chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle pain; This is a spontaneous report received from a non-contactable consumer (patient). This is the first of two reports regarding first dose. A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), at the age of 42 years,  as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced muscle pain after 1st vaccination (non-serious) on an unspecified date with outcome of unknown. No follow attempts are possible. Information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021565062 same reporter/patient different vaccine dose/AE
Vaccine vial was punctured on Friday 11/18/22 at approximately 10am and 6 doses drawn up into syringes. These syringes were stored at room temperature. Dose administered to the patient on 11/21/22 was from a syringe that had been drawn up on Friday 11/18 and stored at room temp.  Pfizer contacted for stability information, which they did not have for these storage conditions. Patient is being contacted for re-vaccination.
One day, post vax, pt noted to have swelling of 3" with warmth, redness and soreness around the right posterior upper arm, in the triceps region. Later on Thursday or Friday, the area began to itch and on Saturday, the area broke into a rash. Pt was treated with Benadryl. It required 3 to 4 days of treatment and it helped to subside the symptoms. Rash is now gone but still has a small hard nodule-like dot remaining. No shortness of breath or tightness in chest noted.
Client developed paresthesia hands, feet 2 days after immunizations, intermittent stiffness in hands, paresthesia spread to extremities as of 8-22-05, no change, has seen MD neuro exam normal.
After 1st dose of Moderna had very severe ringing in both ears (Tinnitus)
Subject felt immediate pain down arm that received vaccine.  Did not lose feeling or range of motion with arm but continued to hurt for at least an hour afterwards when he contacted our clinic.   Subject stated that he took ibuprofen with relief that day The next morning the subject stated that pain has gone away  Self sealing band aid on arm was over center of left deltoid muscle.
Two hours after injection my pinky toe and digit next to it on right foot went numb for two hours total. Felt slight tingle in both feet that night. Had a fever that night and have been congested since getting the vaccine. Had a covid swab test on 1/7 and was negative.
Redness, swelling, throbbing pain, warmth to touch, inability to bend.
PT CAME TO THE PHARMACY ON 08/03/15 AND SAID THAT SHE HAS PAIN AND TENDERNESS IN THE ARM SHE RECEIVED THE VACCINE AND ALSO A RASH ON BOTH ARMS AND LEGS.
Low Titers; This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a male patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B.  Additional information received were as follows: The lot number of Engerix B was not provided. The caller did not thought it was related to lot numbers but that the product has too many variations. The patient received 3 series of Engerix B and did not developed Hepattis B antibody, which led the patient to be therapy non responder. The physician reported that there was one patient got one dose and had more than a million antibodies and another that only had 45-100 antibodies. The caller stated with follow up he could provide more data. No further information provided. This case has been linked with US2019AMR117506, reported by the same reporter.      Lab Comments: On an unknown date, the patient's had test for Hepatitis B antibody which was found to be low titer
pt recv vax & devel autism;It was reported that the pt apparently recv vaccine years prev;
Four hours after receiving I.M. - SOB/increased HR 120 sensation of throat "tightening" - hoarse - very tender throat next day - no other S/S.  O2 sat 100% (chills-aches)
One week after receiving the first shot I began experiencing dizziness and headaches and later weakness in legs that are not resolved with Ibuprofen and Tylenol or any other meds (Meclizine, Sudafed, Ipratromium Bromide nasal spray). The symptoms still persist and I am having more testing done to try to determine the cause.  I have never experienced these symptoms persistently before.
diarrhea; This is a spontaneous report from a Pfizer sponsored program, received from a contactable female consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 05Feb2021 at 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  On 10Feb2021, the patient experienced diarrhea. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2 lumps in rt thigh about 1/2" below vax site noticed 2 days later appears a little bruised 7 red;
The main symptom is a Migraine unlike anything I?ve had before.  I get migraines a lot.  It has now lasted 18.5 hours and is still going.  I?ve been using heat, ice, sleep, and my migraine medication to try to get rid of it.  My body has been achy all over today for the last 9 hours.  My neck and arm have ached since I got the injection at 6:00 PM last night, so for 21.5 hours.  I was nauseous when I woke up this morning, but that went away after 4 hours.
Raised, red, painful area at Sq injection site (ZOSTAVAX). Hot to touch, about 2 square inches in area.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 9th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th February 2019, several hours after receiving SHINGRIX, the patient experienced feeling unwell. On 12th February 2019, the patient experienced shingles, pain and painful rash. The patient was treated with gabapentin. On an unknown date, the outcome of the shingles was unknown and the outcome of the feeling unwell and pain were not recovered/not resolved and the outcome of the painful rash was recovering/resolving. The reporter considered the shingles, feeling unwell, pain and painful rash to be related to SHINGRIX. Additional details were provided as follows: On Saturday morning, the patient received 1st dose of SHINGRIX at her local pharmacy, in her left upper arm. By Saturday evening, the patient began to not feel well and by Sunday she felt very ill. On Monday the patient began to feel even worse and by Tuesday she had a painful, unilateral rash. The patient was in severe pain and saw her physician on Wednesday 13th February 2019 and was diagnosed with shingles. The patient received several medications including Gabapentin for the pain. The pain continued to be so extreme, she went to the emergency room on 17th February 2019 and was placed on several more medications. The patient had just started to feel like she was turning the corner and was able to get up and walk around. The reporter requested for reimbursement and was provided with the information from content that there was no reimbursement provided for vaccines. The reporter consented to follow up. The reporter provide permission to contact her physician for follow-up.
back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back pain). The patient was treated with IBUPROFEN for Back pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (back pain) had not resolved.            No concomitant medications were reported.
Patient received 4 month vaccines on 7/27/20. Was fussy throughout that night and woke up at 5am with a fever of 100.4, which improved with acetaminophen. On the evening of 7/28/20 patient was sleeping deeply in her grandfathers arms when her grandmother thought she was not breathing. Grandmother took the baby and blew on her face causing the baby to startle awake. The total episode lasted approximately 30 seconds. There was no significant color change or change in tone and the baby returned to baseline immediately after waking up. Was brought to the Emergency Room for evaluation. No further episodes.
Patient presented to the ED with gallstone pancreatitis and was subsequently admitted within 6 weeks of receiving COVID vaccination.
Fatigue, headache, chills and fever. Started 8 hours after vaccine was administered and lasted for 24 hours. Mild headache persisted for another 24 hours.
still red; hard; painful; This non-serious case was reported by a consumer and described the occurrence of erythema in a 53-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-SEP-2023, the patient received Shingles vaccine. On 14-SEP-2023, less than a day after receiving Shingles vaccine, the patient experienced erythema (Verbatim: still red), induration (Verbatim: hard) and pain (Verbatim: painful).  The outcome of the erythema, induration and pain were not resolved.   It was unknown if the reporter considered the erythema, induration and pain to be related to Shingles vaccine.     It was unknown if the company considered the erythema, induration and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-Sept-2023 The patient received a dose of Shingles vaccine and still had red, hard painful. The symptoms were not treated. The reporter consented to follow-up.
child received an extra dose of Acthib, received a 5th dose, no advesre event; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 months old male patient who was vaccinated with a fifth dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot LUJ or UJ75AAA) via unknown route in unknown administration site on 25-Oct-2019, who had already received this.  The patients medical history and concomitant medications were not reported.  It was an actual medication error case due to extra dose administered.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
flushed face, hot, excessive full chest feeling, diff breathing, bad h/a, muscle/joint pain;fast heart beat;runny nose;chills, pain,pressure in head/behind eyes;tiredness, exhaustion;weakness;
Information has been received from a physician concerning a 20 year old female with a possible allergy to penicillin and environmental allergies who on 08-JUN-2007 was vaccinated with GARDASIL (Lot #0623U).  Concomitant therapy included ALLEGRA.  On approximately 15-JUN-2007, the patient experienced a red, hard lump at the injection site.  After two days, the patient recovered from the red, hard lump at the injection site.  The patient sought unspecified medical attention.  Additional information has been requested.
Severe stomach cramps, vomiting, diarrhea, 6th nerve Palsy - Rt eye, hand tremors-bilateral; She was taken to Eye doctor, specialist; Severe fatigue-symptoms began on or about 8/20/2016.
joint aches; muscles aches; headache; a low grade fever; body aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VAC-CINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 26Mar2021 at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 on 05Mar2021 at dose 1, single for covid-19 immunisation. On 27Mar2021 the patient experienced joint aches, body aches, muscles aches, headache and a low grade fever. Reporter asked if taking Tylenol for side effects would have an interaction with the vaccine. Reporter is a consumer, 50-year-old female patient, and she stated first dose was received on 05Mar2021. After receiving her second dose of Pfizer-BioNTech COVID-19 Vaccine on Friday (26Mar2021) she experienced: joint aches, muscles aches, headache and a low grade fever. Additional Context: Reporter stated that, I had my second dose of the Pfizer vaccine (Unspecified Vaccine) on Friday and yesterday I started experiencing the symptoms which, that did not concern me or anything, it is just that the body aches and the joint aches and a low grade fever and all. My question is I heard for the longest time they were telling folks that not to take any type of Tylenol or Motrin. But can you now take the Tylenol or will that affect the efficacy of the vaccine. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician assistant concerning her approximately 24 month old son with no pertinent medical history nor drug allergies who in approximately 2007 "at 12 months of age" was vaccinated with VARIVAX (Merck) (lot number, dose and therapy route not reported).  There was no concomitant medication.  The reporter mentioned to a representative that the patient developed shingles after receiving VARIVAX (Merck).  On approximately 23-JUL-2008 "two days ago" the patient woke up with 8-10 clusters of lesions on the inside of his thigh.  He had been crying from the pain.  The patient was seen by two physicians, both of whom diagnosed him with shingles.  The patient was prescribed ACYCLOVIR.  As of 25-JUL-2008, the patient was recovering.  Additional information has been requested.
Nausea and vomiting, diarrhea, migraine,body aches, tiredness, fever and chills. Began around 1pm 8/31/2021 and has progressed to present. Symptoms current.
Varicella vaccine administered on 7/23/2009.  First chicken-pox noticed on 8/07/2009.  Subsequent chicken-pox developed over the next 4 days on trunk and face.
"Severe arm pain" same arm as injection was given. Required two follow up office visits as well as Physical Therapy.
Developed rash, hives, pruritis approx. 1 hour after received influenza vaccine. Treated self with BENADRYL for 3 days & situation resolved itself. Did not seek medical care.
Pt had red, hot, itching rxn at site of injection. Pt also complained of sore mouth and throat as well as a sore tongue. She took Benadryl and used Benadryl Cream at injection site. Redness is dissipating. No complaint of fever.
The pt developed headache, diarrhea, abdominal cramps, night sweats and then it cleared. He had a reoccurrence of diarrhea and was treated with Flagyl at a clinic. Complains of hearing sensation, headache intense, incapacitating and fatigue. He has missed school since August, 2001. An annual report received 7/2/2003 adds: headaches, malaise, juvenile spondyloarthropathy. We do not know if the vaccine caused this.
Subjective data: joint pain, flushed skin, oral temp 102 degree F, local reaction, headache, chills, ringing in her ears.
Patient developed sxs of vasculitis after taking Pneumovax 23 2 days ago. He developed a painful, non-blanching, erythematous, maculopapular rash with fever and joint pain. Treated with IM dexamethasone and a prednisone taper.
Patient woke up the next morning to have her assisted living staff take her blood pressure and noticed her arm was extremely red. Eventually moved all the way down her arm to almost her elbow. Area was very hot and itchy. After a day or so, area turned a pale yellow.
1st dose Janssen, 2nd dose pfizer; 1st dose Janssen, 2nd dose pfizer; rapid heartbeat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20211238479(0) (Janssen).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN) (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Headache" (not ongoing); "Rapid heart beat" (not ongoing); "Heart palpitation" (not ongoing); "Coffee drinker" (ongoing); "Stress" (ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "1st dose Janssen, 2nd dose pfizer"; HEART RATE INCREASED (non-serious), outcome "recovered", described as "rapid heartbeat". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for covid-19 vaccine janssen was unknown.  Additional information: The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unknown date heart rate was high.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for DMT2, toxic multinodular goiter, hypertensive disorder, ckd stage 3. Pt received both doses of covid moderna vaccine at a outside entity, 2nd dose received 2/11/2021. Was admitted to outside entity hospital on 5/4/2021 with a CC of "weakness" . No notation regarding illness or cause of death available.
Patient presented with weakness and worsening shortness of breath. Patient required oxygen supplementation upon admission.
blood issue; neurological issues; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 26Jul2021, this case now contains all required information to be considered valid.  This is spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced blood issue and neurological issues on an unspecified date. The patient stated that because of the reaction she had to talk with those 3 medical professionals they were requesting blood work and tests to confirm the blood issue she is having. She also had neurological issues and the neurologist suggested in addition more blood tests. The clinical outcome of blood issue and neurological issues was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.  Follow-up (26Jul2021): The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 26Jul2021, this case now contains all required information to be considered valid.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unspecified dates in 2016 (reported as starting on or after 28-MAR-2016), unspecified patients were vaccinated with a dose of improperly stored ROTATEQ (which had a lot # of L035510 and an expiration date of 13-MAY-2017. However, dosage number and route of administration were not reported). Although, no adverse effects were reported. The vaccine experienced the following temperature excursions: 27.7 F for 42 hours and 45 minutes on an unspecified date. Reportedly, there had been no previous temperature excursions and the aforementioned ones were no identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Participant was 5 weeks pregnant when she got  the shot due date would have been December 9, 2021. April 17th around five o clock started to experience strange feeling so she just continued to rest, said she was spotting heavy and participant got an ultrasound 2 days later and later on during the day said she heavy bleeding still. On April the 22nd the doctor told her she had a miscarriage.
Patient experienced tingling in arms and legs the day after vaccination.  She also states that she periodically experiences flushing/redness in her forearms that comes and goes, with tingling happening before the flushing occurs.  She visited the ER on 6/24/19 to check into the tingling sensation.  The ER physician referred her to her primary care physician.  The primary care physician referred her to a dermatologist.  The dermatologist that she saw on 7/8/19 stated that they thought she was experiencing an adverse reaction from her vaccination.