she needed to sit back down r/t the "light-headedness".  Asked patient if she would like some water patient stated "no, she was ok". At 09:56 AM, the nurse noticed "red blotches" to neck of patient.  This nurse walked patient to bed in observation room.  Denies SOB nor troubled breathing. Benadryl 25mg was given PO @ 09:56 AM. V/S obtained @ 10:02 AM. BP-120/80, P-124, R-18, O2-99.  Still voices no s/s of SOB nor troubled breathing.  States to this nurse that she had an "anaphylactic reaction" to lobster years ago, in which she did not state this upon receiving the vaccinations.  Also has allergies to Zofran and Macrolides.  Pt remains in observation @ present time @ 10:06 AM.  Redness remains to neck and upper BL arms.  Remains in observation @ 10:30 AM.  S/S somewhat alleviated, no lightheadness, but does voice nausea.  Stated that she only at a "Granola Bar" this morning.  HR remains between 97-114.  V/S taken @ 10:39 AM BP-118/76, P-98, R-18, 02-99.  Remains in observation @ present time.  Time is 10:47 AM.  S/S of feeling better @ 10:52 AM, remains in observation. Will call an Uber home, will remain in observation until Uber arrives.  Denies SOB nor troubled breathing.
Became very fussy; wanting to nurse non-stop; not sleeping well at all; continued for 2 weeks; developed odd hand movements that have tapered but still occurs 5 months later.
1630 developed sore shoulders, left arm. 1800 developed minor HA No treatment, went to bed 1/20 0500 awoke to severe HA, muscle aches. Took Tylenol. Symptoms resolved over 48 hours
patient stated he lost majority of his grip strength. He already has some condition that affects his grip to some degree, but after his second dose of shingrix, he stated he lost all grip strength in that one hand.
I ran fever on Sunday and slept almost the entire day, very lethargic. Lots of pain in my arm. The shot itself was very painful this round. The first injection, I hardly felt it but this time it was extremely painful. I never left my home on Sunday I felt so bad.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown gender and age. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (lot/batch number, expiration date, dose, route, dose number and indication not provided) that were improperly stored. No adverse effects were reported. This case is one of several reports from the same reporter. Additional information has been requested.
site of inj became red & edematous; pt started wheezing & turning blue 5 mins p/vax; given EPi & O2 w/proventil nebulization
administration of an expired product,with no reported adverse event; Initial information received on 27-Mar-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 1 years old male patient and reporter reported administration of an expired HIB (PRP/T) Vaccine [ACT-HIB] ,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Mar-2023, the patient received 0.5 ml Total (1X) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot NUMBER: UJ49AAA; Expiry date: 05-Mar-2023) (Frequency- once) (Strength-standard)  (with an unknown strength) via unknown route in unknown administration site for Immunization.  On 22-Mar-2023, reporter reported administration of an expired HIB (PRP/T) Vaccine, with no reported adverse event (expired product administered) (Latency: same day).  It was reported, This situation is reported as a medication error due to the administration of an expired product.   Action taken: not applicable.  Outcome: Unknown   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 the guidelines. 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.
dizziness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm) and DIZZINESS (dizziness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE PAIN (sore arm). On 02-Feb-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, INJECTION SITE PAIN (sore arm) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This is a spontaneous report from a Licensed Practical Nurse (LPN). A 2-month-old male patient received on 04Nov2014 first dose of PREVNAR 13 (lot h86680; expiration date 31Oct2015; NDC number: 0005197102), intramuscular at 0.5 ml single, first dose of PENTACEL at 1 DF single and first dose of rotavirus vaccine at 1 DF single. The patient did not have any known medical conditions. Patient was not taking any other medications at that time or two weeks prior. The patient experienced respiratory distress on 04Nov2014, within 20 minutes of receiving the vaccines. The patient wound up in the Emergency Room and always on 04Nov2014 was admitted to the hospital overnight but stayed less than 24 hours. The patient was discharged on 05Nov2014 and was followed up in clinic and was doing well. No lasting effects noted. The patient completely recovered from the event on an unknown date.
FLUID IN JOINTS; TENDONITIS; STIFFNESS; DIFFICULTY GRABBING; JOINT INFLAMMATION IN WRISTS, ANKLES, ELBOWS AND HIP (LOWER BACK); FELT LIKE SHE HAD LIFTED HEAVY WEIGHT; MUSCLE SORENESS IN THE BACK; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraine, and rash, and concurrent conditions included: sulpa allergy, alcohol user, non-smoker, and drug allergy, and other pre-existing medical conditions included: Patient did no drug abuse or illicit drug usage. The patient was previously treated with phenobarbital, and hydrocodone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the patient experienced muscle soreness in the back, and felt like she had lifted heavy weight. On JUN-2021, the patient experienced joint inflammation in wrists, ankles, elbows and hip (lower back). On an unspecified date, the patient experienced fluid in joints, tendonitis, stiffness, and difficulty grabbing. Laboratory data (dates unspecified) included: Blood test NOS (NR: not provided) normal, and Diagnostic ultrasound (NR: not provided) showed fluid in joints. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fluid in joints, had not recovered from joint inflammation in wrists, ankles, elbows and hip (lower back), stiffness, and difficulty grabbing, and the outcome of muscle soreness in the back, tendonitis and felt like she had lifted heavy weight was not reported. This report was non-serious. This case, from the same reporter is linked to 20211263625 and 20211240486.
About 1 month after receiving the first vaccine, I had a loss of smell and taste, along with related sinus issues including sinus infection.  Went to allergist first who put me on antibiotics after 1 maybe 2 negative Covid tests.  Allergist referred me to an ENT who had me get a CAT Scan, which showed substantial inflammation and blockage in all sinus cavities, suggesting surgery be done.  Went to another ENT who specialized in Balloon Sinuplasty surgery and waited 8 months before I could have that done because of supply chain issues.  In that time I received first Covid Booster shot.  Had Balloon Sinuplasty done in April of 2022 with good results, but shortly after in June had second booster shot and now the issue has come back in full and I realized the vaccine had something to do with all of this.  My fears were confirmed when my ENT suggested I report my case here.  Now I'm on antibiotics to treat sinus infection.  I have never had health problems of this kind or really any to be honest, in my life.  The only thing, I have a deviated septum on the right side which has been constantly clogged since vaccination.  I should mention, my doctor ordered a covid antibody test, which was negative confirming I did not have Coronavirus.
Rash, temp 100, red eyes. Later dx'd as hives two day Advil.
Patient was scheduled for Pfizer Bivalent vaccine but received Pfizer Monovalent vaccine in error.  No adverse reactions were reported by patient.
flush feeling; chest pain to L lower chest; Vaccine-Related Anxiety (include misc mental health); SOB; NVD; Visual/Neuro concerns; Visual/Neuro concerns; This is a spontaneous report received from a non-contactable Other HCP.  A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205 and Expiration date was not reported) via an unspecified route of administration, on an unknown date (at the age of 37 years), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported.On an unknown date, during his 15 minutes waiting period after the injection, the patient began to experience flush feeling with chest pain to L lower chest. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light headedness, dizziness, facial swelling, lip swelling and tongue swelling. Differential Diagnosis was reported as Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Monitored for approx. 15 minutes. Pt greatly improved. CP resolved within 1 minute of being in the bay after drinking. VS stable/improved. Pt ambulated out of the medical bay w/o assistance. Recommended protein based food and hydration 30 minutes prior to next vaccination. Follow up with pcp as needed. Pt voiced understanding and is appreciative of today's evaluation. Treatment included: water and snacks. Outcome of the events was reported as unknown.  No follow up attempts are possible. No further information is expected.
After14 days of  being vaccinated ,  my right arm at the vaccination sight became very painful and it?s difficult to use my arm.  I had no reaction. Like this until now.  It is some sort of delayed reaction.
Gave vaccination per usual protocol. Immediately upon removal of the syringe, her arm began swelling. By the time we returned to the pharmacy waiting area, her arm was approx twice its normal size. She sat with an ice pack for 15 min, just in which time the swelling subsided. One week later (today) she returned to show the bruise that stretched from Rt. deltoid down to elbow.
Within a day or 2 I broke out in a rash on left upper arm. Some scabs formed some had pus.
From initial correspondence received at the manufacturer on 27/Feb/2003 from the patient, it was reported that a 71 year-old female received a TD adult vaccination administered in her left arm during the evening of 29/Jan/2003. Approximately 3 days after receipt of the shot (Feb 2003) the patient developed red skin and formation of a hard lump on her arm and severe itching. Her left arm became very irritated and painful. Physician on first contact attempt did see patient. Patient self-treated with ointments for relief of itching skin. On 09/Feb/2003, the pt's legs began to ache in the thigh area. The condition became worse as the day continued. Symptoms were less severe when patient was standing. The pain intensified greatly upon sitting down down. The muscles in her thighs were in severe painful spasm condition. Pain became more excruciating upon sitting or lying down. Ice was applied to the back of the pt's thighs until midnight. On 12/Feb/2003 the pt was prescribed "PROPO-N/APAP 100-65 TAB MALL-Darvocet-N 100", which she took until 16/Feb/2003. The pain ceased on 17/Feb/2003. The patient reportedly recovered from this experience.