chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COULD STILL FEEL THE ARM WHERE INJECTION WENT INTO; This spontaneous report received from a patient concerned a 66 year old male. 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, intramuscular, batch number: 20421A, expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021, the subject experienced could still feel the arm where injection went into. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from could still feel the arm where injection went into. This report was non-serious.
Patient called late 2/13/17 to notify the pharmacy that she has had a fever since the day after the vaccination 2/27/2018. She stated that she was tired and achy but that could be due to her underlying fibromyalgia. She stated that taking OTC TYLENOL does bring the fever down.
On 5/19, the day after the vaccine, he developed a warm, erythematous area around the injection sites. He was slightly irritable occasionally but otherwise fine - no fever, nausea, vomiting, diarrhea. He has been active, playful, normal appetite, intake and output. On exam, 10cm x 10cm area of rxn ( L ) ant. thigh.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiry were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 4 year old female child who in approximately 1998 at the age of 1 year old was vaccinated with a dose of varicella virus vaccine live. On 11/30/2001 the pt developed C6 dermatome herpes zoster. The child had herpes zoster on her left thumb and forearm that extended up to her left shoulder. It was unknown if there was a post vaccination rash or exposure to VZV at the time of herpes zoster, although the physician did not think there had been recent VZV exposure. It was noted that a vesicular lesion specimen was taken on 12/21/2001 which was to be submitted for VZV PCR analysis. Subsequently, the child fully recovered. It was reported that there was a family history on the pt's maternal side of an uncle that died from VZV encephalitis (no vaccine) and an aunt with recurring herpex simplex (no vaccine). The pt's brother subsequently experienced cerebellar ataxia after receiving varicella virus vacicne live (WAES0201USA01812). Follow-up info indicated that a vesicular lesion was obtained on 12/01/2001 and sent to the lab on 01/22/02. The lab received the specimen on 01/23/02. The specimen submitted for PCR analysis was an adequate specimen and was negative for both the wild type varicella zoster virus and the vaccine strain virus.  B-globin DNA was amplified. The physician noted that they had "not done a Tzanck smear." No further info is available.
Migraine Headaches (Frequency every 2 weeks); This spontaneous case was reported by a patient family member or friend and describes the occurrence of MIGRAINE (Migraine Headaches (Frequency every 2 weeks)) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Family history included Migraine (Brother also had 3-4 migraines per year prior to vaccination). Concurrent medical conditions included Migraine (3-4 Migraines per year prior to vaccination).    On an unknown date, the patient received fourth 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 MIGRAINE (Migraine Headaches (Frequency every 2 weeks)). At the time of the report, MIGRAINE (Migraine Headaches (Frequency every 2 weeks)) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient had an increase in Migraine Headaches (Frequency every 2 weeks) after vaccination. The patient received 4 Moderna COVID-19 vaccines, the last one about 2 months ago.  Patient had received dose 1, 2 and 3 of Moderna vaccine previously on an unknown date.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-734616 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2023: Live follow-up received contains non significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734616:Patient's brother case
None known.....patient received an MMR and a Td. Patient is 10 weeks pregnant and should not have received a live vaccine and should have received a Tdap not Td to ensure protection against pertussis.
Fever, chills, sweats, headache, insomnia, rapid heart beat for no reason,   Feeling better mid morning after shower and liquids
Pt stated when he left after his 15 minute observation he felt like he had a tickle in his throat.   He got back to work within a few minutes and his eyes were bloodshot and watery.  He began to feel hot and like he had to cough.  Fire department was called and arrived within a few minutes  and checked pt's B/P and did an EKG that was normal.  Pt's B/P was more elevated that normal, "160 systolic over  100 something."    Pt stated he took  2 extra amlodipine and worked the remained of the day.  That night he began to feel hot,  muscle aches, no appetite, and no energy.  The next day felt the same symptoms and stayed in his chair all day.  On 3/3/2021 he was able to go to work but still had no energy.
Patient was vaccinated with a vaccine which was stored in the freezer longer than the recommended time. (over two weeks)
Post herpetic neuralgia; multiple outbreaks of herpes zoster; balance issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) gender not provided. The pt's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified date, the pt received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage information, lot # and expiration date were not provided) for its intended purpose: the prevention of shingles (herpes zoster). On unspecified date, after the receipt of Zoster Vaccine Live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, and balance issues. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a result of the vaccination with Zoster Vaccine Live (ZOSTAVAX) the patient experienced sustained severe and permanent personal injuries, resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX). At the time of the report, the patient had not recovered from the events. The reporter considered the events to be related to the suspect therapy. Upon internal review, the events herpes zoster, postherpetic neuralgia and balance issues were considered disabling as they resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX).
After shot lightheaded. Next day fever, chills, vomiting x 2 days.
For 8 hours felt extreme restlessness and irritability, my body and nervous system were wired and stimulated. I had to take multiple Xanax to finally get asleep after 5am. Awoke the next day and the brain fog and Neuro issues I've battled for 9 years had disappeared. Only 10 days then I went back to baseline. Exact same reaction to second Pfizer dose: extreme restlessness then miracle cure
fever; body aches so that she could barely walk; nausea; chills; sick; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EP6955; Expiration Date: 30Jun2021) via an unspecified route of administration (age at vaccination 77-year) in Left Arm on 31Mar2021 09:30 at AM as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. No prior vaccinations (within 4 weeks) were reported. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional Administered Vaccines If applicable, list of all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. On 31Mar2021 the patient experienced fever, body aches so that she could barely walk, nausea, chills, sick. It was reported that "she had her first dose of the COVID-19 vaccine last Wednesday on 31Mar2021. She knows she had COVID-19 antibodies because she had the COVID-19 virus in Dec2020. They are saying on TV that people who have had the COVID-19 virus and gotten one COVID-19 vaccine should be ok. She thinks she has antibodies from the COVID-19 virus then she went and got the COVID-19 vaccine, and she got more COVID-19 antibodies. She doesn't want to get the second COVID-19 dose because she was so sick with the first COVID-19 vaccine. Clarified caller had fever and body aches so that she could barely walk. She also had a little nausea; the nausea wasn't really bad. Then when she saw on the TV that people who had antibodies maybe shouldn't get the second COVID-19 vaccine. She is scheduled for her second COVID-19 vaccine on 21Apr2021. She got her COVID-19 vaccine at Hospital. When probing for specific event details the caller reports she received her COVID-19 vaccine at 9:30AM on 31Mar2021 and that evening she had chills and a fever. She also had body aches and a little nausea. She had been sick, and she was afraid that she wouldn't be able to go to church on Easter Sunday because she felt bad, but she woke up feeling better on Sunday, 04Apr2021. She was able to go to church. Today, 05Apr2021 she has no symptoms at all. She's concerned over getting her second COVID-19 vaccine." Adverse Events does not require a visit to Emergency Room/Physician Office. No relevant tests were reported. The clinical outcome of the events was recovered on 05Apr2021.  No follow-up information needed. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy nose), POLLAKIURIA (frequent urination), DYSPEPSIA (Indigestion), ABDOMINAL PAIN UPPER (extreme stomach pain) and DIARRHOEA (Diarrhea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In October 2021, the patient experienced NASAL CONGESTION (stuffy nose). On an unknown date, the patient experienced POLLAKIURIA (frequent urination), DYSPEPSIA (Indigestion), ABDOMINAL PAIN UPPER (extreme stomach pain), DIARRHOEA (Diarrhea), HEADACHE (Headaches), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, NASAL CONGESTION (stuffy nose), POLLAKIURIA (frequent urination), DYSPEPSIA (Indigestion), ABDOMINAL PAIN UPPER (extreme stomach pain), DIARRHOEA (Diarrhea), HEADACHE (Headaches), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills) had not resolved. Concomitant medication was not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment drug was not 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.
PATIENT REFERRED FEELING GENERALIZED WEAKNESS, BLURRY VISION AND TIRED. SHE APPEARED PALE AND WITH EXCESSIVE SWEATING.
7/7/16 Vaccine negated effects of recent lesi and hip steroid injection. (7/21/16).
Pt received Varicella vaccine at check up appt on 9-10-2007 with no reaction noted after 20 minute wait time. Pt developed a large local reaction to left arm site on 9-12-2007 including a 7x6 cm area of erythema, soreness, swelling. Instructed per Dr to use warm compresses and anti-inflammatory meds. Spoke with mom on   9-14-2007 - states pt much better - swelling and redness decreased - pt doing fine.
Pt reports pain and swelling to injection site on left upper arm.  States having 'baseball' size swelling at injection site with redness and skin feeling hot that last around 6 days.  Pt notes having a low grade fever for 3 days following injection as well, was reduced with OTC ibuprofen.
I am reporting this as an administration error.  The patient was given dose #1 of the moderna vaccine on 6/3/21.  After administration, the RN found out the patient had received a dose of Janssen on 5/6/21 at a different location.  The patient was uneducated on what was needed for her regimen and did not speak English.
Three days after receiving the first dose, I woke to significant joint pain and stiffness.  It was extrmely difficult to move around as well as ascend and descend stairs and transition from sit <->stand without great effort.  Pain and discomfort was so high that I often felt extreme fatigue going up/down 1 flight of stairs. These adverse events lasted for at least 3 weeks post my second vaccination.  4/3/21 PCP visit for knee pain (R>L) xrays taken referred to Sports Medicine  3/9/2021 visit to Sports Medicine more xrays and ultrasound referred to Rheumatology 4/9/2021 Rheumatology full exam (to rule out rheumatoid arthritis(?) then additional bloodwork) 5/3/2021 Gastronterology appointment (in flare) prescribed steriod and suppository  5/28/2021 Emergency Department visit per direction of GI's office  prescribed tapered course of steriods (Prednisone) and antibiotic (Flagyl)
Narrative:  PATIENT RECEIVED BOOSTER VACCINE FOR COVID-19 AND PROCEEDED TO DEVELOP COVID-19 WITHIN 30 DAYS OF ADMINISTRATION.
12/19- nausea & headache.  12/20- bodyache, sore arm & headache
Patient reported shortness of breath and heart racing approximately 10-15 minutes after getting 1st dose Moderna vaccine. Client was cleared by EMS.
Case number PHEH2012US005259 is an initial spontaneous report received from a consumer on 02 Mar 2012. This report refers to a patient whose age, gender, medical history, past drugs, current conditions and concomitant medications were not reported. This patient received MENVEO (batch number: not specified) though site and route unspecified on an unknown date. On 29 Feb 2012, the patient experienced swollen arm, redness and it was hot. The outcome of the events was not reported.
spreading rash and hives starting at injection site; spreading rash and hives starting at injection site; spreading rash and hives starting at injection site and spreading to all arms  and legs within 20 minutes; hives spread over entire body/Hives were breaking open and leaking pus and blood.; having trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 30Mar2021 09:30 (Batch/Lot Number: EP6955) as single dose, for covid-19 immunization at Doctor's office/urgent care. Medical history included asthma, heart (disorder) and known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included aciclovir (ACLOVIR), sucralfate (CARAFATE) and asthma medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN6203) on 08Mar2021 at 09:00 in the left arm for COVID-19 immunization at a Doctor's office/urgent care. On 30Mar2021 at 19:30, the patient experienced rapidly spreading rash and hives starting at injection site and spreading to all arms and legs within 20 minutes, hives spread over entire body and began having trouble breathing. Hives were breaking open and leaking pus and blood. The hives were size of a dime rash started approx. 11 hours after injection. The patient was given IV steroids and antihistamines and 2 breathing treatments. The patient has not been tested for COVID-19 since the vaccination. The events resulted in Emergency room/department or urgent care visit and assessed as life threatening illness with immediate risk of death from the events. The outcome of the events was recovering.
Information has been received from a Nurse Practitioner (N.P.) concerning a 60 year old female with antibiotic allergy (specific name unspecified) who in approximately August 2010, was vaccinated with a dose of ZOSTAVAX (Merck). In approximately August 2010 ("approximately 1 month ago"), the patient had an anaphylactic reaction following administration in the office. She was treated for the reaction, however it had occurred again and she was admitted into the hospital for this event. It was unspecified what the length of stay was in the hospital. At the time of the report, the outcome was unknown. Anaphylactic reaction was considered to be immediately life-threatening by the reporter. Additional information has been requested.
Pt recv vax on 4/13/99; 5 min post vax pt exp pale color, shaky, nausea, not feeling well then limp w/ jerking, eyes twitching, feeling "everything going black", possibly passed out, unable to sit/stand
Severe pain in right arm immediately after injection.  Weak, range of motion very limited. Pain is from my shoulder blade down to my bicep. 11 days later still in pain
Vomitting (4x), extreme lethargy (sleeping all night and most of the next day), body aches, headache - occurred 36 hours after the vaccine and lasted for 12 hours.
Itching, swelling, redness in upper arm of injection, spreading above and below injection site, but further than elbow.   Doctor gave her "antibiotic ointment" to put on it.  Swelling resolved in 2 days,  itching and redness continued x5 days
This spontaneous prospective pregnancy case reported by a consumer, describes the occurrence of exposure during pregnancy (pregnant) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unknown dosage form. Last menstrual period and estimated date of delivery not provided. On an unknown date, the patient experienced exposure during pregnancy (pregnant). At the time of the report, exposure during pregnancy (pregnant) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided. Sender's comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
light rash started on 28AUG98 & became worse on 29AUG98 p/cheerleading practice-denies fever today has an earache has hx of earaches-plans to take to MD for tx;
Reddish patch approximately 2 inches in diameter, mid-bicep, outside of arm, approximately 2-3 inches BELOW injection site. Patch was well defined, moderately painful to the touch and warm to the touch. Patch was not raised or itchy.  First noticed approximately 84 hours post vaccination and has faded over the last 24 hours but is still present.  No other significant reactions (cardiac, respiratory or severe pain) at this time. Taking NSAID and monitoring. No clinical visits scheduled at this time but, may be if situation worsens or does not resolve.
Information has been received from a physician concerning a 67 year old female who on 3/25/06 was vaccinated with Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included colesvelam hydrochloride Welchol and ezetimibe Zetia. Later that day on 3/25/06 the pt experienced high fever, nausea, and arm was hot and swollen. The pt was advised to use compresses. The pt was to be seen at the office sometime 3/29/06 or 3/30/2006. There were no relevant laboratory or diagnostic tests. Additional information has been requested.
pt recv vax 5/97 then on 3/98 pt devel earache, fever 100.6, a erythematous papule rash on trunk. was dx w/varicella & right otitis media.
Fever; Fatigue; Undiluted vial that was thawed from frozen under refrigeration on 22Jun21 and stored at 2C to 8C. The by use date was 21Jul21. The vaccine was administered 9 days after the by use date; Undiluted vial that was thawed from frozen under refrigeration on 22Jun21 and stored at 2C to 8C. The by use date was 21Jul21. The vaccine was administered 9 days after the by use date; This is a spontaneous report from a contactable other HCP via Medical information team. A patient of 33 age and unknown gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EW0169) via an Intramuscular route of administration on  Right Deltoid on 30Jul2021 as dose 1, single for COVID-19 immunization. The Relevant medical history and concomitant medications were not reported. It was stated that the dose 1 of Pfizer-BioNTech COVID-19 Vaccine was administered to a patient on 30Jul2021.The dose was pulled from an undiluted vial that was thawed from frozen under refrigeration on 22Jun2021 and stored at 2C to 8C. The by use date was 21Jul2021. The vial was thawed at room temperature and diluted before administration on 30Jul2021.Given that the vaccine was administered 9 days after the by use date. The HCP has a concern should dose 1 be re-administered to the patient. On 30Jul2021 at 16:00 , patient experienced fever and fatigue and the outcome for the same was recovered. Patient had received no treatment for the reported events.After vaccine had been administered it was discovered that it was 9 days past the beyond use date. in addition the vial has been @9c for<12 hrs during storage.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (23Sep2021): This is a Follow-up spontaneous report received from a contactable other HCP. This other HCP reported in response to HCP letter sent which included that: Patient age at time of vaccination, Anatomical site of injection, Route of administration, Batch/lot number, onset time of the event.  Follow-up attempts are completed. No further information is expected.  Follow-Up (27Sep2021): Follow-up attempts are completed. No further information is expected.
Tingling in head, dizziness, SOB, chest pain, palpitations, evaluated by EMS-cleared
Information has been received from a consumer concerning his 4 year old son, with no medical history, who was vaccinated on an unspecified date with a dose of MMR (lot # not reported). There were no concomitant medications. A month later the patient experienced deafness. The patient has been deaf since that time. Unspecified medical attention was sought. It was reported that there were no diagnostic studies performed. Deafness was reported to be disabling. No further information is available.