chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tiredness; Slight fever; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 45-years-old male patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown, Expiry Date: unknown), via an unknown route of administration on 10Mar2021 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization. Reason for no lot number of COVID 19 Vaccine consumer stated, "I don't know that it was not on my little card." The patient's medical history included asthma from an unknown date and unknown if ongoing. Consumer stated, "I don't have a Thyroid and I have occasional asthma." Concomitant medications included levothyroxine sodium (SYNTHROID), montelukast sodium (SINGULAIR), meloxicam (MELOXICAM); all were taken for an unknown indication from an unknown date. On an unknown date in Mar2021, the patient experienced tiredness and slight fever. The patient stated, "I was just wondering I had my first dose of Pfizer on Wednesday and had 2 days of tiredness and then Saturday and Sunday I have had like slight fever and I was trying to see if that's normal reaction for it to last this long." Patient stated, "It was 6th, no, it was 13Mar. I had tiredness 2 days before but (incomplete sentence)." Consumer stated that he was about 5 (Feet) 6 (inches) and 225 (pounds) (not sure hence not captured in tab)." No investigation assessment. Received Tylenol as treatment. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Muscle Aches, EXTREME kidney pain (I'm going to drink cranberry juice after work, Hopefully that will help)
Patient reports that within hours of the injection the site became red and painful for multiple days. The site redness then spread down to the elbow and appeared on the right arm as well. He describes it as red and bumpy. He has a prescription for triamcinolone topical that he states he has used along with CALMOSEPTINE topical ointment. Using these products has helped minimally per the patient. At this time he has not shown a pharmacist at pharmacy, but has spoken on the phone with us.
We were not aware that this had happened. The health department called me today and they noticed that this happened. I found the patient and filled out this report for the employee that performed the immunization since that employee is out of the office today. We never had a call that the patient had an adverse reaction of any kind.
Red, warm, swollen area around the injection site.  Treated with fluincodinde cream.  Tx still ongoing as of now.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Pt recv vax on 11/3/98; on same day pt exp rash on vax site arm x 24 hr
Swelling and redness to vaccine site, left leg that worsened as of 7/2/10 and has gradually improved.
Per pt. 48 hrs after he developed rash/hives.  Pt. did not report to any one. Came for second dose and noted with some rash.
Given vaccines 10/7/15. Mom called that night - patient sent to ER - DX urticaria - pt given Prednisone and Benadryl. Follow up visit 10/9/15 - doing well.
Moderate pain in shoulder muscle.  Have been taking Aleve.  Pharmacist today said to take Tylenol rather than Aleve.  Pain is still present today (6 days later).  No swelling or redness or any signs of infection. Have full movement in my arm/shoulder.  Have applied heating pad and whirlpool - both provide temporay relief.
This spontaneous report was received from a pharmacy student refers to a female patient of unknown age. The reporter stated that on 09-JUL-2012, the patient received first dose of GARDASIL 120 Y (dose, route and frequency was not reported). The reporter stated that the patient would like to receive her second dose of GARDASIL on 21-MAY-2014. No adverse symptoms reported. No further information provided. Additional information has been requested.
Woke up morning after vaccine with strong dizziness...sporadic. Bouts of dizziness seemed to subside after 90 minutes.; Arm where shot taken is quite sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Apr2021 09:30 (Lot number: EL3247, Expiration Date: May2021) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot unknown=True , lot unknown reason=Not available/provided to reporter at the time of report completion, administrator route=Intramuscular , administration date=06Apr2021, administration time=11:00 AM, dose number=1 , vaccine location=Right arm, Lot no: EL3247,), administration date: 06Apr2021, when the patient was 45 years old, for covid 19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 28Apr2021 06:45, outcome "recovering", described as "Woke up morning after vaccine with strong dizziness...sporadic. Bouts of dizziness seemed to subside after 90 minutes."; VACCINATION SITE PAIN (non-serious) with onset 28Apr2021 06:45, outcome "recovering", described as "Arm where shot taken is quite sore". Therapeutic measures were not taken as a result of dizziness, vaccination site pain.  Additional information: No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Not covid tested post vaccination. No known allergies. No prior vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No concomitant drugs taken within two weeks before the event onset. Exclude all drugs only administered more than two weeks before the event, and any drug used to treat the event or taken after event onset. No other medical history or family history reported. No other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebro-spinal fluid culture, pleural fluid culture, urine culture, diagnostic imaging, (e.g., chest X-ray, MRI). If COVID-19 testing has been conducted, provide test dates and results. Still alive only felt symptoms day AE reported.  No follow-up attempts are possible. No further information is expected.
One week following vaccine, noted sudden onset of severe joint pain, chills, aches. No fever no rash or other clinical signs
Tachycardia (HR in the 110s), substernal chest pressure, dizziness 15 min post vax Observation and fluids Sxs resolved after 30 mins of close monitoring NKA
Soreness of the arm and armpit, swollen lymph nodes in the armpit, shoulder, and neck
This spontaneous report was received from a nurse practitioner referring to a 65 year old female patient with lymphoma and none history of drug reactions or allergies. Approximately on July 2015 (reported as: 6 months ago) the patient was vaccinated with a dose of PREVNAR 13. On 28-JAN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscular, lot # K020215, expiration date: 15-MAY-2016, (dose number and anatomical place of vaccination were not reported). The patient was not taking any concomitant medication. On 28-JAN-2016, the patient developed supraclavicular and axillary swelling on her left side (local swelling), so the patient sought for medical attention, but no treatment was given for the local swelling. The Nurse reported there was no injection site reaction. At the time of the report, the outcome of the local swelling was reported as not recovered. The reporter did not provide a causality assessment and no product quality complaint was reported. Additional information has been requested.
Three days after the vaccine approximatly 11:45 pm I had raised red very itchy bumps the size of quarters, hot to the touch, next morning they were oozing a yellowish liquid, I applied antibiotic ointment. The next day around 10:00 am i got a bump on my left pink finger and on my left ring finger, all the same issues. Later at night around 9:00 pm I got two quarter zise bumps on my right calf all same symptoms. Next day I got 3 bumps on my upper left thigh, all same issues. On Monday morning I got a bump on my right lower chin, after taking a shower I got a bump on my lower right lip. i got 2 bumps on my upper above my left elbow. I Went to see the doctor on Monday 08/16/2021, had bloodwork done and a cultue on my chin. Today I have more bumps on my inner left arm. a bump is forming on my right hand between my ring and pinky finger.
High pitched ringing in both ears, sometimes associated with pain in the ears.  Primary Care Dr prescribed antibiotics and allergy meds at a later date, none of which helped with the tinnitus
swollen lymph node under armpit (size of orange/grapefruit); fever; chills; Off-label use; Booster; This is a spontaneous report from a contactable consumer (patient). A 32-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: 301258a) via an unspecified route of administration, administered in Arm Left on 06Oct2021 at 11:45 (at the age of 32-year-old) as dose 3 (booster), single for COVID-19 immunization and received influenza vaccine (FLU), via an unspecified route of administration on 06Oct2021 (Batch/Lot Number: ut7325la), as dose 1, single for an unspecified indication. The medical history and concomitant medications were not reported. Patient had no known allergies. The patient received first dose of BNT162B2 on 12Mar2021 (lot number:en6205, administered on arm left) and received second dose on 20Feb2021 (lot number:el9266, administered on arm left) for covid-19 immunisation. . The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 06Oct2021 at 11:45 the patient experienced off-label use and booster. On 07Oct2021 at 14:00 the patient experienced swollen lymph node under armpit (size of orange/grapefruit), fever and chills. Patient did not receive treatment for the events. The outcome of the events swollen lymph node under armpit (size of orange/grapefruit), fever and chills was not resolved. No follow-up attempts are possible. No further information is expected.
She hears it "burns a little"; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), unknown on an unspecified date at SINGLE DOSE for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she hears it "burns a little" on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient experienced generalized muscle aches for 2 days (48 hours) Patient used Tylenol/aspirin during this time period.
No adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25).    Concomitant product use was not provided by the reporter.  It was reported that on 25-May-2023, 20 patients who were over 65 years old was administered with 0.25 ml Moderna bivalent vaccine instead of 0.5 ml. All these patients had their monovalent and a previous booster dose of bivalent vaccine.  Treatment information was not provided.  This case contains information about patient 19th out of 20 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Patient no - 1
Disorientation, imbalance, feeling of being intoxicated including slowing down of thought processes, and speech. Pt was taken to ER and examined, followed up with PCP two days later and was still altered at this time; reports improved mentation when taking benadryl/cetirizine (but it only lasts for a couple of hours).
Info has been received from a registered nurse concerning a 56-year-old female registered nurse with arthritis and environmental allergies who on 10/29/2002, in the AM, was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent (lot #641532/1353L) (also reported as Pnu-immune) administered in the left deltoid. There was no illness at the time of vaccination. On that same date, in the AM, the pt was also vaccinated with a dose of influenza virus vaccine (FLUSHIELD) (lot #4020025) administered in the right deltoid. Concomitant therapy included rofecoxib (MSD) (12.5 mg daily) and montelukast sodium (MSD) ("100 mg daily"). On 10/29/2002, in the evening, the pt developed redness, a lot of erythema of the whole upper arm, a lot of warmth of the whole upper arm, tenderness and significant swelling under the left arm and axilla. The pt was unable to participate in exercise classes. The pt sought unspecified medical attention. Within 72 hours, the pt's symptoms resolved and as of 11/01/2002 she had recovered. There were no diagnostic tests or laboratory results. Additional info is not expected.
No adverse event reported. Vaccine administration error.  Patient received previous dose of pfizer, which he did not tolerate and opted not to get second pfizer dose.  After research online, he opted to get Jansen vaccine instead.
Bells Palsy, body nerve endings pain, GI, vomiting  Weakness. Much like Guillian Barre but not.  Admitted into hospital 5 days
Information has been received from a registered nurse concerning an 11 year old white male, with no illness at time of vaccination, no pre-existing allergies, birth defects or medical conditions and no drug reactions/allergies, who on 04 May 2000 was vaccinated subcutaneously with a 0.5 mL dose of Varivax (Lot # 632616/1688J). That same day he was also vaccinated with DTAP (Lot# DTPA921A2), MMR (Lot # 634043/1716J), and poliovirus (Lot# R0398-2). On 20 Apr 2006 the patient developed breakthrough varicella with a rash consisting of 50 to 100 lesions located over his entire body (also reported as a varicella rash on his head, ears and back, with less than 50 lesions). The rash was itchy and lasted for about 1 week, until approximately 27 Apr 2007. There was no fever present. The patient went to the physician who prescribed therapy with Augmentin for 10 days. Other treatment included oatmeal bathes. There were no other complications or symptoms noted. No product quality complaint was involved. Additional information is not expected.
The following morning the husband noted that patient was "talking out of her head". By noon she could not stand under her weight because of weakness.  She has continued to waiver between orientation and disorientation.  This is her second hospital day.  It is not known when she will be discharged.  12/21/07 Reviewed hospital medical records which reveal patient experienced right arm pain, warmth & swelling with fever, chills, dry mouth, weakness, lightheadedness, decreased oral intake & acute confusion.  Seen at outlying ER 3 days prior to admit for syncope & d/c to home when CT scan head WNL.  Admitted 11/29-12/03/2007.  Exam also revealed submandibular lymphadenopathy & breast tenderness.  Right deltoid w/large area of erythema & tenderness.  Tx w/IVF & IV antibiotics.  Improved & d/c to home. FINAL DX: Presyncope, likely secondary to dehydration; right arm cellulitis; hypokalemia.
Confirmed Breakthrough  1st/2nd Dose - Janssen - 042a21a
Patient arm started to swell and was told to put ice on it. The ice helped but the redness and swelling continued onto the underside of the arm from the top of the arm to the elbow. She came in on a Friday night after her doctors office was closed. I recommended to keep icing and add on BENADRYL. If no better or worse she should seek medical attention at an urgent care. Saturday she stated that it did look a lot better.
Case number PHEH2014US018224, is an initial spontaneous report received from a medical assistant on 09 Sep 2014. This report refers to a 16 years old female patient. Her medical history and concomitant medications were not reported. It was reported that MENVEO vaccine was at 47 F for 10 minutes on 29 Aug 2014. On 02 Sep 2014, the patient was vaccinated with 0.5 ml intramuscular MENVEO (batch number: not reported) which underwent temperature excursion. No adverse event was reported following this administration error.
She got her vaccine, nothing happened after the first 15 minutes, everything was fine.  Her arm was sore for about 2 1/2 days and then 4 days later she was nauseous, had vomiting, and that next morning and ever since she has had a terrible migraine.  Her vision has either started to swirl and miss some spots in her vision, and then migraine pain and nausea that starts shortly after that.   She has not gone to her doctor for her symptoms.  She has taken Tylenol, Excedrin, and a Goodies powder with some relief, but they have not relieved the pain entirely.
Returned to clinic 24 hours after receiving shots, right arm red and swollen from lower deltoid area to elbow, inner, aspect of arm.  Referred to private physician, who advised cold compresses and Benadryl.
Patient received immunization, appeared fine, but then had vasovagal episode on his way to observation chair.  Patient and Caregiver report that patient has had anxiety issues causing him to faint multiple times in the past.
Approximately week after shot given. Injection site on left  Begin to swell harden and form red circular welt. Continued to worsen till approximately size of grapefruit. Went to Hospital ER on 1/25/21. Diagnosed w/ allergic reaction. Prescribed alclometasone
Noticed a rash forming in groin area on the evening of the vaccine. Progressively became worse and slightly spread for the next four days. On the fifth day it began to clear.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 10-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Pain in left shoulder joint, localized. Injection given near top of left shoulder. Pain x 4 weeks.
itching; hives; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Medical history included systemic lupus erythematosus (SLE) and the patient reported that he was allergic to penicillin, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12Aug2021 (about 8 hours later after the injection), the patient experienced itching and hives. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL. The patient outcome of the events was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
pt devel fever 1 day p/vax-sz;devel diarrhea 12hr later;stool c/s negative;still w/diarrhea-non bloody;
ACHINESS; COLD HANDS; FEVER; TINGLING HANDS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (series 1, suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced achiness, cold hands, fever, and tingling hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold hands, and tingling hands, and the outcome of fever and achiness was not reported. This report was non-serious.
Dizziness, headache, body aches. Temp 99.4-99.6. Supportive measures.
8JUL92 fever 104 ax; pain swelling-warmth lt thigh-some joint pain; seen by MD beginning ear infect-ATB;
swelling; hard to the touch; large red spot; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH (large red spot), VACCINATION SITE WARMTH (hot to the touch), SWELLING (swelling) and VACCINATION SITE INDURATION (hard to the touch) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced RASH (large red spot) and VACCINATION SITE WARMTH (hot to the touch). On an unknown date, the patient experienced SWELLING (swelling) and VACCINATION SITE INDURATION (hard to the touch). At the time of the report, RASH (large red spot), VACCINATION SITE WARMTH (hot to the touch), SWELLING (swelling) and VACCINATION SITE INDURATION (hard to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Arm swelling , hand swelling, pain and warm to touch, came into office to be seen. Dr. saw patient same day appt. Dr. examined patient and gave dose of Benadryl. Patient's father advised what to watch for. Patient's father understood.
9-27-12 ZOSTAVAX administered left arm sub-Q post instructing client possible side effects/reactions. Client stayed at office 10 min post injection - no problems. 10-1-12 client calls Health Department office & reports on 9-27-12 evening time itchy/rash. Started on (L) thigh, left wrist - behind knee. Tongue tingling sense - continued Friday & into Saturday. Took BENADRYL Sat pm & Sunday & rash/itching clear - tongue no longer tingle, felt she should call us instructed client to call her PCP.
Lemon size swollen lymph node in axilla.  Denied redness or warmth. C/O constant pain in Left arm  and pain increases with activity with pain more concentrated in L) elbow.  Pain wakes her up at night.  Took aleve, used heat and biofreeze to alleviate pain and didn't help.    When having pain with activity c/o pain 7-8. 5/5/2021: Saw primary care provider.  Started on Aleve 4 tabs daily for a week and Gabapentin 300mg PO daily.