chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported that she had itching around and in mouth after her first dose which persisted for several weeks; patient was pulled aside to monitor closely after dose was administered.  She stated that she started to feel itchy and swelling around mouth about 4-5 minutes after her dose was administered.  We discussed treatment with Diphenhyrdramine d/t fact that she wasn't experiencing issues breathing.  We delayed treatment initially to see if symptoms subsided.  At 1051 she felt that the itching sensation had gotten slightly worse, 50mg of Diphenhydramine was administered.  I discussed that we could refer her to ED for further treatment but patient declined and waited for an additional 15 minutes to see if sx resolved.  She stated that sx were improving at that time.  She was advised the Diphenhydramine can cause drowsiness and dizziness but stated that she does not typically have ADR w Diphenhydramine.  Patient refused any additional offer for treatment and departed clinic.  On 4/21 I contacted patient and she stated that she has continued Diphenhydramine at home and that sx do reoccur if she does not take dose.  I gave her my contact info and instructed her to follow up with MD.  During discussion with patient she did mention that she was diagnosed with COVID in March 2020, "long haul sx" persisted through Aug and then tested positive a second time in the fall.
RECEIVED VACCINE IN LEFT ARM, IM, AT 0520, FRIDAY, 1/8/2021. LEFT SHOULDER JOINT PAIN BEGAN SAME DAY AT 12:00 PM (NOON.) SATURDAY, 1/9/2021, CONTINUED L SHOULDER JOINT PAIN AND AT 12:00 NOON, ONSET OF CHILLS AND FATIGUE BEGAN.  SUNDAY, 1/10/2021 ONLY LEFT SHOULDER PAIN CONTINUED.  MONDAY, 1/11/2021 LEFT SHOULDER PAIN CONTINUES.
Facial nerve palsy ( Bell's Palsy) began 09/29/04. Patient had fever for 48 hours, 09/27/04 and 9/28/04.
Per doctor's notes 5/12/21: She got her second COVID vaccine last week and did get hives a few days later. The hives are resolving and she has not had any further issues. No difficulty breathing, tongue swelling. She will use Zyrtec or Claritin for hives, but her symptoms have been improving overall.
Headache, Myalgia, NauseaVomiting, Fatigeu Narrative:
Patient received his COVID-19 (Pfizer) off base. Received first dose on 6 Jan 2021 and his second dose on 28 Jan 2021.  Patient had his firs rash develop one week after his first dose. Developed rash to right upper arm that extended down to right hand, reports redness and swelling to right hand. Placed on Prednisone 50mg Daily x 5 days and Zyrtec daily. Woke up on 29 Jan 2021 with rash to right and left hands, extending fro wrists to thumbs and index fingers. No itching, no pain, no warmth. Skin red, raised.  Started on Triamcinolone cream, continue zyrtec 10mg, and motrin 800mg PRN.
Large amount of blood in stool with mucous 2 days after Rotarix  given. Normal stools until one week later when patient again had blood in stool, less amount
Pt reports arm inflammed, painful, fever-did not call office to report or be seen. Pt was checked in office after 15 minutes with no reaction.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (get Covid/ could have been much worse) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer vaccine (Initial series 1 dose) and Pfizer vaccine (Initial series 2 dose). Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (get Covid/ could have been much worse). At the time of the report, COVID-19 (get Covid/ could have been much worse) outcome was unknown. Not Provided. No concomitant medications was reported. The patient received primary series of Pfizer and then received Moderna Booster dose. The patient was fully vaccinated but had COVID and said that it could be much worse. No treatment drug details was reported. Company comment: This is a spontaneous case concerning a female patient of unknown age with no medical history reported, who experienced the non-serious unexpected AESI COVID-19. A dose of mRNA-1273.222 vaccine, given as a booster dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. No further details were provided for medical review, The benefit-risk relationship of the mRNA-1273.222 vaccine is not affected by this report. Reporter did not allow further contact. Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no medical history reported, who experienced the non-serious unexpected AESI COVID-19. A dose of mRNA-1273.222 vaccine, given as a booster dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. No further details were provided for medical review, The benefit-risk relationship of the mRNA-1273.222 vaccine is not affected by this report.
Beginning 1/1/2021 the small lump (marble sized) in my arm grew to about 3 marble sizes (all put together). It was a raised area that was red and hot in a circular shape that was 4 inches across. Remained this was until 1/5/2021. It was painful to move the arm (2/10). I used Tylenol for discomfort and ice to the site. Helped some.
Acute onset of unspeakable back pain 10/10; Unable to move without screaming and crying; Unable to move without screaming and crying; Unable to move without screaming and crying; Lost 7.8 lbs in 6 days; This is a spontaneous report from a contactable physician. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8733), via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (received at 64-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to receiving bnt162b2. Medical history included refractory lymphocytic microcolitis. The patient was not pregnant. She had no COVID prior to vaccination. Concomitant medication(s) included budesonide (BUDESONIDE) taken for an unspecified indication from 01Apr2021 to an unspecified stop date; vedolizumab (ENTYVIO) taken for an unspecified indication from 09Mar2021 to an unspecified stop date. The patient previously took diflucan, nitrofurantoin, flagyl [metronidazole] and experienced allergies (known allergies). On 05Apr2021 06:00 AM, the patient had an acute onset of unspeakable back pain 10/10. She was unable to move without screaming and crying. The patient received Flexeril and was hospitalized 5 days. The patient underwent laboratory test and procedures which included: CRP (C-reactive protein) =170, Sedimentation rate=34. She had no cardio or pulmonary issues. She lost 7.8 lbs in 6 days (weight 103). It was reported that all adverse events occurred on 05Apr2021 06:00 AM. The patient was tested for COVID post vaccination via nasal swab on 02Apr2021 and 07Apr2021 with results of negative. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient received corrective treatment in response to the adverse events, which included Dilaudid and Valium and hold still in bed. Outcome of the events was recovering.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
right knee was bone on bone; Right Knee pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (right knee was bone on bone), FATIGUE (fatigue) and ARTHRALGIA (Right Knee pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Knee replacement (Left Knee replacement).   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 21-Sep-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced OSTEOARTHRITIS (right knee was bone on bone) and ARTHRALGIA (Right Knee pain). At the time of the report, OSTEOARTHRITIS (right knee was bone on bone), FATIGUE (fatigue) and ARTHRALGIA (Right Knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were 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-2021-633751 (Patient Link).
MA gave 6M-5Yr incorrectly.  Pt should have received Mod 6-11yr as the child was age 10 on 10-26-2022.  VAERS report filed.
. In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermittent; . In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermittent; . In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermittent; local pain/bodyache; Fatigue; feverish feeling; dry cough; This is a spontaneous report from a contactable Physician (patient). A 49-years-old female patient (no pregnant) received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 08Jan2021 11:00 at single dose at left arm  for covid-19 immunisation .  Medical history included bee sting.  There were no concomitant medications. The patient previously received the first dose bnt162b2 on 18Dec2020 10:30 AM at Left arm. The patient experienced a retrosternal chest discomfort, scratchiness, tightness that has been intermittent, local pain, bodyache, fatigue, feverish feeling, dry cough on 08Jan2021. The patient did not received any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 26Aug2020.  The outcome of events was not recovered.  No other vaccine in four weeks; No covid prior vaccination;   Information on the Batch/Lot number has been requested.
It is Day 13. My arm is still red, swollen, and hot to the touch. The redness has spread bigger than it was Day 1. My left index finger is numb and tingling, but wakes me up at night in excruciating pain. I cant lift with that hand, or even unscrew a bottle lid.
Severe headache, fever, and blood pressure drop leading to fainting starting the day after receiving the Pfizer-BioNTech COVID-19 Vaccine EUA.
Injection site: Extreme arm pain, not able to use left arm, throbbing, tingling, redness, swelling, itching, hardness.  Overall: lethargy, fever > 101 f, chills, sweating, muscle cramps, headache, fatigue.
About 2 hours after vaccine, experienced soreness down entire left arm. Later that evening  low grade fever of 99.9, chills, headache, nausea and fatigue that persisted until Friday evening. Saturday I experienced a headache and nausea, loss of appetite and whole body fatigue and soreness in back, neck and arm. Headache, fatigue, loss of appetite and nausea persists till now (Monday/Day 4)
I woke in pain in my shoulder. The pain was similiar to the day of/after I received the shot.  It hasn't gone away since.
Patient had redness & swelling at the injection site. She went to the ER and was diagnosed with cellulitis.
Pt recv vax on 8/18/98; on 8/25/98 pt exp RA swelling the size of a quarter, was hard, hot&itchy. Pt tx=Neosporrin& bandaids.Pt left upper arm warm to touch,tender, swollen w/ red erythemous ring around upper arm.
Site of injection was red, rash surrounding site, hardness, hot, swollen.  Pain in back of arm, shoulder and back on that side.  Headache, nausea, fatigue and felt weak.  Legs felt heavy. Shot was given at about 4pm and symptoms started at about 5:30am the next morning.  Reported to Dr. took tylenol and motrin every four hours.  Slept alot.  Next day was a little improved but still had headache and felt woozy when moving head around.  Day three was a little more improved still soreness at site and arm, slight headache.  Day four rash began to get smaller but still had redness.
Hiberix was not given with the diluent it comes with and given with sterile water.
Narrative:  COVID fully vaccinated, presents with diarrhea incidental COVID positive, admitted for observation
Persistent swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient herself) of 36-years-old non pregnant received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Jan2021 01:15Pm in Arm Left (Batch/Lot Number: EL1284) and dose 2 via an unspecified route of administration on 24Jan2021 11:15 Am (Batch/Lot Number: EL3247) in Arm left both as single dose for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing. No Allergies to medications, food, or other products. Prior to the COVID vaccine, patient didn't receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had been tested for COVID-19. The patient's concomitant medications were not reported. On 24Jan2021 03:00, after second dose the patient experienced persistent swollen lymph nodes and were swollen for a week. Now they were frequently swollen. Event does not caused hospitalization. No treatment was received for the adverse event caused. The patient underwent lab tests and procedures which included sars-cov-2 test results negative on an unspecified date. Outcome of event was reported as not recovered.   No follow up attempts were possible. No further information was expected.
22JUL94 3AM pt woke up was very hot & mom cooled pt in front of air condition; pt went back to sleep; woke again 5AM; mom took pt's temp & it was 102.7; mom called MD; pt was lethargic; pt had diarrhea for 1 wk;
Headache, chills,  joint pain, my eyes turned into koi fish, slight fever, fatigue
This spontaneous report was received from a Medical Assistant referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 01-MAY-2018, the patient was vaccinated with an expired dose of VAQTA lot # M031806 with an expiry date on 30-MAR-2018, for prophylaxis (strength and route of administration were not reported). The Medical Assistant confirmed that the expired VAQTA had no temperature excursions prior to being administered. No adverse effects were reported.
I contracted Covid19 on 5/11/2022 with symptoms of sore throat, earache, runny nose, congestion, fever, myalgia, and cough. I took Claritin D, Flonase, and Tylenol along with ear drops for my symptoms. I was prescribed Paxlovid on 5/14/2022 and my symptoms are resolving. I still have a runny nose and a slight cough lingering at this time.
We noticed that at our vaccination on Thursday, July 7, 5 people were mistakenly vaccinated with a batch of Pfizer (FM7553) that expired on July 6, 2022.
MANUFACTURE DATE ON VIAL 9/2021. VACCINE EXPIRED 2/28/22
Swelling and severe pain in left armpit lymph nodes, swelling above left breast, chest area, and swelling in lymph around the collar bone.  Started Friday morning 12/10/21 second day after vaccine injection.
p/vax pt devel rash on lt leg, periumbilical area, lt side of abd & lt buttock;pt presented to MD said rash not vesicular but maculopapular in nature;MD reported could not r/o simple but bites;
Information has been received from a registered pharmacist concerning a 65 year old female who on 13-NOV-2006 was inadvertently vaccinated in the arm with a second dose of Pneumovax 23. It was noted that it had been only 9 months after the patient had received her first dose of the vaccine. On 15-NOV-2006 the patient experienced a cellulitis-like reaction in her injection site arm. She was treated in the emergency room with an antibiotic and then released. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
pt recvd 3 doses of vax & exp swollen lips 5 hrs p/dose 3; pt went to dermatologist for treatment; recovered p/4 days on Zovirax orally & a steroid ointment to the lips;
the patient's arm was sore for a little bit of time; the patient's arm was sore for a little bit of time; This spontaneous report was received from the patient's mother referring to an 11-year-old male patient. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. His concomitant medications included and unspecified influenza virus vaccine (unspecified)(reported as "QUAD RIV ALET PF"); an unspecified diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid; and meningococcal acyw conj vaccine (crm197)(MENVEO).      On 03-DEC-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 1 shot in the arm, for prophylaxis (strength, route of administration, lot # and expiration date were not reported). On the same date, the patient's arm was sore for a little bit of time (skin lesion and pain in extremity). It was stated that the patient did not  receive any medical attention or received any treatment for the events. On the same date, the patient recovered from the events.  The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
injection site warm to the touch; injection site was hard; injection site was red; soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness), INJECTION SITE WARMTH (injection site warm to the touch), INJECTION SITE ERYTHEMA (injection site was red) and INJECTION SITE INDURATION (injection site was hard) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included CALCIUM, VITAMIN D NOS and SALMON OIL for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE PAIN (soreness). On 29-Jan-2021, the patient experienced INJECTION SITE WARMTH (injection site warm to the touch), INJECTION SITE ERYTHEMA (injection site was red) and INJECTION SITE INDURATION (injection site was hard). On 25-Jan-2021, INJECTION SITE PAIN (soreness) had resolved. At the time of the report, INJECTION SITE WARMTH (injection site warm to the touch), INJECTION SITE ERYTHEMA (injection site was red) and INJECTION SITE INDURATION (injection site was hard) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided by reporter included cold compress to relieve the symptoms.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.
No adverse effect; Improperly stored VARIVAX; This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 14-OCT-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose and frequency were not reported) (lot # S015460, expiry date: 20-MAY-2021) subcutaneously for prophylaxis. It could not be determined, if the sterile diluent(STERILE DILUENT) was properly stored. The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in temperature of -11.5 degree Celsius (C) for 76 hours. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.
Right after injection of Hep A, client reported feeling heavy and dizziness for one hour. Client taken out on clinic in wheelchair to her car with her husband. Client reported swollen lips in the ear and husband drove to ER. Client stated she was given an injection of an unknown steroid. In the ER her BP was elevated and then given an IV with Benadryl. Client also reported taking 125mg Benadryl in car to ER. In ER for 2 hours.
Case number PHEH2014US000692 is an initial spontaneous report received from a consumer (patient) on 06 Jan 2014: This report refers to a 49-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with a trivalent seasonal influenza vaccine (manufacturer was reported as Novartis, batch number and trade name: unknown) as a single dose, on 28 Dec 2013. One to two days after vaccination, he developed minor sore throat, headache, fever and severe yellow brown sputum. The reaction turned into a full blown viral infection. It was reported that he was declining in health since the time vaccine was administered. Outcome of the events was reported as unknown. Reporter assessed the events as serious causing disability. No additional information about causality was reported.
January 30--Benign Positional Vertigo, PT, ongoing couple of sores in mouth  with both vaccines ongoing March 24th, 2021 severe outbreak of virus on body of erythema multiforme; antiviral drug;  results from biopsy; ongoing; outbreaks are from 1" to 3-4"
PAIN IN ARM; ARM FELT FULL LIKE SOMETHING IN THERE; This spontaneous report received from a consumer concerned a female 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 (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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced pain in arm, and arm felt full like something in there. The action taken with covid-19 vaccine was not applicable. The outcome of the pain in arm and arm felt full like something in there was not reported. This report was non-serious. This case, from the same reporter is linked to 20210941324.
Headache chills, back, neck, and hip pain Narrative:  states sx lasted about 36 hours