chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(R) arm reddened, swollen, warm to touch, approx 2" x 3" in size- sore painful - time 24 hr-plus notified of reaction-mom gave BENADRYL
From telephone contact with reporting LPN it was stated that an 18 month old male patient received a Tripedia vaccination lot # U0532CB and an IPOL vaccination, lot #tT1128 administered in left thigh on 8/21/01. Left upper thigh developed a large erythematous area that was treated with ice, Advil and Pediapred. Resolved with the treatment. Reviewd, no additional information. This case is closed.
an unspecified number of pts have tested neg p/completing Engerix-B series;
Upper arm pain with limited movement. Activities of daily living hindered. It started at about 2 hours after administration. Took Ibuprofen, but has not had much of an impact on pain. I am unable to sleep on my side or lift my arm. ROM is limited. I continue to be in pain.
Information has been received from a physician concerning a male (age not reported) who on an unspecified date was vaccinated with a dose of PEDVAXHIB (OMPC) (lot #653523/0063U).  Subsequently the patient developed an injection site reaction described as red, warm, swollen, painful knot at the injection site.  Unspecified medical attention was sought.  At the time of this report, the outcome was unknown.  The office requested a lot check to be performed on lot 653523/0063U.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency was released.  This is one of several reports from the same source.  Additional information has been requested.
Fever, bedridden for 2 days. Heart pain 1 week after lasting 2 months
A couple minutes after patient got the first dose of Pfizer vaccine, patient complaint not feeling well, sweating, tongue feeling funny and not able to see. My technicians laid him down on the floor and contacted 911 to send medics. Patient was still alert but later complaint difficulty breathing. Pharmacist notice swelling around pt's neck area and weak  pulses. Pharmacist administered an epipen and stayed with patient. A few minutes later, patient symptoms subsided , medics arrived and brought him to the hospital.
L axilla swelling x 5 days, not improving.  VEARS completed. Advised her to see MD as this is most likely from the injection, but could also be from another cause - including Covid infection.
Headache, dizzy spells, GI upset. Tx: TYLENOL or MOTRIN q4 hours prn pain/discomfort; increase fluids.
February 1 2021 6:30am Severe Vertigo  Called 911 Was then transported to hospital for further testing.   Was kept overnight for  Observation and then released.
It was reported in a published article that a 35 year old male presented to his primary care physician with 1 week of severe flu-like symptoms. A week prior to presentation, the patient received multiple immunizations as part of preparation for overseas deployment. The vaccinations, all administered on a single occasion, were MMR, typhoid vaccine, hepatitis A virus vaccine, diphtheria toxoid/tetanus toxoid and poliovirus vaccine live oral. The patient also has a purified protein derivative test placed to complete his health screening, which was subsequently negative. Several days following the vaccinations, the patient started to feel ill with fatigue, malaise, and general flu-like symptoms that progressed over several days. The patient had no significant surgical history or prior transfusions. The patient was currently taking a beta-blocker and diuretic for hypertension. He denied any recent ingestion of over the counter supplements. The patient denied any family history of liver disorders or autoimmune diseases. He denied a smoking history and his alcohol intake was infrequent small quantities. The patient denied any allergies to medications or foods. Physical exam was unremarkable. At presentation, the patient's lab tests were significant for elevated liver associated enzymes, with an aspartate aminotransferase level of 1361 u/L, alanine aminotransferase of 2656 u/L, and alkaline phosphatase of 152 u/L. Total bilirubin was 4.8 mg/dL, albumin of 4.2 mg/dL, and gamma glutamyl Transpeptidase of 386 u/L. Hepatitis A, B, and C serologies were negative. Initially ANA and ASMA were negative. A liver biopsy performed 1 month after initial presentation showed severe chronic hepatitis with widespread parenchymal injury, chronic portal inflammation, numerous plasma cells, and piecemeal necrosis. These findings were suggestive of AIH. Steroid therapy was initiated, and after 2 months of therapy, the liver enzymes responded well, with AST decreasing to 46 u/L and ALT to 73 u/L. Azathioprine was added to the medical regimen at 2 months post steroid therapy and the liver enzymes increased, AST to 895 u/L and ALT to 1922 u/L, after 7 weeks of therapy. Repeat autoimmune markers showed ASMA of 1:80 and negative ANA, with IgG elevated, at 1590 mg/dL. Endoscopic retrograde cholangiopancreatography was normal. Azathioprine was discontinued, steroids, were increased, and tacrolimus was initiated. The medical regimen over the next 5 years consisted of prednisone, 10-20 mg qd, and tracolimus, 1 mg bid. Attempts to taper the prednisone lower than 10mg caused significant elevation in AST and ALT. A repeat biopsy performed 5 years following presentation showed moderate inflammatory activity consisting of plasma cells with mild periportal fibrosis. Upon internal review, autoimmune hepatitis was deemed to be an important medical event (OMIC). Additional information has been requested.
Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: she mentioned that this is a common reaction after vaccinations. she felt hot, sweat, nausea symptoms. nurse practioner  on duty monitored her while she waited in the wait area for abour 20mins. she was feeling fine before she left. Rph  called her about an hour and half later and she was back to normal.
Large hives on torso. Itching on torso, arms, head, back. Faster heartbeat, but not extreme. I told the pharmacist where I went to pick up a prescription. He said if I had trouble breathing to go to the E.R. I have not had swelling in my throat or trouble breathing, so I have not sought medical attention for the reaction.
Diarrhea, NauseaVomiting, right shoulder hurts Narrative:  Other Relevant History:
On 07/06/2001 the patient experienced a fever of 104F and wheezing. On 07/07/2001 the patient developed a rash and fussiness.
Vaccine supposed to be mixed with adjuvenated solution prior to administration. Instead of mixing with solution, APRN gave just the adjuvenated solution without the live vaccine.
I developed tinnitus in left ankle, right wrist and right shoulder with rupture of two tendons in my right shoulder. Which lead to surgery 06/18/2021.
Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Really bad headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Really bad headache). On 11-Feb-2021, HEADACHE (Really bad headache) had resolved.
This is a booster shot of Moderna after two doses of Pfizer in April. I had a fever and could fell asleep the night after booster shot on 11/23. The next day on 11/24, I discovered that I had ringing in the ears. At 9:52 pm I turned off the heater fan, all the environmental noises went away and I noticed ringing in my ear. The 9:52pm on 11/24 is a precise moment because I happened to watch a Youtube video about tinnitus. The  timestamp is logged by Youtube history.  It's a high-pitched ringing similar to electrical noises, which has been very consistent since 11/24.
nausea & vomiting began 2hr p/vax;vistaril given;VS WNL;no edema, no erythema, no heat @ inj site, no angioedema, lungs clear;
Severe headache; Fever; itching and small rash at injection site; itching and small rash at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jan2022 17:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: covid prior to vaccination: yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, unknown lot number, in left arm, at 04:00 PM), administration date: 20Dec2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 11Jan2022, outcome "recovered with sequelae", described as "Severe headache"; PYREXIA (non-serious) with onset 11Jan2022, outcome "recovered with sequelae", described as "Fever"; VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE RASH (non-serious) all with onset 11Jan2022, outcome "recovered with sequelae" and all described as "itching and small rash at injection site". Therapeutic measures were not taken as a result of headache, pyrexia, vaccination site pruritus, vaccination site rash. Additional information: Non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Reported Event: Severe headache, fever, and itching and small rash at injection site. No know allergies. The patient has not been tested for COVID-19 since the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-AUG-2015, the patient was vaccinated at a clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 01-JUL-2016, the patient was treated bat a clinic for blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. The patient has been prescribed valacyclovir (VALTREX) and pregabalin (LYRICA) for management of her painful and persistent symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sore injection site arm; Did not feel good for a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not feel good for a day) and VACCINATION SITE PAIN (Sore injection site arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Did not feel good for a day) and VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION COMPLICATION (Did not feel good for a day) had resolved and VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-369096 (Patient Link).
Patient received the high dose flu shot and pneumovax shot on the same day. After two days patients left arm was severely bruised from upper deltoid to elbow. Patient took benadryl and reaction subsided.
When I woke up I was very weak and having trouble walking, a couple day after that I started getting tingling in my left leg and now I am limping and having trouble walking. Now it starting to spread down my left leg,  I just started getting tingling in my right leg. My arms are also very week and it?s been two weeks since I got this vaccination that my employer made me get.
4/1/11 - 3.5 inch moderate erythema with minimal puffiness. Slightly warm to touch. She said discomfort is "enough to make me miss a party". No other s/s. Gave ice pack for comfort at intervals. Mom said will use TYLENOL & BENADRYL.
father died/Her parents got Pfizer as well as her brother and sister got Pfizer; This is a spontaneous report received from contactable reporter (consumer or other non-HCP).  A male patient received BNT162b2 (BNT162B2), as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal" described as "father died/Her parents got Pfizer as well as her brother and sister got Pfizer." The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Additional information: The reporter received the shot as her and her sister take turns staying with mom after her father died. Her parents got Pfizer as well as her brother and sister got Pfizer and she doesn't want to get COVID.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: father died/Her parents got Pfizer as well as her brother and sister got Pfizer
Information has been received from a nurse concerning a 12 month old patient who on 31-MAY-2012 was vaccinated with a dose of VARIVAX (Merck) (lot# 671913/1945AA). The nurse mentioned that on 14-JUN-2012 the patient had outbreak of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Follow-up information was received from a registered nurse who stated that the 12 month old male patient with a history of rash and lactose intolerance and no illness at the time of vaccination who on who on 31-MAY-2012, was vaccinated SQ in the left leg with the first dose of VARIVAX (Merck) (lot# 671913/1945AA) at 19:00 pm. The nurse reported that the patient went to the clinic on 14-JUN-2012 with a rash described as "several erythematous papules with vesicles developing on arms and legs". The patient was diagnosed with varicella. At the time of the report, the patient's outcome was unknown. The patient did not have any testing done. A lot check has been initiated. Additional information has been requested.
Extreme tiredness. I had to lie down; slept for an hour and woke up tireder than before. This state continued until about 10:00 PM, followed by rapid recovery to normalcy. I think it worth reporting because never before, as far as I know, have I received an injection of Tdap. I was given it this time principally for the tetanus protection--which I had not had for more than a decade. None of the medical professionals were aware that at age 3 months I had nearly died of whooping-cough. I am reporting now in the belief that the Pertussis portion of the vaccine may have caused the reaction I experienced.
Information has been received from a medical assistant concerning her neighbor's 19 year old daughter who received 3 doses of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified).  In the spring of 2008, in approximately April 2008, her hair started to fall out.  By August 2008, she was completely bald and had no eyelashes or eyebrows.  He mother stated that the physician said that it may have been caused by GARDASIL.  The daughter is not a patient at the practice where the medical assistant works.  The patient sought medical attention.  At the time of the reporting, the outcome of the patient was unknown.  No further information is available.
Rash ( looks like chickenpox ) on both arms and especially hands on inside palms; Rash ( looks like chickenpox ) on both arms and especially hands on inside palms; This is a spontaneous report from a contactable consumer reported that :A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Jun2021 12:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization(Age at vaccination 14 years). The patient medical history was not reported. Concomitant medication(s) included amoxicillin, clavulanate potassium 875-125 mg taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient experienced rash (looks like chickenpox) on both arms and especially hands on inside palms on 15Jun2021 08:00. No treatment was reported. The event outcome was Not recovered.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (get breast cancer in 2000. It was stage 1, took a chemo pill for 5 years did not need chemotherapy), Smoker (as a result of smoking all of my adult life I have mild COPD (I quit smoking in 2008).) in 2018, Lumpectomy, Mastectomy NOS and Radiation therapy. Concurrent medical conditions included Allergy to antibiotic (Bactrim- Break out in hives), Pollen allergy (Oak pollen= wheezing), COPD since 2018, Asthma (Since 1956) since 1995, Dyspnea (Patient went For ECHO on 9/6/2021), Depression, Anxiety, GERD and High cholesterol. Concomitant products included FAMOTIDINE from 2007 to an unknown date for Acid reflux (oesophageal), CLONAZEPAM from 2005 to an unknown date for Anxiety, SALBUTAMOL SULFATE (VENTOLIN HFA) for Asthma, ALBUTEROL [SALBUTAMOL] and PREDNISONE for COPD, BUPROPION HYDROCHLORIDE (BUPROPION HCL XL) from 1995 to an unknown date and VALPROATE SEMISODIUM (DIVALPROEX) from 1995 to an unknown date for Depression, FENOFIBRATE and PRAVASTATIN SODIUM from 2008 to an unknown date for High cholesterol, CALCIUM and VITAMIN D3 for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN ongoing since an unknown date for Symptomatic treatment and Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.    This case was linked to MOD-2021-193745 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant  follow-up information included patient height, weight, current conditions, concomitant medications and suspect batch number added.
Pt reports redness and swelling below site of injection. Pt reports taking BENADRYL and using ice. Pt reports symptoms getting better.
Information has been received from a physician concerning a 6 yr old white female who on 18Sep00 was vaccinated with a first SC dose in the right arm of varicella virus vaccine live (lot 632727/0089K). It was reported that on 29Jun05 the pt developed an attenuated case of varicella while on vacation, and it was noted that it occurred two week after a known exposure. Additional information has been requested.
Pain, swelling and rash. Occurred one day after. Better with ice and bendadryl. No similar prescription. No fever, chills. No night sweats. No shortness of breath. No wheeze. No tongue or lip swelling. No nausea, vomiting.
I was very sore in the back and shoulders the following day.  Also, my blood sugar dropped severely into the low 60's and I was shivering cold.  Two days later I started to develop a rash that worsened over the next several days.  I tried treating it with Benadryl spray and tablets but there was no relief.  A doctor prescribed Prednisone which also provided little to no relief.
The patient, was administered Moderna for his second dose, while he received Pfizer for his first vaccination. The tech checking the patient in, double verified with the patient that he was getting his Moderna vaccination. Pt states, ?yes, I am receiving Moderna for my second vaccination.? The car window states moderna 2nd dose from registration. The RN administering vaccines, confirmed with pt, ?are you receiving your second dose of moderna?? Pt again states, ?yes, I am receiving Moderna for my second vaccination.? After being vaccinated, the scribe, noticed the vaccination card has Pfizer for first vaccination. Clinical Lead, went to our Tech Master to verify in the system what the pt received for his first dose. System shows that pt received Pfizer for the first dose. Pt was observed for 15 mins and displayed no adverse reactions. Pt is alert and oriented x4, walking and talking independently. Medical Director, was called and notified.
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Shortly after administration of the vaccine (~3 min) pt started shaking, sweating, looking flushed, feeling clammy, dizziness, lightheaded and briefly fainted. Pt was put on the floor and legs were elevated, given water and a snack and started feeling better. 911 was called and an evaluation was done.
The day after vaccination injection site sore. On Friday morning soreness  not as bad at injection site.I noticed discomfort in armpit later upon examining underarm area and noticed visible swelling in armpit. I contacted primary care physician via portal to ask if swelling was common. No response.
PT CAME TO PHARMACY TO REPORT ADVERSE EVENT. ACCORDING TO PT-  DID NOT FEEL WELL WITHIN 24 HOURS, WENT TO ER AND WAS DIAFNOSED WITH PE IN THE LEFT LUNG. PT WAS HOSPITALIZED AND TREATED WITH A HEPARIN DRIP,  AT DISCHARGE  PT WAS PRESCRIBED ELIQUIS .