chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 58-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 09:00 (Lot number: FF2589) at the age of 58 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing), notes: lupus. There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Drug allergy: erythromycin", notes: erythromycin; Hydroxychloroquine, reaction(s): "Drug allergy: hydroxychloroquine", notes: hydroxychloroquine. Vaccination history included: Bnt162b2 (Time: [Pfizer] 08:30 AM, Batch/lot number: FD0809, Anatomical Location: Arm Left, Dose Number: 1), administration date: 28Aug2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 21Sep2021 09:00, outcome "recovered" (Sep2021), described as "Tingling on tip of tongue"; DYSGEUSIA (non-serious) with onset 21Sep2021 09:00, outcome "recovered" (Sep2021), described as "Metallic taste". Therapeutic measures were not taken as a result of paraesthesia oral, dysgeusia. Additional information: Patient was not pregnant at time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination. No follow-up attempts are possible. No further information is expected.
I had a miscarriage which started on May 27th.  I believe I ovulated the day I received the shot (May 4th).  My last period started on April 15th.  I had a positive pregnancy test on May 22nd and bleeding began on May 27th.
Apart from the expected side effects (soreness of injection site, muscle ache and fatigue, which all started the night after the injection, I experienced severe dizziness associated with vertigo (up and down motion of room), nausea, profuse sweating and near syncope around 7:15 AM the day after the injection. Symptoms lasted about 3-4 hours before they gradually subsided. There was no arrhythmia at the time of the near syncope, I was unable to check blood pressure, as I had to stay on the ground to avoid a fall. Fatigue and a sense of disequilibrium persisted for an additional 48 hours before resolving.
Body sweats; Shaking; Really cold; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERHIDROSIS (Body sweats), TREMOR (Shaking) and NASOPHARYNGITIS (Really cold) 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) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced HYPERHIDROSIS (Body sweats), TREMOR (Shaking) and NASOPHARYNGITIS (Really cold). At the time of the report, HYPERHIDROSIS (Body sweats), TREMOR (Shaking) and NASOPHARYNGITIS (Really cold) 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.   Reporter did not allow further contact
I had minor iritiation the day after receiving the vaccine.  A little bit of redness and soreness that went away in 24 hours.  On the 7th day at the site of the injection I developed significant  iritiation, swelling, and redness.  The size of the area was the size an orange on my arm that seems to be getting bigger.  I was advised by an RN to report this finding and I have since reported to my physician's office through the portal.  They are closed today, Sunday.
idiopathic intracranial hypertension (pseudotumor cerebri), 2 spinal taps, medication acetazolomide and lasix
Periorbital swelling and mild facial swelling and erythema. Epinephrine Auto-Injector 0.15 mg given at 10:50 am .10 mg of prednisone at 11:30 am, 12.5 mg of Diphenhydramine.
Daughter has a small rash patch on the left leg where the vaccine was administered. It first appeared 10-13-18. The mother put AVEENO hydro-cortisone cream on leg, and also at different times AQUAPHOR but did not notice it helping the rash. After a week I took her to her pediatrician, she commented it looked like a reaction from the shot. She said it just needed time, and there wasn't really anything we could do. At this point the coloring is getting darker, from the bright red. But it is still visible.
We are a county health department operating an immunization clinic. A 15 month-old child was given TDAP instead of DTAP as a 4th dose. The child was given ADACEL lot number C3353AA, from a single dose vial. She also received #4 HIB, #1 hep A, #4 pneumococcal 13. The parents will be notified. As per instructions from LPN the parents will be informed that is not necessary to repeat this immunization.
Baby received seasonal Fluzone for 36 mo. and older instead of flu vaccine for 6mo. to 36 mo.
27Apr90 pt vax;  13May90 pt devel mild aching in rt arm.  09Jun90 exp arthralgia of rt leg, behind knee.  18Jun90 exp arthralgia in both arms, & paresthesia radiating down from elbow to last two fingers. Sx impaired ability to walk/stairs.
diarrhea; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021253629 Same product and similar event, different patient
Patient stated that she experienced nausea, vomiting, chills, fever over night and blurred vision the following morning.
No adverse effect reported; received improperly stored PEDVAXHIB; This spontaneous report was received from a nurse refers to a 9 week old male patient. The patient's concurrent condition, concomitant medication and medical history were unknown. On 06-SEP-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) of lot # S000353 with expiry date 09-SEP-2021 (strength, dose, frequency, route of administration date unspecified) for prophylaxis (product storage error). On an unknown date, the vaccine was exposed above 47 Degree Fahrenheit (47.4 F) temperature for 23 hours. There was no previous excursion reported. Digital data logger was involved and no adverse effects reported (no adverse event). The outcome of the events was unknown.  This is one of three reports received from the same reporter.
Dizzy, fuzzy feeling starting within about 5 minutes, lasting approx 1 hour. Major headache focused behind the left eye. Starting about 2 hours later, lasting about 2 - 3 hours.
Pt's paperwork for her vaccine appointment showed Pfizer as a first dose.  After pt rec'd her vaccine she stated she knew her paperwork was incorrect and stated "you can't take it back now and nothing was going to stop me from  getting my vaccine."  She then produced a vaccination record from a different location with Moderna as a first dose.  She also stated that she spoke to someone and was told it was ok to receive Pfizer as a second dose.  There was no documentation of a call where she was told it was ok to receive Pfizer instead of Moderna.  She also stated she was going to return for her second Pfizer dose.  There was no reaction or medical issue after pt received her vaccine and was sent home in no apparent distress.
Shortly after received vaccinations, complaint of extreme heat to upper toroso and tightness in chest.  Laid client down and O2 via mask.  Ct recovered and declined seeking further medical evaluation by PMD.
I had a fast heartbeat approx 1-hour post vaccine and then it calmed down.. Two weeks later (4/2/21)) I had another arrhythmia but much stronger and then it calmed down with 10 mg Inderal, 4 days later my arrhythmia was strong once again, high HR and I was rushed to the hospital and transferred to my transplant hospital and was admitted for cardiac rejection workup including echo, biopsy,  plasmapheresis, chemo, and IVIG treatments, blood tests etc from 4/8/21 to 4/21/21.  -- I have not had any further Covid vaccinations but did receive a dose of Evushield on 2/25/22. I am currently taking 30 mg per day of Inderal to control tachycardia.
H.A., nausea, low B.P. (decreased upon standing), rested - pale, dizziness, nausea increased when stood up and got ready to leave - hospital. 1/21/10 - message - mother called back. Child is fine. Anxiety hx will not get dose #2.
i have them even though had shot / suspected vaccination failure; shingles; pain in certain areas; 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: i have them even though had shot / suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: pain in certain areas). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she had them (shingles) even though he/she had the shot, the patient still had pain in certain areas. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 79-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 07-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804089 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Around July 29, 2021 noticed a sharp pain in my right calf.  I thought it was likely a superficial blood clot.  I had two other superficial blood clots in my right calf on 11/18/2020 and  12/13/2020 that felt the same.  In Nov and Dec I was also checked for DVT, but it was negative.  I believe these were my first blood clots.  In Jan 2021, I was diagnosed with Factor V Leiden.  On  Aug 6, I had another xolair injection at 10:30 am.  Around 4:30 pm I developed a moderately painful headache localized on the right side of my head - especially around my eye.  Around 6:30 my husband noticed that my right eye was pointing inward unless I was consciously focusing my eye.  I did have a lazy eye in my right eye when I was 4-6 years old.  I have had localized headaches in the past, but never with the odd eye movement.  I observed it in the mirror as well.  Although, it stopped.  I'm not sure when, but before 9:00 pm.  I went to the ER around 7:00 pm, but wasn't seen for a few hours.  I was given lots of blood work and a CAT scan with and without contrast in my head and neck.  They came back negative.  They sent me home (around 1:30 am) with instructions to return at 8:00 am for Lower Limb Venous Duplex.  I came back as instructed.  The doppler showed a superficial blood clot in my right calf.  The ER doctor, noting I still had a localized headache around my right eye, ordered a MRI of my head and neck.  They also came back negative.  In coordination with my hemotologist, I was prescribed 2*10mg xarelto (1 tablet morning, 1 tablet evening) for 12 days.  I was given tylenol and discharged.  The headache went away after about 24 hours.  And the superficial blood clot stopped hurting within a few days.  Note - I have had a tight chest since around June 1.  I was tested for COVID with PCR test on June 3, but it was negative.   For the next few weeks, my chest felt tight and hurt mildly, especially when breathing deeply.  I had a spirometry test on 6/11/2021 that showed a slightly reduced FEF25-75.   I went to the ER on 6/17/21 for the breathing problems.  They did a ECG and CAT scan of my chest, but didn't find an aneurysm or pulmonary embolism.  I followed up with a pulmonologist on 7/21/21 and they prescribed Flovent HFA 220 mcg/actuation inhaler (2 puffs twice a day) for two months.  We think the problem was likely dust caused by having the siding replaced at my house.   My tight chest is mostly better now.
Light headed immediately after the shot; No energy; Feels sedated; Vaccine has made him calm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed immediately after the shot), ASTHENIA (No energy), SEDATION (Feels sedated) and THERAPEUTIC RESPONSE UNEXPECTED (Vaccine has made him calm) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLONAZEPAM (KLONOPIN) for an unknown indication.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced DIZZINESS (Light headed immediately after the shot), ASTHENIA (No energy), SEDATION (Feels sedated) and THERAPEUTIC RESPONSE UNEXPECTED (Vaccine has made him calm). At the time of the report, DIZZINESS (Light headed immediately after the shot), ASTHENIA (No energy), SEDATION (Feels sedated) and THERAPEUTIC RESPONSE UNEXPECTED (Vaccine has made him calm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This patient reported he doesn't need clonopin after this vaccine because it has made him so calm down and he feels off. These symptoms started right away and he is still feeling them, but not quite as bad as the day after the vaccine.  Treatment information was not provided by the reporter.
all kinds of issues; she got the virus; skin loss; her first dose 12-15 months and the second dose at 4 years old; This spontaneous report was received from a consumer referring to his daughter, a female patient of unknown age. Information regarding the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.     On an unknown date, when the patient was between 12 to 15 months old, she was vaccinated in the arm (unspecified) with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX), dose, route of administration, lot number and expiration date were not provided for prophylaxis. Later, on an unspecified date, when the patient was 4 years old, she received the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (inappropriate schedule of product administration). On an unspecified date, few months after the second dose, the patient got the virus (varicella) and had a piece of skin missing on her lip (skin exfoliation). The reporter also stated that the patient had all kind of issues (ill-defined disorder), additionally he stated that they saw many doctors and they all said that it was normal. The reporter also wanted to find out about the varicella virus vaccine live (oka/merck)(VARIVAX) and what kind of virus was in it.  At the time of reporting, the outcome of ill-defined disorder, skin exfoliation and varicella was unknown.     The reporter did not assessed the causal association between the adverse events and the varicella virus vaccine live (oka/merck)(VARIVAX).
This spontaneous report was received from an office manager via company representative refers to 40 patients of unknown age (gender unspecified). On an unknown date, the patients were vaccinated with PROQUAD (merck), (lot number, expiration date and route not reported). No concomitant medications were reported. On an unknown date, the office manager informed the company representative that the clinic had experienced a power failure and there supply of PROQUAD was stored outside of the required temperature range but 40 patients had already been received the medication before it was discovered. Additional information has been requested.
fatigue, slept for five days; fatigue, slept for five days; severe headaches (tension and migraines) that don't go away; severe headaches (tension and migraines) that don't go away; neck and left shoulder pain; neck and left shoulder pain; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown) via an unspecified route of administration in right arm on 17Feb2021 at 05:00 PM as unknown, single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included migraines, depression from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX 20 mg); linaclotide (LINZESS 290 mg); buspirone (BUSPIRONE 30 mg) for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 18Feb2021 at 09:00 AM, patient experienced fatigue, slept for five days, severe headaches (tension and migraines) that don't go away, neck and left shoulder pain, had to go to emergency room twice for headaches, prescription medication for migraine doesn't work. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken with IV tramadol, Compazine, Benadryl. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from an office manager and refers to multiple unspecified patients of an unknown age and gender. The patient's pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # L040054, expiration date 26-DEC-2017 or lot # M009378, expiration date 23-APR-2018 (dose, route and site of administration were not reported). The administered doses of vaccine were exposed to the temperature of 30 degrees Fahrenheit for 1 hours. No adverse effects were reported. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
cold sores/had an outbreak/not just a single sore, it was her entire mouth; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Lot Number: eW0167), via an unspecified route of administration, administered in arm left on 03May2021 10:00 (at the age of 36-year-old) as dose 2, single for COVID-19 immunisation. Medical history included currently undergoing in vitro fertilisation (IVF) (so hormones also playing a role), allergies: Sulfa drugs (hives) and ongoing cold sores. Concomitant medications included clobetasol for poison ivy (topical) and levocetirizine for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Lot Number: ER8730), via an unspecified route of administration, administered in arm left on 12Apr2021 10:00 (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation. The patient stated she had cold sores, which had been under control for a decade with 1-2 outbreaks a year. She stated starting 6 weeks after her vaccine on 13Jun2021, she had an outbreak that did not go away for more than a few days before returning again. She stated her immune system just didn't seem able to suppress it, clarifying it was extremely aggressive (not just a single sore, it was her entire mouth) and didn't respond as well to antivirals as past out breaks. The patient went to doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event and included Valtrex prescription. The event outcome was not recovered.
This spontaneous report was received from an approximately 60 year old female patient who is also a company representative regarding herself. Current conditions of the patient included seasonal allergies. There were not pertinent medical histories. On 04-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) on outer aspect of upper left arm at the pharmacy. Concomitant therapies included SYNTHROID, MUCINEX D, vitamins (unspecified) (reported as multivitamin), omega-3 marine triglycerides (reported as fish oil)(manufacturer unknown), glucosamine (manufacturer unknown) and chondroitin (manufacturer unknown). On 06-OCT-2013, the patient experienced the outer aspect of upper, left arm was warm, red and raise. Approximately on an unknown date in October 2013, the affected area on upper, left arm then became bigger, left arm started to swell and patient became itchy on other unspecified parts of her body. The patient sought medical attention at physician office on 07-OCT-2013. The patient was prescribed with the an unspecified dose of KEFLIN for 10 days which was begun on 07-OCT-2013 and BENADRYL (50 milligrams, as needed). No lab tests were performed. The patient was recovering from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
This initial spontaneous case received from other non-health care professional on 10-Nov-2017, concerning a 70-year-old adult male patient. On 13-Oct-2017, patient was administered with FLUAD (TIV) (dose, route of administration, anatomical location, batch number, and expiry date: not reported). On the same day after vaccination, about 15-20 minutes later, the patient experienced pain in the arm. The patient wanted to get recommendations to treat the patient in his arm. At the time of this report, the patient had not recovered from the event. The reporter assessed the event as non-serious.