chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. called to report that site of shingles vaccine has a large red knot with red streaks around it and about the size of a small orange. States that has had reactions to flu vaccine this year but did not report this to CCHD at this time of vaccine. Takes Allegra Q 24 /hr daily and Benadryl at HS. Instructed to use Benadryl or Cortaid type cream to area and apply a cool compress to area today. May take her Benadryl this afternoon and at bedtime but to not exceed 4 tabs (25 mg) at a time due to icreased sleepiness. Told if condition worsens with edema to elbow or below site of injection and /or has red streaks going down the arm toward fingertips to seek prompt medical treatment at the ER this weekend. RN will call to recheck on pt. on 10/27/08. Copy of VAERS report to be sent to pt. per mail today. 10/24/08. DN 10/24/08 12:45 pm CST
On day 8 of smallpox vaccine developed sparse macular mildly erythematous rash. Improved slightly with IM Benadryl. Reported having SOB the night prior to presentation along with chilling. Also c/o itch with rash. Will f/u PMS until rash resolved. Digital photos submitted to hospital. Confirmed diagnosis of normal varient of smallpox.
Case number PHEH2014US007135 is a combined initial spontaneous report received from a physician's assistant on 08 Apr 2014 and a follow-up received on 09 Apr 2014 with a follow up information received from the physicians' assistant on 05 May 2014. This case was reported as a batch report of 2 patients and upon follow up the identifiers were reported. This report refers to a 10 years old male patient. His medical history included allergy to penicillin. His concomitant medications were not reported. He was vaccinated with initial dose of MENVEO (batch number: X13015/X13059) intramuscularly on 26 Mar 2014. It was reported that MenA lyophilized conjugate component reconstituted with a sterile diluent other than MenCYW-135 liquid conjugate. No adverse event was reported after the administration error. Follow up information received from physician's assistant on 05 May 2014: Patient demographics (initial, age, gender, weight and height) medical history and date of vaccination were updated.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020) for prophylaxis. On 25th April 2018, the patient received SHINGRIX. On 25th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient experienced pain in the arm for about 2 days after the injection, and then resolved. At the time of report, the patient stated that, this arm pain comes on intermittently ever since the injection. The patient stated, on and off again arm pain.
RN reported child was exposed to wild type chicken pox&devel shingles as a result of exposure to children that were recently vaccinated w/varicella;It was noted that the MD was not convinced that the varicella vax was the cause;
No adverse reaction. Guardian misrepresented DOB of children for a walk-in vaccine. Vaccine was given to 11-year-old outside of guidelines.
One minute after receiving her vaccination, she started feeling lightheaded. She was taken to a private section of the arena and monitored. Her vital signs were within normal limits. Her lightheadedness resolved within 10 minutes of monitoring.
Pain in Left Arm and  Pain in Left Wrist beginning January 28,2022.   Shingles rash Left Upper Arm February 4, 2022.   Redness and pain area around Left Eye February 6, 2022.
headache; stomachaches; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from medical information team.  A 10-year-old patient received BNT162b2 (BNT162B2), on 01Jun2022 as dose 3, (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single), administration date: 11Jan2022, for COVID-19 immunization; BNT162b2 (Dose 2, single), administration date: 01Feb2022, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomachaches". Additional information: Patient is immune-competent.   The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Bell's Palsy. R/S, facial drooping eyebrow, lip mouth, right eyelid stays open not blinking. R/S Tongue, numbness. Taste buds lessen. Pain muscle inside jaw, R/S chin to ear. With slight earache. Speech slurred, hard to eat. Loss of weight. Eye dryness and tearing constant R/S. Started 10-6-12 and still ongoing, no change.
DTaP given 8/28/2003 within 1 hour after shot pt had 102 temp. Motrin/fluids, follow up in office 9/2/03.
Second day after vaccine , intense migraine, dizziness, chest pain, sensitivity to light, chest tightness, vision going dark. Since then, every week I have a headache followed with panic attacks. Every week, probably 5/7 days if the week I have a headache or a panic attack. I didn?t have any of these issues before, and I was NOT anxious about the vaccine, I supported and believe in it. It?s almost debilitating snd have spent thousands of dollars at the ER now because these panic attacks feel like heart attacks and I thought I was having a stroke. This was NOT part of my everyday life before the vaccine. My head also feels like is constantly in a fog. I also now have high blood pressure.
VAGINAL BLEEDING POST-MENOPAUSAL; ANAL FISSURE TEAR; THICKENED ENDOMETRIUM; This spontaneous report received from a patient concerned a 58 year old female of unspecified race and ethnicity. 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 (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered 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 thickened endometrium with vaginal bleeding post-menopausal which occurred 3 days after shot and anal fissure tear which occurred 10 days after shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anal fissure tear, vaginal bleeding post-menopausal, and thickened endometrium. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210912883-COVID-19 VACCINE AD26.COV2.S-vaginal bleeding post-menopausal. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
lower back aches that ache more than the rest of their body; Has had two episodes of loose bright orange stools; two episodes of loose bright orange stools; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back aches that ache more than the rest of their body), DIARRHOEA (Has had two episodes of loose bright orange stools), FAECES DISCOLOURED (two episodes of loose bright orange stools) and FATIGUE (Tiredness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Aug-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced BACK PAIN (lower back aches that ache more than the rest of their body), DIARRHOEA (Has had two episodes of loose bright orange stools), FAECES DISCOLOURED (two episodes of loose bright orange stools) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, BACK PAIN (lower back aches that ache more than the rest of their body), DIARRHOEA (Has had two episodes of loose bright orange stools), FAECES DISCOLOURED (two episodes of loose bright orange stools) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported
shingles after receiving the Moderna COVID-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles after receiving the Moderna COVID-19 vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for an unreported indication: SHINGRIX in October 2018 and SHINGRIX in March 2021.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced HERPES ZOSTER (shingles after receiving the Moderna COVID-19 vaccine.). At the time of the report, HERPES ZOSTER (shingles after receiving the Moderna COVID-19 vaccine.) outcome was unknown.
My symptoms began with a funny throat feeling. The next day I had overall fever feeling and body aches. I tested positive for COVID-19 on 04/14/2023. I was in out of town at the time with a tour group. I had a very bad headache for the entire time. I had head congestion. My throat was hoarse. It moved to my chest. I used Mucinex and nasal spray. I spoke with a nurse and was prescribed Paxlovid. I began taking Paxlovid once I arrived back home in the states on Wednesday 4/19/2023. I took it for 5 days and I tested negative today. I feel a lot better but my chest continues to feel heavy when I lay down and then I need to cough. It is still a productive cough.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes (type 1)" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; PAXIL CR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Positive covid test seven days after finishing Paxlovid treatment and testing negative on rapid and PCR; (23May2022) Positive, notes: Positive covid test seven days after finishing Paxlovid treatment and testing negative on rapid and PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had my vaccination on 09/20/2022. I had fatigue and warm on 02/27/2023. My temperature was 97.6 and did not raise. I went to my doctor office on 03/28/2023 and tested COVID-19 Positive.
Shingles infection; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles infection diagnosed on 04Jan2021. 2nd dose scheduled for tomorrow, 08Jan2021. The outcome of event was unknown.   Information on Lot/Batch number has been requested.
received Shinrix last year and this year I had singles on my face/ Suspected Vaccination failure; shingles on my face; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shinrix a year before time of reporting and this year experienced singles on face. This case was considered as suspected vaccination failure as details regarding vaccination schedule and time to onset for target disease were unknown at the time of reporting.  The reporter consented to follow up.
Pt vaccinated with DTP/OPV became pale, limp, lifeless-shock like state, w/decreased color & perfusion.
A rash inflammation on one side of the face. The polyclinic said it's shingles. A lot of pain and itching in the cheek and moving toward lip and head.
Pt reported spells of difficulty raising and picking up fork, undoing clothes in arms and legs, lasting 15 minutes. Had to slide objects, multiple times a day on 9/29, 9/30 and 10/1 and only 3 times. On 10/2, had 1 episode. On 10/6, had normal exam.
Severe flu symptoms: congestion, coughing, headache, slightly high temperature, whole body ache.
Patient presented to the emergency department with sensory loss and loss of reflexes, evaluated by neurology and diagnosed with Guillain- Barre Syndrome thought to be secondary to the Pfizer Covid Vaccine
Breakthrough case admission after 2 vaccines  moderna 3/16/21 Lot# 002B21A;  Moderna 4/13/21 Lot# 025B21A
Case number PHEH2015US002454, is an initial spontaneous report received from a pharmacist on 02 Feb 2015. This report refers to an adult female patient. Medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN, (batch number: 14554D) 0.5 ml intramuscular on 12 Nov 2014. On an unknown date post vaccination she developed difficulty in moving arm at the injection site, muscle pain and stiffness. Outcome of the events, seriousness and causality assessment was unknown.
muscle aches; fever; malaise; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EK9231) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "chronic back pain" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; MORPHINE SULPHATE. The following information was reported: MYALGIA (non-serious), outcome "recovered", described as "muscle aches"; PYREXIA (non-serious), outcome "recovered", described as "fever"; MALAISE (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Addition information: Other vaccine in four weeks was none. Adverse event: Patient describes receiving the COVID-19 vaccine and developing approximately 1 weeks of fever, muscle aches and malaise. Subsequently, she developed periodic fever, muscle aches, chills and malaise. Her inflammatory markers were checked and she has an elevated ESR and CRP to moderate to high level.  Due to her cyclical symptoms of fever a CT chest abdomen and pelvis was ordered to rule out underlying malignancy such as lymphoma. Incidentally this picked up inflammatory changes within her lung parenchyma consistent with organizing pneumonia. Initiation of steroid therapy improved her symptoms but with weaning of the dose her symptoms have recurred now out to approximately 16 months. Covid prior vaccination was none. Covid tested post vaccination (Nasal Swab). Known allergies was none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200742763 Same reporter, patient, drug, different event
Torticolis (stiff neck). Have been taking ibuprofen, and applying tiger balm the last 2 days. Am on day 3. The ibuprofen and balm seem to be helping. Not as much discomfort.
On 1/27/21,  my arm at injection site and around developed a red itchy rash, intensified throughout day/ night, continued into Thursday , today , reporting day
This spontaneous report as received from a registered nurse refers to unspecified number of patients. It was reported that unspecified number of unspecified patients were vaccinated with improperly stored GARDASIL (dose no., lot no. unknown). No concomitant medication was reported. No adverse effects were reported. Product quality complaint was not reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
immediately i got a rash on my neck they gave me benadryl.  a few days later my vision became slightly blurry and progressively got worse.  I was afraid it was optic neuritis again or i needed new glasses so i saw dr.  He said my optic nerve was inflamed most likely from the vaccine as I hadn't had anything new since.  Luckily it wasn't permanent this time.
Terrible headache, minor fever, chills, tiredness, hot and sweaty and freezing at the same time.
NO ADVERSE EVENT REPORTED - patient received a Moderna 0.25mL COVID-19 booster vaccine when he was only eligible for the pfizer vaccine due to his age (< 18 yrs). Mother is aware and no adverse effects reported at this time.
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Lot number: EW0172) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN6204), administration date: 11Mar2021, when the patient was 74-year-old, for COVID-19 immunisation, reaction(s): "sore arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: ER8733), administration date: 31Mar2021, when the patient was 74-year-old, for COVID-19 immunisation, reaction(s): "sore arm"; flu shot, administration date: 26Oct2021, for Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional information: The patient had no problems with the first 4 doses. The patient did not receive other vaccines within four weeks prior to COVID vaccine. No investigation were conducted. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No additional vaccines administered on same date of the pfizer suspect.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201241797 same reporter/patient/AE, different dose;
Nausea vomiting headache chills fever and pain; Nausea vomiting headache chills fever and pain; Nausea vomiting headache chills fever and pain; Nausea vomiting headache chills fever and pain; headache; body ache rated as 7 out of 10, 10 being the highest; fever.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Nausea vomiting headache chills fever and pain), HEADACHE (headache), MYALGIA (body ache rated as 7 out of 10, 10 being the highest), PYREXIA (fever.) and VOMITING (Nausea vomiting headache chills fever and pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immunosuppression (Sofa clindamycin codeine Supressed immune system) since an unknown date. Concomitant products included CLINDAMYCIN for Immunosuppression, DULOXETINE HYDROCHLORIDE (CYMBALTA), CILNIDIPINE and Garvapetine for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced HEADACHE (headache), MYALGIA (body ache rated as 7 out of 10, 10 being the highest) and PYREXIA (fever.). On an unknown date, the patient experienced PAIN (Nausea vomiting headache chills fever and pain), VOMITING (Nausea vomiting headache chills fever and pain), NAUSEA (Nausea vomiting headache chills fever and pain) and CHILLS (Nausea vomiting headache chills fever and pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN (Nausea vomiting headache chills fever and pain), HEADACHE (headache), PYREXIA (fever.), VOMITING (Nausea vomiting headache chills fever and pain), NAUSEA (Nausea vomiting headache chills fever and pain) and CHILLS (Nausea vomiting headache chills fever and pain) had not resolved and MYALGIA (body ache rated as 7 out of 10, 10 being the highest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: No specific follow-up information recorded.
About 1 week after 2nd shot,  fairly large rash area appeared on inside of left elbow area.  Still there after 2 1/2 weeks.
violent shaking   Thought I would shoot an email to you; because I thought you might want to document the reaction I had to the vax. Dose was administered at 12:45 pm Monday.  Felt fine. Went to bed around 10 pm. Woke up less than an hour later shaking violently and couldn?t stop. (Lasted over an hour.) It was so bad, Couldn't hold phone. I couldn?t call out to my husband. When he came to bed, I did have a temp of 101.4.  I?ve had kidney infections, so fever with chills is not new to me; but NOTHING like this. It was terrifying.
Patient reported having pain both local injection site and generalized body pain starting day after vaccination and continuing for several days. Also experienced cognitive impairment for several days.
This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A patient of unspecified age (reported as 17, unit unknown) and gender received TRUMENBA, (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had an allergic reaction (could not breathe) on an unspecified date. The outcome of the events was unknown. The reporter would like to know what component in vaccine adjuvant was used that they needed to be aware of and to avoid in future. The information on the batch/lot number and expiration date has been requested.