chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sleep/dream disturbance; sleep/dream disturbance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose number: 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose number: 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: ABNORMAL DREAMS (non-serious), SLEEP DISORDER (non-serious), outcome "unknown" and all described as "sleep/dream disturbance".  Additional information: The reporter reported that, After further discussion with my 40-year-old daughter, my mom was no longer frightened. My daughter told her she had very similar sleep/ dream disturbances after dose#4. We feel the problem was a side effect due to 4th dose and having had covid in May2022. We feel it was just the way my Mom's 94-year-old body reacted and that there was nothing wrong with the serum, as the same thing happened to my daughter who is 54 yrs. Younger and her dose #4 in a clinic setting.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sunday, I started having breathing problems, I had to use my rescue inhaler, on Monday, my breathing was getting worst, I had to use oxygen, and nebulizer and inhaler every 9-12 hours. I have been on oxygen for two days. My oxygen is on a level 2.
pt recv vax; lt upper arm swollen w/ red swollen centers; painful to touch;advised to have MD evaluate;
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 with a home test on 11/8/2022. I had a minor scratchy throat, dry cough, congestion and no temperature. I contacted my doctor and got a prescription for cough medicine and antibiotics. As of today, I continue to test positive, and I have a stuffy nose and scratchy throat.
I woke up with a sore throat, laryngitis, a fever that went up to 103F, a cough, diarrhea. I went to a Clinic to get tested for COVID-19, RSV, Pneumonia, Influenza A and B all tests were negative except COVID-19. I was given a prescription for the antiviral Lagevrio, within 8 hours my fever started coming down. I tested negative on April 23, 2023, but I was feeling good within a week, the cough lingered it has gone now.
I started to get a weird feeling in my chest a week after the vaccine. It was a burning sensation and I thought it was vaping at first. It started to get worse and worse. A week later I went to the ER and they ran some tests. After testing it was confirmed that I was having a heart attack. I had blot clot in my OM1discovered on 04/07/2021. I had had an angiogram in 2019 and there were no problems then. I was hospitalized for four days and I was given a Stent which ended up getting a blood clot. The original Stent was removed and a larger one was put in. I am now taking some blood thinners, Aspirin, Atorvastatin, Carvedilol 6mg, Prasugrel 10mg, and I am scheduled to see a cardiologist because I still a have a little chest pain.
Anaphylaxis approx. 5 minutes after injection, recieved Epi Pen injection, Benadryl injecton, rescue inhaler used, symptoms resolved after 5-10 minutes
No additional adverse effects; Nurse reported patient received an expired dose of M-M-R II; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concomitant therapies included sterile diluent. The patient's concurrent conditions, historical drugs and conditions were not provided.  On 25- JUN-2020,  the patient was vaccinated with an expired dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) (Expired product administered)  0,5 ml/once, Lot # R011221, expiration date 17-APR-2020, for prophylaxis(strength and patient route of administration were not provided).          No additional adverse effects were reported.  The nurse reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and sterile diluent used to reconstitute the vaccine were stored properly.
received Moderna bivalent booster vaccine at pharmacy 9/16/22 by RPH but it was administered too low in the left arm and deltoid was greatly missed. Pt started to develop pain radiating to tricep that evening and then next morning started with redness and swelling and warmth to arm that increased Sunday. started to improve redness today Monday 9/16/22 but still swelling and warm to touch. instructed to use cool compress and elevate. F/u PCP in 3 days if worsens.
I was pregnant (unknown) at time of vaccine. I had positive HCG on 09/18/2022 and miscarried on 10/26/2022. I have had recurrent miscarriages since then. Major adverse event: 11/2/2022 I was seen in ER for chest pain, near fainting, and painful breathing at sternum. Bloodwork showed extremely elevated white cell count (24.9 K/CUMM). Antibiotics were given to help with infection. I was sent home with verbal diagnosis of pericarditis/myocarditis with pleuritic event.  Secondary possible adverse event: 09/02/2022 I was sent by ambulance to ER for near fainting and inability to obtain blood pressure reading. I was diagnosed with long QT syndrome. At this time I was 19 weeks pregnant and currently I am 23 weeks pregnant.
Had convuls type seizure @ home per moms hx; pt became cyanotic & was placed in towel & taken to ER;
This patient. Received her first dose of pfizer in January without receiving a second dose. For some reason unknown to this nurse, she did NOT receive her second dose. Per patient she was instructed by her physician to redo the entire series of vaccines for SARS-CoV-2. Today, she received her 1st dose of Moderna. This was immediately brought to this RN's attention by the administering RN once the administering RN discovered she received Pfizer in January.
laryngeal swelling; swollen lips; This case was reported by a pharmacist via sales rep and described the occurrence of laryngeal edema in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   In July 2020, the patient received Shingrix and PREVNAR. In July 2020, 2 hrs after receiving Shingrix, the patient experienced laryngeal edema (serious criteria GSK medically significant) and lip swelling. On an unknown date, the outcome of the laryngeal edema and lip swelling were unknown.   It was unknown if the reporter considered the laryngeal edema and lip swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however it could be 64 or 65 years. The patient received Shingrix vaccine and Prevnar vaccine at the same time at the end of July and experienced swollen lips and laryngeal swelling within 2 hours of vaccination. It was unknown if the reporter considered the laryngeal edema and lip swelling to be related to Prevnar vaccine.  The permission to follow-up was denied.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 06-MAR-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J007954 and expiry date: 27-JUN=2015) which was improperly stored. Primary reporter was reported excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality (PWC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
No additional AE information provided; administered the first dose ofGARDASIL 9 on 4/30/2019 and was administered the second dose ofGARDASIL 9 on 2/20/2020; This spontaneous report was received from a pharmacist referring to a 29 years old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 30-APR-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose details, route, lot # and expiration date were not reported) for prophylaxis. On 20-FEB-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). The patient had not received the third dose yet. No additional adverse event information was provided.
Chills; arm pain; Fever; Nausea; Feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 09:00 (Lot number: FC3181) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CENTRUM MULTIGUMMIES; GRAPE SEED EXTRACT [CITRUS AURANTIUM FRUIT;VITIS VINIFERA SEED]; TART CHERRY. Vaccination history included: Bnt162b2 (Covid vaccine details:, Product: COVID 19, Brand: Pfizer, Lot number: Fa7484, Lot unknown: False, Administration time: 12:00 PM, Vaccine location: Left arm, Dose number: 1), administration date: 30Jul2021, when the patient was 60 years old, for COVID-19 Immunisation.  The following information was reported: CHILLS (non-serious) with onset 20Aug2021 19:00, outcome "recovering", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 20Aug2021 19:00, outcome "recovering", described as "arm pain"; PYREXIA (non-serious) with onset 20Aug2021 19:00, outcome "recovering", described as "Fever"; NAUSEA (non-serious) with onset 20Aug2021 19:00, outcome "recovering", described as "Nausea"; MALAISE (non-serious) with onset 20Aug2021 19:00, outcome "recovering", described as "Feeling unwell". Therapeutic measures were not taken as a result of chills, pain in extremity, pyrexia, nausea, malaise.  Additional information: No other vaccine received with in four weeks. No Covid prior vaccination and has not been tested after vaccination. Patient did not receive any treatment.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Pfizer / BioNTech; vaccine dose number=2/ vaccine brand other= Moderna; vaccine dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Dec2022 at 14:30 as dose 5 (booster), single (Lot number: GJ6739) at the age of 59 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Jan2021 at 10:15 as dose 1, single (Lot number: EH9899), in right arm and on 29Jan2021 at 14:45 as dose 2, single (Lot number: EL1283), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Dec2021 at 09:00 as dose 3 (booster), single (Lot number: 033H21A), in right arm and on 14May2022 at 14:00 as dose 4 (booster), single (Lot number: 001M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "need thyroid medication" (unspecified if ongoing), notes: other medical history: need thyroid medication. Concomitant medication(s) included: LEVOTHYROXINE, start date: Nov1995.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Dec2021 at 09:00, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech; vaccine dose number=2/ vaccine brand other= Moderna; vaccine dose number=3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Patient received flu and pneumonia shot on 9/24. Started having fever and pain in the arm the next day. Continued until 9/27 when patient decided to seek medical treatment. Continued with fever  (103) and muscle pain/weakness/redness in the arm.
Some of the vaccine came out of the injection site after administration/she noticed the fluid coming out of the injection site, which was followed by blood; Some of the vaccine came out of the injection site after administration/she noticed the fluid coming out of the injection site; This spontaneous case was received on 18-Oct-2022 from Communications (reference number: SEQW22-04698), reported by other healthcare professional and concerned a 65-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 18-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: not reported, route of administration: intramuscular, anatomical location: reported as 'right deltoid', and indication: influenza prophylaxis). The batch number was not reported. During administration of the Fluad Quadrivalent, the patient's arm was tense and firm. When pharmacist delivered the dose and removed the needle, she noticed the fluid coming out of the injection site, which was followed by blood (Explicitly coded as 'Incorrect dose administered'). Additionally, the pharmacist confirmed that there was no issue with the pre-filled syringe.  The outcome of the event of 'vaccination site bleeding' was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 65-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. As reported, when pharmacist delivered the dose and removed the needle, fluid was coming out of the injection site, which was followed by blood (Explicitly coded as 'Incorrect dose administered'). Causality for vaccination site haemorrhage is assessed as possibly related. Causality for incorrect dose administered is assessed as not related based on company specific guidelines.; Sender's Comments: A 65-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. As reported, when pharmacist delivered the dose and removed the needle, fluid was coming out of the injection site, which was followed by blood (Explicitly coded as 'Incorrect dose administered'). Causality for vaccination site haemorrhage is assessed as possibly related. Causality for incorrect dose administered is assessed as not related based on company specific guidelines.
Pain that radiated up arm and neck, plus down arm to hand. 2 days of body aches, chills, followed by on going pain from injection site to elbow that increases when arm is raised up from side. Its a shooting, aching, nerve irritation like pain, persisting to today.
had shingles shots and still got the shingles/suspected vaccination failure; shingles; nerve pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shingles shots and still got the shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and post herpetic neuralgia (Verbatim: nerve pain). The patient was treated with analgesic, nos (Pain Medicine (Medication Unknown)). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was resolving.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2023 This case was reported by a patient via interactive digital media. The patient had his/her shingles shots and still got the shingles.  The patient had nerve pain for three years now.  They had gotten better because he/she took pain medicine everyday since.  The reporter further stated that he/she felt sorry for anyone that got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Initial unsolicited report was received on 04 December 2014 from another manufacturer (manufacturer report number 2014297065) who received it from an investigator. An 11 year-old female patient had received on 06 November 2013 the following vaccines: a 0.5 ml intramuscular right deltoid injection of DTP Absorbed Vaccine (manufacturer and lot number not reported) and a 0.5 ml intramuscular left deltoid injection of MCV4 (manufacturer and lot number not reported). The patient also received on 02 October 2013 a dose three 0.5 ml intramuscular left deltoid injection of Meningococcal Group B RLP2086 (other manufacturer lot number not reported) and on 26 November 2013 the patient had a positive PCR for Bordetella pertussis. The patient had no significant past medical history but had a cough without fever at time of Tdap vaccination. The patient received dose one and two of Meningococcal Group B RLP2086 on 07 May 2013 and 19 June 2013 respectively. Treatment included Azithromycin from 26 November to 30 November 2013. According to the report the initial aware date of the event was 27 October 2013. No further information was available at the time of the report. Outcome was recovered on 04 April 2014. Documents held by sender: none.
I am of child bearing age. The vaccine brochure did not state that I could get spotting but I started getting spotting after 3 days. Other than that I am fine. Just had minor achy arm at the injection site.  I just wonder if other woman are experience this? And if this will affect my fertility?
Patient started to have tongue numbness and periorbital tingling immediately after vaccination. Patient was subsequently transported to the ED. No medications were administered in the emergency department. Patient was released to home.
Within 60 seconds my heart started racing and my breathing became mildly labored. Had to go home and take a nebulizer treatment to reduce symptoms.
105.6 fever, crying, loss of appetite, sleeping a lot more, and cranky. Trips to the ER and private Doctors, they prescribed Tylenol and Motrin.
pain; rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 41 year-old female patient (not pregnant) received BNT162B2, administered in arm left, administration date 03Aug2021 (Lot number: PA7484) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "covid-19" (unspecified if ongoing); "Zoster Herpes" (unspecified if ongoing), notes: Diagnosed: Zoster Herpes in past. Took Valacyclovir 1 Gram; 7 days -blisters and pain subsided. Concomitant medication(s) included: METOPROLOL; ZOLPIDEM; DIAZEPAM; ESTRADIOL. Past drug history included: Valacyclovir, notes: Diagnosed: Zoster Herpes in past. Took Valacyclovir 1 Gram; 7 days -blisters and pain subsided. Vaccination history included: Bnt162b2 (product-COVID 19, brand-Pfizer, lot number-EW0198, lot unknown-False, administration date-13Jul2021, administration time-10:45 AM, dose number-1, vaccine location-Left arm), administration date: 13Jul2021, when the patient was 41 years old, for covid-19 immunisation, reaction(s): "shingles appeared on left side midline back to midline front". The following information was reported: PAIN (non-serious) with onset 15Aug2021, outcome "unknown", described as "pain"; RASH (non-serious) with onset 15Aug2021, outcome "unknown", described as "rash".  No follow-up attempts are possible. No further information is expected.
swollen arm, warm/hot to touch, itching and burning also had fever on tuesday 10/05/2021 which lasted until wednesday 10/06/2021
The night of 4/27/21 patient developed chills, malaise and weakness along with altered mental status. Patient started running a fever and had increased AMS so wife brought pt to ER. Upon arrival to ER pt had temp of 100.2F and SpO2 was 84% on room air. Patient was admitted to the hospital for altered mental status and is still currently inpatient and is currently A/O and stable.
Patient developed a headache similar to her chronic migraines (bifrontal, rated 4/10) with no associated nausea/vomiting, altered mental status, LOC, shortness of breath.  She preferred to leave with mom (who agreed that her symptoms were similar to chronic headaches) and were going to take medication when she got home.  Mom was going to bring her back if the symptoms worsened or were not resolved with her regular medication.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:41 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 68.87 for dose administered on 03-Nov-2021. No concomitant medications were reported. Batch number 035C21A underwent temperature excursion on 03-Nov-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 05-Oct-2021 and beyond use date for the vial was reported as 05-Nov-2021. Product moved to clinic on 03-Nov-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.