chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy technician refers to a 17 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 20-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Cellulitis at injection site of PNEUMOVAX - Doctor prescribed Doxycycline 100mg.
experienced most of these same symptoms after being inoculated three times with your vaccine; experienced most of these same symptoms after being inoculated three times with your vaccine; Debilitating fatigue; Extreme chills; Headaches; Joint pain; Loss of taste and smell; Loss of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Contracted covid", start date: Dec2020 (unspecified if ongoing), notes: contracted covid last December. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1, Debilitating fatigue), for Covid-19 immunization, reaction(s): "Debilitating fatigue"; Bnt162b2 (DOSE: 1, Extreme chills), for Covid-19 immunization, reaction(s): "Extreme chills"; Bnt162b2 (DOSE: 1, Headaches), for Covid-19 immunization, reaction(s): "Headaches"; Bnt162b2 (DOSE: 1), for Covid-19 immunization, reaction(s): "Joint pain"; Bnt162b2 (DOSE: 1, Loss of taste and smell for 3 weeks), for Covid-19 immunization, reaction(s): "Loss of taste and smell", "Loss of taste and smell"; Bnt162b2 (DOSE: 2, Debilitating fatigue), for Covid-19 immunization, reaction(s): "Debilitating fatigue"; Bnt162b2 (DOSE: 2, Extreme chills), for Covid-19 immunization, reaction(s): "Extreme chills"; Bnt162b2 (DOSE: 2, Headaches), for Covid-19 immunization, reaction(s): "Headaches"; Bnt162b2 (DOSE: 2), for Covid-19 immunization, reaction(s): "Joint pain"; Bnt162b2 (DOSE: 2, Loss of taste and smell for 3 weeks), for Covid-19 immunization, reaction(s): "Loss of taste and smell", "Loss of taste and smell". The following information was reported: IMMUNISATION (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "experienced most of these same symptoms after being inoculated three times with your vaccine"; FATIGUE (non-serious), outcome "unknown", described as "Debilitating fatigue"; CHILLS (non-serious), outcome "unknown", described as "Extreme chills"; HEADACHE (non-serious), outcome "unknown", described as "Headaches"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Loss of taste and smell".  Additional information: patient who, having contracted Covid last December and experienced symptoms of debilitating fatigue, extreme chills, headaches, joint pain, loss of taste and smell for 3 weeks, has experienced most of these same symptoms after being inoculated three times with your vaccine. Each time I have gotten the vaccine, the side effects have gotten worse. I hate to think that if I have to get a booster twice a year, I will have to experience more severe side effects.   The lot number for bnt162b2 was not provided and will be requested during follow up.
MENACTRA, Tdap given left deltoid 9/6/11. 9/7/11 redness & mild tenderness. 9/8/11 am bigger pm slightly bigger 6" x 2" area erythema, hot, NT, (L) deltoid.
she's so tired; really bad low backache; diarrhea; I slept all day; didn't eat; She feels she has less appetite; Real bad allergy; she couldn't breathe very well; her arm was red; her arm was swollen; her arm was hard; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events real bad allergy, she couldn't breathe very well, her arm was red, her arm was swollen, her arm was hard, slept all day, didn't eat, she's so tired, really bad low backache, diarrhea, and she feels she has less appetite.  The patient's medical history was not provided. Concomitant medications reported were losartan, atorvastatin, bupropion for drug use for unknown indication.  On 19 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the events real bad allergy, she couldn't breathe very well, her arm was red, her arm was swollen, and her arm was hard. On 20 Feb 2021, the patient experienced the events I slept all day, and didn't eat. On 21 Feb 2021, the patient experienced the events she's so tired, really bad low backache, diarrhea, and she feels she has less appetite.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   On 21 Feb 2021, the outcome of events real bad allergy and she couldn't breathe very well was resolved. On 20 Feb 2021, the outcome of events, slept all day, didn't eat and diarrhea was resolved. The outcome of events her arm was red, her arm was swollen, her arm was hard, she's so tired, really bad low backache, and she feels she has less appetite was unknown.
Administered Infanrix DTap vaccine to a 30 year old female pt instead of TDAP for adults.  Pt has been called x 3 and message left on voicemail as of now (6.23.23 12:35PM) but have not had a response from patient yet.  Patient left clinic with no complications after vaccine administration. Contacted GSK as a result and was told not to readminister adult dose due to higher antibody response in Infanrix compared to TDAP.
15 days later, felt pressure in the ear, distorted sound and whooshing sounds.  No fluid in the ear.  No other conditions observed. GP suggested antihistamines and ibuprofen for a couple of days.  Third day after onset I called ENT who performed hearing test (see next box) and provided me with oral prednisone.  After 3 days of no improvement, she added local injections through the ear drum of cortisone (a series of 3 of these, one  every three days)
This spontaneous report was received from a nurse via company representative refers to a three number of male patients of unknown age. Pertinent medical history and drug allergies were unknown by the reporter. On an unknown date, the three patients were vaccinated with GARDASIL 9 (lot and expiry date was not reported). Concomitant medications were unknown by the reporter. On an unknown date, the 3 patients passed out after receiving the GARDASIL 9. The outcome of the event loss of consciousness was unknown by the reporter. The causality assessment was not provided by the reporter. No PQC filed. Upon internal review the event loss of consciousness was determined to be medically significant. Additional information has been requested.
Petechia and Bruising - idiopathic Thrombocytopenia; 12/13/07 Platelets 5,000; 2/27/08 Platelets 276,000; no medications 3/24/08-records received-Consultation report for 12/14/07-Assessment:ITP platelet count of 4000 with skin bleeding. Bruises for 1 weeks and nose bleeds on and off for past week. Petechia.
On June 5th, I had a negative test. June 8th I had a positive test and I got care that day at an urgent care. And that day I started the medication. I had what I thought was a bad cold, I had stuffiness, loss of appiete, not a whole lot of loss of energy. A little bit of nausea. I didn?t have a headache it was just a stuffy head and light gi symptoms made worse by the medicine persisted beyond the medication for 2 weeks. It took me 3 weeks before I feeling like myself. I had diherra, gassiness, and nausea
1 day p/vax pt devel T103.1 w/nausea & vomiting;responded to antipyretics & antiemetics, IV fluids;
pt returned to clinic 40-50mins p/vax presented w/redness to abd & to rt leg where Tetramune given & to other leg also but worse to rt leg; called PMD for instructions; pt OK; HR regular, resp regular;
Severe headache, muscle aches, joint pain, especially prominent in upper back neck, nausea, chills, feeling hot, fever onset at 0200 1/10/2021 (100.8-100.9), I have taken Tylenol 650mg q 6 hrs. Ibuprofen 800mg once 1/9/21 at 2200.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 12:38 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 12:38 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 58.72.  Concomitant products were not provided.  On 11-Jan-2021, At excursion time 02:00 PM, temperature was 35, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 9 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
This case was reported by a consumer and described the occurrence of brain swelling in a 6 week old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. The subject's medical history included allergic reaction to eye drops. Concurrent medications included paracetamol (Tylenol). On 29 May 2003, the subject received 1st dose of Infanrix (lot DTPA594A2). On 29 May 2003, the subject also received inactivated poliomyelitis virus vaccine (IPOL lot 94030), 7 valent pneumococcal conjugate vaccine (Prevnar lot 492-588), and combination haemophilus influenzae type B conjugate/hepatitis B vaccine (Comvax lot 0641M). On 30 May 2003, 1 day after vaccination with Infanrix, the subject experienced brain swelling, fever and neurologic developmental delay. The events were considered to be disabling to require clinical intervention (OMIC). The mother of the subject reported that after 29 May 2003, the subject, "has never received vaccines with pertussis, but rather diphtheria and tetanus toxoids vaccines to complete the series." The subject is seeing a "child neurologist." At the time of initial reporting, 02 March 2006, the brain swelling and fever had resolved and the neurologic developmental delay was ongoing.
Shots given 8/1/02. 8/7/02 mother called to report child had "large marble size knot" to Rt leg. By records this was site of Hep B/Hib (Comvax) vaccine. Mother reports knot occurred two days post shots received and remain at present and using cold compresses at present. Advised to warm next 24 hous. PMD was notified. NO fever or redness reported. No c/o pain by child.
Patient reported onset of lip numbness, swelling, tingling  and bluish discoloration approximately 10 minutes following vaccine administration.  Epinephrine 0.3 mg administered 1512, O2 provided via nasal cannula. EMS contacted and monitored.  Recovered and transported home by parent at 1600
Arthralgias beginning day after anthrax #2 Persistant symptom/but variable joint/primary-elbow/, greater trochanter and SI
3 days after injection, patient had sudden onset numbness and weakness of lower extremities. Unable to stand. Symptoms had disappeared by next morning without recurrence
Presented to the ED unresponsive to stimuli, hypothermic, hypoglycemic, and bradycardic. CT H and angiogram was negative for acute intracranial process or acute ischemic stroke. Patient had bradycardia, PEA arrest and underwent CPR was intubated on 1/10/21 and had ROSC. Transcutaneous pacing started as patient remained bradycardic. Dopamine, levophed, and vasopressin was started. Patient was admitted to the hospital with hypercapnic hypoxemic acute respiratory failure, Diffuse bilateral alveolar damage, Covid-19
Injection received prior day, returned to doctor for swollen, sore injection site.  Arm warm to touch, red, examined by physician, ordered antibiotics.
I woke up around 6am with a terrible headache, body aches and nausea. Around 3pm, I began experiencing a fever of 101.3°F and chills. The fever, chills, headache, and nausea have subsided, but body aches remain.  I am also still experiencing what I believe to be swollen lymph nodes around my collar bone.
Received the vaccine 1/8/21 at 4:45pm, the next day had a sore arm and was tired. Woke up Sunday at 4:37am to take some ibuprofen for my arm pain and didn't get to take the meds, I had a seizure the meds and my glass were all over the floor. I never even felt it coming on, I just remember waking up. I looked at the clock at 4:46am. It seemed like a very long time to be out. When I woke up I felt very nauseas and had a hard time getting up to go to the bathroom. I never did get sick but laid down and fell asleep immediately. I slept all day Sunday. Today, Monday 1/11/21, I am still exhausted and light headed but not as nauseas.
pt recvd vax 7OCT93 to lt deltoid place of employment; lt UE numbness 8OCT93 (no weakness); exam-nl- c-spine; nl grip strength & deltoid strength; dec in pin prick sensation lt radial dorsal hand;
dizzy after a few minutes of receiving vaccine  lowered onto ground with assist of staff   stood by self and repositioned onto stretcher taken to OBS 1,  pt feeling better once laying down on floor   pt given apple juice in obs area, pt feeling better  vs monitored as noted. pt feeling better and denies further symptoms after repositioned to sitting, dangling and standing  okay to leave obs  amublated to exit by self without difficulty at 1121   vs 1104  bp 127/83 hr 77 rr 18 o2 100   1109 bp 129/82 hr 76 rr 18 o2 100 sitting up, 1115 dangling bp121/77 hr 76 rr 18 o2 100  1120 standing bp137/69 hr 82 rr 18 o2 100
Rash started on head, down stomach, arms, underarms, back of neck, vomiting and choking, then fever.
Similar to second by worse- fever, chills, headache and eventual migraine for three days, swolling on l collarbone and pain in arm pit. Now, swelling enlargement of left breast and side of chest
Information has been received from a pharmacist concerning a 20 year old female nursing student who was part of a study, who on unspecified dates in 1992 was vaccinated with a first and second dose of Varivax. on 16-NOV-2006 the patient was found to have a low or negative titer. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Dizziness, Headache, Joint and Muscle Pain, Weakness, Fatigue, Parasthesia, Numbness, Nerve Damage.
Hurting all over body; Short term memory feels affected; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), PAIN (Hurting all over body) and AMNESIA (Short term memory feels affected) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 037A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID) and OMEPRAZOLE for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On 25-Feb-2021, the patient experienced PAIN (Hurting all over body) and AMNESIA (Short term memory feels affected). At the time of the report, PAIN IN EXTREMITY (Arm sore), PAIN (Hurting all over body) and AMNESIA (Short term memory feels affected) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication were not provided.   This case was linked to INC.-MOD-2021-056418 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-Jun-2021, contains Non significant information.; Sender's Comments: INC.-MOD-2021-056418:Second Dose.
This spontaneous report as received from a medical assistant and a company representative, refers to a 55 year old female patient with hypertension and hyperlipidemia. No drug reactions/allergies were reported. On 27-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H022153 exp 18-MAR-2014), 0.65 ml, subcutaneous in the left arm. The patient developed a rash at the injection site on 29-MAR-2013. The patient came into the physician's office on 01-APR-2013 and had a rash on her left buttock. Treatment included unspecified antiviral medications. The physician took a sample of the rash and sent it to a local lab to be tested for herpes simplex and herpes zoster. Results currently not available. The outcome of rash at the injection site and rash on her left buttock was reported as not recovered. Additional information is not expected.
There was a marked flare of symptoms in an area of muscular strain (RIGHT forearm),  in an area remote from the vaccination site (LEFT deltoid). The flare began14 hours after injection and subsided 72 hours after vaccination. Symptoms went from "1" (on a scale of 10) to 10, then returned to "2".  The patient's husband, also an MD, also noted an identically timed flare of his own pre-existing inflammatory state with the same time frame.
A week after shot her arm was fairly red.  pt counselled to watch for fever or signs of infection.
Swollen armpit; This is a spontaneous report from a non-contactable consumer. A patient of unknown age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021, the patient experienced swollen armpit. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the event swollen armpit was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
High fevers of over 101.5; severe body ache/malaise; shortness of breath; elevated blood pressure; extreme fatigue; no appetite-- all these symptoms continued over the course of 2 weeks, followed by severe, sporadic internal pain in the left ear--- my physician believed this was post-herpetic trigeminal nerve pain. Lab tests performed at clinic indicated raised white blood count but no evidence of bacterial infection. Treatment discussed for me was a visit to the neurologist, an MRI and putting me on a course of anti-seizure med's, long term, to control the nerve pain. Fortunately, after two days of extreme pain, my symptoms went away.
Went to get out of bed, experienced vertigo for the 1st time in my life. Sat down, waited a minute, and was fine. Since then, I've experienced vertigo every morning and after sitting for a prolonged period.
I have a very irregular period and had not had one for several months prior to the vaccine. Almost a week after my second covid vaccine, I started my period and it lasted 6 days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Aug2021 (Lot number: FA7484) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "I have a very irregular period and had not had one for several months prior to the vaccine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 08Aug2021, outcome "recovered" (Aug2021), described as "I have a very irregular period and had not had one for several months prior to the vaccine. Almost a week after my second covid vaccine, I started my period and it lasted 6 days.". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: No COVID prior vaccination. Not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.