chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 11-year-old male patient who received MENVEO (batch number M15125, expiry date 31st May 2017). Concomitant products included BOOSTRIX. On 8th August 2016, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 9th August 2016, 1 days after receiving MENVEO, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were not recovered/not resolved. The reporter considered the injection site swelling and injection site pain to be almost certainly related to MENVEO. Additional details were provided as follows: This case was not previously reported to anyone. This case was reported by a physician's assistant. On 8th August 2016, the patient received BOOSTRIX (batch number K2D2T, expiry date 8th December 2018) in left arm intramuscularly. The patient experienced swelling (8 cm) administration of MENVEO in right arm.
Covid arm, red rash and red bullet type welt , swollen glands, hand, throat pain on same side of injection site.
Pt did not have an adverse event, but there was a temperature excursion of the J &  J vaccine vial. Vaccine was taken out of fridge at 12:03pm, then 1 dose drawn up at around 12:11pm. I then accidentally left the vial out at room temperature for around 35 minutes. At this point I then put the vial back in the fridge. I asked a couple other pharmacists if okay to use and they said yes, so I drew up more doses around 3:30pm (this is an estimate). I also administered this particular pt's dose shortly after. All doses were administered within the 6 hour timeframe. Per conversation w/ manufacturer the vial was out at room temperature longer than what is suggested (i.e. probably around 5 minutes longer than it should have been out of fridge), so the representative at the mfr is sending this to the safety team to find out if re-vaccination may be necessary.
Redness at injection site; Itching at injection site; had some pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (receieved vaccine a couple years ago).   On 27th February 2020, the patient received the 1st dose of Shingrix. On 28th February 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 85 or 86 years. After receiving Shingrix, the patient experienced redness and itching at the injection site. The patient also experienced pain at the injection site. The reporter was consented to follow up.
Join pain, muscle pain,  triggered my neurological disorder (common when I'm fighting illness), dizziness, head fog, disorientation, slurred words, tiredness, and headaches.
Within a few hours, I had a bad headache, severe congestion, sore arm, tiredness, muscle aches, fatigue- expected, but then it didn't go away. Three days later I had joint pain/swelling and tingling/numbness in my right big toe intermittently. A week following numbness and tingling in the right middle, ring, pinky fingers intermittently. Every few days I would have a low-grade fever for about 3-4 hours. I was taking Ibphrophen for pain and fever during this time. This lasted in total about 2.5 weeks before I saw a doctor. Following the doctor's appointment, the trouble moved from mostly being in the upper sinuses into the chest which has caused me some trouble with breathing. Using an inhaler has not helped. Though the symptoms have faded, muscle soreness, fatigue, and difficulty breathing remain more than one month post the shot. I still plan to get the second shot once the symptoms have ceased.
Half inch diameter redness; non healing sore at the inoculation site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jul2022 as dose 3 (booster), single (Lot number: 30/4s8a) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Gout" (unspecified if ongoing); "Anemia" (unspecified if ongoing). Concomitant medication(s) included: IRON; CALCIUM; LOSARTAN; B-12; SIMVASTATIN; ALLOPUR. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 14Jul2022, outcome "not recovered", described as "Half inch diameter redness"; VACCINATION SITE PAIN (non-serious) with onset 14Jul2022, outcome "not recovered", described as "non healing sore at the inoculation site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pain. Additional information: No other vaccine in four wees. No COVID prior vaccination. The patient had no known allergy. The patient didn't have COVID tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300163630 same reporter/patient/product/AE, different dose;
Red Rash; Top of feet swelling up; Product availability; Rash; Intentional underdose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Red Rash), PERIPHERAL SWELLING (Top of feet swelling up), PRODUCT AVAILABILITY ISSUE (Product availability), INTENTIONAL UNDERDOSE (Intentional underdose) and RASH (Rash) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dyskinesia, Parkinson's disease, Dystonia, Cirrhosis liver on 17-Mar-2021, Hemochromatosis on 17-Mar-2021, Fibromyalgia on 17-Mar-2021, Arthritis on 17-Mar-2021 and Hepatic steatosis. Previously administered products included for an unreported indication: FLU in September 2020, PENICILLINS WITH EXTENDED SPECTRUM and TETANUS DIPHTHERIA. Concurrent medical conditions included Rash erythematous, Peripheral swelling, Drug allergy (sulfa drugs cross reactors), Product availability issue, Rash, Intentional underdose on 17-Mar-2021 and Underdose. Concomitant products included DULOXETINE, AMITRIPTYLINE, TIZANIDINE, DESMOPRESSIN ACETATE, GABAPENTIN, PREGABALIN, LOSARTAN POTASSIUM, AMLODIPINE BESYLATE and OXYCODONE for an unknown indication, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MELOXICAM.   On 03-Feb-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Nov-2020, the patient experienced INTENTIONAL UNDERDOSE (Intentional underdose). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red Rash), PERIPHERAL SWELLING (Top of feet swelling up), PRODUCT AVAILABILITY ISSUE (Product availability) and RASH (Rash). The patient was treated with AMANTADINE HYDROCHLORIDE (GOCOVRI) (oral) at a dose of 274 mg at bedtime. At the time of the report, RASH ERYTHEMATOUS (Red Rash), PERIPHERAL SWELLING (Top of feet swelling up) and RASH (Rash) outcome was unknown and PRODUCT AVAILABILITY ISSUE (Product availability) and INTENTIONAL UNDERDOSE (Intentional underdose) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-065722 (Patient Link).
Patient developed swelling, itching and warmth of arm around vaccine site. She took Benadryl.
called received from the patients daughter that her father was admitted to the hospital with a PE 5 days after getting COVID booster. Daughter requested report be submitted as a side affect of the vaccine.
Erythema at site of injection spreading circumferential around left arm Treatment-prednisone, Benadryl, Zyrtec.
Case number PHEH2015US023947, is an initial spontaneous report from a health case professional (pharmacy student) received on 13 Nov 2015. This report refers to a patient of unknown identifies. Past medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: not reported) intramuscularly in the shoulder joint on an unknown date. After vaccination the patient experienced pain in the shoulder joint area. The outcome, seriousness and causality of the event were not reported.
Headache on the next day throwing up the day after that diarrhea aches pains chills fever severe nausea severe diarrhea.
Marked edema, erythema, and induration of left deltoid area (site of DTaP and IPV vaccines)
Cough  Fatigue  Headache  Sore throat  Congestion or running nose  10/23/2021 URGENT CARE Chief Complaint Patient presents with  ? Covid positive       trouble breathing   HPI   a 34 y.o. female Presents with cough, shortness of breath, chest tightness x1 week.  Patient was diagnosed with Covid 6 days ago.  Symptoms gradually worsening.  States unable to take over-the-counter cough/cold medications.  Has been taking ibuprofen with some relief.  Patient denies fever/chills, ST, nausea/vomiting, diarrhea, abdominal pain, rash, neck stiffness, chest pain,  dizziness.  Denies history of pulmonary disease.
Three (3) large, itching red lumps. One under chin. Could feel the bulge under tongue. One on right forearm. Has a small scab from scratching. One on upper left arm very close to arm pit. Two days later still itching but lumps going slowly down.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated with first dose on 04/09/21.
The vaccine has aggravated a tinnitus condition that I have had for around 20 years.  The perceived "volume" of the ringing in my ears became much louder.  This began the day after the vaccine (1st shot), and I have delayed the 2nd shot, and I am considering foregoing the 2nd shot.  The volume has increased considerably, and stays fairly constant from day-to-day.  To date, I have not seen either my Physician or an ENT - both of which I will be doing soon.  Disappointing annoying.  I think this was a known issue and was not communicated.
Severe arm tremor from elbow down to hand; significant nerve pain and muscle weakness.  This tremor was severe Monday, Tuesday.  Still experiencing muscle weakness and nerve pain 6 days post shot only in right arm that vaccine was injected into.
See email form patient: Hi. I had the 1st part shingles Zoster vaccine last Thursday morning, December1 19th. By late afternoon I was feverish, had chills, aches and pains, headache, felt off balance , which lasted for a few days. By Sunday I just felt tired, a little off balance at times, and slightly achey. I read the handout on the vaccine I was given and it said this may happen in a small percentage of people. Online I read that the CDC recommends the Shringrix over the Zoster because it's more effective. I'm wondering about this. I felt I should report to you my reaction from this vaccine. Hopefully today will be a healthier feeling day. I very rarely catch any viruses or feel badly. Happy holiday to you.
Both office visits attached. Ataxia, ?Fever, Irritability, Decreased appetite 10/27/08 and 10/29/08
Woke up to what felt like a runny  nose and i noticed a trickling that wouldn?t  stop.  After running to the bathroom my face had clotted blood and my kept bleeding.  Bleeding stopped after 15/20 minutes
Almost immediately after receiving the shot, my throat started to close up. I became dizzy. A nurse took my vitals and my blood pressure was higher than it has ever been in my life - 130/87. My normal blood pressure (even in times of stress) is right around 110/70 or lower. In addition, my pulse was 100. Again, this was way out of the ordinary for my body. About two hours after I received the shot, my experienced a warming sensation all over my body. This happened three separate times.
The next day I was experiencing severe itching all over my body and then the day after that I experienced rashes on my arms and swelling
pt recv vax & c/o dizziness p/vax;stiffened briefly;eyes rolled back;arms jerked 2-3 times;felt limp but was able to walk w/suppport to exam room;pt does not remember what happened;pt gets nervous during shots & blood test;poss over-reactio
Chills; Nausea; Fatigue; Rash/generalized exanthem; HA; Experienced sore Right arm (at site of immunization); This is a spontaneous report received from contactable reporter(s) (Physician).  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 15:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 04, Lot number: FP4554, Manufacturer: Pfizer), administration date: 05Apr2022, when the patient was 69-year-old, for COVID-19 immunization; Bnt162b2 (Dose: 03, Manufacturer: Pfizer), for COVID-19 immunization; Bnt162b2 (Dose: 02, Manufacturer: Pfizer), for COVID-19 immunization; Bnt162b2 (Dose: 01, Manufacturer: Pfizer), for COVID-19 immunization.The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Sep2022, outcome "recovering", described as "Experienced sore Right arm (at site of immunization)"; CHILLS (non-serious) with onset 18Sep2022, outcome "recovering"; FATIGUE (non-serious) with onset 18Sep2022, outcome "recovering"; HEADACHE (non-serious) with onset 18Sep2022, outcome "recovering", described as "HA"; NAUSEA (non-serious) with onset 18Sep2022, outcome "recovering"; RASH (non-serious) with onset 18Sep2022, outcome "recovering". Therapeutic measures were taken as a result of vaccination site pain, chills, nausea, fatigue, rash, headache. Additional information: After the dose of bivalent vaccine administered, patient experienced sore right arm (at site of immunization) with no real limitation of activity within a few hours after administration, followed by generalized exanthem, chills, Headache (HA), nausea, fatigue which did limit activities beginning morning of Sunday, 18Sep. These symptoms were treated with ibuprofen with relief. The main reason for this report is that on 19Sep2022, patient experienced a generalized, blanching red exanthem, particularly prominent on her chest, mid back, thighs (particularly right inner thigh) and extremities. This rash appeared to completely spare her face. There was no redness, rash, or swelling at site of vaccine administration. The rash was non-pruritic and non-tender. Withheld had no respiratory or gastrointestinal symptoms at time of this appearance and was otherwise feeling well. By the morning and time of this report on Tuesday, 20Sep2022, the rash was beginning to fade, but still present.  Follow-up attempts are completed. No further information is expected.
Pt. presented in office on 10/28/09 with painful blistered area to L cheek and left nare. Thick yellow crust. Pt. given rx for BACTROBAN 2% ointment. Spoke with mom on 11/3/09 and she reports it is improving.
Got the breakthrough case and they both quarantine; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Got the breakthrough case and they both quarantine) and HEADACHE (Headache) 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 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced INFECTION (Got the breakthrough case and they both quarantine) and HEADACHE (Headache). On 14-Oct-2021, HEADACHE (Headache) had resolved. On 28-Oct-2021, INFECTION (Got the breakthrough case and they both quarantine) had resolved.            No concomitant medications were provided. No treatment medications were reported.  This is a Spontaneous case concerning a male patient  of unknown age and unknwon medical history,  who experienced the unexpected non serious (AESI) event of Breakthrough infection. The event occurred approximately 5 months and 22 days after the second dose of mRNA 1273 vaccine. Patient was reported to had a breakthrough infection and refered that he had to quarantine but was unwilling to give more details regarding the definite diagnosis or diagnostic lab data regarding this infection that could confirm the case was refering to a COVID 19 breakthrough infection.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a male patient  of unknown age and unknwon medical history,  who experienced the unexpected non serious (AESI) event of Breakthrough infection. The event occurred approximately 5 months and 22 days after the second dose of mRNA 1273 vaccine. Patient was reported to had a breakthrough infection and refered that he had to quarantine but was unwilling to give more details regarding the definite diagnosis or diagnostic lab data regarding this infection that could confirm the case was refering to a COVID 19 breakthrough infection.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
tingling hands, feet began in JUL96, went to MD 20AUG96;numbness-hands, legs, arms AUG96;weakness in arms  & loss of balance AUG96;pain in the extremities arms, legs;dx w/MS 17SEP96; Per follow-up, the pt suffers from multiple sclerosis, CNS lesions, persistent paresthesia, and radiculopathy.
I started to feel rundown/fatigued in the evening on the day I got the vaccine and my arm was very sore.  I woke up very early the next morning with a fever of 101-102, body aches, severe headache, nausea, chills, severe fatigue, dizziness, difficulty concentrating, I would get tunnel vision, my eyes ached and felt very strained, sinus congestion and pressure.  My fever spiked at 103.6 that evening and then stayed below 100 after that.  For the following 7 days I still had the severe fatigue, nausea, headaches, chills, dizziness, difficult concentrating, tunnel vision that was especially  bad when I had to drive, eye aches, sinus congestion and pressure, and my head felt very strange.  The best way to describe it is that I felt like someone had drugged me.  The only time I would leave my house was to take my daughter to school and when I would drive my head would feel super tight, my eye ache would intensify and they would feel super strained, I would get the tunnel vision and I would have trouble making it to the school and back home.  Then I would go back to sleep for several hours, get up and drink some fluids and go back to bed.  On day 7 or 8 I was able to stay up for periods of time and either watch movies or just lay in bed.  I went back to work on 1/20 and am doing desk work.  I am doing a lot better but still have daily headaches, moderate fatigue that is worse in the morning, mild intermittent nausea, my head still feels weird like I've been taking some kind of pain med or mild sedative, and I'm easily exhausted.  I have trouble going grocery shopping because I get exhausted.  I had a rapid COVID test done on 1/06/20 due to a headache and temp of 99.6-100.2, it was negative and we thought the temp was due to the Trokendi as that is a side effect of it.  I also had a PCR done on 1/12 that came back negative.
No adverse event; administration of improperly stored vaccine; This spontaneous report was received from a healthcare business professional referring to a 18-month unknown gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On 13-SEP-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 1 dosage form, lot #T026960, expiration date: 17-MAR-2023, administered for prophylaxis (strength and route of administration were not provided) after temperature excursion 32.5 Fahrenheit (F) for 6 hours 12 minutes (product storage error). It was not reported if there was previous temperature excursion. No additional adverse events were reported (no adverse event).
Hives on the torso and then neck; This is a spontaneous case was received on 19-Oct-2020 from pharmacist via Health Authority (reference number: SEQW20-03881) and concerned an elderly female patient of an unspecified age.  The patient's concurrent conditions were not reported. The patient's historical vaccine included Afluria QIV vaccine (influenza vaccine). The patient's concomitant medications included several unspecified medications for an unreported indication.  On 08-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid, and route of administration: intramuscular) as influenza prophylaxis. The batch number reported was 276539.  On the same day, immediately after receiving Flucelvax QIV, the patient developed hives on the torso and then neck.  On an unspecified date in Oct-2020, the patient recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The event 'urticaria localized' is considered as related to Flucelvax QIV vaccine.; Sender's Comments: The event 'urticaria localized' is considered as related to Flucelvax QIV vaccine.
This spontaneous report was received from a nurse regarding to a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 29-JUN-2016, the patient was vaccinated with GARDASIL dose 3, lot # m014929/ expiration date-27-MAY-2017, 23 weeks after 2nd dose that is on 20-JAN-2016. No concomitant medication was reported. No adverse event was reported. The outcome of event was unknown. Additional information has been requested.