chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough fever of 100.3 with 1000 mg Tylenol Q 6 hours, nausea, inappetence, exacerbation of back pain.  Abdominal pain and alternating diarrhea and constipation of 3 weeks afterward
No Adverse event; 1 dose of the Moderna vaccine was administered past the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna vaccine was administered past the expiration date.) 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 COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-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. On 13-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna vaccine was administered past the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna vaccine was administered past the expiration date.) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna vaccine was administered past the expiration date.).    No concomitant medication was reported.    The vial was pulled from the freezer on 09-Mar-2023. Expiration date was 12-Mar-2023. The vial did not undergo any temperature excursions. No treatment information was reported.
12/20/22 I was coughing. I woke up the next morning with a sore throat and achy. I was still coughing. I had been exposed to COVID. I took a home COVID test and it was positive. I had a telehealth on 12/21/22 and was prescribed PAXLOVID. I started taking it that day around noon and stayed on it for the full 5 days. I ran a low grade fever and generally did not feel very well. I am still getting over the cough.
Patient received a dose of Menquadfi after temperature excursion(max temperature was 14.6C; low temperature 0.1C, excursion lasted a total of 12 hours and 10 minutes) with no reported adverse event; Initial information received on 05-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA272373(CLUSTER).  This case involves a 16 years old male patient who received a dose of menquadfi after temperature excursion(max temperature was 14.6c; low temperature 0.1c, excursion lasted a total of 12 hours and 10 minutes) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero) for Prophylactic vaccination.  On 28-Aug-2023, the patient received 0.5 ml dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection lot U7633AB expiry- 25-Apr-2028 via intramuscular route in the left arm for immunization (strength: unknown), patient received a dose of menquadfi after temperature excursion(max temperature was 14.6c; low temperature 0.1c, excursion lasted a total of 12 hours and 10 minutes) with no reported adverse event (poor quality product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
This spontaneous report received from a patient concerned a 35 year old male. The patient's weight, height and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series was 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified date in MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date in MAY-2021 following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series was 1), the patient experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lethargic was not reported. Non-company suspect vaccine included: BNT 162 (Dose number in series was 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 19-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-DEC-2021, following vaccination with BNT 162 (Dose number in series was 2), the patient had allergic reaction (vaccine made his left eye swell up, eye inflamed and his upper eye lid was inflamed). On 21-DEC-2021 patient went to the emergency room and diagnosed with an allergic reaction and prescribed him Zyrtec which failed to work and it has gotten worse in the last two days. According to caller he needs to go to another doctor for this adverse reaction and the patient barely see out of left eye and symptoms got worse and whole left eye was a lot more lower sitting than right eye. The patient was about to lose his mind.  The action taken with bnt 162 was not reported. The patient had not recovered from allergic reaction. This report was non-serious.
Had Td 6/21/04. Was a little pink at injection site that night. On 6/22 morning, was the size of a quarter; during the day size increased. Patient given Tylenol and site was iced. Size 9cmx8cm. Internal aspect of left arm: red, warm, slightly firm to touch. No pain. Cellulitis 2 hours after DTaP. On 6/23, mom took patient to ER as cellulitis increased in size. Advised no other treatment. Continue with Erythromycin and use ice. Recommended to see PCP for follow up but not done.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild
Pt came to ER c/o weakness, nausea, vomiting onset 2 weeks prior.
edema on chin and lower eyelids; edema on chin and lower eyelids; This is a spontaneous report from a non-contactable consumer. This consumer reported for an other HCP (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was injected with 1ml Voluma in temples, 3 ml Voluma cheeks, 1 ml Volift midface, 1 ml Volbella tear trough and 3 ml Volux in chin. Two months later patient also received 0.5 ml non-Allergan dermal filler in lips and a small correction of 0.1 ml in the left tear trough. Following month, patient received a covid19 vaccine. Next morning, patient woke up in the morning with edema on chin and lower eyelids. The outcome of the events were not recovered (symptoms on going).  No follow-up attempts are possible. Information related to batch/lot number could not be requested.
Non-itchy, warm visible rash over left arm. Same arm I recieved my first dose shot.
This spontaneous report as received from a medical assistant refers to a 24 year old patient. On 28-MAY-2013 the patient was vaccinated with GARDASIL dose 2. Dosing information, route of administration and lot number were not provided. The patient received the 1st dose (dosing information, route of administration and lot number not provided) of GARDASIL approximately in 2003 (at the age of 14). No adverse effect was reported. Additional information has been requested.
Patient received first dose of COVID vaccine. Following administration, patient only remained in store for several minutes before departing. Patient began to develop anaphylactic symptoms (stated rash and swelling in throat). Patient informed pharmacist that she went to her provider's office and received an EpiPen injection from them to reverse the reaction. Patient was unable to provide pharmacist name of the provider's office when asked for reporting purposes.
Pt called several hours after receiving vaccines c/o "swollen lips". No c/o SOB, throat problems, etc. Advised to contact MD - go to ER if symptoms worsen.
Raised red area around site about size of silver dollar. Warm and hard. Itchy. Was not given in deltoid but in lower floppy part of arm toward back of arm. Symptoms persist today 10/05/2012.
pt recv vax 11OCT96 & states arm became warm to touch & swollen below inj site @ 2" below elbow;felt chills on 12OCT96 but did not take temp;states has arthritis in rt elbow;has not had pneumovax in past;arm still sore;
Within fifteen minutes my vision became blurry./vision remains slightly blurry.; Was too weak to stand.; Over the course of the following days, my left eye area has become swollen; Over the course of the following days, my left eye area has become swollen and painful; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 24Apr2021 at 09:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included aripiprazole (ABILIFY) and fluoxetine hydrochloride (PROZAC); for unknown indication from unknown start date and unknown if ongoing. On 24Apr2021 at 10:00 within fifteen minutes the patient's vision became blurry and also felt too weak to stand. This reaction faded within an hour. On an unknown date in Apr2021, over the course of the following days the patient's left eye area had become swollen, painful and vision remained slightly blurry. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events too weak to stand was recovered with sequelae within an hour on 24Apr2021 at 11:00; while that of the events left eye area had become swollen and painful was recovered with sequelae on an unknown date in Apr2021. The clinical outcome of the event vision became blurry was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
he also was like paralyzed like caller was; This is a spontaneous report form a contactable consumer. This is report 3 of 5. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. On an unspecified date, the patient experienced he also was like paralyzed like caller was. Consumer reported for patient stating that: reporter's girlfriends cousin's housemate, her ex-husband is patient. Patient got the Pfizer Covid vaccine and he had basically the same symptoms that reporter did; but patient went for his second shot and felt good for 24 hours like he did on first shot; but patient also was like paralyzed like reporter was. The clinical outcome of the he also was like paralyzed like caller was unknown.  Follow up attempts are needed. Further information has been requested.
35 minutes after immunization, "not feeling good". 45 minutes - nausea. That evening vomited 3-4 times. Then chills, body aches, lethargy. After 24 hr sweating and hot. 72 hrs later felt normal.
Extreme dizziness to the point of not being able to stand, nausea, vomiting, elevated blood pressure, chills, burning heavy ness in chest, fatigue.   Nausea, dizziness and fatigue for over 2 weeks after 2nd shot.
Since last VAERS report- -03/08/2021 I was recently diagnosed with severe hip, knee, groin pain, and back pain. I ended up needing to get a referral to see a rheumatologist because my orthopedics doctor couldn't figure out what was wrong. My rheumatologist put me on prednisone taper and leflunomide and it seems that I'm getting some relief with those two medications and I have to follow-up with my rheumatologist soon. I never had any inflammatory issues before so this is a whole new diagnosis for me.
Upon waking up the day after receiving shot, 1.5" inches welt at injection site. Welt was raised, perfectly round, bright red, itchy and sore area. Welt remained for 48 hours. Injection site still sore and has 1 inch bump under skin. No treatment requested or given.
There were no adverse reactions or symptoms. Pt received Pfizer vaccine for Pediatric pt instead of Pfizer vaccine for correct age limit.
pt recvd 1st dose of Hep B & 5 days following vax & devel a generalized urticarial rash; no further details provided;
Severe and widespread itching in every inch of my body, initially on my head/scalp and my pelvis and then expanded all over. Duration a good amount of time, maybe 10-15 minutes and then it went away. Same event the day after.  The third day I woke up with a more severe itching mixed to a strong and painful stomach pain, very similar to an acid reflux/heartburn type of pain, where I could barely swallow my saliva. I spent a mostly sleepless night fighting against this chest pain/burning feeling. The third day I needed to go to the Urgent Care. The itching kept migrating all over my body and showing severely, mostly in the morning after my awakening and in the evening before sleeping. At times I would wake up with red and swollen eyes, herpes on my lips and tonsillitis. Stomach pain very painful for a week before improving slightly with medications.
no symptoms reported/No additional AEs reported; 33 year old patient received dose of PROQUAD; This spontaneous report was received from a nurse who refers to a 33-year-old patient of an unknown gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 23-JUL-2021, the 33-year-old patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 05 milliliter, subcutaneously, for prophylaxis, lot # T030944, which has been verified to be valid, expiry date was not reported, but upon internal validation was established as 09-MAR-2022 (formulation, concentration, dose number, frequency were not reported). No additional adverse event was reported. No product quality complaint (PQC) was involved.
under dose administration of quadracel due to the child moving during administration with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 years old female patient who had under dose administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] due to the child moving during administration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination.  On 02-Sep-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE at a dose of 0.5 ml lot U7526AA via intramuscular route in the left deltoid for immunisation.  On 02-Sep-2022 the patient had under dose administration of quadracel due to the child moving during administration with no reported adverse event (underdose).  Action taken: Not applicable.  Outcome: Unknown.
This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction, swollen arm, erythema of extremities and fatigue. SHINGRIX was discontinued. On an unknown date, the outcome of the allergic reaction, swollen arm, erythema of extremities and fatigue were unknown. It was unknown if the reporter considered the allergic reaction, swollen arm, erythema of extremities and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The other health professional reported that, she had a patient who had a strong reaction to the first shot. The swollen red arm and fatigue. She wanted to know how efficacious was the vaccine if she only gets one shot. Her primary care thought she might be allergic so they recommended her to not get the second dose. No additional information was reported.
At 2 month visit, DaPT/Comvax given right thigh; IPV Prevnar given left thigh. At 4 month visit DaPT/Prevnar give right thigh; IPV/HIB given left thigh. DaPT site at 2 months and Prevnar site red, warm, swollen with fat neurosis to be drained by surgeon.
Initially, 1.5 weeks of local redness, swelling and tenderness that resolved. Presently, she has 2 weeks of dizziness and a feeling of shortness of air requiring deep breaths to feel better
Booster given too early on 3/17/2022 Pfizer dose 1 11/18/2021 Pfizer dose 2 1/10/2022 Pfizer booster 3/17/2022
diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (reporter's father and mother). This is first of two reports.  A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration in Jan2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that his parents received the first dose of the Pfizer COVID vaccine in Jan2021 and then was diagnosed with COVID-19 and could not receive the second dose of the vaccine. He had been told conflicting things regarding if and when they should receive the second dose. He was originally told they had to wait 90 days to receive the second dose and then he was told they had to restart the series and not just receive the second dose. He would like to know what the correct guidance for his parents is. He would like to know if the first and second dose is the same composition and quantity. He stated the vaccination facility where his parents received the first dose of the vaccine ran out Pfizer COVID vaccines so he was wondering if he could go to another location that had Pfizer COVID vaccines. He would like to know if the vaccine will be still as effective if given greater than 90 days apart from the first dose. He was trying to get answers regarding the Covid-19 vaccine. His parents received the first dose of the vaccine in Jan2021. Between the first and second dose they had Covid and was unable to get the second dose. They were told they had to wait 90 days and start over. After 90 days was told only the second dose was needed. He tried to schedule the vaccine and was told they had to start over. He kept getting the back and forth.  Case was reported as non-serious. Outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021414637 same reporter/drug/event, different patient
No adverse effect reported; patient was inadvertently administered M-M-R II intramuscularly; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history or drug/ allergies reactions were not provided.   On 21-JUN-2019, the patient was inadvertently administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Lot number N027779, expiration date 08-AUG-2019; formulation and dose were not reported) intramuscularly for prophylaxis (incorrect route of product administration) and sterile diluent (DILUENT MRK INJ) (Lot number N006324, expiration date 24-JUL-2019;. No adverse effect reported. No product quality complaint (PQC) was involved.
extreme fatigue/ more tired and sleeping 12 hrs that night; more tired and sleeping 12 hrs that night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 23Mar2021, outcome "recovered" (24Mar2021), described as "extreme fatigue/ more tired and sleeping 12 hrs that night"; HYPERSOMNIA (non-serious) with onset 23Mar2021, outcome "recovered" (24Mar2021), described as "more tired and sleeping 12 hrs that night". Therapeutic measures were not taken as a result of fatigue, hypersomnia.  Additional event: Age: 61; Units: Unknown. The patient experienced extreme fatigue within 10 minutes of receiving the injection, becoming progressively more tired and sleeping 12 hrs that night. This fatigue lasted for two days and ended by the evening of the second day. It was unknown if patient received any other vaccines within four weeks prior to the vaccination. 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 lot number for bnt162b2 was not provided and will be requested during follow up.
tightness in the face; numbness in the face; throat was swollen; This spontaneous case was reported by a consumer and describes the occurrence of FACE INJURY (tightness in the face), HYPOAESTHESIA (numbness in the face) and PHARYNGEAL SWELLING (throat was swollen) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced FACE INJURY (tightness in the face), HYPOAESTHESIA (numbness in the face) and PHARYNGEAL SWELLING (throat was swollen). On 31-Jan-2021, FACE INJURY (tightness in the face), HYPOAESTHESIA (numbness in the face) and PHARYNGEAL SWELLING (throat was swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
2.5 weeks after second dose. Hives all over body. High tropinin T High sensitivity test. Confusion, dizziness, lightheaded, chills, hot flashes.