chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hypertension/Blood pressure high; Really tired; some stuff with her kidneys; This is a spontaneous report a Pfizer Sponsored Program from a contactable consumer (patient).  A 79-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EL8982) on 16Jan2021 14:30 at single dose in right arm for to prevent Covid-19. Medical history included ongoing sjogren's syndrome, hypertension.  Prior vaccinations, the patient maybe tired and unwell from the flu vaccine and shingles vaccine (SHINGRIX) for immunization. There were no concomitant medications.  No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient got her first vaccine on 16Jan2021. About 3 days later, on 19Jan2021, she was really tired but it only lasted for that one day. States that on 19Jan2021, 20Jan2021, and 21Jan2021, her blood pressure shot way up and she went to the ER on 21Jan2021 because it had been so high for a few days. States that at home it was 172/104, 172/107, and 200/103. When she got to the ER it was 200/110. States that her blood pressure has improved on it's own today. While she was in the ER, they checked her Troponin's which were low, her EKG was normal, and the doctor said everything looked okay, except some stuff with her kidneys but that doesn't have anything to do with her blood pressure. Before she got the first dose she had a history of hypertension but it was already managed by medication and her BP was on normal range prior to vaccination. The AEs High blood pressure and Really tired require a visit to Emergency room on 21Jan2021. The patient was on BP medications. The patient was hospitalized for hypertension and Really tired. The outcome of hypertension was recovering, of Really tired was recovered on 19Jan2021, of other events were unknown. Second dose was scheduled on 06Feb2021.
no adverse event; HCP reported patient was given PROQUAD and VARIVAX concomitantly in error to a 40-year-old patient. No additional AE/no PQC.; HCP reported patient was given PROQUAD and VARIVAX concomitantly in error to a 40-year-old patient.; This spontaneous report was received from a medical assistant and refers to a 40-year-old patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 25-OCT-2023, the patient was concomitantly vaccinated with measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, therapy type: rHA, lot #W034213, expiration date: 24-APR-2024, (strength, and route of administration were not provided) and  varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, lot #W022605, expiration date: 17-JUL-2024 (strength, and route of administration were not provided), both administered for prophylaxis (Accidental overdose) (Product administered to patient of inappropriate age). No additional adverse event was reported (No adverse event).
Pt received immunizations on 7/26/01. Parents phoned our on call MD at 20:30 on 7/27/01 with complaint of a 4 X 4 area of redness on right thigh. Declined to go to ER at that time. Went to ER at 23:30. ER wanted to admit him and parents refused. Was admitted later to a hospital with fever. Given IV Unasyn. Discharged home on oral Augmentin. Dx'd with cellulitis.
H1N1 LAIV on 10/29. Developed fever and cough later that day. Febrile sz 10/30 0300 (known hx feb. sz).
NAUSEA, VOMITING, SEVERE HEADACHE GIVING TYLENOL
swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "swollen lymph nodes".  Additional information: Reporter was stated her sister swollen lymph nodes for 3 months after 1st shot. In May2021 I noticed some hair loss but blamed it on getting older until the fall of 2021 when I noticed more than usual was falling out. Since I already had a 6 mo follow-up appointment with my dermatologist on 01Dec2021. I waited to be checked until then. she could see some disease was going on my scalp so did a biopsy of the scalp. Diagnosis was Lichen Planopilaris. In my research I found cases of hair loss in # after vaccination.  Follow-up attempts are completed. No further information is expected.
"More reactions" than usual / reported-diarrhea; This case was reported by a physician via call center representative and described the occurrence of diarrhea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The reporter stated that the patient received the dose of Shingrix and experienced diarrhea.as opposed to the usual muscle pain and fever The reporter asked information about Shingrix recall and mentioned that they had none to return and was not sure if she had any from the lots that were affected, she also asked what was the risk to the patient. The reporter was not certain though if the reaction was from the Shingrix nor if they were of the same batch of recalled Shingrix. The reporter did not consented to follow up. The reporter did not have any additional information regarding the events or the patients (demographics). This case was linked with US2021057184 and US2021AMR057596 reported by the same reporter. Note- Since the reporter was just inquiring about recall of Shingrix and Hub also added comment about the same, no event about product recall has been coded. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021057184:Same reporter. Patient #1. US-GLAXOSMITHKLINE-US2021AMR057596:Same reporter. Master case "several pts".
Heart palpitations; a strange hard beating in his chest; panic attack; This is a spontaneous report from a contactable consumer (Patient's wife). This consumer reported for her husband. A 41-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration, administered in Arm on an unspecified date in 2021 (at the age of 41-year-old ) as single dose for COVID-19 immunisation. The patient medical history was reported as none. About family history she has not heard of anything and is not 100 percent sure. Concomitant medications were not reported. Prior Vaccinations, the patient had not received any other vaccine within 4 weeks. No additional vaccines was administered on same date of the Pfizer suspect. Patient historic vaccine included first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date (at the age of 41-year-old) as single dose for covid-19 immunisation. On 19Aug2021 (guessing in the afternoon), the patient experienced heart palpitations, a strange hard beating in his chest and panic attack. As per the report, caller is a Pfizer employee calling on behalf of her husband. It is only suspected, but the call is regarding the Pfizer Covid-19 vaccine. She is actually reporting it today because he just suspected it today. He did get the vaccine back in Apr2021. He is getting some heart palpitations and does not know if it a true correlation. Today. Today was the day he told her he was feeling this way. He was just informing her today that he felt heart palpitations. It was like a strange hard beating in his chest. It was kind of like a panic attack. That is how he described it. Started today, she is guessing in the afternoon. He didn't give too many details. He has always been fully healthy. States they were vaccinated around the same time and that it was probably May2021 or Apr2021. States that he had both doses. She is unsure if he got the vaccines in the right or left arm. Patient was concerned and was going to probably see a heart doctor which to her, felt very concerning. Patient did not visit to emergency room or physician office due to adverse event. No relevant test was performed. The outcome of events was unknown.  Follow-up attempts are completed. No further information expected.
Mom noticed rash on stomach, back, neck, face, arms 2 days after immunization. Mother called clinic on 11/26/03 to speak to MD who instructed her not to have pt vaccinated with 2nd dose.
Patient received booster dose of Moderna on 10/25/21. We found out that lot 026C21A expired on 10/24/21. No adverse reaction was noted. We have reached out to Modera for guidance and have quarantined vials under that lot.
15 1/2hr post vax pt crying x 2 1/2hr straight, irritable >24hr;OK on exam 48hr later
Information has been received from a nurse concerning a 16 year old female with sulfonamide allergy and no medical history reported who on 20-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 660553/0070X), 0.5 mL, I.M. and on 17-SEP-2008 was vaccinated with the second dose of GARDASIL (Lot # 659184/0843X). Concomitant therapy included (OCELLA). After receiving her second dose, the patient fainted, fell and received a jagged laceration on her head about one inch in length. The patient was treated in an emergency room, where she received "7 sutures" to the laceration site. The patient was recovering from the events. The patient sought medical attention at the office. This is one of two reports received from the same source. Additional information has been requested.
Lumps at injection sites on both thighs. Children Motrin given and warm clothes applied to lumps for 7 days.
Started with choking on saliva that had thickened couldn't cough up was choking. High fevers 103+ that would not break heat rash lethargic diarrhea vomiting. Hospitalized for 7 days because of such high fevers and diarrhea.
Pt reported swelling around the eye around 6 days after the 2nd covid vaccine was given. Pt stated that she called 911 and was instructed by EMT to use cold compress around the area. Per pt EMT staff confirmed that her breathing, heart, and blood pressure were normal. Pt informed the pharmacy about this event 3 days after the adverse reaction event.
S/P TIV c/o tingling in both upper extremities with dizziness 10:45 BP 140/90 P=80 10:55 BP 148/100 P=76 Temp=98.1 F po 11:20 BP 140/90 P=76. Denies pregnancy; no illness prior to shot, denies HTN except when pregnant ambulated back to classroom, c/o since initial onset, not feeling like her usual self. Urged seeking visit with PCP, have someone take her.
tinnitus/Tinnitus Left Ear / ringing in my left ear; smelling something like, I keep smelling something burning, everything smell burnt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 14May2021 (Lot number: EW0176, Expiration Date: Aug2021) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (ongoing); "she had tinnitus off and on before but it was in her right ear", start date: 2009 (unspecified if ongoing), notes: Caller states she had tinnitus off and on before but it was in her right ear from something in 2009. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose: Lot: ER8727 Expiration: Jul2021), administration date: 23Apr2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 16May2021, outcome "recovered" (Aug2021), described as "tinnitus/Tinnitus Left Ear / ringing in my left ear"; PAROSMIA (non-serious) with onset 2021, outcome "unknown", described as "smelling something like, I keep smelling something burning, everything smell burnt". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus. No follow-up attempts are possible. No further information is expected.
sore arm 2 days past injection.  (2/26/2021  onset Extreme fatigue, muscle aches and weakness, left side headache, left side underarm pain and shoulder pain, left side breast and chest pain, papiltations, short breath.  ER visit on 3/1/2021 to Kaiser Permanent Sacramento  due to pain and short breath.  4  days past onset, pain left, 5 days past onset muscle aches left      7 days past onset energy slowly coming back.
A serious report of trauma has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 26-Sep-2008, the subject received FLUMIST. The subject was admitted to the hospital for trauma on 17-Oct-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
Left arm is red and sore near injection site (3 inches round); Left arm is red and sore near injection site (3 inches round); 7 year old being administered PENTACEL; She states that the hib was expired so they decided to give her PENTACEL since it has hib in it; Initial information was received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 7 years old female patient to whom pentacel being administered, she states that the hib was expired so they decided to give her pentacel since it has hib in it and left arm is red and sore near injection site (3 inches round) while receiving vaccines HIB (PRP/T) VACCINE and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past vaccination(s) included pentacel with patient had already received 4 doses of vaccine. The patient's past medical history, medical treatment(s) and family history were not provided.   On 17-Oct-2022, the patient received a dose 5th dose of 0.5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number not reported) (formulation, strength and expiry;unknown) instead of hib was expired so they decided to give her pentacel (wrong product administered) (latency same day) via unknown route in the left arm for immunization.   On 17-OCT-2022 the patient developed a non-serious 7 year old being administered pentacel (product administered to patient of inappropriate age) (latency same day)  On an unknown date the patient developed a non-serious left arm is red and sore near injection site (3 inches round) (injection site erythema and injection site pain) (unknown latency)   Action taken:not applicable.  Corrective: unknown for (injection site erythema and injection site pain)   Outcome- unknown for all events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
7 days had arm very sore; pain in shoulder & arm; not able to raise arm/shift; no fever sl swelling;
Progressive (stabbing) joint pain in left side:  shoulder, groin, thigh, chest, back; followed by extreme fatigue for over 24 hours
I awoke at 3:00 a.m. with a fever and significant muscle aches, primarily in my legs and back.  I had a strong headache that felt like I had a band around my head.  I also felt delirious, i.e. that I could connect my thoughts.  The next morning I felt awful, with lots of body ache, as though I had a bad case of influenza.  I went to work and actually felt as though I probably shouldn't have been driving.  I was unable to stay and returned home at noon.  I went to bed and felt chills.  I took Nyquil and was able to sleep.  I took another dose at @ 8:00 at night and slept until @ 2:30 a.m.   I took another dose of Nyquil and slept thru the night.  By the next morning, most of the symptoms had dissipated (other than feeling tired).
1/8/21- within a few minutes of vaccine administration:  Dizziness, lightheaded, confusion/disoriented, tingling in hands and feet, blood pressure issues, pale, cold limbs, warm trunk/head.   1/2/21- approximately 1:00pm- developed headache.   1/9-1/10/21- joint pain/muscle pain/headache.
Individual was vaccinated and syringe malfunctioned causing less then the required dose to be administered. Administred another dose of half to complete the vaccination.
lethargy 6 days later; she started with swelling in the clavicular lymph nodes then it progressed under her arm and to the clavicular area; swollen lymph nodes/swelling in clavicular lymph node; received the pfizer covid vaccine booster; really bad headache which is worsening; pressure in both eyes; her lips feel numb; scalp sensitivity; Mild fever 100 F; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 27Nov2021 (Batch/Lot number: unknown) at the age of 54 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown Manufacture), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "received the pfizer covid vaccine booster"; LYMPHADENOPATHY (non-serious) with onset 28Nov2021, outcome "unknown", described as "swollen lymph nodes/swelling in clavicular lymph node"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "really bad headache which is worsening"; OCULAR DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "pressure in both eyes"; HYPOAESTHESIA ORAL (non-serious) with onset 2021, outcome "unknown", described as "her lips feel numb"; PAIN OF SKIN (non-serious) with onset 2021, outcome "unknown", described as "scalp sensitivity"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Mild fever 100 F"; PERIPHERAL SWELLING (non-serious) with onset 28Nov2021, outcome "unknown", described as "she started with swelling in the clavicular lymph nodes then it progressed under her arm and to the clavicular area"; LETHARGY (non-serious) with onset 03Dec2021, outcome "unknown", described as "lethargy 6 days later". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter states her daughter feels like she has puffy lips but her lips don't look puffy. she started with swelling in the clavicular lymph nodes then it progressed under her arm and to the clavicular area; it is very sensitive. She understands that this side effect can happen and is par the course but what she is concerned about is the headache. She has had the headache since getting the vaccine and it is getting worse. This she does not think is normal; she would think that her daughter would get a side effects and then it would get better, not worse  The lot number for bnt162b2 was not provided and will be requested during follow up.
Vaccines done Thurs PM - welt up around (R) arm - 5" diameter, redness and warm to touch - no discomfort. Is improved since Thursday - assessment localized reaction - monitor for increased sx.
Started with itching at injection site in the evening one week post injection. Today with erythemic, slightly raised area approximately 2 cm, circular. Extreme itching. Until this, no issues beyond a sore arm the first two days.
Left arm: severe nerve pain, numbness of all fingertips, constant buzzing sensation up and down entire arm and left hand. Nerve pain stopped after 8 weeks, still experiencing all other symptoms.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided  The vaccine was stored in the freezer and one to two vials were taken out and placed in the fridge each day as needed.
Rpt LOC in chair - LOC post injection. Pale, diaphoretic, warm, vagal reaction and mild dehydration.
Gave Tylenol about 1 hour after the shots because he seemed a little uncomfortable. However, these reactions came about 3 hours after the shots. 1) ear piercing screams and crying, 2) whimpering, and 3) pale, clammy and limp. They lastest about 4 hours until he fell asleep. We continued giving Tylenol.
Became acutely ill early morning of 12-30. I was then seen in ER by DNP with diagnosis of covid pneumonia, UTI, high CRP and shortness of breath.
This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient was vaccinated with lot # (672612/1653AA) ZOSTAVAX on 06-JUL-2012 and experienced chicken pox like rash at the injection site and localized bruising. The outcome of the events is unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Confirmed no symptomatic adverse events were reported; Inbound call from medical assistant calling to report administration of expired PEDVAXHIB.; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On 18-AUG-2023, the patient was vaccinated with an expired dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, at a dose of 0.5 milliliters once as prophylaxis (lot number: T037651, which was determined to be valid, with an expiration date on 20-JUL-2023) (strength, route and anatomical location of administration were not reported) (Expired product administered).  The reporter confirmed there were no symptomatic adverse events, and confirmed that product did not have any temperature excursions in the past.
High fever and rash 5 days after vaccine. Body aches and pain. Fevers lasted 3 days
Severe fever chills shakes numbness of face headache weakness left arm heaviness unable to get up for 2 hours. Took acetaminophen shaking improved, fever/chills persisted through the night with nausea, stomach cramps.