chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Apr2021 as dose 1, single for COVID-19 immunisation; doxycycline (DOXYCYCLINE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose single for melanocytic naevus/have some moles. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. The patient was going to get second Pfizer shot on Friday the 30th. On yesterday, the doctor prescribed with some antibiotics (later clarified as Doxycycline) and patient wanted to know if antibiotics can be taken without it interfering with the Pfizer (Vaccine). Next one (Pfizer COVID Vaccine) was on Friday, 30th. Took one antibiotic last night because it was one every night. Patient just had a headache but did not know if it was coming from that. Took it last night. Had the first shot on April 9, the second shot on April 30th. The antibiotic was for face. Have some moles removed, that was what the antibiotic was for. Still experiencing headache, consumer stated as no. Consumer was unwilling to share further information, hence, product details (NDC#, UPC#) reporter type and other details were unknown. Limited information was available over the call. Outcome of the event was resolved on an unspecified date. The action taken in response to the event for doxycycline was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Patient received second dose of Pfizer vaccine.  Vaccine expiration time 0930 on 5/12/2021. Patient received vaccine on 5/12/2021 at 0932. MD made aware.  No harm to patient.
Severe dizziness, rare front or left headache with pain, pain in both eyes and left eyelid tremor, diarrhea, muscle and joint pain, stiff fingers, feet and leg muscles, rash all over the body, fatigued and shortness of breath, tiredness.
The client was given a Pfitzer vaccine that was stored at room temp greater than 12 hours
the same sensation and then it disappears; like a cramp; difficulty to walk; extreme tension in both legs; Tingling sensation around the right ear and in the hairline; It seems to be superficial; had the same sensation immediately after the second injection; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation around the right ear and in the hairline), SKIN DISORDER (It seems to be superficial), FEELING ABNORMAL (had the same sensation immediately after the second injection), FEELING ABNORMAL (the same sensation and then it disappears) and MUSCLE SPASMS (like a cramp) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (had the same sensation immediately after the second injection). On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation around the right ear and in the hairline), SKIN DISORDER (It seems to be superficial), FEELING ABNORMAL (the same sensation and then it disappears), MUSCLE SPASMS (like a cramp), GAIT DISTURBANCE (difficulty to walk) and MUSCLE SPASMS (extreme tension in both legs). At the time of the report, PARAESTHESIA (Tingling sensation around the right ear and in the hairline), SKIN DISORDER (It seems to be superficial), FEELING ABNORMAL (had the same sensation immediately after the second injection), FEELING ABNORMAL (the same sensation and then it disappears), MUSCLE SPASMS (like a cramp), GAIT DISTURBANCE (difficulty to walk) and MUSCLE SPASMS (extreme tension in both legs) outcome was unknown.        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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.    This case was linked to MOD-2021-042915, MOD-2021-026666 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Reporter contact details was updated.
pt recv vax in 1983 & in 1983 pt became ill immed & exp unspecified autoimmune medical problems;
This spontaneous report as received from a licensed practical nurse refers to her 6 year old grandson. On an unknown date the patient was vaccinated with the second dose of VARIVAX 0.5 ml, subcutaneous. Lot# was unspecified. On an unknown date, after receiving VARIVAX (merck) the patient developed "chicken pox some time after receiving the vaccine but it was a mild case." Within a year, he also ended up having a small patch of shingles on an unspecified area of his arm. There was not any lab study. The patient was recovered from events on unspecified date. The patient just sought medical attention from the reporting nurse. Additional information has been requested.
Extreme pain in left arm, cannot sleep on left side because of the pain. Pain has been continuous since vaccinations in April of 2021. Arm throbs randomly, is extremely sore periodically throughout the day. There are random bursts of heat from vaccination site on the arm. Hurts to lift the arm and use the arm periodically throughout the day. Spot where vaccine was administered is very tender generally 24/7. Have not seen a medical professional because an overnight nurse line said it will go away. There is nothing that can be done.
Client presented with father to receive  Pfizer COVID vaccine Dose 1. Client was sitting down in chair by himself.  When Vaccinator RN inserted the needle in to client?s arm, client moved arm. None of the  Pfizer COVID vaccine was administered. Client was slightly bleeding at injection site. Per Vaccinator RN, ?client was not scraped by needle, it was only from the needle going in?. Client was crying and after five minutes, father was able to safely hold client in his lap. PEDS Pfizer COVID vaccine Dose 1 (Lot# FK5618) was administered. Education was given by Vaccinator, RN on adverse reactions and when to seek emergency care.
The pt had a positive reaction to purified protein derivative (PPD) in 11/00. On 11/3/00 (lot ENG3359A4), 12/3/00 (lot ENG3232A4) and 5/3/01 (lot unk), the vaccinee received his 1st, 2nd and 3rd injections of Engerix-B, respectively. One month following his 3rd injection, the vaccinee was tested using a "new machine" for "immunity threshold". The results of this test indicated the vaccinee was a non-responder to the vaccine series. On 3/6/02, Hep-B surface antibodies were "non-reactive". The reporter stated that the lack of efficacy could have been associated with erroneous administration ("did not shake bottle"). As of 4/22/02, the outcome of the event was unknown. The reporter indicated that there were an unspecified number of pts who also experienced the same event, however, they could not be identified.
Arm at injection site started swelling on 12/7/21.  The area has gotten progressively larger.  Today 12/09/21 (day 4), it is red, hot, swollen to the size of a baseball.  The injection site is also very sore.   She is calling her family doctor.
Pt developed light red erythematous splotches around injection site. These splotches were slightly indurated and very tender. Pt had a very tender chain of lymphadenopathy in left axilla.
nausea and minor body aches develop around 5:00 PM low grade fever develops around 7:00 PM  full body aches, fatigue, fever and chills fully developed around 9:00 PM high fever, chills, headache, and full body aches continue overnight fever breaks around 6:00 AM intermittent low grade fever, fatigue, and body aches over course of next day (24+ hours post vaccination) no adverse events (48+ hours post vaccination)
severe adverse reaction to the second booster; laid up in bed for the past couple of days; he has been battling for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe adverse reaction to the second booster), BEDRIDDEN (laid up in bed for the past couple of days) and MALAISE (he has been battling for a couple of days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (severe adverse reaction to the second booster), BEDRIDDEN (laid up in bed for the past couple of days) and MALAISE (he has been battling for a couple of days). At the time of the report, VACCINATION COMPLICATION (severe adverse reaction to the second booster), BEDRIDDEN (laid up in bed for the past couple of days) and MALAISE (he has been battling for a couple of days) had not resolved.            No concomitant medication was provided. The patient was administered the second booster. It was reported that the patient had experienced severe adverse reaction to the second booster that had been distributed. Reported wanted to know what was the best course of action and may have to take him in to the Emergeny Room if don't hear soon.  Reporter had already talked to the pharmacy that gave him the booster shot and they really didn't have much to say other than that well it's gonna last for a couple of days.  Treatment medication was not provided by the reporter.
Information has been received from a physician concerning a 21 year old female who was vaccinated with Gardasil.  Subsequently, after the patient received the first dose of Gardasil (Lot #0522U), the patient experienced a sore throat and a low grade fever.  The patient subsequently recovered.  Following the second vaccination with Gardasil (Lot #0424U), the patient again developed a sore throat and low grade fever.  As of 21-AUG-2007, the patient had not recovered from the sore throat and low grade fever.  The patient sought medical attention for her experience.  Additional information has been requested.
I circled the wrong vaccine needed when coworker told me about it and administered DTAP instead of TDAP.  Immunization will be counted as adolescent booster, no need to give TDAP at the time.
The day of the vaccine I had a headache for one week straight and fatigue, chills and was seating a lot, June 19th I noticed my menstrual period was on time but on July I got it on the 27th which it lasted 4 days and September I didn't have one and October I got it on the 1st of the month. Normally I have always been normal with my menstrual period but this month of November the cramping were worse, I had nausea and I thought I was expecting. I waited 10 days and I made an appointment to see my doctor, the only thing they checked was my thyroid and I'm still waiting on my results. Labs also were done but I don't remember the exact lab work.
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 50-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that vials had not undergone any temperature excursion. Total of 173 doses/vials were given from LOT 070H21A.  Date the vial was initially stored in the refrigerator was reported as unknown.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains Non significant information.
expired Bexsero was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Reporter's comment: Medical assistant reported that the expired Bexsero was administered to patient. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Bexsero which was already expired, which led to expired vaccine used. This case had been linked with case US2022144896, reported by the same reporter.; Sender's Comments:  US-GSK-US2022144896:same reporter
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gener. Patients medical history and current conditions were not provided. On an unknown date since 26-NOV-2014, the patients were vaccinated with an incorrect storage doses of GARDASIL (lot #, expiration date, dose and route were not reported). No concomitant medication was reported. No concomitant medication was reported. No adverse effect reported. This is one of several reports receive from the same reporter. Additional information has been requested.
Started dry cough, sore throat 10/16/21 - 10/26/21 Visited the doctor 10/20/21 @ 2:00PM, diagnosis viral infection Pain in lower right calf 10/22/21 and 10/23/21  Pain in posterior upper thigh/hip 10/25/21 and 10/26/21  Shortness of breath, dizziness evening 10/26/21 CT Scan and diagnosis of PE in lower left lobe 10/27/21 Started Eliquis 10/27/21
No symptoms reported; Patient received improperly stored vaccine (RECOMBIVAX); This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 7 months old patient of unknown gender. Om 23-AUG-2016, the patient received improperly stored doses of RECOMBIVAX HB and ROTATEQ (orally, dose was not reported). This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012916:
Headache, Myalgia, SkinRash, Rash, UrticariaPruritus & Palpitations  Narrative:
Brain fog,usually when you kind of feel retarded,like you had concussion or stroke or high altitude sickness,like less oxygen in brain,you just felt kind of gazed/confused or you felt extremely tired; Brain fog,usually when you kind of feel retarded,like you had concussion or stroke or high altitude sickness,like less oxygen in brain,you just felt kind of gazed/confused or you felt extremely tired; Brain fog,usually when you kind of feel retarded,like you had concussion or stroke or high altitude sickness,like less oxygen in brain,you just felt kind of gazed/confused or you felt extremely tired; vertigo; This is a spontaneous report from a contactable nurse (psychiatric nurse at a mental institute; reporting for the second family member, who also had the same symptoms, as reported). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient, who was described as another family member of the reporting nurse and had the reporting nurse's DNA, further described as another sibling, experienced "brain fog, usually when you kind of feel retarded, like you had a concussion or stroke or high altitude sickness, like less oxygen in the brain, you just felt kind of gazed or confused or you felt extremely tired." The reporting nurse didn't know if there was a bad batch, but they got like a horrible batches of Pfizer; had no clue and did not know if it got mixed with something else. The reporting nurse also mentioned that they (all) had tiredness; they went to sleep for 8 hours, woke up for 2 or 3 hours, and got some coffee, then were really tired, then had to lay in bed and deal with vertigo on an unspecified date. The outcome of the events was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: There is a reasonable possibility that the event fatigue was related to BNT162b2 based on known drug safety profile. The association between the events feeling abnormal and confusion can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
dT administered 3/13/08.  Mod/severe pain, induration and swelling locally by next day, severe burning pain and swelling, mild induration, in axilla started 3/16/08.  Vaccine manufacturere Sanofi Pasteur.  Rxed ibuprofen, lidocaine gel.
Pt vaccinated with DTP/OPV experienced excessive high pitched crying more than 4 hrs.
18 hours after vaccine my spleen, liver and bladder were hurting along with headache, diarrhea, joint pain all of them. Spleen, liver  hurt for 3 days. After 6 days I still have headache and bladder pain along with constipation for last 2 days.
Patient stating day after vaccine was administered began experiencing nausea and vomiting and body aches. 4/4/2021 patient states began to experience loss of appetite, fatigue and weakness. Described all food and beverage having an acidic taste. As of today, 4/21/2021 patient states symptoms are still persistent but seem to be subsiding.
Elevated resting heart rate (102 bpm), accompanied by flu-like symptoms (moderate chills, fever, headache, lethargy)
Pt vax /w MMR pt felt funny & sleepy/tired & arm was hurting.Pt fell to floor & had no P,unresponsive &not breathing.Went to hosp.Pt awoke c/o headache & stomach ache.Hosp for observation.Pt exp life threatening
My FSH levels were taken on 12/7/2021 (one week after dose one) and were 9.1 (high end of normal prompting retest in three cycles).; My period which previously was 27 days consistently and light flow. Since December my period has been very heavy and also my cycle has been 23-25 days in length.; My period which previously was 27 days consistently and light flow. Since December my period has been very heavy and also my cycle has been 23-25 days in length.; This is a spontaneous report from a contactable other hcp (patient). This is the first of two reports. A 38-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: ELI284) dose 1 via an unspecified route of administration, administered in Arm Right on 30Dec2020 07:00 as DOSE 1, SINGLE for covid-19 immunisation (at the age 38 years). The patient was not pregnant at the time of vaccination. Medical history included drug hypersensitivity with penicillin (Known allergies: Penicillin) and chronic fatigue syndrome from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient experienced my fsh levels were taken on 12/7/2021 (one week after dose one) and were 9.1 (high end of normal prompting retest in three cycles) on 07Jan2021, my period which previously was 27 days consistently and light flow. Since december my period has been very heavy and also my cycle has been 23-25 days in length on Dec2020. Therapeutic measures were taken as a result of all the events included treatment with patient was not being treated by a fertility doctor. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood follicle stimulating hormone: 9.1 (high end of normal prompting retest in three cycles) on 07Jan2021 9.1, sars-cov-2 test: negative on 17Dec2020 test type: Nasal swab. Binax Now as well as by PCR. I have had daily & weekly testing since December for work, sars-cov-2 test: negative on 17Dec2020 Nasal swab Binax Now as well as by PCR test. The clinical outcome of all the events were unknown.  No follow-up attempts are needed. No further information is expected.