chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tired; Low grade fever within 24 hour.; Rash covering torso and face; headache after 24 hours; Dose received 3; This is a spontaneous report from a contactable reporter (consumer or non HCP).   A female patient of unknown age (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 16Dec2021 at 11:30 (Lot number: FL3197) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER8734, vaccine location: Left arm, administration time: 09:45 , route of administration: intramuscular), administration date: 27Mar2021, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0162, vaccine location: Left arm, administration time: 09:45, route of administration: intramuscular), administration date: 17Apr2021, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 at 11:30, outcome "unknown", described as "dose received 3"; FATIGUE (non-serious) with onset 17Dec2021 at 08:00, outcome "not recovered", described as "Tired"; PYREXIA (non-serious) with onset 17Dec2021 at 08:00, outcome "not recovered", described as "Low grade fever within 24 hour"; RASH (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Rash covering torso and face"; HEADACHE (non-serious) with onset 17Dec2021, outcome "not recovered", described as "headache after 24 hours". Therapeutic measures were not taken as a result of fatigue, pyrexia, rash and headache.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
I had COVID like symptoms again. After that I was doing good for about two weeks, but I still had a stiff neck. I have had a stiff neck for about 6 weeks now. I have had steroid medication provide for me and I felt better this lasted for about two weeks. After this I have went back to the hospital because I have not been able to stand, or barely make a fist.
About 10 minutes after receiving inject patient reported feeling light headed and tunnel vision. Patient appeared pale, and his head was nodding backward. 911 was called. I checked his pulse, and breathing which were both normal. Patient started to gradually lose consciousness and confused speech, but was roused by me asking him questions, to which he responded and shaking his shoulder. Patient gradually began to regain color and normal speech returned. Patient stated that he was panicked and is afraid of needles and worked him self up after receiving the vaccine.
Moderate severe pain at site and erythema 4" diameter resolved after 48 hours.
Initial information for this unsolicited case was received from a consumer on 22 January 2015. A female patient, was vaccinated on an unspecified date with influenza vaccine, manufacturer, batch, route and site of administration were not reported. The patient has a history of MS (multiple sclerosis) and an unspecified disability. The patient experienced the "flu over Christmas and had the flu shot", date not reported. The patient experienced a froggy voice today at the time of the report. The patient has a history of taking AUBAGIO which the patient says has been working well for her and other MS injectables and oral medications did not work as well. Laboratory tests were not reported. The patient outcome is unknown. Documents held by sender: None.
Day after vaccination: stiff neck, pain in jaw, ears, and teeth.  Day two: I woke up with a rash all over my torso area. The rash appeared mainly under the arm pits, above and below the breasts, bilateral creases of the upper thighs, and down the spine. The evening prior, I was shaking from being so cold, but was sweating throughout the night, in the morning I discovered the rash. The rash did not itch, I just felt internally hot, but was not running a fever during the duration of the rash. The rash worsened in color (red) by the evening, but was completely gone by the next morning.
This spontaneous report has been received from a physician regarding an 11 year old twin patient (gender not reported). No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). After receiving the vaccine GARDASIL 9, the patient experienced sleepiness, described as "sleeping off and on for a whole day". The patient is currently 17 years old and the physician is inquiring whether would be appropriate to continue to vaccinate. The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the event. The next day after vaccination, on an unknown date, the patient recovered from the event. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA007442.
Insomnia for 4 weeks. Vertigo started soon after. Needed 6 months of Physical Therapy to reduce vertigo symptoms.
Low grade fever for 2 days after first shot (101) Rash beginning 8 days after shot, swollen and red but not painful at the vaccine site
Patient called today. She stated today she noticed a red, itchy, achy circle, about 4" round at the injection site. She stated vaccine was 8 days ago. She denies any fever today. RN advised her to call her provider for follow up. She stated no one is answering the phone today because of the holiday. RN Advised her to go to Urgent care today then to have it looked at. She stated understanding and stated will go in a couple hours after work. She denies any other side effects. She did call and report initial side effects soon after the vaccine, and Vaers form was also submitted at that time, too.
Left arm at injection site has been very painful during the past 6 weeks since I got the injection. It feels like I have a pulled muscle and sometimes I can barely move my arm. It is a sharp constant pain, right at injection site that causes pain and weakness.
No known adverse event - patient was given live, attentuated 2009 H1N1 influenza vaccine and then disclosed that she was pregnant.
Large area of localized swelling, redness, and warmth at injection site and throughout arm.
Sore throat, headache, fever.  H/A began after 8 H --> now warmth + ST 48 H after injections.
patient is receiving a 2-dose course of IMOVAX for pre-exposure prophylaxis; the patient will likely receive his 2nd dose of IMOVAX on day 10, with no reported adverse event; Initial information received on 24-Feb-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was receiving a 2-dose course of RABIES (HDC) VACCINE [IMOVAX RABIES] for pre-exposure prophylaxis; the patient will likely receive his 2nd dose of imovax on day 10, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE (strength, formulation, route, lot number and expiry date: not reported) in unknown administration site for pre-exposure prophylaxis (Immunisation) and patient was receiving a 2-dose course of imovax for pre-exposure prophylaxis; the patient will likely receive his 2nd dose of imovax on day 10, with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  It was reported, Pharmacist reports that the patient has received his 1st dose of IMOVAX and is due for his 2nd dose today (24Feb2023); reports that she does not have IMOVAX available today and cannot get IMOVAX until day 10. Pharmacist asks if there are any studies on how effective IMOVAX would be if the patient received the 2nd dose late? This situation is reported as an off-label use as per local labelling.   Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  At time of reporting, the outcome was Unknown.  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.
I experienced a severe headache, with double vision which came and went for 2 days, then I developed a severe migraine that would not abate with medication which lasted for 6 days. After the headache went away I was still experiencing double vision. Doctors thought it could be a transient ischemic neurological event and the vision would return to normal as it cleared itself, which took 2 months. 4 months after the vaccine I began experiencing dizziness and when they performed a head scan they found a clot, arterial venous malformation fistula, and evidence of a bleed. I am under ongoing care from physicians. I was out of work due to double vision and neurological procedure.
Red hives/rash covering upper body, face, and upper thighs; red lines that looked like scratches (but weren't) up and down left and right shoulders/arms; gradually has dissipated over the last 2 days; the red scratch like marks are fully gone and the redness is dissipating a little more each day;
she was in bed for 3 days / is not feeling well since she got the vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of mobility decreased in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of mobility decreased (received 1st dose on unknown date, refer case US2021AMR043056).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced mobility decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient was in bed for 3 days after receiving shingrix vaccine and then she was fine. On 21th January 2021, the patient received Pfizer BioNtech covid vaccine on left upper arm intramuscularly and experienced headache, profound fatigue and felt unwell. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR043056:same reporter
patient felt lethargic the next afternoon at supper tablet. He continued to push through the next day and felt lethargic again the next evenng at supper and then pasted out. Wife is a nurse and she noted his pulse faint (cardiac event) and immediately took him to the ER. He was stabilized at the emergency room and attending physician could not explain what happened, tests showed nothing unusual. Cardiologist working his case said he has seen very infrequently a reaction like this with his Atenolol medication and the Quad flu shot. He was released out of hospital the next morning. All screenings/test done and only thing showed was early stages of double pneumonia. Patient wife came to mea with Levaquin 750mg prescription and told me about the incident that Saturday afternoon.
I developed mild tinnitus several weeks after this first vaccination. I did not (at the time) relate the two.
pt recv vax 15NOV96 & 27MAY97 pt devel chickenpox;
HCP called to report Administered supported TE for VAXNEUVANCE.   No Previous Excursions VAXNEUVANCE LOT #: X005583  EXP: 12/10/20245 42 Hours 5 Minutes 0 Seconds @ 33.9F. Associated AE Cases: 02503187 // 02503224. No PQC.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 01-NOV-2023, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) lot # X005583, expiration date 10-DEC-2024 (dose and route of administration not reported) for prophylaxis (product storage error).  The vaccine underwent a temperature excursion of 33.9 degrees Fahrenheit for 42 hours and 5 minutes.
Began with tension, pain and stiffness in left gluteus muscle within 24 hours of vaccine.  Moved to severe pain, stiffness, weakness of muscles in right groin and leg. Stiffness, muscle weakness, and pain in right leg that has persisted and has now spread to front of hip. Extreme Difficulty waking, sitting, bearing weight since symptoms began a few days after receiving the vaccine.   I hesitate to say this is a permanent disability. I?m praying it gets better, but my mobility has been extremely impaired and I am in constant pain. The issues are spreading in my right hip and entire groin.
I had appendicitis and had my appendix removed with surgery at the hospital.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 52 years of age), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021 12:00 (Batch/Lot Number: EN6204) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included metoprolol, lisinopril, apixaban (ELIQUIS) and amiodarone, all taken for an unspecified indication, start and stop date were not reported. The patient had no Covid prior vaccination. The patient had no known allergies. It was reported that on 05Apr2021 the patient had appendicitis and had his appendix removed with surgery at the hospital. The event resulted to Emergency room/department or urgent care. The patient was hospitalized for the event with a duration of 1 day. Therapeutic measures were taken as a result of the event with surgery. He had a covid test post vaccination through nasal swab on 07Apr2021 with negative result.
three days before the patent died he started having sloop apnea and for several days before the event he started having memory problems and the day before the event he started having a issue with his heart where he just said his heart felt irregular.
Felt lethargic; Felt "crappy"; Woke up middle of the night; Have fever of 99.3-100.1 degrees F; Puked; Woke up middle of the night with chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Felt lethargic), FEELING ABNORMAL (Felt "crappy"), SLEEP DISORDER (Woke up middle of the night), PYREXIA (Have fever of 99.3-100.1 degrees F) and VOMITING (Puked) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced LETHARGY (Felt lethargic), FEELING ABNORMAL (Felt "crappy"), SLEEP DISORDER (Woke up middle of the night), PYREXIA (Have fever of 99.3-100.1 degrees F), VOMITING (Puked) and CHILLS (Woke up middle of the night with chills). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 16-Apr-2021, LETHARGY (Felt lethargic), FEELING ABNORMAL (Felt "crappy"), VOMITING (Puked) and CHILLS (Woke up middle of the night with chills) had resolved. At the time of the report, SLEEP DISORDER (Woke up middle of the night) had resolved and PYREXIA (Have fever of 99.3-100.1 degrees F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 99.3-100.1 (High) fever of 99.3-100.1 degrees F.         Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the events was not applicable.
It just got to where I was coughing every fifteen minutes, I took cough medicine for about week and the coughing was keeping me awake at night so I scheduled a Doctors appointment. No results were found. A seven day course Doxicycline.
Moderna vaccine booster was administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry has been submitted to Moderna requesting validation of vaccine potency.  A response from Moderna is expected to be received between 8-10 business days.  Expiration date is currently not printed on the vaccine vial or carton and vaccine expiration date listed in is 12/31/2069.  To find the expiration date, ?look up expiration date? tool is to be used from Vial Expiration Date Lookup | Moderna COVID-19 Vaccine (EUA) (modernatx.com). Patient contacted on 12/4/2021 and no adverse effects reported.
On 11/19/2001 the patient called to report having numbness and loss of feeling to the left hand and arm on 11/17/2001. The physician instructed the patient to call Dr for further follow-up.
PATIENT SAID VACCINE WAS GIVEN UPWARDS OF SHOULDER AND SHE'S BEEN EXPERIENCING PAIN EVER SINCE.  HER DOCTOR TOLD HER THAT THE VACCINE WAS ADMINISTERED AT THE WRONG SITE.
Covid Arm ... Arm rash at sight of injection 7 days after Injection. Looks like a ring . Itches and Swollen and Red.
This is a spontaneous report from a noncontactable consumer (patient). A 49-year-old (non-pregnant) female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 49, via an unspecified route of administration, on Mar 2, 2021, at 13:30, single dose, for COVID-19 immunisation. No medical history reported. No known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not have any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the vaccination. On Mar 2, 2021, patient experienced a very deep sleep at the night after the vaccine. The day after the vaccine, patient felt sleepy as though like jetlagged. The events did not result in doctor or other healthcare professional office/clinic/emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the event. The outcome of feeling sleepy: not recovered (at the time of this report). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Redness, pain, swelling right deltoid, 36 hr after vaccination, Tx: Benadryl, warm compresses prn
vaccinate past its expiration date of 10/1/21; Vaccine that had been more than 30 days in the refrigerator was given to 16 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinate past its expiration date of 10/1/21) and PRODUCT STORAGE ERROR (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinate past its expiration date of 10/1/21) and PRODUCT STORAGE ERROR (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (vaccinate past its expiration date of 10/1/21) and PRODUCT STORAGE ERROR (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-352746, MOD-2021-352611, MOD-2021-352860, MOD-2021-353006 (Patient Link).
c/o severe arm, elbow joint pain w/in a day of recvd 1st Hep B vax; states took wks to get over the discomfort; did not report this to ER or emp hlth; recvd Hep B #2 4 wks later caused pain in lt arm & elbow;
Patient could not lift left arm the day after the vaccination was given for one whole day and injection site hurt for 3 days.
Information has been received from a physician via Pfizer Inc. concerning a male patient of unknown age. Patient's current condition or medical history was not reported. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, dose, route not reported). Concomitant medications were not provided. The physician reported that the patient had local reaction to PNEUMOVAX 23 (date unspecified). The outcome of local reaction was not reported. The causality was unspecified. Additional information has been requested.
Patient had dime size area of redness within one hour of injection. 24 hours later was 7cm diameter with warmth; no induration.
Headache, Myalgia, NauseaVomiting, localized injection site pain and swelling Narrative:
This spontaneous report as received from a Registered Nurse via a company representative refers to a 15 year old female patient. The patients current conditions or medical history were not reported. On an unspecified date the patient was vaccinated with the first and second dose of GARDASIL (dose, route, lot number and expiration date not reported) no adverse effects reported with the first and second dose. On an unknown date in 2014, the patient was vaccinated with the third dose of GARDASIL intramuscular injection, 1 single shot (lot number and expiration date not reported). On 29-JUL-2014, the nurse reported that after receiving the 3rd dose GARDASIL, the patient developed a severe case of  hives. The patient sought medical attention and was treated with BENADRYL (dosages, frequencies, manufacturers unknown). The patient was recovering from severe case of hives at the time of the report. No lab diagnostics were performed. Additional information is not expected as the reporter did not wanted to be contacted.