chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started crying at 4:45 pm same day as immunization. Inconsolable almost 3 hours. Now somewhat difficult to console but possible and had prolonged calm period with holding and bouncing. Cannot be certain which vaccine but most consistent with pertussis.
Undiluted dose of Pfizer Vaccination given no adverse reactions noted , no additional treatment needed.
Redness, swelling, large knot along arm where vaccine was injected. Lasted for approx. 3 weeks. Was given BENADRYL and cream recommended by RPh at different location. Condition has improved.
Pain at the injection site, pain is on and off, and notice more when weather get colder.
Had small spot on tongue and went to the dentist to have the spot looked at. The dentist referred her to an ENT. ENT looked at the spot and took a punch biopsy and it came back as Squamous Cell Carcinoma. A PET scan was performed and it was found in her lymph node. The spot in my tongue was removed but the lymph node couldn't be removed. She is currently receiving radiation and chemotherapy to address the Lymph Node and any remaining cancer in tongue.
Had vaccine in am - that evening started with hives (no new foods, products) also with fever 101 - mom gave BENADRYL and resolved - but in office 5/31/12 - again with hives and febrile 101.5 BENADRYL given RTCX 48 hours and then ZYRTEC; Today 6/4/12 - all has resolved.
Patient has hx amaphylaxis had own epipen that was used -light headed, Rapid pulse 140-150 had lay down feet up until EMT  arrived checked out by EMT  in store felt didnt need to go to ER
light-headed; This case was reported by a physician via call center representative and described the occurrence of light headedness in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX751AA, expiry date 29th February 2020) for prophylaxis.   On 6th June 2019, the patient received Bexsero. On 6th June 2019, less than a day after receiving Bexsero, the patient experienced light headedness. On an unknown date, the outcome of the light headedness was unknown.   It was unknown if the reporter considered the light headedness to be related to Bexsero.  Additional details were provided as follows: The doctor reported that the patient felt light-headed. This was 4 of 4 cases, reported by same reporter.
The evening after vaccine she had trouble speaking and fatigue 3/2020.  She went to lay down and outx 24 hours, on 3/21 friends were not able to wake her and went to the hospital where she was admitted.  Had BP at the time of 220/100s.  She was treated for PRES with seizure  started on Keppra.  She was discharged from the hospital 3/27
Pt discovered to be pregnant.  Urine pregnancy test obtained prior to vaccination.  Urine HCG negative.  Pt discovered a couple weeks later that she was pregnant. LMP-31Aug2008.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 20-SEP-2012, patient received improperly stored VARIVAX dose 2, from lot # 0610AE (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax; exp elev T,myalgia & arthralgia coincident w/ adm of vax;was tx w/ pred & recovered
Vaccine dose given from expired vaccine vial/Vaccine given after refrigerated beyond best use date.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine dose given from expired vaccine vial/Vaccine given after refrigerated beyond best use date.) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     The patient's past medical history included Asthma in 2004.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine dose given from expired vaccine vial/Vaccine given after refrigerated beyond best use date.). On 24-May-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine dose given from expired vaccine vial/Vaccine given after refrigerated beyond best use date.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow up appended On 30-Jun-2021: Additional information received
Loss of voice after Pfizer shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 2, single (Lot number: EN6199), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Anatomical Site of injection: Arm , Batch/Lot number: EN6198), administration date: 01Mar2021, for Covid-19 Immunization, reaction(s): "Loss of voice after Pfizer shots". The following information was reported: APHONIA (non-serious), outcome "not recovered", described as "Loss of voice after Pfizer shots". The event "loss of voice after pfizer shots" required physician office visit. Therapeutic measures were taken as a result of aphonia.  Additional information: It was reported that there was loss of voice and went to (withheld) 1st time. Botox with no positive results. Reportedly, loss of voice after Pfizer shots went to a Clinic and another clinic 12 times (presented as reported). No positive results. Never Pfizer again. Prior Vaccinations reported as Manufacturer Moderna Batch/Lot number was 1394.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300224001 same reporter/patient/AE, different dose;US-PFIZER INC-202300144501 same reporter/patient/AE, different dose;
10-28-03 adm 11 am.  Given IM 0.5cc approx. 2:30 pm arm turned red and became tender. At 5pm hives began at site and extended to underarm and to left side of chest.  Arm painful and itched terribly.  No treatment
sore arm, lethargy, chronic fatigue, fever, fluid on lungs, lack of oxygen, death Husband received first dose of MODERNA vaccine on 1/30/21. Mild side effects. Received second dose on 2/24/21. For the first week after the second dose, the side effects seemed normal. By the second week he was gasping for air. Rused to ER via ambulance on 3/9/21. High heart rate, poor oxygen. Received numerous blood transfusions over 3-days (typical treatment for his blood disorder), yet body would not retain the transfused products. Died on 3/12/21 at 4:35 am from cardia arrest caused by respiratory failure.
Mild rash at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th October 2021, 1 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   The reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of  Shingrix vaccine and experienced mild rash at her injection site.  The reporter stated that the rash started the day following her injection and had resolved. The patient didn't wish to give her birthday or any more information in regards to her Shingrix vaccine. No health care professional details were provided. The patient did not consent to follow-up. This case has been linked with case US2021224256, reported by the same reporter (husband's case).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021224256:Husband's case
really really big allergy attack; Impairing his breathing; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 08Apr2021, as 1st dose, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that he received the first dose of BNT162B2 on 08Apr2021 and was scheduled to receive his second dose on 03May2021. However, on an unspecified date, he experienced a "really really big allergy attack" which was impairing his breathing. He stated that the events were not related to the vaccine. He wanted to reschedule his second dose appointment and wanted to know if it was okay to take the second dose more than 21 days after the first dose. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: The events are hypersensitivity and dyspnea are likely intercurrent and are unrelated to suspect product BNT162B2.
has had a rash on her arms for a few days , rash to be itchy on the inside of her elbows; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included drug hypersensitivity Caller states that her mother is allergic to sulfa and almost any antibiotics. The patient's concomitant medications were not reported. It was Reported that, calling on behalf of mother who received the first dose of the Covid vaccine, states that her mother has had a rash on her arms for a few days, in which she believes it could have been there anywhere between 3-4 days to a week. Caller states that the rash comes and goes, is blotchy and has little red spots. Caller states that her mother reports the rash to be itchy on the inside of her elbows and that she has an allergic reaction to a lot of stuff. Caller states that her mother is allergic to sulfa and almost any antibiotics. Caller reports that it's been 5 weeks since her first dose in which she is supposed to receive her second dose tonight. The patient experienced has had a rash on her arms for a few days, rash to be itchy on the inside of her elbows on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
pt saw MD 12JAN98 for persistent cough;MD states pt had no fever or unusual sx on assessment;MD gave rx;
Pt received PNEUMOVAX and AFLURIA in the afternoon of 11/14/14. The next day she woke up with a swollen arm, a fever of 102 degrees F, feeling fatigued and nauseated. She contacted her PCP and has been taking regular BENADRYL. Today (11/18/14) her arm is still swollen but she is feeling better, jut tired from the BENADRYL.
shingles flare up; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 2-Jun-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient recently got the Shingrix vaccine and was having shingles flare up at the time of reporting. The patient had the anti-viral medicines and the patient was asking if he or she should take it or not.  Additional Supportive Information: Follow-up would not possible as no contact details were available.
No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms).      No concomitant drug was reported.  Reporter called in to report success of non-indicated use of vaccine to treat long-haul COVID symptoms and asking to connect with research team. Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of "long-haul COVID" and had seen 88-90% success rate in resolving the symptoms of long-haul COVID.  Vaccine was given to the patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms off 50% or more. Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches.  No adverse reactions occurred.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Per mother on 5/18/01, child was given Motrin between 16:00 and 17:00. Child appeared "sluggish" in PM. Child had seizure at approx. 19:15 on 5/16/01. Child taken by EMS to a medical facility. Mother was told WBC's were elevated. Child was given antibiotics. On 5/18/01, child was still receiving antibiotics and Motrin. No further problems. Seizure precautions discussed with mother.
Patient was seen in clinic on 6/8/22. Patient's chart showed that he was due for the 2nd COVID booster even after querying the local Immunization Registry. Patient was asked if he wanted the COVID vaccine, he said yes so it was given. Clinic later received an update from patient's daughter via database that patient already ready received his 2nd COVID booster on 5/9/2022 at another healthcare facility. Patient's daughter reported uploading the vaccine via database. Per report filed, patient has some memory issues, but attends appointments alone and does not have an activated online chart. When chart was reviewed the following day (6/9/22), the vaccine from 5/9/2022 was available. Of note, at times there have been delays when querying the local Immunization Record (sometimes up to 5 minutes or at times it errors out). Due to potential system error and patient's memory concerns, he ended up receiving a total of 5 doses of the vaccine vs 4. Patient denied any current symptoms and provider is aware.
Have had intermittent tinnitus after receiving first vaccine; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 20Sep2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On an unknown date in 2021, after receiving the first vaccine, the patient had intermittent tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event intermittent tinnitus was not resolved at the time of this report.
Initial unsolicited report received from a non-healthcare professional on 19-Jan-2016. This case involves a 69-year-old female patient who was vaccinated with first dose of ADACEL (batch number: U5264AA, expiry date: 15-Jan-2018, dose and route of administration was not reported) in left deltoid and also received first dose of PREVNAR 13 (manufacturer: other, batch number: L99262, dose and route of administration was not reported) in right deltoid on 13-Oct-2015. The patient had no illness at the time of vaccination and no known allergies. Patient had medical history of afib and regularly sees cardiology for monitoring. Concomitant medications were not reported. On 29-Oct-2015, 16 days following the vaccination, the patient developed afib. It was reported that the patient required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. At the time of this report patient was not recovered from the event. Upon internal review, the case was considered to be serious due to important medical event: afib. List of documents held by sender: none.
This spontaneous report was received from a physician refers to a male patient of unknown age. There was no pertinent medical history and there were no drug reactions or allergies reported. On unknown dates the patient was vaccinated with dose 1 and 2 of  RECOMBIVAX HB 1 ml, intramuscular  (lot number reported as J008227 and expiration date unspecified, for dose numbers 1 and 2 in the series). The patient received the third dose on an unknown date (lot #J008505, expiration date 07-FEB-2016) 1 ml intramuscular. Thimerosal status of the vaccine was not reported. There were no concomitant medications reported. On an unknown date the patient experienced negative hepatitis B titers. The physician reported that the patient had the titers measured 31 or 32 days after the third dose, and they measured less than 5 which was determined to be negative. No additional symptoms were reported. IT was reported that there was no treatment given for the patient. There was no product quality complaint (PQC) involved. The outcome of the event was reported as not recovered. The causality of the event was not provided.  This is one of several reports received from the same reporter. Additional information has been requested.
Initial information received on 28-Jun-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves male (age not reported) patient who had an event reported as nurse was unable to administer IMOVAX Rabies to a male patient because it was leaking. This is actual medication error case due to Product issues. No medical history no concomitant therapies were reported. On 27-Jun-2018, the patient received a 1 ml dose of suspect IMOVAX Rabies lot N1G40, exp date: 31-July-2019, via unknown route in unknown administration site. Pharmacist reported that nurse was unable to administer IMOVAX Rabies to a male patient because it was leaking. Pharmacist states that the nurse probably had never given the IMOVAX before and wasn't sure if it was nursing error or product issue. Pharmacist got the Nurse to explain event details. Nurse reports that I had never given Rabies vaccine, put the needle on, was not sure if it loosened up in process, put sterile water into powder and then tried tightening the needle both needle and then when it was drawn up, it was leaking. The leaking was coming from the syringe at the top. Nurse states that she removed the cap and the piece on the syringe kept turning. After looking at the syringe with the Pharmacist, it was decided to use another IMOVAX. Nurse diluted it with 1cc of sterile water. It was unclear how to take the cap off the syringe because it has two pieces and the bottom one got loose and spun. Caller mentioned that it was difficult to remove the cap off the sterile water initially. Pharmacist/Nurse stated several times that the instructions were not clear on the PI and no administration instructions were included in the box of how to reconstitute the product/attach the needle. This needs to be clear. Pharmacist reports that the patient received the Imovax after they reconstituted/prepared the second syringe. First syringe was unused. But his injection was delayed due to this issue. Caller states that numerous rabies vaccines have been administered at the hospital and they have never seen anything like this before. Date of event: 27Jun2018 Account Number: 70074468 Product Lot: N1G40 Exp: July 2019; Diluent Lot: Exp: was discarded; no Lot/Exp available Carton Lot Lot: N1G402M Exp: July 2019 NDC: 49281-0250-51 How purchased: Wholesaler; Ameris Number of units affected: one Was dose used or not used: not uses Available for return: vial Only. It was not reported if the patient experienced any adverse event. 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 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. Documents held by sender: none.