chrisvoncsefalvay/vaers-outcomes huggingface dataset:
multiple doses of ROTATEQ had partially sealed foil pouches/ 1 dose of ROT ATEQ that experienced PQC was administered to a patient on 18JUN2021; No additional information provided; 1 dose of ROT ATEQ that experienced PQC was administered to a patient on 18JUN2021; This spontaneous report was received from a nurse referring to a 4-month old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On unknown dates, it was noticed that multiple doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had partially sealed foil pouches. There were 19 doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# T033634, expiration date 16-MAR-2022) were affected.  On 18-JUN-2021, one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# T033634, expiration date 16-MAR-2022, 1 dosage form; strength and dose detail were not reported) that experienced product quality complaint was administered to the patient orally as routine vaccination (product container seal issue and poor quality product administered). No additional information was reported. The product was available for return.
I was having some vertigo issues in early October 2022. I went to urgent care. I was given ANTIVERT. Symptoms, such as, standing still the room felt like it was spinning or I was on a boat, went away but then they came back. I had another episode in early December. I got COVID-19 again in January 2023.
Got sick; Every joint in body hurt; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) and ARTHRALGIA (Every joint in body hurt) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick) and ARTHRALGIA (Every joint in body hurt). At the time of the report, ILLNESS (Got sick) and ARTHRALGIA (Every joint in body hurt) had resolved.            No concomitant medication information was provided. No treatment medication were provided. Patient took  shingrix  vaccine after 2 doses of Moderna vaccine
side effect in her throat; swelling under her arm; swelling next to her shoulder blade; She had received the first two doses of Pfizer. The boosted with moderna vaccine; A lot of aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling next to her shoulder blade), SWELLING (swelling under her arm), OROPHARYNGEAL DISCOMFORT (side effect in her throat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had received the first two doses of Pfizer. The boosted with moderna vaccine) and MYALGIA (A lot of aches and pains) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034FUA) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had received the first two doses of Pfizer. The boosted with moderna vaccine) and MYALGIA (A lot of aches and pains). On 14-Nov-2021, the patient experienced SWELLING (swelling next to her shoulder blade). On 15-Nov-2021, the patient experienced SWELLING (swelling under her arm). On an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (side effect in her throat). On 13-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had received the first two doses of Pfizer. The boosted with moderna vaccine) had resolved. On 14-Nov-2021, MYALGIA (A lot of aches and pains) had resolved. At the time of the report, SWELLING (swelling next to her shoulder blade), SWELLING (swelling under her arm) and OROPHARYNGEAL DISCOMFORT (side effect in her throat) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported.
I started my symptoms on third but only morning on the fourth I started to get bleeding through my nose I woke up and somebody was coming out from the liquid was coming out from my nose so I went to the bathroom and signed a glass of wine with the bleeding and then I cleaned it out I put some ice I took a Tylenol and then I?m gonna contact the city is the Pfizer . Pfizer customer service representative took down my details what happened and all the symptoms and he told me that one of their medical team will call me to discuss about it but nobody called me so afterwords I call the CDC and ask them if this is normal they told me that it is all listed on the list which they have of the side effects then I called the nurse helpline and she told me that I was the second third patient who?s complaining about a nose bleeding she asked me whether I had any allergies or in anything like that but I don?t have no allergies at this the first time it started and since then my nose is bleeding at least twice but rice a day deal dated and I?m off from work from there
Approx 15 hours after vaccination, pt experienced malaise and pain at inject site.  Presented to clinic the following day, with 27 x 20 cm erythematous indurated area on r/deltoid at inject site.
I got a blister rash between my breast and Right elbow. I put nerosporn on the ras and it was gone in 72 hour but left a small mark.
Information has been received from a consumer concerning her 11 month old daughter who was vaccinated with a dose of VARIVAX. There was no concomitant medication. It was reported that the patient was vaccinated five days prior to her first birthday. The patient had a red spot at the injection site which went away. It was noted that there were no other adverse reactions. No medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Large red welt formed around one of the shot sites. About the size of a silver dollar. Lasted 4 days.  He was very cranky and not able to sleep well for the first 2 days.
High fever, pain at injection site spread into surrounding joints, chills, muscle cramping in legs, muscle weakness, prolonged  headache and earache
Influenza vaccine given 10/14/2002. Pt not showing any significant symptoms at that time. Pt returned to office 10/15/2002 due to significant crying episodes since previous day. Mom reported that pt had some mildly rhinorrhea and congestion the previous week and pt's brother has a URI with OM recently. On exam pt was noted to have an erupting tooth and some mild nasal crusting but no other findings. Pt returned to the office 10/17/2002 with persistent crying and was crying non stop yesterday according to the mother. pt had normal liquid intake but had limited solid intake. Nothing other than the erupting tooth and mild nasal congestion were found on exam. On 10/19/2002 the pt was taken to a local hospital after calling this physician due to leg pain and limp, no tenderness with passive movement noted. At hospital pt had no x-rays and was diagnosed with Transient Synopis. With in 1-2 days pt had normal ambulation and no week presumed to be due to teething. Pt returned to the office on 10/28/2002 after developing mild diarrhea, significant anorexia and several episodes of vomiting over the prior weekend. Pt had no solid intake the entire weekend but drank some Pedialyte and some milk. Pt's irritability persisted. On 10/28/2002 pt had a rectal exam which showed a questionalbly positive hemoccult on 1 small area of the card. On 10/30/2002 pt returned to the office again with irritability. This time pt was noted in the office to have episodic irritability. Pt was monitored in the office for several hours and eventually sent to hospital with concern for intussusception. Pt was found to have slightly decreased bowel gas on the right with small air fluids levels within the right lower quadrant. Pt had a barium enema which showed a small ilececal intussusception which was hydrostatically reduced. Pt was monitored overnight and sent home the next afternoon. Within 1-2 days pt was acting perfectly normal. The discharge summary states abdominal pain.
roughly within 10mins post vaccine - patient was having severe back pain described as (someone hitting me with a sledgehammer on my back) - ambulance was called by store staff because patient did say she was having chest pain. After being checked by medics - she requested to be released. Store asset protection leader on duty reported to pharmacy the patient incident that happened because she had just received her vaccine.  After talking to patient later that evening, she reported to feeling much better and no pain was indicated.
Shivering; Weak; feeling achy; Fever; Sore arm/inj site pain/pain in arm; been Tired/staying home; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd September 2019, couple of hours after receiving Shingrix, the patient experienced pain in arm. On 4th September 2019, the patient experienced tiredness, shivering, weakness, pain and fever. On 5th September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm, tiredness, shivering, weakness and pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness, shivering, weakness, pain and fever to be related to Shingrix.  Additional case details were reported as follows: The patient received the 1st dose of Shingrix in right arm. The patient experienced painful resulting in a sore arm a few hours later.  On 4th September 2019, the patient experienced fever, feeling achy, weak, shivering, and being tired. The patient stayed at home for two days. Fever reported to be gone the following day.  The reporter did not consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR140996, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR140996:first dose
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unkonwn age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, unspecified number of patients were vaccinated with ZOSTAVAX (lot# unspecified) (dose, temperature ranging from -9C to -4.7C was reached and was supported by defrost cycle information. No adverse effects were reported. No concomitant medications were reported. This case is linked to case # 1401USA000286, 1401USA000288, 1402USA010744, 1402USA010745, 1312USA011848 and 1402USA010747 (same reporter link). Additional information is not expected.
Two days after vaccine: Redness on Arm (Covid Arm) Lasted May29-30 1st week of June I had a swollen neck, felt when I swallowed Currently (week of June 6 two weeks after vaccine), I have blurred vision, dizzyness, nausea, and diarrhea.
Tested positive for covid after receiving three moderna covid vaccines; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for covid after receiving three moderna covid vaccines) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy to antibiotic (Azithromycin).    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced COVID-19 (Tested positive for covid after receiving three moderna covid vaccines). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 28-Dec-2022 to 02-Jan-2023 for COVID-19, at a dose of 100 milligram twice a day; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for covid after receiving three moderna covid vaccines) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2022, SARS-CoV-2 test: Negative. On 26-Dec-2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported.  Patient ethnicity reported as Other.  Patient received 1st and 2nd dose of Moderna vaccine.  It was reported patient got rebound Covid a couple days after finishing the sequence of Paxlovid medication. Patient got COVID again but did not have a temperature the second time. Treatment medication also included allergy medication and was taking that for the temperature in the beginning and patient had chest cough and Phlegm in patient throat and moved down further the second time and was constant cough that turned in to a dry cough and patient still had coughing, but nothing is coming up.  Patient was first diagnosed with Covid on 26-Dec-2022 or 27-Dec-2022 and got paxlovid on 28-Dec-2022. Patient tested self twice when patient was feeling very bad. Test again next day and was positive. It was kind of delayed on the first day with a temperature, patient did not test positive, it was the second day that patient tested positive.
17cm x 15.5cm area of erythema and induration with min. tenderness, no fever.
This spontaneous report as received from a health professional refers to unspecified patients. On an unknown date the patients were vaccinated with improperly stored doses of M-M-R II (lot #, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Patient had a hemorrhagic conversion of a traumatic brain injury and a right pontine infarct 24 hours after administration of the vaccine
Vaccine administered 10/13/16. On 10/19/16, Pt. came and reported a local reaction: redness on injection site and surrounding area.
Patient given Moderna vaccine 1455. Patient reported feeling numb tongue, dizzy and nauseous. Patient took 25 mg diphenhydramine oral. Observed at vaccine clinic. began feeling more nausea. Tongue numbness not improving, took another 25 mg diphenhydramine. Patient sent to ED - taken by PALS/RN. Arrived in ED at 1600 complaining complaining of chest tightness with tingling in her throat. Out of concern that she may have progression to anaphylaxis so 0.3 mg of epinephrine was ordered intramuscularly. Patient also given 25 mg of Benadryl IV as well as Pepcid and Solu-Medrol.  Patient was observed here in the emergency department for several hours. She did have some complain of some itchiness of her skin so additional 25 mg of Benadryl was given.  She also was having some persistent chest tightness and appeared quite anxious and due to concern for anxiety is possibly a contributing factor, IV Valium was given for anxiolysis.  On reevaluation, symptoms have improved significantly.  She was counseled in regards to use of an EpiPen and a prescription was given for this. Prescription was also given per few days of prednisone and Pepcid. Provider recommended avoiding further covid19 vaccination.
My adverse event was pain in my mouth from a toothache on the left side wisdom tooth. I went to see Dr. and he told me to see a dentist also seen him for itchy ears, he prescribed amoxycillin. I have scheduled an appointment to see the dentist. He said my ears were clear. I told him a was having productive cough of yellow.
10-1-15 Flu vaccine given - gradual pain in left deltoid and weakness. No effect on ROM.
Throat swelling; Tongue tingling; Numbness in back, mouth, hands, lips.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic moderate asthma, allergies, shellfish allergy, peanut allergy and allergy to nuts. Concomitant medications included mometasone furoate (FLONASE), vitamin D nos (MANUFACTURER UNKNOWN), BREO 100 and fish oil supplements; all from an unknown date for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 11:00, the patient experienced throat swelling, tongue tingling, numbness in back, mouth, hands and lips. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events throat swelling, tongue tingling, numbness in back, mouth, hands and lips were resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.
05/15/2022 congestions lasted about 2 weeks. It came back again on June for 2 weeks again. It clear up on 06/11/2022. 06/18/2022 congestions came back again. It was on 07/04/2022 hospitalized for leakage in the lung. I went into the ER with clasped lung. 01/23/2022 tested positive for COVID urgent care prescribed me with PAXLOVID for 5 days.
Received shots 1 week ago woke up this morning stated headache, neck ache, thas fever. States is spitting a little lethargic - but dose answer questions. Fever 97.6 - now. MMR, IPV4, DTAP5
Pt awoke 29JUN AM in very somnolent state; Seen @ hosp ER; PE found enlarged lymph nodes on lt side of neck; CBC done & told pt had viral infect; tx anti-inflammation med only;
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-418891 (Patient Link).
Headache; Felt real tired; Chills; This is a spontaneous report from a contactable Other HCP (patient himself). A 44-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration in Arm Right on 04Feb2021 at 15:00 as single dose for covid-19 immunization. Historical vaccine included bnt162b2 (COMIRNATY, Formulation; solution for injection, Batch/Lot Number: EL3247), dose 1 via unspecified route of administration, administered in Arm Right on 04Jan2021 at 15:00 for covid 19 immunization. The patient had no medical history and no known allergies. The patient had no concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine, no treatment was received for the adverse events, has not been diagnosed with covid-19 prior vaccination. The patient underwent lab tests and procedures, which included Nasal Swab post vaccination on 28Dec2020 which resulted negative. Patient experienced a headache, felt real tired and chills for about 6 hours all on 05Feb2021 at 04:30 PM. After 6 hours the symptoms went away. The outcome of the events was recovered.
Breakthrough case admission after three vaccines Pfizer 3/2/21 Lot# EN6202;  Pfizer 3/23/21 Lot# Er8727;  Moderna 12/6/21 Lot# 012HH21B
patient received third (booster) dose of bnt162b2; had a breakthrough positive C19 infection; had a breakthrough positive C19 infection; This is a spontaneous report received from contactable reporter (Consumer) from a sales representative. The reporter is the patient. A 40 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine), administration date 21Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "patient received third (booster) dose of bnt162b2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "had a breakthrough positive C19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive, notes: breakthrough positive C19 infection. Patient received first 2 vaccines on the set timelines, then the booster on 21Nov2021 and had a breakthrough positive C19 infection. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Oral lesions and extreme fatigue developed per pt 2 days after vaccination. Patient reports these symptoms are consistent with a lupus flare. Unknown if vaccination triggered flare. Also usually gets SLE flares at this time of year "change of season flare" s/s significantly resolved after 3 days of prednisone.
I was having cough and congestion as well as a sore throat. I tested positive on the 28th of June wit a home COVID-19 test. Then I contacted my doctor and she prescribe the PAXLOVID but I didn't take it. I used over the counter medication MUCINEX, cough drops, and they helped with the cough and the irritation in my throat. It took about 11-12 days to get through the sickness. The thing that I did find strand was the person I believe gave me COVID-19 tested negative and I am not sure if she tested too soon or did the test wrong. This individual also shared a long road trip with another individual and they shared a room and this person was negative as well.
Dizziness, headache, sore throat, tiredness Large painful lump near collarbone on left side notice the morning after when she woke up, still present.
Head and muscle aches, "fuzzy" confused head, blurry vision, extreme fatigue, running nose, irritated gravely voice, nasal congestion.  All of the above started, except the fuzzy head and headache which started within 5 hours of the shot,  didn't start until about 36 to 48 hours later.  They lasted for 5 days!!!  Then they started to slowly subside.