chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient the liquid portion only of PENTACEL and did not give the lyophilized portion containing the Acthib with no reported adverse event; patient the liquid portion only of PENTACEL and did not give the lyophilized portion containing the Acthib with no reported adverse event; Initial information received on 14-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient to whom the liquid portion only of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and did not give the lyophilized portion containing the acthib with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 29-Aug-2022, the patient received 0.5ml (Dose 3) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (strength, formulation was unknown, lot UU668AAA and expiry date: 13-May-2023) via intramuscular route in vastus lateralis for Immunization. Patient was not using it for the first time.  On 29-AUG-2022 the patient developed a non-serious event of patient the liquid portion only of pentacel and did not give the lyophilized portion containing the acthib with no reported adverse event (single component of a two-component product administered and product preparation error) (unknown latency). The reporter was inquiring how to proceed with this patient. This situation was reported as a medication error due to incorrectly not mixing both of the portions with this vaccine as directed.   Action taken: not applicable.  Outcome: Unknown  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 guidelines. 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.
several days after covid vaccine, was seen in ED with c/o chills, nausea/vomiting, and congestion. Diagnosed with viral syndrome and discharged same day from ED.
I had a low-grade fever, achy, and sore arm at first. The next day I had a 103 fever. About 7 days later, I was still having an itchy arm. I had a softball size lump on my arm, and I had to take BENADRYL. Then, I started having a fever again. I went to the closest hospital to my house, and they tested me for COVID-19, and I tested positive. I was prescribed 5 days PAXLOVID. Not long after taking PAXLOVID I felt much better. One day after the final dose of PAXLOVID, I had a rebound case of COVID-19, but it was very mild this time.
Fever; chills; swollen lymph nodes; pain and swelling at injection site; pain and swelling at injection site; tiredness; muscle and joint pain; muscle and joint pain; feeling unwell; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 12:00 (Lot number: FH8027) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing), notes: Other medical history: IBS, asthma, allergies; "asthma" (unspecified if ongoing), notes: Other medical history: IBS, asthma, allergies; "allergies" (unspecified if ongoing), notes: Other medical history: IBS, asthma, allergies. Concomitant medication(s) included: SPIRONOLACTON; BUPROPION; SINGULAIR. Past drug history included: Ammoxicillin, reaction(s): "Known allergies: Ammoxicillin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left), administration date: 10Aug2021, when the patient was 25 years old, for COVID-19 immunization, reaction(s): "Dose 1: 01May2021, Dose 2: 10Aug2021"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left), administration date: 01May2021, when the patient was 25 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset 22Nov2021 20:00, outcome "recovered" (2021), described as "Fever"; CHILLS (non-serious) with onset 22Nov2021 20:00, outcome "recovered" (2021), described as "chills"; LYMPHADENOPATHY (non-serious) with onset 22Nov2021 20:00, outcome "recovered" (2021), described as "swollen lymph nodes"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 22Nov2021 20:00, outcome "recovered" (2021) and all described as "pain and swelling at injection site"; FATIGUE (non-serious) with onset 22Nov2021 20:00, outcome "recovered" (2021), described as "tiredness"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 22Nov2021 20:00, outcome "recovered" (2021) and all described as "muscle and joint pain"; MALAISE (non-serious) with onset 22Nov2021 20:00, outcome "recovered" (2021), described as "feeling unwell". Therapeutic measures were not taken as a result of pyrexia, chills, lymphadenopathy, vaccination site pain, vaccination site swelling, fatigue, myalgia, arthralgia, malaise.  Additional information: The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. Hospitalization prolonged was reported as no. The device date was on 24Nov2021.  Follow-up attempts are completed. No further information is expected.
she usually have 85-87 BPM heartrate it went up to over 100 that day; shortness of breath; injection site was terribly itchy; Injection site was hard; injection site was red; rash under the injection site; Chills; muscle ache; severe nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (she usually have 85-87 BPM heartrate it went up to over 100 that day), DYSPNOEA (shortness of breath), VACCINATION SITE PRURITUS (injection site was terribly itchy), VACCINATION SITE INDURATION (Injection site was hard) and VACCINATION SITE ERYTHEMA (injection site was red) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CHONDROITIN SULFATE SODIUM, GLUCOSAMINE (GLUCOSAMINE AND CHONDROITIN), MAGNESIUM, ESTRADIOL, CLONAZEPAM, BUPROPION HYDROCHLORIDE (WELLBUTRIN), ALENDRONATE SODIUM (ALENDRONATE) and VILAZODONE HYDROCHLORIDE (VIIBRYD) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced HEART RATE INCREASED (she usually have 85-87 BPM heartrate it went up to over 100 that day), DYSPNOEA (shortness of breath), VACCINATION SITE PRURITUS (injection site was terribly itchy), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE ERYTHEMA (injection site was red), VACCINATION SITE RASH (rash under the injection site), CHILLS (Chills), MYALGIA (muscle ache), NAUSEA (severe nausea) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 29-Jan-2021, HEART RATE INCREASED (she usually have 85-87 BPM heartrate it went up to over 100 that day), DYSPNOEA (shortness of breath), CHILLS (Chills), MYALGIA (muscle ache), NAUSEA (severe nausea) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE PRURITUS (injection site was terribly itchy), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE ERYTHEMA (injection site was red) and VACCINATION SITE RASH (rash under the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non-significant TCR FU -  Adress provided; Reporter's Comments: .
18 years old with complaints of fever 102. Headache nausea, back pain, muscle pain, started at 12 midnight. 12 hours after imm. pt went to ER for treatment. Received a spinal tap
Within 24 hours developed localized hot/swollen injection site to full fever nearly 101 for two days, alternating sweat and chills, severe headache, body aches, mental fogginess, severe fatigue, and rash with raised fluid filled vesicles on her abdomen.  Continues to have fever.
This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (I am having cold symptoms), CHEST DISCOMFORT (Chest tightness), COUGH (Non-productive cough), RHINORRHOEA (Runny nose) and DYSPHONIA (someshoarseness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.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 NASOPHARYNGITIS (I am having cold symptoms), CHEST DISCOMFORT (Chest tightness), COUGH (Non-productive cough), RHINORRHOEA (Runny nose), DYSPHONIA (someshoarseness), HEADACHE (I also have a headache) and FATIGUE (and fatigue). At the time of the report, NASOPHARYNGITIS (I am having cold symptoms), CHEST DISCOMFORT (Chest tightness), COUGH (Non-productive cough), RHINORRHOEA (Runny nose), DYSPHONIA (someshoarseness), HEADACHE (I also have a headache) and FATIGUE (and fatigue) outcome was unknown.    No  Concomitant medications were provided. No Treatment medications were provided. This case was linked to MOD-2021-310884 (Patient Link). Reporter did not allow further contact
Day of shot took prophylactic ibu and took as well Tuesday am. By Tuesday at 2-3 pm 1 day post shot-  felt poor (similar to first shot- headache, tired). By 4 pm felt like getting fever. Finished shift got home by 5 o'clock fever 101.  Restarted ibu laid down. By 12 pm terrible chills sweats fever now up to 102.8.  By Wednesday morning at 101. Went back down to normal by afternoon but still felt very tired with splitting headache. By 4 fever returned almost at 101. Thursday fever free without meds. Today (Friday) fever free without meds- just tired.
severe neurological complications; pain; inability to walk; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 30 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 30 years 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: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "severe neurological complications"; PAIN (non-serious), outcome "unknown", described as "pain"; WALKING DISABILITY (non-serious), outcome "unknown", described as "inability to walk".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a literature case, initially received on 19-Feb-2019, concerning a 70-year-old, elderly male patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient's medical history included chronic obstructive pulmonary disease and coronary artery disease. The patient had no hypersensitivities. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, 258 minutes after the vaccination, the patient experienced anaphylactic reaction, difficulty in breathing and cardiopulmonary arrest. The documented cause of death was anaphylactic reaction (causality: related). It was unknown whether autopsy was performed or not. The author considered this case as serious (death). This case is cross-linked to the original case: 201902085 due to the same reporter.; Reporter's Comments: A 70-year-old, male patient with medical history (chronic obstructive pulmonary disease and coronary artery disease) developed difficulty in breathing and cardiopulmonary arrest, 258 minutes after administration of INN Flu Vaccine. The reported cause of death was anaphylactic reaction. The case meets level 2 of Brighton Collaboration criteria of diagnostic certainty for anaphylactic reaction. Considering the plausible temporal relationship between vaccination and reported fatal events and lack of any alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event anaphylactic reaction as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic reaction.
A few hours after receiving the vaccine I became nauseous and began vomiting. The next day I developed a large, red and tender bump at the injection site.
Rec'd vaccine on 5/11/07. 5/12/07 - call to clinic as pt had rash on bilateral feet/ankles (2:11 PM), 5/12/07 - call to clinic, c/o lg rd bump at injection site, swelling (4:52PM), 5/13/07 - call to clinic c/o larger lump at injection site, worsened rash, feet/ankles swollen.
20MAR92 pt recvd 1 dose of Engerix-B & 10 mins post inject c/o pruritus, local swelling, heat @ inject site, mild redness & swelling; transient swelling, erythema & pain around inject site, shoulder mildly tender, swollen dx allergic rxn;
Child developed hives approx. 1 3/4 hrs. after receiving TDAP. Hives located on (R) shoulder (1/2 dollar size) (L) base of neck (small), and 4 tiny hives on back. Shot given at approx 2pm, TYLENOL given at 3:10 pm. Hives and itching started at 3:45 p. Mom gave him a 25 mg tablet of BENADRYL. Seems OK. 8-2-10 Spoke with Pt's mom and she said pt woke up at 4am Saturday morning (7-31-10) and complained of being itchy. He was covered pretty much head to toe in hives. She took him to hospital where he was treated with DECADRON and sent home on a MEDROL Pack. Mom states that pt is fine and the hives and itching have resolved.
Acute appendicitis diagnosed 11/26/21, appendectomy 11/27/21
Shot given in rt arm-within 12 hrs inj site started to itch and a little redness. Then swelling started in upper arm (abt 1 1/2 size of norm) kept swelling lower clear to hand-abt 3 wks swelling and itching gone and arm fine.
negative for both in spite of two doses of vaccine; This is a spontaneous report from a contactable Physician (patient). A 70-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration, the second dose on 11Jan2021 (lot number: EL1284) in right arm and the first dose on 21Dec2020 (lot number: EK5730) in left arm, both at single dose for covid-19 immunisation. Medical history included osteoarthritis, diagnosed 10 years prior to the report. Concomitant medications included metformin at 500mg tablet by mouth once daily for longevity (off label); paracetamol (TYLENOL) at two one time and on occasional acetylsalicylic acid (ASPIRIN) at one 325mg tablet on as needed basis. Patient was calling about the COVID vaccine, and he received two doses, and the problem was, he had an IgM and IgG test on 25Jan2021 and he was negative for both in spite of two doses of the vaccine. The outcome of the event was not recovered. Serious criteria for the event was reported as medical significant. The reporter considered the event was unrelated to COVID vaccine, stated it was the exact opposite, it didn't cause anything, which was unfortunate.; Sender's Comments: Event represents an intercurrent medical condition and unrelated to bnt162b2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Immediately after vaccine, the arm was sore, which was consistent with the shot.  The following day the soreness spread through the arm and shoulder and kept progressing with each day throughout the body.  Friday morning (11/10/23), the headache and photosensitivity were added to the list of symptoms and by Monday 11/13/23, I was unable to get out of bed unassisted.  The symptoms were very consistent with a very bad case of flu, such as body aches, dizziness, photosensitivity, headache, weakness, dry hacking cough,  dizziness.  Unable to get out of bed unassisted.    Negative fever. Negative for influenza A/B and COVID (rapid and PCR). Oral hydration and symptom management with: Ibuprofen, acetaminophen, fluticasone nasal, fexofenadine.    On 11/17/23 symptoms began to subside, but not enough to regain full function.  Lost 5 days of work,
runny nose; Chills; fatigue; weakness; sore arm; slept for 14 hrs/slept a lot; Headache; Body ache; Injection site pain; This is a spontaneous report from a contactable nurse (patient). This 77-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) intramuscularly on 24Feb2021 at 13:00 (at the age of 77-years-old) as a single dose in the left deltoid for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM II), hypothyroid for over 20 years, glaucoma in right (R) eye, and hypertension (HTN), all ongoing. The patient was not pregnant at the time of vaccination. Concomitant medications included metformin; levothyroxine sodium (SYNTHROID); lisinopril; atorvastatin; amlodipine; "HOPZ 25 mg;" multiminerals, multivitamins (CENTRUM SILVER); brimonidine tartrate (BRIMOT); and dorzolamide, timolol (COSOPT) from unspecified dates for unspecified indications. The patient previously received acetaminophen (TYLENOL EXTRA STRENGTH) from 04Feb2021 to 09Feb2021 for pain (severe headache). The patient previously received dose 1 of BNT162B2 (lot number EL9261) intramuscularly on 03Feb2021 as a single dose in the left deltoid for COVID-19 immunization and experienced pain, unable to think clearly, headache, aching body, and feeling out of sorts. On 25Feb2021 after dose 2 of BNT162B2, the patient experienced chills, fatigue, weakness, sore arm, slept for 14 hours, headache, injection site pain, body ache. On an unspecified date the patient experienced runny nose. The patient was treated with acetaminophen (TYLENOL) at "3 per day" from 24Feb2021 to 27Feb2021. The outcomes of chills, fatigue, weakness, sore arm, slept for 14 hours, headache, injection site pain, and body ache were recovered on 27Feb2021. The outcome of runny nose was unknown.  No follow-up attempts are needed. No further information is expected.
Hives on trunk, extremities, and face. Fever up to 103. Abdominal muscle spasms.
05/13/2022 I had nausea, diarrhea, headache and congestion that evening. The next morning, I had a terrible sore throat, coughing like crazy and general fatigue. I could not do much of anything. The nurse practitioner referred me to the state. I received the monoclonal antibody infusion. Since then, I am still lying around feeling bad.
Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 26-SEP-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a blistering vesicular rash outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 71 year old female patient with none drug reactions/allergies. On 02-OCT-2013 (also reported as 02-OCT-2014) the patient was vaccinated with 0.5 ml PNEUMOVAX 23 (lot # H014653, exp. 19-APR-2014) intramuscularly in the right arm and influenza virus vaccine (manufacturer unknown) (strength, dose, frequency and lot # were not provided) in the left arm in the same vaccination session. Concomitant therapies included ranitidine, TOPROL XL Tablets, atorvastatin and LIALDA. On 02-OCT-2013, the patient experienced swelling, redness and pain at injection site. The patient had call to pharmacy for seeking medical attention. None treatment was given for AE. None lab diagnostics studies performed. The patient had been putting ice packs on the site, and was planning on taking BENADRYL at the time of the conversation with the pharmacist. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Patient presented to clinic on 12/28/10 with a 10-day history of left ear pain and left-side facial droop. Stated that it was sometimes difficult to talk. Patient had no other illnesses at this time.
1:55 p.m. - patient waiting in lobby after shot as instructed: clerk observed start of reaction with gurgling breath sounds, head dropped to right, patient became limp in chair.  I responded to patient who demonstrated "seizure-like" activity: mild shaking, stiffness, eyes and mouth closed but could not tell if teeth clenched.  Within a minute, activity stopped, skin and lips pallid, patient opened eyes, appeared dazed but was responsive.  Parent denied history of seizures.  Patient was kept in clinic til 2:40 p.m. when I walked her to vehicle with parent.  Treatment: cold packs to head/neck area, caffeinated cola drink given, later placed in supine position with legs elevated.  3:40 p.m. - called father who said patient was sleeping.  2/14/08, 8:50 a.m. - called father who stated patient was feeling fine.