chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose of Moderna Covid-19 vaccine in December 2020; waited 8 months after 1st dose can I still receive 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose of Moderna Covid-19 vaccine in December 2020; waited 8 months after 1st dose can I still receive 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose of Moderna Covid-19 vaccine in December 2020; waited 8 months after 1st dose can I still receive 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose of Moderna Covid-19 vaccine in December 2020; waited 8 months after 1st dose can I still receive 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment information was provided.
Red, hard, hot, raised swelling at injection site with defined border. Moderate pain after ibuprofen. No itching.
PT VACCINATED WITH DTP EXPERIENCED GENERALIZED SEIZURE W/FEVER, 1 MINUTE; PT WITH KNOWN HX OF BENIGN FEBRILE SEIZURE. NO SEQUELLAE
unusual screaming (as in pain) for 2+ hrs following vax; slept poorly, nursed poorly; seen in office @ 24 hrs p/vax; PE nl, good color alert, no abnormalities x/fussiness, t101;
Very tired, chilled, ached all over, vomited twice (This did not occur with first vax), loss of appetite, slept most of the time.
Administration of expired moderna vaccine that were given as booster shot to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported. Reporter stated that they have administered expired Moderna COVID-19 vaccine that were given as booster shot to the patient.
This is a spontaneous report from a non-contactable consumer or other non hcp (Patients wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache and kind of tired on an unspecified date. The Caller stated she went on the next day to get the vaccine with her husband for the Pfizer. They received the vaccines at (withheld) and it said BioNTech EW0187 on a document the caller was reading from. Caller confirmed the vaccine was the Pfizer BioNTech COVID-19 Vaccine. Caller stated her husband had a headache and kind of tired. Caller did not specify if this lot number also pertained to her husband's vaccine. The outcome for the events was unknown. No follow attempts are needed; information about lot/batch number cannot be obtained.
Major outbreak of eczema on hands, lasted for weeks, while using Betamethasone Dipropionate ointment 0.05%.
This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 08-AUG-2018, the patient was vaccinated with improperly stored dose of PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004439: US-009507513-1809USA004440: US-009507513-1809USA004441: US-009507513-1809USA004442: US-009507513-1809USA004443: US-009507513-1809USA004444: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004448:
Narrative: 82 yo male presented to the ED on 01/12/2022 due to altered mentation in the setting of recently diagnosed COVID-19 infection and UTI. COVID positive 01/12/2022. Patient admitted to hospital with ACUTE TOXIC METABOLIC ENCHEPALOPATHY, likely DELIRIUM due to COVID19, UTI, possibly in part due to fluoroquinolones. Pt switched to rocephin for UTI tx. Treated with supplemental oxygen, vitamin c/d/zinc, dexamethasone and remdesivir. Delirium resolved. Discharged to SNF after 28 day hospital stay. PMH includes Parkinson's Disease, HLD, Actinic Keratosis, BPH, Iron Deficiency Anemia, Idiopathic peripheral neuropathy, Osteoarthritis, Finding of frequency of urination, Urgent desire to urinate, recent UTI
Per request of  all patients who tested positive for COVID19 after receipt of the COVID19 vaccine must be reported. No other adverse events reported. The patient tested positive for COVID19 on 12/22.
This spontaneous report as received from a medical assistant refers to patients of unknown demographics. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (Lot # M019641 with expiry date 20-APR-2018, Lot # L013063 with expiry date 14-APR-2017, Lot # L035124 with expiry date 14-SEP-2017, Lot # L032395 with expiry date 26-AUG-2017 and Lot # L034267 with expiry date 08-AUG-2017). The temperature and timeframe that the VARIVAX was exposed to were as follows, Temperature: 14.9F, Time frame: 1 hour. There were no previous temperature excursions. Data Logger was involved. The medical assistant confirmed that the improperly stored vaccines were administered. No adverse effect was reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 16:30 (at the age of 43-years-old), as a single dose for COVID-19 immunization. Medical history included diabetes insipidus and high blood pressure. The patient was allergic to penicillin, tramadol, Avapro, Norvasc, and clindamycin. Concomitant medications included desmopressin acetate (DDAVP), atenolol (MANUFACTURER UNKNOWN), losartan potassium (MANUFACTURER UNKNOWN) and esomeprazole magnesium (NEXIUM). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 03Mar2021 at 17:00 (at the age of 43-years-old), as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks, prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, the patient experienced flu like symptoms, uneasiness, lightheadedness and feeling spaced out. The patient found it hard to focus or concentrate and felt as if she was drugged. The patient worked as a legal assistant and was struggling with performing her duties. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event flu like symptoms, uneasy (unwell), light headed, spaced out feeling and poor concentration was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
Patient was underage when he received covid 19 moderna vaccine. Patients parents approved for him to get dose 2
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 75-year-old male patient who received BOOSTRIX (batch number 393D9, expiry date 28th May 2018) for prophylaxis. Concomitant products included FLUAD and PREVNAR 13. On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the patient received BOOSTRIX which was already expired on 28th May 2018. Follow up information was pharmacist on 26th November 2018: The reporter details were updated. The patient's demographic details was updated. On 7th October 2018, the patient received BOOSTRIX intramuscularly in left deltoid. On 7th October 2018 (Sunday), the patient came morning for a flu shot. The reporting pharmacist checked the immunization registry and found that the patient was due for PREVENAR 13 and Tdap as well. The reporter discussed with the patient and the patient said that he wanted all three vaccinations, so that he would be up to date, understood that his options were to get them all that day or get two vaccines on the same day and come back for one vaccine if he didn't wanted to receive 2 shots in one arm. They went over adverse risks for the vaccines. The reporter told to the patient that he wanted to make sure that all the vaccine should be in stock and went to the refrigerator to pull products and check expiry plates. The pharmacist misread 2018 as 2019 and told to the patient that it will took 15 min to process the vaccine. They were busy and reporter were processed the labels and drew up the Tdap and vaccinated the patient giving the flu shot and pneumonia in right deltoid and the Tdap in left deltoid. The pharmacist discovered after the patient left and was finishing with the paperwork that the expiry date was actually 28th May 2018. The reporter contacted CDC on 8th October 2018 (Monday), they recommended to contact manufacturer. Then the pharmacist contacted manufacturer and they defer to the CDC recommendation on revaccinate because expired dose invalid. The reporter contacted the patient and planned to come on 7th October 2018 for revaccination but forgot. The patient said that less than a year after receiving BOOSTRIX his arm were swollen for a couple of days. On 4th November 2018, the patient was revaccinated with BOOSTRIX. The reporter called to remind the patient that he need to had Tdap repeated due to invalid on 7th October 2018. The primary care physician was also agreed on revaccination. The VAERS details were updated. This was medication error with harm.
Redness, induration, and soreness at least 6x8 cm around site.  Feelings of fatigue, stomach upset, sore throat, and clamminess.  Symptoms improved next day, with local reaction improving as well.
She is experiences loss of consciousness, loss of coherent speech, loss of mobility, and  in one instance loss of bowels.  This happened on 6.16.2021, again on 8.19.2021 and most recently on 11.19.2021.    She went to the ER and they say she is having seizures but the seizure medications they have given has not been effective and the episodes keep occurring .  After each episode it is taking her more days to recover.   It is followed by weakness in the body, restricted mobility, lack of of interest in eating, or taking in fluids.   These occurrences began after her second vaccine dose and now after her booster shot.
pt recvd vax & 24hrs later pt devel a local rxn @ the inj site; 48hrs p/inj pt was hospitalized w/myocardial infarction
Extreme fatigue; 3 - 5 times per week; occurring mid to late afternoon. Six months later, occurs 1 - 3 times per week & still occurring mid to late afternoon.
Patient experienced swelling, red welts and itching in the right arm (the vaccinated arm). She also complained of fever, chills and headache that lasted for a couple days after vaccination.
Swollen red knot that is warm touch at the site of injection; Swollen knot at site of injection; Red knot at site of injection; A spontaneous report was received from a 64 years old female patient concerning herself, who received two doses of Moderna's covid-19 vaccine (mRNA -1273) and experienced the events, swollen red knot(injection site swelling), swollen red knot(injection site erythema), swollen red knot that was warm to touch at the site of injection(injection site warmth).  The patient's medical history was not provided. Concomitant medications were not reported.  On 07 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 037K20A) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.  On 07 Jan 2021, the patient experienced swollen red knot that was warm to touch at the site of injection. Treatment for the events included antibiotics (Unspecified) and Diphenhydramine.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events swollen red knot that was warm to touch at the site of injection  were considered not resolved.; Reporter's Comments: This case concerns a 64-year-old female who experienced nonserious events of unexpected injection site warmth and expected injection site erythema, injection site swelling.  Event onset occurred 8 days after the first dose of mRNA-1273. Treatment with antibiotics and diphenhydramine. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Tinnitus (ringing in both ears), constant since injection. Can be masked by white noise but does not go away.
This spontaneous report was received from a 58 year old female patient, who was reporting on herself. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 04-OCT-2017, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, strength, dose, route of administration, an anatomical location were not provided), for prophylaxis; as well as the influenza virus vaccine inactivated (unspecified) (lot #, expiration date, strength, dose, route of administration, anatomical location, and indication were not reported); both administered in the same spot. On 06-OCT-2017 (reported as "today"), the patient noticed a red rash forming described as "not bumpy", from which she had not recovered. The patient did not seek medical attention. Her laboratory data was unknown. No product quality complaint (PQC) was involved. The causal relationship between the rash erythematous with ZOSTAVAX and influenza virus vaccine inactivated (unspecified) was not provided.
Subsequent to receiving one dose of Engerix B the pt immediately developed hives. Outcome: unresolved. Subsequent to receiving the second dose of Engerix B the pt immediately developed hives. Outcome: unresolved. The pt was treated with Zyrtec, Periactin, Medrol and steroids (NOS). The most recent information received reports the outcome of the event as unresolved.
Patient received second dose of Pfizer on day 16, which is less than the required 17 day spacing between dose 1 and dose 2 of Pfizer.    Dose one was received on 12/23/2020 Dose two was received on 01/08/2021
Exposed to varicella in class at school. 15-20 small papular to vesicullar lesions on trunk and neck.
This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concurrent medical conditions included Pregnancy (Planning for pregnancy). Concomitant products included CYANOCOBALAMIN (VIT B 12) for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced RASH (rash). On 18-Mar-2021, RASH (rash) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. This case was linked to US-MODERNATX, INC.-MOD-2021-073893 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-073893:Crossed linked.
Very tired and achy the evening I received the flu vaccine and developed a red spot on my arm. Day 2 - back pain and very tired. Day 3 - developed shingles rash on my back.
Headache, Myalgia, Arthralgia, lost 3 days of work- severe symptoms requiring medeication  Narrative: severe stiff neck with torticollis, pain all cranial muscles, difiiculty chewing, total body pain requiring MD consultation and medication - from PCP hydrocodone, cyclobenzaprine, heating pad ., otc ointments - lost 3 days of work declining second dose of Moderna vaccine
Patient stated that he was getting headaches prior to the vaccine but after the vaccine they were coming more frequent... patient is currently taking Heart medicine for a different situation but nothing is going on with that
All 3 of my children were vaccinated at the same time (ages 7 yrs, 14 yrs, and 18 yrs). From the next day until the present, which has been 2 weeks, their injection site is sore (not red) and they have had very sore, swollen lymph nodes in their arm pits and up their necks just on the side of the injection.  2 were on the left and one on the right, but same reaction with all three children. One child was adopted and is no blood relation, so this isn't a genetic reaction.  I have just wanted to report this about the swollen and sore lymph nodes, which are getting better, but still swollen and sore 2 weeks later. No one else has had this reaction before, according to the nurse who gave the shots.
This spontaneous report was received from a medical assistant and refers to a patient of unknown demographics. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 19-SEP-2017, the patient was vaccinated with a dose of VARIVAX injection, lot # M041081 with expiration date on 06-OCT-2017 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent a temperature excursion of 47 to 77 degrees Fahrenheit for 53 hours. No previous excursions were reported. Digital Data Logger was involved in recording the temperature excursion. The vaccine was reconstituted with correctly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. This is one of two reports from the same reporter.; Sender's Comments: US-009507513-1709USA015132:
Swelling, heat, pain at infection site 48 hrs after DTaP & hepatitis A.
RIGHT AFTER THE PATIENT RECIEVED HIS SHOT, HIS COLOR TURNED PALE AND WAS UNCOHERENT FOR A FEW SECONDS. ALMOST PASSED OUT AND  HE WAS TOO HOT WE CHECKED HIS BLOOD PRESSURE IT WAS TOO LOW . AFTER A WHILE AND AFTER GIVING HIM SOME WATER AND COOLING HIM DOWN WITH A SMALL FAN , HE STARTED TO FEEL BETTER
While vaccinating, client's WIR stated 1 Moderna dose given on 3/3/2022.  I verified with the client that this will be his 2nd Moderna dose to be fully vaccinated.  He confirmed.  The nurse who then vaccinated the client also verified that he is receiving his second dose of Moderna, and he confirmed.  After the dose was administered, the nurse told the client that he can receive his booster in 5 months.  Client then stated "this was my 2nd booster.  I had the J&J shot last year when I was in jail.  This full dose of Moderna was given within the incorrect time frame, and as a 2nd booster.
She was vomiting and had continuous fever that wouldn't break on 03/17/2023. We decided to take her to her pediatrician. They drew bloodwork and conducted several tests to confirm what was wrong with her including a CT scan, x-rays, and an ultrasound. On 03/23/2023, they confirmed she had appendicitis where her appendix ruptured. She had it surgically removed and was hospitalized. She was prescribed antibiotics for a period of time and has made a full recovery.
Client stated one week after first dose she developed a rash of "red patches" on her back, chest, neck, and upper arms. The client stated the rash was "itchy" and lasted one week.  Client also reported onset of muscle cramps and headache 3 hours after both doses of the vaccine that lasted 3 days. Client denied any dizziness or shortness of breath after either dose of COVID vaccine. The client reports a history of fibromyalgia controlled with over the counter pain medications. The client reports a history of anaphylaxis after taking penicillin. The client stated she cannot take aspirin due to ulcers.
expired dose of Engerix-B was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 83-year-old female patient who received HBV (Engerix B) (batch number 54A32, expiry date 12th November 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th December 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 28th December 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The patient received an expired dose of Engerix-B, which led to expired vaccine used. The reporter consented to follow up.
At 1:15-1:30am the next day (about 8 hours after injection) woke up with extremely hot/swollen/itchy feet and toes.
c/o chest pain/pressure today after vaccination yesterday, along with fever, chills, SOB, body aches. She was instructed to call her cardiologist immediately to report.