chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 patients received ActHIB, the diluent had expired before the date of administration/No AE; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves two patients who received expired diluent of vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patients received a dose of suspect HIB (PRP/T) VACCINE (Powder- Lot: UJ193AA and Expiry date: 01-Mar-2021 and Diluent- Lot: UTR, and Expiry date: UTR, before 18 Nov 2019) via unknown route in unknown administration site.  It was a case of actual medication error due to expired product administered.  At the time of report no adverse event was reported.  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 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.
hives p/10-11 days;cont until day 21;redness @ inj site;
This spontaneous report was received from a healthcare worker refers to a patient of unknown age. On 06-MAY-2014, the patient was vaccinated with expired MMR II lot # 0496E (Expiry: 07-MAR-2014), 0.5 ml, intramuscular. No adverse effect was reported. No further information was provided. Additional information has been requested.
To bed about 10:30p. Awoke 11:30p  & could not talk, shivering uncontrollably, couldn't move my legs, &  no feeling in feet & legs. Very difficult to breathe. Was alert.  Wife up to BR, looked over, I was trying to say help.  Brought me  water. she assisted me up , then back to bed, still shivering uncontrollably.  30 mins to 1 hr later, my son saw me in the hall and said, "Dad, you look like ****".  I could not make a sentence. Per my son all I said was, "Gatorade".   I drank it then fell asleep. next morning 101 temp, severe fatigue, severe aches and pains, could not make complete sentences I was told.  I did have COVID 19 for 4 weeks Oct-Nov 2020.
Immun on 10SEP91 late 18SEP91 pt had quesitonable sz, t103 18SEP91; taken to ER cat scan done sound-normal; BOM dx; taken to MD; pt given ATB for ear infect & APAP for fever also exp soreness @ DTP site inject 10SEP91;
DEATH Narrative: NO INFORMATION AVAILABLE IN RECORD OTHER THAN DATE OF DEATH VACCINE GIVEN 02/10/2021 DATE OF DEATH 03/11/2021 PT DID NOT RECEIVE CARE AT CLINIC SINCE 2013 (AUDIOLOGY ONLY AT THAT TIME) NO DOCUMENTATION OF PREVIOUS COVID INFECTION NO IMMEDIATE ADR FOLLOWING VACCINE NO DOCUMENTATION OF HOSPITALIZATIONS (RECENT OR AFTER VACCINE) NO DEATH NOTE OR AUTOPSY Likely that vaccine did not contribute to this patient's death.
itchy; red patch on left arm; sore arm; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchy), ERYTHEMA (red patch on left arm) and PAIN IN EXTREMITY (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 024M20A and 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter. The patient had never been diagnosed with/ tested positive for COVID-19.  Concurrent medical conditions included Penicillin allergy (Penicillin). Concomitant products included SIMVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), AMLODIPINE BESYLATE, LEVOTHYROXINE SODIUM (SYNTHROID), FISH OIL, UBIDECARENONE (COQ-10) and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced PAIN IN EXTREMITY (sore arm). On 29-May-2022, the patient experienced ERYTHEMA (red patch on left arm). On 30-May-2022, the patient experienced PRURITUS (itchy). At the time of the report, PRURITUS (itchy), ERYTHEMA (red patch on left arm) and PAIN IN EXTREMITY (sore arm) was resolving.            Patient height was reported as 5 inch. The patient had received First booster dose of Moderna vaccine on 12-Oct-2021. The patient had received second booster dose of Moderna vaccine on 27-May-2022. Concomitant medications also included Multivitamin and Vitamin D. No treatment medications were provided.
Maldaministration of two Fluarix QIV doses on the same clinic day; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 14-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number AF749, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLUARIX).   On 13-SEP-2023, the patient received the 2nd dose of Fluarix Quadrivalent 2022-2023 season. On 13-SEP-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced accidental overdose (Verbatim: Maldaministration of two Fluarix QIV doses on the same clinic day).  The outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-SEP-2023 The nurse reported that a patient received by error two Fluarix QIV vaccines, which led to accidental overdose. The reporter did not consent to follow-up.
6/28, pt vomited; 6/29, difficulty sleeping; 6/30 & 7/1, watery diarrhea (frequent); 7/2 dec appetite, whining
All-over ache, swollen eyes and throat, stiffness, fatigue, weakness, sweating, croupy cough, congestion (3 days); stomach and abdominal sharp pain, vomiting, low-grade fever (2 days).
I had Covid 19 in December of 2020.  It ran its course while I was isolated and I didn't require hospitalization.  My 1st vaccination was JNJ on 04/05/21. I had no adverse reactions after receiving it. I received the Moderna shot as my Booster late on the evening of 12/23/21. I woke up on 12/24/21 with Tinnitus in my left ear which is constant and has not gone away. It has been reported to my Primary Care Physician and I have an appointment with a Neurologist in July and I will report it to them as well.
The next morning (Weds) I was in complete pain from head to toe couldn't get out of the bed---without a level 10 pain. Thurs--50% of pain gone, but headache got worse  Fri-- woke up in a pool of water after freezing to the bone, but clamy to the touch all night Thursday  Sat-- lost my voice and developed a wet cough Sun-- hoarseness continued and cough got worse  Mon-- cough so bad that I was choking--chills returned-- even though I had a space heater right next to me Tues-- chronic cough--called to request cough medication-- doctor didn't call in so I had a miserable night Wednesday -- went to store to get Halls Relief cough drops and Delsym despite taking the cough drops and Delsym, I am still coughing. It gets worse as the sun goes down.
Stroke about 2 weeks after first dose; This is a spontaneous report from a contactable consumer.  A 74-years-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jun2021 (Batch/Lot Number: EW0191) and second dose via an unspecified route of administration on 15Jul2021 (lot# EW0191) both as single dose (at the age of 74) for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included cerebrovascular accident from an unknown date and unknown if ongoing (a while back). There were no concomitant medications. The patient experienced stroke about 2 weeks after first dose on 09Jul2021. The outcome was recovering. It was reported the patient had stroke about 2 weeks after first dose and stroke less than 2 months after second dose and was hospitalized for stroke about 2 weeks after first dose from 2021 to an unknown date.   The treatment includes hospitalization and rehab. The outcome of the events was recovering.
He received Kinrix on June 26th in right thigh.  He developed 2 x 2 1/2 inch area of warmth, redness and tenderness at injection site over past 48 hours.
left shoulder pain and previously decreased range of motion appears to be likely due some reactive subacromial bursitis from her recent vaccine and then swimming afterwards causing further inflammation of the underlying bursa and resulting in pain with movement called shoulder impingement syndrome.  Pain resolved with at home treatment.
pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
PATIENT STARTED TO GET ACHE IN BACK OF HAND LIKE ARTHRITIS WORKED UP ARM INTO SHOULDER AREA.  CURRENTLY STILL ACHES AT TOP OF SHOULDER BLADE , DIDN'T DO ANYTHING PHYSICAL TO INFLAME ARTHRITIS
Sudden onset of pleuritic chest pain, unaccompanied by dyspnea, orthopnea, edema, or significant limitations in exercise capacity. Normal EKG with the exception of subtle ST elevation (~1mm) and PR depression (~0.5mm) in lead AVF; rhythm was NSR in the low 60s without ectopy or conduction disturbances. Transthoracic echocardiogram showed 1.5 cm pericardial effusion without evidence of RV collapse or tamponade. CK, CK-MB, and troponin I all normal. Final diagnosis made of vaccinia-associated pericarditis; treated with indomethacin with good relief. No admission required.
Approximately 4pm - fatigue, pain at injection site, low grade fever (1.5 degrees higher than usual temp.), nausea.  Approximately 8:30pm - extreme diarrhea, abdominal pain. Not sure this is a related symptom, it may have been a reaction to drinking vegetable juice, but did not experience this when drinking the same juice 2 days prior.
One week after receiving the first dose the injection site became red, itchy, swollen, and very warm. Within 12 hours of the start of the reaction the redness and swelling spread throughout my entire upper arm. The swelling and redness lasted about 4 days.
Severe headache with photophobia and dizziness for 3 days.  Still unresolved
57-year-old female presenting for sharp chest pain that radiates to the left upper back. She was awakened from sleep by the pain and it was severe.  She began coughing and felt short of breath.  She ultimately coughed so hard she began vomiting.  Symptoms have gradually improved but she still feels the pain has been recommended she come in for further evaluation.  Acute pericarditis, unspecified type Single subsegmental pulmonary embolism without acute cor pulmonale    Your medications have changed  START taking: colchicine  Eliquis DVT-PE Treat 30D Start  predniSONE (STERAPRED DS)
Given pneumovax 10/23 - evolved pain, swelling, restricted motion left upper arm and shoulder - when seen 10/25 already receding Told use NSAID's - cold pak if needed
Unsure of reaction related to vaccination. Pt experienced nausea/vomiting 24 hours following vaccination with Janssen c-19 vaccine. Pt reports "food poisoning" when presenting to clinic >24 hr after receiving covid vaccine.
This is a 38 year old male who developed body aches, muscle spasms, GERD and "pins and needles" sensations in his extremities and back in temporal association with receipt of his anthrax vaccinations. Patient states that following receipt of his first vaccination he developed GERD symptoms of nausea and heartburn. He denies any other symptom such as fever, chills; night sweats, nausea, vomiting or muscle/joint aches or pains.    However, his medical record reflects on 14 March 2003, that he reported night sweats for the previous 3-4 nights, inability to sleep well, loose stools for a couple of days and a mild rash on his abdomen and upper legs. The medical record describes the rash as "slightly raised papules in a line on abdomen, approximately one inch in length and what looks like mild folliculitis on thighs".  On 24 April 2004 he received his second anthrax vaccination. He states that he developed chills, night sweats and nausea beginning the same day and lasting approximately one week. Again he denies experiencing any rash, muscle aches or joint pain.  He received his third anthrax on 19 May 2003. He states that the same day he developed muscle spasms in his back, legs and arms with "pins and needles" sensation in the same areas. He states he also developed abdominal pain. These symptoms reportedly progressed over the next few days to feeling like he was "being jabbed with spikes", which reportedly last 3-4 days and slowly dissipated and subsided completely.  In August of 2003 the client relates that again he experienced a two-week episode of intermittent "pins and needles" sensation in his back, arms and legs. At this time he began seeing a doctor.  He also reportedly had a head cat scan done that was negative. His total cholesterol level at the time was 225. He was started on proton pump inhibitor for his GERD and Lipitor for his hyperlipidemia.  A letter dated 04/05/2004 from the doctor states that the client has "suffered from body aches, abdominal pain, dizziness, fatigue and odd twitching movements", he continues "based on his [the client's] description his extremity pain has consistently been neuropathic". He further relates that the client has been seen by a neurologist and diagnosed him with nocturnal myoclonus and a Pulmonologist who diagnosed an alpha-1-trypsin deficiency, not requiring management at this time.  Currently, he has been found fit for full duty and is awaiting reassignment to a ship. He states that the "pins and needles" sensation has not re-occurred for the past two weeks and prior to this has only been an isolated "jab" from time to time.
9/18/07 Morning after injection noticed redness and swelling, temperature later that day drainage noted from site increase redness and swelling the next day 9-19-07 seen in office 9-19-07 at 16:30p - area of induration and erythema 3' x 4" - cellulitis - Rx with Keflex. Received Varivax #2 afternoon of 9-17-07 in left arm. Rechecked 9/21/07 decrease Rx.
Pt vaccinated with Influenza onset peripheal hypesthesias, facial diplegia, dysphagia, leg weakness, resolved w/long course prednisone.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 01-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Initial report from the nurse received on 16 Dec 2009: This patient had received FLUVIRIN 0.5 ml on 12 Dec 2009 and second dose of unspecified H1N1 vaccine on 15 Dec 2009 at the age of 3 years. No further information received at the time of the report.
Approx. 10 mins after received TDAP; MENACTRA and VARIVAX pt returned to clinic and facial erythema; cough; "having a reaction". O2 sat monitor placed immediately with sats 90% on RA. Exam with erythema of face; cough, stridor; wheezing; edema of eyelids and lips. Sub cu pen given immediately and repeat after 15 mins and again 20 mins later given 0.3 cc of 1:1000 epinephrine. Also gave 50mg BENADRYL po. Hives devp. after 30 mins. Sats 68-92 throughout visit. BP: 105/48 Edema of face improved prior to transport.
S.E. started the evening after the immunization was given. Child had complaints of headache, temp of 101 degrees F, nausea, stomach ache, & dizziness. Physician recommended that he not receive the 3rd dose; no treatment was given.
DIZZINESS WHEN SUPINE; KNEE PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included left knee surgery - complete knee replacement, and concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2020, Laboratory data included: CAT scan (NR: not provided) unknown.  On 12-APR-2021, the subject experienced knee pain. On 19-APR-2021, the subject experienced dizziness when supine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knee pain on 28-APR-2021, and had not recovered from dizziness when supine. This report was non-serious.; Sender's Comments: V0:Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
11/4/14: Pt reports generalize malaise and chills. 11/12/14 pt reports to ED complaining of shaking chills, headache, achiness, rash/vesicles. All lab tests within normal limits. Extreme fatigue.
Severe headaches - when seen in clinic 2 days later headache resolving.  To monitor for now.
After shot #1, fever of 100 for 2 days, chills, fatigue, headache. After shot #2, fever of 102 within 4 hours of shot. Four days of fever, chills, vomiting, fatigue.
2nd dose administered to patient from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021 at 7:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported. Patient did not report any adverse event   This case was linked to MOD-2021-305415 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Added relevant history, patient demographics and vaccine information.
A few minutes after receiving the vaccine the patient stated she was dizzy and sat down in the waiting room. I was talking to her and she put her head down on the chair then started to slump over. I helped her to the ground, and the pharmacy tech called the paramedics. The patient was unresponsive for a few moments then she came to, I stayed with her while she was on the ground until the paramedics arrived. She initially did not want to be taken to the hospital but they paramedics did convince her.
beginning at approximately 0430 on 1/26/21 I woke up with Extremely sore arm, could not lift above head.  loss of appetite, upset stomach, headache, body aches, chills and low grade fever 100.1.  Every muscle and joint in my body hurt. I was not able to go to work. I took 500mg Tylenol and the fever went away but body aches did not. my symptoms continued all day into the night, I continued to take Tylenol and Ibuprofen alternating. 1/27 I woke up with no symptoms and returned to work
Said she started experiencing a bitter taste in her mouth after eating her dinner.  The bitter taste got worse this morning .
12noon, pt became cyanotic in hands & feet;body then became rigid;diff getting breath
Patient received a vaccine past the beyond used by date.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided   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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date.).    Concomitant medication was not reported.  Treatment medication was not reported.  This case included information of patient 181 out of 190 reported patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
p/ recv vax 4/1/98 approx 8 days later pt exp generalized rash w/approx 40 lesions & vesicles on back, neck, chest, ankles & back of knees. fever 100. lesions lasted 2 days. lab tests were done.