chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Significant and long lasting hot flashes; This is a spontaneous report from a contactable other hcp. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot Number: EL1284 ), dose 2 via an unspecified route of administration, administered in Arm Left on 18Jan2021 as 2nd dose, single for covid-19 immunisation(Age at vaccination: 37 Years). Medical history included hepatitis c. Concomitant medications included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE) , bupropion hydrochloride (WELLBUTRIN), meloxicam, lamotrigine (LAMICTAL). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot Number: EK5730), administered in Arm Left on 28Dec2020 for covid-19 immunisation and experienced Soreness in arm extending beyond injection site, fatigue for 2 days after the first dose. The patient experienced significant and long lasting hot flashes after getting the second dose in Jan2021, experienced them almost two weeks. The patient underwent lab tests and procedures which included covid test post vaccination on 28Dec2020, 30Dec2020, 04Jan2021, 08Jan2021, 11Jan2021, 14Jan2021, 19Jan2021, 25Jan2021 and result of all was negative. patient was not diagnosed with COVID-19 post vaccination.She is not pregnant at the time of vaccination. She did not receive treatment for the adverse event. Patient has no allergies to medications, food, or other products. The Outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Syncopy. Fainting attack after 5-10 min of Menactra and Gardasil vaccination
really bad headache/doctors think I am having a reaction to the vaccine, The headache is getting worse, it is not responding to medication; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (really bad headache/doctors think I am having a reaction to the vaccine, The headache is getting worse, it is not responding to medication) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (really bad headache/doctors think I am having a reaction to the vaccine, The headache is getting worse, it is not responding to medication). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at an unspecified dose and frequency; ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) ongoing since an unknown date for Headache, at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (really bad headache/doctors think I am having a reaction to the vaccine, The headache is getting worse, it is not responding to medication) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: clear (normal) The CT scan was clear. On an unknown date, SARS-CoV-2 test: normal (Negative) A COVID test came back negative.     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.   It was reported that the headache was not responding to medication and was  getting worse.  Relevant concomitant medications were not provided.
About 15 hours recieving vaccine, began feeling feverish with chills, headache, and muscle aches.  Treated with ibuprofen.
This case was reported by a nurse via a sales representative and described the occurrence of injection site rash in a subject aged between 4 to 6 years old of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included live attenuated measles, mumps (strain not specified), rubella vaccine (manufacturer unspecified) and varicella virus vaccine (manufacturer unspecified) both given in 2011. In 2011 the subject received unspecified dose of KINRIX in an unknown shoulder. In 2011, less than one year after vaccination with KINRIX, the subject experienced injection site rash and swelling injection site. At the time of reporting the events were resolved. The sales representative indicated that a nurse reported 4 to 5 instances of rash and swelling at the injection site following administration of KINRIX. Specifics for each subject were not available. It was reported that the subject were between 4 to 6 years of age and included males and females. There were 3 to 4 instances in 2011 and 1 in 2012. The KINRIX vaccinations were given in the right or left shoulder. The subjects all received MMR and Varicella vaccines concurrently, but the rash and swelling were only noticed with the KINRIX vaccine. Linked case for episode in 2012 - A0973638A.
Rebound of symptoms on day 11; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound of symptoms on day 11) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    No Medical History information was reported.   On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 15-May-2022, the patient experienced COVID-19 (Rebound of symptoms on day 11). At the time of the report, COVID-19 (Rebound of symptoms on day 11) had not resolved.            No concomitant medication was reported. It was unknown that whether the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a 41-year-old female patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine and 11 days after receiving the co-suspect, non-company product Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19 treatment. As reported, patient had rebound of symptoms on day 11, no other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 41-year-old female patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine and 11 days after receiving the co-suspect, non-company product Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19 treatment. As reported, patient had rebound of symptoms on day 11, no other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Noted on morning of 01Oct2014. 3 cm x 2 cm urticarial wheal surrounding injection site, pink, slightly pruritic. still present as of afternoon of 02Oct2014.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 61-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. On 27th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th December 2018, 2 days after receiving SHINGRIX, the patient experienced injection site warmth and pain in arm. On an unknown date, the outcome of the injection site warmth and pain in arm were unknown. The reporter considered the injection site warmth and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. The patient called the pharmacist on 31st December 2018 but he felt the adverse events started on 29th December or 30th December 2018. The patient stated there was a hot spot at the injections side with pain and achiness in the arm in which the vaccine was administered. The pharmacist was transferred to Medical Information for information on whether the 2nd dose should be administered.
Patient was given the second dose / reconstituted with sterile water; Patient was given the second dose / reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number P2J7E, expiry date unknown) for prophylaxis.   On 17th May 2021, the patient received the 2nd dose of Shingrix. On 17th May 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix reconstituted with sterile water instead of the ASO1B approved diluent,which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Blotchy/Rash appearance on skin, lethargic, chest pressure, shortness of breath
Extremely dizzy; barely walk to the bathroom without holding on to something.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extremely dizzy) and GAIT DISTURBANCE (barely walk to the bathroom without holding on to something.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DIZZINESS (Extremely dizzy) and GAIT DISTURBANCE (barely walk to the bathroom without holding on to something.). On 07-Mar-2021, DIZZINESS (Extremely dizzy) had resolved. At the time of the report, GAIT DISTURBANCE (barely walk to the bathroom without holding on to something.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information was provided.
Random menstrual bleeding mid cycle began 2 days after first shot,  irregular long periods ever since.
Information has been received from a health professional concerning a 50 year old male who on 07Apr04 was vaccinated in the right deltoid with a first dose of hep b virus vaccine rHBsAg (yeast) (lot 646601/1352N). It was noted that the pt had a pertinent medical history. Subsequently, the pt experienced a local reaction at the right deltoid including swelling at the site and redness at the site. It was reported that the pt did not return for his second dose until 09Jun04. Unspecified medical attention was sought. Additional information has been requested.
Four days post vax, pt developed an injection site reation characterized by redness, itching, and swelling.  She was seen by a physician on 02/07/1999 and treated with Tylenol and Benadryl.  She recovered on 02/09/1999.
pt recvd vax; unconsolable crying for more than 3 hrs; fever of 103 x 2 days;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jun2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "insomnia" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known Allergies: Ibuprofen"; Aspirin, reaction(s): "Known Allergies: Aspirin". The following information was reported: DRUG INEFFECTIVE (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 antibody test: (30Dec2022) Positive, notes: Tested positive on at home test 30Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Patient received Vaccine, Anti viral details: [product=COVID 19 Treatment, Treatment start date Dec2022, Treatment stop date Dec2022, Indication, Treatment of COVID-19]   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt sustained a rash starting 1 day after vaccine both times. papular irregular rash lasting at least 1 week that faded to  hyperpigmentation for first injection. currently 7 days post second vaccine
Pt experienced facial palsy, was seen in ER and worked up for stroke. Stroke was ruled out and dr diagnosed him with hyoglosal nerve palsy and indicated that his recent vaccine was most likely cause and that it would resolve on its own and it did after about a week or so.
This non serious case was extracted from the VAERS database via QSCAN on 11 March 2009 (reference number 292440). A 61-year-old female patient had received a tenth dose intramuscular injection of FLUZONE SV 2007-2008, lot number U2467AA on 05 October 2007 and  eight hours after vaccination she became very sleepy. The patient slept 12 hours straight and awoke with a cough, wheezing, tightness of her chest, red painful eyes with blurry vision and reported as recovered (date of recovery not reported).
CURED CHRONIC BRONCHITIS, TEN YEAR LONG COUGH (ESPECIALLY MORNINGS) FADED AWAY; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced cured chronic bronchitis, ten year long cough (especially mornings) faded away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cured chronic bronchitis, ten year long cough (especially mornings) faded away was not reported. This report was non-serious.
Scheduled for second COVID 19 dose. Pfizer Lot # EW0153 vial was reconstituted with .8 mL 0.9% sodium chloride instead of 1.8 mL. RN withdrew 0.3 mL diluent and administered IM to left deltoid. Pt remained for 15 minutes post injection. Arm pain at injection site, no other reaction noted or reported.
Fever, chills, change in menstrual cycle, extreme all full body joint pain, muscle spasms, head ache, nausea, extreme fatigue, shortness of breath on exertion.
I had an itchy dry patch on my right ankle. Dry patches on both knees and elbows. Dry red cracking irritated areas on the knuckles of my hands/joints. It flares and recedes. When it flares, I use clobetasol propionate cream 0.05% twice daily until it calms down. Usually for about 2 weeks at a time. I had not had these symptoms since childhood. The symptoms on the hands are new for me and I've never had these before.
A nurse reported that a pt received an injection of Prevnar and experienced pain at the time of administration. She indicated that this particular vaccine appears to be causing more discomfort that the other vaccine products administered. The reporter indicated that other children have experienced this event but she was unable to specify the number of pts involved. Additional reports will be generated when identifying information is received. No further information was available at the date of this report.
Fever; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Lot number: FF2588) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose:, lot number: EL3247,, administration time: 16:00, dose number: 1,, vaccine location: Right arm), administration date: 14Jan2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache".  No follow-up attempts are possible. No further information is expected.
Right thigh cellulitis-  red, hot, swollen, taut, tender entire right thigh from hip to knee -tx cephalexin 50 mg/kt/day divided doses   X10 days
COVID-19 Treatment; COVID-19 Treatment; 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), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt reported lower lip blistering, 3-4 blisters with swelling and burning, fatigue and headache. Pt is an employee of the facility and was assessed by Dr. at the time of the event.  No additional outside clinic or office visit.
Covid arm- redness, swelling, rash, soreness in arm. No itch as of today but rash is getting larger in size of area.
Headache c/o pain immediately upon admin. of vaccine. Followed Rapidly by Urticarial Reaction (redness) nose, eyelids, cheeks + 2 solitary urticaria on R ant. chest
Sleep walking; This spontaneous case was reported by a consumer and describes the occurrence of SOMNAMBULISM (Sleep walking) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sleep walking (She had one episode of sleep walking 40 years ago, but has no history of sleep walking since then).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNAMBULISM (Sleep walking). At the time of the report, SOMNAMBULISM (Sleep walking) outcome was unknown.            Patient was on concomitant medication, but did not specify the names.  It was reported that the patient drove her car and opened the sunroof at 3 am. Patient had done all this in her sleep and did not recall it. The next morning she went to her car, and saw the sunroof was opened about 6 inches, it triggered patient's memory that she was driving with the sunroof open at 3 am and it was raining.  Treatment information was not reported.   This case was linked to MOD-2022-535830, MOD-2022-535838, MOD-2022-535849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Follow-up received contains signification information. Causality updated.
Reports soreness to injection site since 5/24/21 however developed increased swelling and warmth at the injection site on 5/26/2021. On 5/27/2021 the swelling and redness began to spread down his arm and he started to not feel well with chills and nausea. The patient was then seen by primary care this a.m. on 5/28/2021 who obtained blood work and an ultrasound. The patient was then instructed to present to the emergency department for IV antibiotics. He reports the arm is painful however declines need for pain medication.  The patient does have a scabbed over area to the right hand which he reports is from his daughter's puppy that happened approximately 3 weeks ago. He has been applying bacitracin to this at home.
102 Fahrenheit Fever; Sore arms; Stiff arms; Flu-like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fever, pain in arm, limbs stiffness and influenza-like symptoms. On an unknown date, the outcome of the fever, pain in arm, limbs stiffness and influenza-like symptoms were unknown.   It was unknown if the reporter considered the fever, pain in arm, limbs stiffness and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The case was reported by the managing pharmacist and pharmacy technician. After receiving Shingrix, the patient experienced fever, sore and stiff arms and flu like symptoms. The patient's body temperature was recorded as 102-degree Fahrenheit. The reporter did not consent to follow up.
8/20/10 patient given GARDASIL #1 LD/IM. Approximately 2 min later, patient passed out.